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CN117919365A - Traditional Chinese medicine composition for preventing and treating alcoholic liver injury as well as preparation method and application thereof - Google Patents

Traditional Chinese medicine composition for preventing and treating alcoholic liver injury as well as preparation method and application thereof Download PDF

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Publication number
CN117919365A
CN117919365A CN202311710863.3A CN202311710863A CN117919365A CN 117919365 A CN117919365 A CN 117919365A CN 202311710863 A CN202311710863 A CN 202311710863A CN 117919365 A CN117919365 A CN 117919365A
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China
Prior art keywords
parts
liver
traditional chinese
alcoholic liver
liver injury
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Pending
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CN202311710863.3A
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Chinese (zh)
Inventor
周晓玲
张蓓
陆世银
李秋萍
张志杰
陈峭
李�灿
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Liuzhou Traditional Chinese Medicine Hospital Liuzhou Zhuang Medical Hospital
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Liuzhou Traditional Chinese Medicine Hospital Liuzhou Zhuang Medical Hospital
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Priority to CN202311710863.3A priority Critical patent/CN117919365A/en
Publication of CN117919365A publication Critical patent/CN117919365A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/23Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/233Bupleurum
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56Materials from animals other than mammals
    • A61K35/618Molluscs, e.g. fresh-water molluscs, oysters, clams, squids, octopus, cuttlefish, snails or slugs
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    • A61K36/06Fungi, e.g. yeasts
    • A61K36/07Basidiomycota, e.g. Cryptococcus
    • A61K36/076Poria
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    • A61K36/236Ligusticum (licorice-root)
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    • A61K36/906Zingiberaceae (Ginger family)
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    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
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Abstract

The application relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for preventing and treating alcoholic liver injury, and a preparation method and application thereof. Sixteen medicinal materials are taken as the whole prescription. The Chinese thorowax and cassia twig are used as monarch, the Chinese thorowax is used for soothing liver and gall Qi machine, the cassia twig Wen Tonggan is used for removing cold and harmonizing stomach, the dried ministerial drug Jiang Wenzhong is used for dispelling cold and harmonizing stomach, the szechuan lovage rhizome and the Chinese angelica are used for promoting qi circulation and tonifying blood, the dangshen, the poria cocos, the white atractylodes rhizome stir-fried with bran and the oriental waterplantain rhizome are used for strengthening spleen and promoting qi circulation and transforming middle-jiao Qi machine, the baical skullcap root is used for soothing liver and gall, the shaoyang is used for harmonizing liver and tonifying yang, the oyster is used for calming liver and suppressing yang, the Chinese thorowax is used for inducing the liver, the kudzuvine flower is used for activating spleen and dispelling alcohol, the abrus herb and the virgate wormwood herb are used for clearing and dispelling dampness and heat of liver, the schisandra chinensis is used for astringing yin and promoting the production of body fluid, the roasted liquorice is prepared by mixing medicines with the Chinese thorowax and cassia twig dried ginger Shang Hua.

Description

Traditional Chinese medicine composition for preventing and treating alcoholic liver injury as well as preparation method and application thereof
Technical Field
The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for preventing and treating alcoholic liver injury, and a preparation method and application thereof.
Background
Alcoholic Liver Disease (ALD) is one of the most common types of liver disease worldwide, due to long-term or short-term consumption of alcohol, and has the pathological features of long duration and repeated persistence. ALD initially develops Alcoholic Fatty Liver (AFLD) and develops alcoholic hepatitis, liver fibrosis and cirrhosis, and severe cases can induce liver cancer or lead to liver failure, which is one of the leading causes of death. 90% of ethanol taken by human body is metabolized in liver, and poor ethanol metabolism is a main cause of alcoholic liver disease. At present, a plurality of health care products for dispelling the effects of alcohol and protecting the liver are on the market, but no medicament with definite curative effect is provided clinically.
The traditional Chinese medicine has relevant records such as 'wine hurting', 'wine stuffiness', and the like, and the traditional Chinese medicine considers that excessive drinking can lead damp evil to block liver and spleen, liver to lose and dredge, spleen failing to transport and lead to distending pain in chest and hypochondrium, anorexia, abdominal distention, hiccup, belch, borborygmus and gas in the vector, loose stool, takes soothing liver and harmonizing stomach, strengthening spleen and removing dampness as treatment rules, and simultaneously treats the response, causes and is suitable for people, and combines regional environmental climate characteristics and traditional Chinese medicine physique of people, thereby pertinently increasing the medicine taste dosage of main pathogenesis, and embodying the characteristic of dialectical treatment of traditional Chinese medicine.
The traditional Chinese medicine preparation for preventing and treating the alcoholic liver disease disclosed at present is not applied to the clinical animal and cell experimental results only in vivo and in vitro, has possibility of playing the drug effect in the animal experiment, but is ineffective for clinical use; the drug effect detection index of alcoholic liver injury of part of the traditional Chinese medicine preparation does not detect key cytokines, and the drug effect is possibly not obvious.
For example, a traditional Chinese medicine composition CN 116549576A for preventing and treating alcoholic liver injury has only pharmacodynamic experimental results of cells and mice in vitro and in vivo, is not supported by empirical data, and cannot support clinical curative effects.
For example, an anti-acute liver alcoholic liver injury traditional Chinese medicine composition, a preparation method and medical application CN 116585427A thereof disclose in vivo pharmacodynamic experiments, but lack of cytokine detection of CYP2E1, and cytochrome P4502E1 (cytochrome P4502E1, CYP2E 1) is a compound mainly located in liver cells and a metabolic enzyme of poison, is an important member of CYP450 metabolic enzyme family, plays an important role in metabolism and activation of toxic substrates such as alcohol, carbon tetrachloride and the like, cannot be explained by the patent application, and the effect of the cytokine cannot be possibly not obvious.
Therefore, the traditional Chinese medicine preparation which is extremely suitable for the physique of the patient with the alcoholic liver injury in the local area and can be accepted by clinic is found, is a regional civil health requirement, and has extremely remarkable practical significance.
Disclosure of Invention
In order to solve the technical problems in the prior art, the invention provides a traditional Chinese medicine composition for preventing and treating alcoholic liver injury, and a preparation method and application thereof. The method is realized by the following technical scheme:
a traditional Chinese medicine composition for preventing and treating alcoholic liver injury is characterized by comprising the following raw material components: radix bupleuri, radix Scutellariae, ramulus Cinnamomi, rhizoma Zingiberis, flos Puerariae Lobatae, concha Ostreae, rhizoma Chuanxiong, radix Angelicae sinensis, poria, rhizoma Atractylodis Macrocephalae preparata, rhizoma Alismatis, radix Codonopsis, fructus Schisandrae chinensis, herba abri, herba Artemisiae Scopariae, and radix Glycyrrhizae Preparata.
Further, the weight ratio of the raw materials is as follows: 1-5 parts of radix bupleuri, 1-5 parts of radix scutellariae, 1-5 parts of cassia twig, 1-3 parts of dried ginger, 1-5 parts of flos puerariae lobatae, 1-4 parts of oyster, 1-4 parts of ligusticum wallichii, 1-4 parts of angelica sinensis, 3-7 parts of poria cocos, 2-6 parts of bran-fried bighead atractylodes rhizome, 1-5 parts of rhizoma alismatis, 2-6 parts of radix codonopsis, 1-5 parts of schisandra chinensis, 2-6 parts of herba abri, 2-6 parts of herba artemisiae capillaris and 1-3 parts of honey-fried licorice root. Preferably, the weight ratio of the raw materials is as follows: 3 parts of bupleurum chinense, 3 parts of baical skullcap root, 3 parts of cassia twig, 1.6 parts of dried ginger, 3 parts of kudzuvine flower, 1.8 parts of oyster, 2 parts of szechuan lovage rhizome, 1.6 parts of Chinese angelica, 4.8 parts of Indian buead, 3.6 parts of white atractylodes rhizome fried with bran, 3 parts of oriental waterplantain rhizome, 4 parts of pilose asiabell root, 3 parts of Chinese magnoliavine fruit, 4 parts of abrus herb, 4 parts of virgate wormwood herb and 1.2 parts of prepared liquorice.
Further, auxiliary materials can be optionally added.
The preparation method of the traditional Chinese medicine composition for preventing and treating alcoholic liver injury comprises the following steps:
(1) Weighing the raw materials of bupleurum, scutellaria baicalensis, cassia twig, dried ginger, flos puerariae lobatae, oyster, ligusticum wallichii, angelica sinensis, poria cocos, bran-fried bighead atractylodes rhizome, rhizoma alismatis, codonopsis pilosula, schisandra chinensis, abrus herb, herba artemisiae capillaris, honey-fried licorice root and the like according to the proportion;
(2) Mixing the weighed Chinese medicinal materials, adding 8-12 times of water, decocting for 1-3 times, each for 1.5-2.5 hr, mixing decoctions, concentrating, standing, centrifuging, and collecting supernatant.
Further, pharmaceutically acceptable carriers and/or excipients can be added into the supernatant to prepare any clinically acceptable dosage form, and the finally obtained dosage form comprises tablets, pills, capsules, granules and medicinal granules. Further, specifically, a proper amount of steviosin, benzoic acid and ethyl hydroxybenzoate are added into the supernatant to prepare the mixture.
The application of the traditional Chinese medicine composition for preventing and treating alcoholic liver injury in the aspect of serving as/preparing acute alcoholic liver injury medicines.
The traditional Chinese medicine composition for preventing and treating alcoholic liver injury is applied to the preparation of medicines for treating chest and hypochondrium distending pain, anorexia, abdominal distention, hiccup, eructation, borborygmus, flatulence, loose stool and other diseases caused by incoordination between liver and stomach and spleen deficiency and dampness.
The traditional Chinese medicine composition disclosed by the application is consistent with the treatment rules of most of ' hurting wine ' and ' fullness in the wine ' by combining the physical characteristics of traditional Chinese medicine of patients in the local area, but has the regional characteristics, and secondly, the traditional Chinese medicine composition uses the road-area medicinal materials ' Gui Shiwei ' -Jigucao ' in the local area, and has a positive pushing effect on the development of national medical and health caregivers in the local area. Finally, the most important point of the composition is that the composition is higher than other similar compositions in clinic, the traditional Chinese medicine composition is clinically used for more than ten years, the composition is fully approved by clinic and patients, further the composition is processed and refined according to the characteristics of the combined medicine flavor, and finally the composition is prepared into a proper dosage form, so that the medicine effect is fully exerted.
Compared with the prior art, the invention has the technical effects that:
The pharmaceutical composition is a pure traditional Chinese medicine preparation, and has the effects of soothing liver, harmonizing stomach, dispelling the effects of alcohol and activating spleen. Can be used for treating chest and hypochondrium distending pain, anorexia, abdominal distention, singultus, belch, borygmus, flatulence, loose stool, etc. due to incoordination between liver and stomach and spleen deficiency and dampness. Sixteen medicinal materials are taken as the whole formula. The Chinese thorowax and cassia twig are used as monarch, the Chinese thorowax is used for soothing liver and gall Qi machine, the cassia twig Wen Tonggan is used for removing cold and harmonizing stomach, the dried ministerial drug Jiang Wenzhong is used for dispelling cold and harmonizing stomach, the szechuan lovage rhizome and the Chinese angelica are used for promoting qi circulation and tonifying blood, the dangshen, the poria cocos, the white atractylodes rhizome stir-fried with bran and the oriental waterplantain rhizome are used for strengthening spleen and promoting qi circulation and transforming middle-jiao Qi machine, the baical skullcap root is used for soothing liver and gall, the shaoyang is used for calming liver and suppressing yang, the oyster is used for inducing the liver, the kudzuvine flower is used for activating spleen and dispelling alcohol, the abrus herb and the virgate wormwood herb are used for clearing and dispelling dampness and heat of the liver, the Chinese magnoliavine fruit is used for astringing yin and promoting the production of body fluid, the roasted liquorice is used for harmonizing medicines, and the prescription is cut by the dried ginger Shang Hua of the Chinese thorowax twig, and the functions of soothing liver and harmonizing stomach, invigorating spleen and promoting diuresis and tonifying qi and nourishing blood are combined. Modern pharmacological researches show that bupleurum contains mainly saponin components, and the highest content is saikosaponin a and saikosaponin d. Wherein the saikosaponin d has different degrees of prevention and treatment effects on alcoholic liver disease, nonalcoholic steatohepatitis, liver cirrhosis, liver fibrosis and the like. The main ingredient of cassia twig is cinnamaldehyde, and the compatibility of the cassia twig and bupleurum is favorable for the dissolution of the purple Hu Zaogan, and the drug effect is enhanced. The dried ginger is rich in gingerol compounds, and researches show that gingerol and 6-shogaol can effectively improve liver lipid deposition. Both Ligusticum wallichii and Chinese angelica contain ferulic acid, and have good effects of resisting oxidization and inhibiting liver injury. The dangshen contains dangshen acetylenic glycoside, and has the pharmacological effects of treating gastric ulcer, promoting intestinal canal promotion, improving the digestion capacity of organisms and the like. The baicalin-containing radix Scutellariae has antioxidant and liver protecting effects. The components in the prescription act together, the modern pharmacological research action accords with the function and main treatment of soothing liver and harmonizing stomach oral liquid, all the medicinal herbs complement each other, the medicine of the prescription is combined with the pathogenesis of alcoholic fatty liver disease without going through, the physical characteristics of the traditional Chinese medicine in the local area are combined, the effect of relieving damp-heat toxin of viscera to dredge liver qi is emphasized, and the efficacy of soothing liver and activating spleen to relieve alcohol is achieved. The pharmaceutical composition is a compound preparation, has the effects of soothing liver and harmonizing stomach, dispelling the effects of alcohol and activating spleen in clinic for many years, can be used for treating chest and hypochondrium distending pain, anorexia, abdominal distention or hiccup, belch, borborygmus, loose stool and other diseases caused by incoordination between liver and stomach and spleen deficiency and dampness, and has obvious curative effect, small side effect and wide application.
Drawings
FIG. 1 is a flow chart of a preparation method.
FIG. 2 is a graph showing changes in liver histopathological morphology of rats (HE staining, 100×, 200×).
FIG. 3 is a graph showing the effect of liver soothing and gastric oral fluid on liver function index in rats with alcoholic liver injury model (A, B); results of the effect of liver soothing and gastric oral fluid on the oxidative balance in rats model of alcoholic liver injury (C, D).
FIG. 4 is a graph showing the effect of liver-soothing and stomach-harmonizing oral liquid on fat metabolism in rats with alcoholic liver injury model (A, B); the effect of liver soothing and stomach harmonizing oral liquid on serum inflammatory factors of rats with alcoholic liver injury model (C, D) is shown.
FIG. 5 is a graph showing the effect of liver soothing and stomach harmonizing oral liquid on serum and liver alcohol metabolism related enzymes of an alcoholic liver injury model rat.
Detailed Description
The technical scheme of the present invention is further defined below in conjunction with the specific embodiments, but the scope of the claimed invention is not limited to the description.
Example 1
(1) Weighing raw material Chinese medicinal materials such as 3g of bupleurum chinense, 3g of scutellaria baicalensis, 3g of cassia twig, 1.6g of dried ginger, 3g of flos puerariae lobatae, 1.8g of oyster, 2g of ligusticum wallichii, 1.6g of angelica sinensis, 4.8g of poria cocos, 3.6g of bighead atractylodes rhizome stir-fried with bran, 3g of rhizoma alismatis, 4g of codonopsis pilosula, 3g of schisandra chinensis, 4g of abrus cantoniensis hance, 4g of virgate wormwood herb, 1.2g of honey-fried licorice root and the like;
(2) Mixing the weighed Chinese medicinal materials, adding water 8 times of the weight of the Chinese medicinal decoction pieces, decocting for three times each for 1.5 hours, mixing decoctions, concentrating, standing, centrifuging, and collecting supernatant;
(3) Adding 20mg steviosin, 100mg benzoic acid and 20mg ethylparaben into the supernatant in step (2), sterilizing at 105deg.C for 40 min, and making into mixture.
Example 2
(1) Weighing 1g of bupleurum chinense, 5g of scutellaria baicalensis, 1g of cassia twig, 3g of dried ginger, 5g of flos puerariae lobatae, 4g of oyster, 4g of ligusticum wallichii, 4g of angelica sinensis, 7g of poria cocos, 6g of bighead atractylodes rhizome fried with bran, 5g of rhizoma alismatis, 6g of codonopsis pilosula, 5g of schisandra chinensis, 6g of abrus herb, 6g of virgate wormwood herb, 3g of honey-fried licorice root and other raw material Chinese medicinal herbs;
(2) Mixing the weighed Chinese medicinal materials, adding 8 times of water, decocting for three times each for 1.5 hours, mixing decoctions, concentrating, standing, centrifuging, and collecting supernatant;
(3) Adding 20mg steviosin, 100mg benzoic acid and 20mg ethylparaben into the supernatant in step (2), sterilizing at 105deg.C for 40 min, and making into mixture.
Example 3
(1) Weighing 5g of bupleurum chinense, 1g of scutellaria baicalensis, 5g of cassia twig, 1g of dried ginger, 1g of flos puerariae lobatae, 1g of oyster, 1g of ligusticum wallichii, 1g of angelica sinensis, 3g of poria cocos, 2g of bighead atractylodes rhizome fried with bran, 1g of rhizoma alismatis, 2g of codonopsis pilosula, 1g of schisandra chinensis, 2g of abrus herb, 2g of virgate wormwood herb, 1g of honey-fried licorice root and other raw material Chinese medicinal herbs;
(2) Mixing the weighed Chinese medicinal materials, adding 8 times of water, decocting for three times each for 1.5 hours, mixing decoctions, concentrating, standing, centrifuging, and collecting supernatant;
(3) Adding 20mg steviosin, 100mg benzoic acid and 20mg ethylparaben into the supernatant in step (2), sterilizing at 105deg.C for 40 min, and making into mixture.
Example 4
(1) Weighing raw material Chinese medicinal materials such as 3g of bupleurum chinense, 3g of scutellaria baicalensis, 3g of cassia twig, 1.6g of dried ginger, 3g of flos puerariae lobatae, 1.8g of oyster, 2g of ligusticum wallichii, 1.6g of angelica sinensis, 4.8g of poria cocos, 3.6g of bighead atractylodes rhizome stir-fried with bran, 3g of rhizoma alismatis, 4g of codonopsis pilosula, 3g of schisandra chinensis, 4g of abrus cantoniensis hance, 4g of virgate wormwood herb, 1.2g of honey-fried licorice root and the like;
(2) Mixing the weighed Chinese medicinal materials, adding 8 times of water, decocting for three times each for 1.5 hours, mixing decoctions, concentrating, standing, centrifuging, and collecting supernatant.
Example 5
(1) Weighing raw material Chinese medicinal materials such as 3g of bupleurum chinense, 3g of scutellaria baicalensis, 3g of cassia twig, 1.6g of dried ginger, 3g of flos puerariae lobatae, 1.8g of oyster, 2g of ligusticum wallichii, 1.6g of angelica sinensis, 4.8g of poria cocos, 3.6g of bighead atractylodes rhizome stir-fried with bran, 3g of rhizoma alismatis, 4g of codonopsis pilosula, 3g of schisandra chinensis, 4g of abrus cantoniensis hance, 4g of virgate wormwood herb, 1.2g of honey-fried licorice root and the like;
(2) Mixing the weighed Chinese medicinal materials, adding water 8 times of the weight of the Chinese medicinal decoction pieces, decocting for 1.5 hours each time, mixing decoctions, concentrating, standing, centrifuging, and collecting supernatant;
(3) Adding 20mg steviosin, 100mg benzoic acid and 20mg ethylparaben into the supernatant in step (2), sterilizing at 105deg.C for 40 min, and making into mixture.
Example 6
(1) Weighing raw material Chinese medicinal materials such as 3g of bupleurum chinense, 3g of scutellaria baicalensis, 3g of cassia twig, 1.6g of dried ginger, 3g of flos puerariae lobatae, 1.8g of oyster, 2g of ligusticum wallichii, 1.6g of angelica sinensis, 4.8g of poria cocos, 3.6g of bighead atractylodes rhizome stir-fried with bran, 3g of rhizoma alismatis, 4g of codonopsis pilosula, 3g of schisandra chinensis, 4g of abrus cantoniensis hance, 4g of virgate wormwood herb, 1.2g of honey-fried licorice root and the like;
(2) Mixing the weighed Chinese medicinal materials, adding water 10 times of the weight of the Chinese medicinal decoction pieces, decocting for 1.5 hr twice, mixing decoctions, concentrating, standing, centrifuging, and collecting supernatant;
(3) Adding 20mg steviosin, 100mg benzoic acid and 20mg ethylparaben into the supernatant in step (2), sterilizing at 105deg.C for 40 min, and making into mixture.
Example 7
(1) Weighing raw material Chinese medicinal materials such as 3g of bupleurum chinense, 3g of scutellaria baicalensis, 3g of cassia twig, 1.6g of dried ginger, 3g of flos puerariae lobatae, 1.8g of oyster, 2g of ligusticum wallichii, 1.6g of angelica sinensis, 4.8g of poria cocos, 3.6g of bighead atractylodes rhizome stir-fried with bran, 3g of rhizoma alismatis, 4g of codonopsis pilosula, 3g of schisandra chinensis, 4g of abrus cantoniensis hance, 4g of virgate wormwood herb, 1.2g of honey-fried licorice root and the like;
(2) Mixing the weighed Chinese medicinal materials, adding 12 times of water, decocting for three times each for 1.5 hr, mixing decoctions, concentrating, standing, centrifuging, and collecting supernatant;
(3) Adding 20mg steviosin, 100mg benzoic acid and 20mg ethylparaben into the supernatant in step (2), sterilizing at 105deg.C for 40 min, and making into mixture.
Example 8
(1) Weighing raw material Chinese medicinal materials such as 3g of bupleurum chinense, 3g of scutellaria baicalensis, 3g of cassia twig, 1.6g of dried ginger, 3g of flos puerariae lobatae, 1.8g of oyster, 2g of ligusticum wallichii, 1.6g of angelica sinensis, 4.8g of poria cocos, 3.6g of bighead atractylodes rhizome stir-fried with bran, 3g of rhizoma alismatis, 4g of codonopsis pilosula, 3g of schisandra chinensis, 4g of abrus cantoniensis hance, 4g of virgate wormwood herb, 1.2g of honey-fried licorice root and the like;
(2) Mixing the weighed Chinese medicinal materials, adding water 8 times of the weight of the Chinese medicinal decoction pieces, decocting for 2 hours each time, mixing decoctions, concentrating, standing, centrifuging, and collecting supernatant;
(3) Adding 20mg steviosin, 100mg benzoic acid and 20mg ethylparaben into the supernatant in step (2), sterilizing at 105deg.C for 40 min, and making into mixture.
Example 9
(1) Weighing raw material Chinese medicinal materials such as 3g of bupleurum chinense, 3g of scutellaria baicalensis, 3g of cassia twig, 1.6g of dried ginger, 3g of flos puerariae lobatae, 1.8g of oyster, 2g of ligusticum wallichii, 1.6g of angelica sinensis, 4.8g of poria cocos, 3.6g of bighead atractylodes rhizome stir-fried with bran, 3g of rhizoma alismatis, 4g of codonopsis pilosula, 3g of schisandra chinensis, 4g of abrus cantoniensis hance, 4g of virgate wormwood herb, 1.2g of honey-fried licorice root and the like;
(2) Mixing the weighed Chinese medicinal materials, adding water 10 times of the weight of the Chinese medicinal decoction pieces, decocting for three times each for 2 hours, mixing decoctions, concentrating, standing, centrifuging, and collecting supernatant;
(3) Adding 20mg steviosin, 100mg benzoic acid and 20mg ethylparaben into the supernatant in step (2), sterilizing at 105deg.C for 40 min, and making into mixture.
Example 10
(1) Weighing raw material Chinese medicinal materials such as 3g of bupleurum chinense, 3g of scutellaria baicalensis, 3g of cassia twig, 1.6g of dried ginger, 3g of flos puerariae lobatae, 1.8g of oyster, 2g of ligusticum wallichii, 1.6g of angelica sinensis, 4.8g of poria cocos, 3.6g of bighead atractylodes rhizome stir-fried with bran, 3g of rhizoma alismatis, 4g of codonopsis pilosula, 3g of schisandra chinensis, 4g of abrus cantoniensis hance, 4g of virgate wormwood herb, 1.2g of honey-fried licorice root and the like;
(2) Mixing the weighed Chinese medicinal materials, adding 12 times of water, decocting for 2 hr each time, mixing decoctions, concentrating, standing, centrifuging, and collecting supernatant;
(3) Adding 20mg steviosin, 100mg benzoic acid and 20mg ethylparaben into the supernatant in step (2), sterilizing at 105deg.C for 40 min, and making into mixture.
Example 11
(1) Weighing raw material Chinese medicinal materials such as 3g of bupleurum chinense, 3g of scutellaria baicalensis, 3g of cassia twig, 1.6g of dried ginger, 3g of flos puerariae lobatae, 1.8g of oyster, 2g of ligusticum wallichii, 1.6g of angelica sinensis, 4.8g of poria cocos, 3.6g of bighead atractylodes rhizome stir-fried with bran, 3g of rhizoma alismatis, 4g of codonopsis pilosula, 3g of schisandra chinensis, 4g of abrus cantoniensis hance, 4g of virgate wormwood herb, 1.2g of honey-fried licorice root and the like;
(2) Mixing the weighed Chinese medicinal materials, adding water 8 times of the weight of the Chinese medicinal decoction pieces, decocting for three times each for 2.5 hours, mixing decoctions, concentrating, standing, centrifuging, and collecting supernatant;
(3) Adding 20mg steviosin, 100mg benzoic acid and 20mg ethylparaben into the supernatant in step (2), sterilizing at 105deg.C for 40 min, and making into mixture.
Example 12
(1) Weighing raw material Chinese medicinal materials such as 3g of bupleurum chinense, 3g of scutellaria baicalensis, 3g of cassia twig, 1.6g of dried ginger, 3g of flos puerariae lobatae, 1.8g of oyster, 2g of ligusticum wallichii, 1.6g of angelica sinensis, 4.8g of poria cocos, 3.6g of bighead atractylodes rhizome stir-fried with bran, 3g of rhizoma alismatis, 4g of codonopsis pilosula, 3g of schisandra chinensis, 4g of abrus cantoniensis hance, 4g of virgate wormwood herb, 1.2g of honey-fried licorice root and the like;
(2) Mixing the weighed Chinese medicinal materials, adding water 10 times of the weight of the Chinese medicinal decoction pieces, decocting for 2.5 hours each time, mixing decoctions, concentrating, standing, centrifuging, and collecting supernatant;
(3) Adding 20mg steviosin, 100mg benzoic acid and 20mg ethylparaben into the supernatant in step (2), sterilizing at 105deg.C for 40 min, and making into mixture.
Example 13
(1) Weighing raw material Chinese medicinal materials such as 3g of bupleurum chinense, 3g of scutellaria baicalensis, 3g of cassia twig, 1.6g of dried ginger, 3g of flos puerariae lobatae, 1.8g of oyster, 2g of ligusticum wallichii, 1.6g of angelica sinensis, 4.8g of poria cocos, 3.6g of bighead atractylodes rhizome stir-fried with bran, 3g of rhizoma alismatis, 4g of codonopsis pilosula, 3g of schisandra chinensis, 4g of abrus cantoniensis hance, 4g of virgate wormwood herb, 1.2g of honey-fried licorice root and the like;
(2) Mixing the weighed Chinese medicinal materials, adding water 12 times of the weight of the Chinese medicinal decoction pieces, decocting for 2.5 hours each time, mixing decoctions, concentrating, standing, centrifuging, and collecting supernatant;
(3) Adding 20mg steviosin, 100mg benzoic acid and 20mg ethylparaben into the supernatant in step (2), sterilizing at 105deg.C for 40 min, and making into mixture.
Example 14
(1) Weighing raw material Chinese medicinal materials such as 3g of bupleurum chinense, 3g of scutellaria baicalensis, 3g of cassia twig, 1.6g of dried ginger, 3g of flos puerariae lobatae, 1.8g of oyster, 2g of ligusticum wallichii, 1.6g of angelica sinensis, 4.8g of poria cocos, 3.6g of bighead atractylodes rhizome stir-fried with bran, 3g of rhizoma alismatis, 4g of codonopsis pilosula, 3g of schisandra chinensis, 4g of abrus cantoniensis hance, 4g of virgate wormwood herb, 1.2g of honey-fried licorice root and the like;
(2) Mixing the weighed Chinese medicinal materials, adding water 12 times of the weight of the Chinese medicinal decoction pieces, decocting for 2.5 hours each time, mixing decoctions, concentrating, standing, centrifuging, and collecting supernatant;
(3) Adding 20mg steviosin, 100mg benzoic acid and 20mg ethylparaben into the supernatant in the step (2), sterilizing at 115 ℃ for 30 minutes, and preparing into a mixture.
Treatment effect test part:
1. The curative effect detection method comprises the following steps:
1. Determining a test object: the method comprises the steps of selecting 300 cases of patients with Western diagnosis meeting the diagnosis standard of alcoholic liver disease in the guide for preventing and treating alcoholic liver disease (updated version in 2018) and with Chinese medicine diagnosis meeting the diagnosis standard of liver depression and spleen deficiency in the guide for diagnosing and treating common diseases in Chinese medicine, grouping by adopting computer random codes, and hiding by adopting reasonable allocation, namely, loading the computer random codes into sealed envelopes to enable the patients to randomly extract, and sealing the codes by a designer. The 300 patients were randomly divided into 3 groups of 100 patients each;
wherein, the inclusion criteria are as follows:
Diagnostic criteria, traditional Chinese medicine diagnostics meet inclusion criteria:
① Age >18 years, unlimited for men and women;
② The history of drinking is more than or equal to 5 years, the amount of ethanol is more than or equal to 40g/d for men and 20g/d for women.
Exclusion criteria:
① Combining hepatophilic virus infection, drug and toxic liver disease, non-acute alcoholic liver injury, autoimmune liver disease, and genetic metabolism liver disease;
② Combining liver cancer or other malignant tumors;
③ Other severe primary diseases (cardiovascular and cerebrovascular diseases, kidney diseases, etc.);
④ Patients are reluctant to cooperate.
2. The usage amount is as follows: the mixture prepared in example 1 was orally taken. 20ml at a time, 2 times a day; or follow the doctor's advice. The composition is applied by shaking.
3. Standard of efficacy:
the clinical symptoms are completely eliminated, and main experimental indexes such as blood, liver functions and the like are restored to normal levels without diseases;
The clinical symptoms are obviously improved or the main symptoms disappear, and the laboratory indexes are recovered to be normal;
improvement, the main symptoms are controlled, partial symptoms possibly occur, but the disease is improved before the disease is developed;
Ineffective, symptoms fail to control or interrupt the treatment.
The total effective rate is the sum of clinical cure rate, obvious effect rate and good conversion rate.
4. The treatment effect is as follows: by using the mixture obtained in the example 1 of the invention for treatment for 1-2 months, in the case of the clinical observation patient, no side effects such as obvious abnormal reaction and the like are seen during the treatment period, and the specific curative effects are shown in the following table 1:
TABLE 1
Therefore, the invention has obvious effects for treating chest and hypochondrium distending pain, anorexia, abdominal distention, hiccup, belch, borborygmus, borygmus, loose stool and the like caused by incoordination between liver and stomach and spleen deficiency and dampness.
2. Introduction of specific cases:
1. the patient is in Tan certain, men, 34 years old
Complaints: the liver function was found to be abnormal for 5 days.
The current medical history: slight drowsiness and hypodynamia, no abdominal pain, no hypochondriac pain, no aversion to cold and fever, no cough and expectoration, no yellow urine of eyes, no dizziness and headache, occasionally dry mouth and bitter taste, no anaesthesia and greasiness, poor sleep and adjustment of urination. No significant decrease in body weight was seen after onset. The lower border of the liver is not touched under the hepatic rib, the liver-voiced sound border is normal, and the liver area is not tapped. The gallbladder is not reached, the gallbladder region is not painful, and the moat syndrome is negative. No mobility and no large spleen voice. The double kidney areas have no tap pain and the ureter has no pressure pain. Borborborygmus 5 times/min. Liver function: ALT159U/L, AST64U/L; two halves of hepatitis B: positive hepatitis B surface antibody, hepatitis B antibody and hepatitis B core antibody. Chest CT: no obvious abnormalities were seen in chest CT scans; fatty liver.
Western diagnosis: liver insufficiency; fatty liver
Diagnosis of traditional Chinese medicine: syndrome of liver depression and spleen deficiency
The treatment method comprises the following steps: liver soothing and spleen strengthening
The treatment method comprises the following steps: the oral liquid prepared in example 1 was orally administered. 20ml at a time, 2 times a day, 60 consecutive days.
Curative effect: the liver protection and the dialectical treatment of the traditional Chinese medicine are carried out in hospital, and the illness state of the patient is stable. Liver function, glutamic pyruvic transaminase (ALT) 87 ≡U/L. The patient has no abdominal pain, no hypochondriac pain, no aversion to cold and fever, no cough and expectoration, no yellow and dyed urine, no dizziness and headache, no greasy feeling, no somnolence and no adjustment of urination.
2. The patient is someplace on his or her trunk, male, 40 years old
Complaints: the whole body is tired and debilitated for more than 1 year, and the limb convulsion is carried out for 6 hours.
The current medical history: the whole body is drowsy and hypodynamia, no tiredness, dull pain in the right hypochondrium, bitter taste, no convulsion of limbs, muscle soreness of the two lower limbs, slight nausea, discomfort of gastric cavity, headache, no aversion to cold and fever, no damp heat and night sweat, no body yellow and dyeing of eyes. No significant weight loss was seen in recent times. Liver function: glutamic pyruvic transaminase 95 +.U/L and glutamic oxaloacetic transaminase 255 +.U/L.
Western diagnosis: liver cirrhosis decompensation period after hepatitis B
Diagnosis of traditional Chinese medicine: syndrome of liver depression and spleen deficiency
The treatment method comprises the following steps: liver soothing and spleen strengthening
The treatment method comprises the following steps: the oral liquid prepared in example 1 was orally administered. 20ml at a time, 2 times a day, 60 consecutive days.
Curative effect: the patients complain of general drowsiness and hypodynamia, no dull pain in the right hypochondrium, no bitter taste in the mouth, no convulsion in the limbs, no nausea, no headache and dizziness, no aversion to cold and fever, no damp heat and night sweat, no yellow eyes and normal urine and feces. Liver function VI, glutamic pyruvic transaminase (ALT) 51 ≡U/L, glutamic oxaloacetic transaminase (AST) 77 ≡U/L, gamma-glutamyl transferase (GGT) 405 ≡U/L and glutamate dehydrogenase 7.18 ≡U/L.
3. Patients with wei certain, men, 42 years old
Complaints: the distending pain of the epigastrium part is repeated for more than 3 months, and half a month is repeated.
The current medical history: the stomach pain, the pain of the stomach and the poststernum burning sensation, the pain of the right hypochondrium, the dry mouth and bitter taste, frequent belching, chest distress and discomfort, no aversion to cold and fever, no spontaneous perspiration and night sweat, headache and body pain, dizziness and waist soreness, chest distress and heart pain, no discomfort such as anaesthesia and greasiness, insomnia, convenient adjustment and no obvious decrease of the weight in recent years. The alcohol intake is about 80g every day for more than 10 years after long-term alcoholism, and the family history of liver cirrhosis and liver cancer is provided; overviews the history of infection such as viral hepatitis, tuberculosis and typhoid fever. Liver function: (national HR) glutamic pyruvic transaminase (ALT) 161.0 ≡U/L, (national HR) glutamic pyruvic transaminase (AST) 171.2 ≡U/L, (national HR) gamma-glutamyl transferase (GGT) 479 ≡U/L. Blood convention: WBCs, RBCs were slightly lowered. Upper abdominal color Doppler ultrasound: no abnormality.
Western diagnosis: alcoholic liver disease
Diagnosis of traditional Chinese medicine: syndrome of liver depression and spleen deficiency
The treatment method comprises the following steps: liver soothing and spleen strengthening
The treatment method comprises the following steps: the oral liquid prepared in example 1 was orally administered. 20ml at a time, 2 times a day, 60 consecutive days.
Curative effect: the patients have no obvious pain in the gastric cavity, no burning sensation after the gastric cavity and the sternum, sometimes pain in the right hypochondrium, no dry mouth and bitter taste, no belch, chest distress and discomfort, no aversion to cold and fever, no spontaneous perspiration and night sweat, no headache and body pain, no dizziness and waist soreness, no discomfort such as chest distress and heart pain, no anaesthesia and greasiness, and no insomnia and the like, and can regulate the urination and the defecation. Liver function vi: (national HR) glutamic pyruvic transaminase (ALT) 148.6 ≡U/L, (national HR) glutamic pyruvic transaminase (AST) 118.3 ≡U/L, (national HR) gamma-glutamyl transferase (GGT) 466 ≡U/L, prealbumin 382mg/L. Hepatitis B virus deoxyribonucleic acid assay <1.00E+02IU/mL.
3. Rat animal experiment:
the purpose is as follows: the liver protection effect of liver soothing and stomach harmonizing oral liquid on rats with acute alcoholic liver injury is explored.
The method comprises the following steps: SD rats are randomly divided into a normal group, a model group, a metadoxine (50 mg/kg) group, a low-dosage group and a high-dosage group (3, 6g/kg, which are equivalent to 3,6 times of the equivalent dosage of clinical adults) of liver soothing and stomach harmonizing oral liquid, gradient infusion is adopted to prepare acute alcoholic liver injury models of rats by taking distilled spirit with different concentrations, and corresponding medicines or distilled water are infused during the modeling for 14 days. HE staining observed liver tissue pathology and scored; the kit detects indexes such as rat serum glutamic pyruvic transaminase (ALT), glutamic oxaloacetic transaminase (AST), superoxide dismutase (SOD), malondialdehyde (MDA), triacylglycerol (TG), total Cholesterol (TC), tumor necrosis factor-alpha (TNF-alpha), interleukin 6 (IL-6) and the like and expression levels such as Alcohol Dehydrogenase (ADH), cytochrome P4502E1 (CYP 2E 1) and the like in the liver. Compared with the normal control group, the liver cells of the liver tissue of the rat in the model group have obvious pathological damage, the contents of serum ALT, AST, MDA, TC, TG, TNF-alpha, IL-6 and CYP2E1 are obviously increased (P is less than 0.01), the activity of SOD is obviously reduced (P is less than 0.01), and the expression of ADH in the liver tissue is obviously reduced (P is less than 0.01). Compared with the model group, the liver-soothing and stomach-harmonizing oral liquid has obviously reduced pathological injury of liver cells of rats in each dosage group, obviously reduced contents of serum ALT, AST, MDA, TC, TG, TNF-alpha, IL-6 and CYP2E1 (P < 0.05 or P < 0.01), and obviously increased activity of serum SOD and liver tissue ADH (P < 0.01).
Conclusion: the liver soothing and stomach harmonizing oral liquid can effectively relieve liver tissue injury of rats with alcoholic liver disease, and the mechanism of the liver soothing and stomach harmonizing oral liquid is possibly related to relieving oxidative stress of liver cells, lipid accumulation and inflammatory reaction.
The specific experimental contents are as follows:
1 Material
1.1 Test drug
The liver soothing and stomach harmonizing oral liquid is provided by a preparation room of a traditional Chinese medicine hospital in Liuzhou market (batch number 20231001, the specific ratio of the raw materials is the same as that of example 1); metadoxine capsule (specification: 0.25 g/granule, lot number 221001), purchased from Zhejiang Jiyuan pharmaceutical Co., ltd, and prepared with ultra-pure water; 43% strength white spirit (lot 2022123139) and 56% strength white spirit (lot 2022092037) were purchased from Beijing red star Co., ltd.
1.2 Animals
SPF-grade male SD rats were 25, mass (150.+ -.10) g, purchased from Guangdong Vetolihua laboratory animal technologies Co., ltd., laboratory animal mass eligibility number: 44829700021770, the feeding environment is as follows: placing in IVC rat cage, and circulating for 12 hr at relative temperature (25+ -2deg.C) and relative humidity (50+ -5%). 5 animals per cage, after 5 days of adaptive feeding, the formal test is started.
1.3 Reagents
ALT, AST, SOD, MDA, TC, TG, ADH detection kit (Nanjing institute of biological engineering, lot numbers 20231103, 20231103, 20231016, 20231101, 20231108, 20231108, 20231016, respectively); TNF-alpha, CYP2E1, IL-6 enzyme linked immunoassay kit (Wuhan Hua Likeside biotechnology Co., ltd., batch number 20231010); 4% paraformaldehyde (lot 21235935, siring biosciences, guangzhou); hematoxylin-eosin (HE) staining solution (beijing solibao technologies limited, lot 20210419).
1.4 Instruments
Bio-Rad iMark microplate reader (Shanghai Berle Life medicine Co., ltd.; model: bio-Rad 680); electric heating constant temperature water bath (Ningbo Xinzhi biotechnology Co., ltd., model: SC-20); a high-speed low-temperature centrifuge (model: TGD-20MC, manufactured by Changsha sharp centrifuge Co., ltd.); ice machine (model: IMS-130, established snow refrigeration equipment limited); ultrapure water machine (Beijing general analysis general instruments Co., ltd., model: GWB-1).
2 Method
2.1 Grouping, modeling, and administration methods for animals
25 SD rats were randomly divided into a normal group, a model group, metadoxine 50mg/kg group, a liver soothing and stomach harmonizing oral liquid soup low and high dose group (3, 6g/kg, equivalent to 3, 6 times of the clinical adult equivalent dose) of 5 each. An acute alcoholic liver injury animal model [1] is constructed by referring to the model preparation specifications proposed by the Chinese medical science of the Chinese traditional medicine laboratory pharmacology professional committee. 1 d-4 d, except that rats in the normal control group are subjected to gastric lavage with distilled water every day, rats in each group are subjected to gastric lavage with 10mL/kg of 43% concentration white spirit twice a day at intervals of 8 hours. And 5 d-14 d, filling the stomach of rats in each group with distilled water every day except for rats in the normal control group, wherein the rats in each group are filled with 10mL/kg of 56% concentration white spirit twice a day at intervals of 8 hours. After 1h of each alcohol infusion, each group of corresponding drugs or pure water was administrated by stomach infusion, and the administration volume was 10mL/kg for 14 days.
2.2 Sample collection
After the last administration, the rats of each group are fasted without water control for 12 hours, and the abdominal aorta after anesthesia is sampled and kept stand for 1 hour at room temperature. Centrifuging at 3500r/min for 10min, collecting supernatant, packaging, and transferring to-80deg.C refrigerator for storage. Two pieces of liver tissue with the same size are respectively taken at the same position of the left leaf and the right leaf of the liver of each rat. The left hepatic leaf tissue is frozen and stored in a refrigerator at the temperature of minus 80 ℃, and the right hepatic leaf tissue is fixed in 4% formaldehyde fixing solution and is used for HE staining to observe pathological changes of the hepatic tissue.
2.3 Liver histopathological examination
Taking out the fixed liver tissue sample, slicing, dehydrating with gradient ethanol, and making xylene transparent. After treatment, the sections are placed in hematoxylin dye solution, after 5min of dyeing, the sections are rinsed with tap water, differentiated and rinsed with differentiation solution, and rinsed with running water after returning to blue. Dewatering with 85% and 95% gradient alcohol for 5min, and adding eosin dye solution for dyeing for 5min. And (3) dehydrating by absolute ethyl alcohol, and sealing the neutral resin after the xylene is transparent. The liver histopathological changes of the rats in each group are observed under an electron microscope, and the inflammatory cell infiltration condition of liver tissues, the hepatic cell steatosis, the hepatic fibrosis and the like are examined. The literature uses a Knodell scoring system to evaluate [3] the pathological manifestations of liver tissue, a pathology negative score of 0, a weak positive score of 1, a positive score of 2, and a strong positive score of 3.
2.4 Biochemical index detection
Preparing relevant solutions and samples according to ALT, AST, SOD, MDA, TC, TG, TNF-alpha, IL-6 and CYP2E1 detection kit specifications, uniformly mixing all the reagents, detecting the index absorbance of the rat serum by using an enzyme-labeling instrument, drawing a standard curve according to the absorbance and the standard concentration, and calculating the index concentrations of the rat serum of each group according to the absorbance of the samples.
2.5 Statistical methods
Data processing and metering by SPSS20.0The comparison among multiple groups is firstly performed with variance alignment test, the variance alignment person selects ANOVA for single-factor variance analysis, LSD is used for pairwise comparison, and P is smaller than 0.05 to indicate that the difference has statistical significance.
3 Results
3.1 Effects of liver soothing and stomach harmonizing oral liquid on liver tissue pathological changes in rats with alcoholic liver injury model
The liver lobule structure of the normal group rat is clear and normal, the liver cells are orderly arranged radially from the central vein to the periphery, and the liver cells have no degeneration, necrosis and inflammatory cell infiltration; the liver lobule cells of the rats in the model group are arranged in disorder, the liver cells around the central vein are swollen, the liver cells have focal necrosis, inflammatory cells infiltrate, and the intracytoplasmic vesicular steatosis is seen; the liver lobule structure of metadoxine group rats is basically normal, and the liver cells rarely have edema and steatosis; the liver soothing and stomach harmonizing oral liquid has various improving effects, wherein liver lobules of rats in liver soothing and stomach harmonizing oral liquid-L groups are basically normal, liver cells are slightly edematous, a small amount of inflammatory cells infiltrate is visible, and liver cell steatosis is not visible; liver soothing and stomach harmonizing oral liquid-H group rat liver cells liver lobule structure is normal, and liver cell edema, steatosis and inflammatory cell infiltration are not seen. And the improvement effect of the liver-soothing and stomach-harmonizing oral liquid-H group is better than that of the metastatin group. See fig. 2.
3.2 Effects of liver soothing and stomach harmonizing oral liquid on liver function index of alcoholic liver injury model rats
Compared with the normal group, the serum ALT and AST activities of the rats in the model group are obviously improved (p < 0.01). Compared with the model group, the activity of ALT and AST in rat serum in liver-soothing and stomach-harmonizing oral liquid-L and liver-soothing and stomach-harmonizing oral liquid-H groups is obviously reduced (p is less than 0.01). See fig. 3A, B.3.3 effects of liver soothing and stomach harmonizing oral liquid on the oxidative balance in rats model of alcoholic liver injury
The model group rats had significantly reduced SOD activity (p < 0.01) and significantly increased MDA content (p < 0.01) compared to the normal group. Compared with the model group, the SOD content of each dosage group of the liver-soothing and stomach-harmonizing oral liquid is obviously increased (p < 0.01), and the activity of MDA is obviously reduced (p < 0.01). See fig. 3C, D.
3.4 Effects of liver soothing and gastric oral liquid on fat metabolism in alcoholic liver injury model rats compared with normal groups, the serum TG and TC contents of the model rats are obviously increased (p < 0.01); compared with the model group, the content of TG and TC in each dosage group of the liver-soothing and stomach-soothing oral liquid is obviously reduced (p < 0.01). See FIG. 3 (A, B).
3.5 The effects of liver soothing and gastric oral liquid on serum inflammatory factors of rats with alcoholic liver injury models are compared with normal groups, and the serum TNF-alpha and IL-6 contents of rats with the models are obviously increased (p < 0.01); compared with the model group, the content of TNF-alpha and IL-6 in each dosage group of the liver-soothing and stomach-soothing oral liquid is obviously reduced (p < 0.01). See FIG. 3 (C, D).
3.6 Effects of liver soothing and stomach harmonizing oral liquid on serum and liver alcohol metabolism related enzymes of rats with alcoholic liver injury model
Model group rats had significantly reduced ADH activity (p < 0.01) and significantly increased CYP2E1 content (p < 0.01) compared to the normal group. Compared with the model group, the ADH content of each dosage group of the liver-soothing and stomach-harmonizing oral liquid is obviously increased (p < 0.01), and the CYP2E1 activity is obviously reduced (p < 0.01). See fig. 4A, B.
In conclusion, the liver soothing and stomach harmonizing oral liquid is found to be capable of effectively relieving liver tissue injury of rats with alcoholic liver disease, improving liver function, restoring internal oxidation balance and promoting liver fat metabolism through detecting indexes of rat in whole state, liver tissue pathological morphology, biochemistry, molecular biology and the like, so that the protective effect of alcoholic liver injury is exerted
Finally, it should be noted that the above embodiments are merely representative examples of the present invention. Obviously, the technical solution of the invention is not limited to the above-described embodiments, but many variations are possible. All modifications directly derived or suggested to one skilled in the art from the present disclosure should be considered as being within the scope of the present invention.

Claims (10)

1. A traditional Chinese medicine composition for preventing and treating alcoholic liver injury is characterized by comprising the following raw material components: radix bupleuri, radix Scutellariae, ramulus Cinnamomi, rhizoma Zingiberis, flos Puerariae Lobatae, concha Ostreae, rhizoma Chuanxiong, radix Angelicae sinensis, poria, rhizoma Atractylodis Macrocephalae preparata, rhizoma Alismatis, radix Codonopsis, fructus Schisandrae chinensis, herba abri, herba Artemisiae Scopariae, and radix Glycyrrhizae Preparata.
2. The traditional Chinese medicine composition for preventing and treating alcoholic liver injury according to claim 1, wherein the weight ratio of the raw materials is as follows: 1-5 parts of radix bupleuri, 1-5 parts of radix scutellariae, 1-5 parts of cassia twig, 1-3 parts of dried ginger, 1-5 parts of flos puerariae lobatae, 1-4 parts of oyster, 1-4 parts of ligusticum wallichii, 1-4 parts of angelica sinensis, 3-7 parts of poria cocos, 2-6 parts of bran-fried bighead atractylodes rhizome, 1-5 parts of rhizoma alismatis, 2-6 parts of radix codonopsis, 1-5 parts of schisandra chinensis, 2-6 parts of herba abri, 2-6 parts of herba artemisiae capillaris and 1-3 parts of honey-fried licorice root.
3. The traditional Chinese medicine composition for preventing and treating alcoholic liver injury according to claim 2, wherein the weight ratio of the raw materials is as follows: 3 parts of bupleurum chinense, 3 parts of baical skullcap root, 3 parts of cassia twig, 1.6 parts of dried ginger, 3 parts of kudzuvine flower, 1.8 parts of oyster, 2 parts of szechuan lovage rhizome, 1.6 parts of Chinese angelica, 4.8 parts of Indian buead, 3.6 parts of white atractylodes rhizome fried with bran, 3 parts of oriental waterplantain rhizome, 4 parts of pilose asiabell root, 3 parts of Chinese magnoliavine fruit, 4 parts of abrus herb, 4 parts of virgate wormwood herb and 1.2 parts of prepared liquorice.
4. The traditional Chinese medicine composition for preventing and treating alcoholic liver injury according to claim 1, wherein auxiliary materials are also added.
5. The method for preparing the traditional Chinese medicine composition for preventing and treating alcoholic liver injury according to any one of claims 1 to 4, which is characterized by comprising the following steps:
(1) Weighing the raw materials of bupleurum, scutellaria baicalensis, cassia twig, dried ginger, flos puerariae lobatae, oyster, ligusticum wallichii, angelica sinensis, poria cocos, bran-fried bighead atractylodes rhizome, rhizoma alismatis, codonopsis pilosula, schisandra chinensis, abrus herb, herba artemisiae capillaris, honey-fried licorice root and the like according to the proportion;
(2) Mixing the weighed Chinese medicinal materials, adding 8-12 times of water, decocting for 1-3 times, each for 1.5-2.5 hr, mixing decoctions, concentrating, standing, centrifuging, and collecting supernatant.
6. The method for preparing the traditional Chinese medicine composition for preventing and treating alcoholic liver injury according to claim 5, wherein a pharmaceutically acceptable carrier and/or excipient can be added into the supernatant to prepare any clinically acceptable dosage form.
7. The method for preparing a traditional Chinese medicine composition for preventing and treating alcoholic liver injury according to claim 6, wherein the finally obtained dosage form comprises mixture, tablet, pill, capsule, granule and electuary.
8. The method for preparing a Chinese medicinal composition for preventing and treating alcoholic liver injury according to claim 6, wherein a proper amount of steviosin, benzoic acid and ethylparaben are added into the supernatant to prepare the mixture.
9. Use of the traditional Chinese medicine composition for preventing and treating alcoholic liver injury according to any one of claims 1-4 as/in preparing acute alcoholic liver injury medicine.
10. The use of the Chinese medicinal composition for preventing and treating alcoholic liver injury according to any one of claims 1-4 as/for preparing a medicament for treating chest and hypochondrium distending pain, anorexia, abdominal distention, hiccup, belch, borborygmus, and loose stool caused by incoordination between liver and stomach and spleen deficiency and dampness.
CN202311710863.3A 2023-12-13 2023-12-13 Traditional Chinese medicine composition for preventing and treating alcoholic liver injury as well as preparation method and application thereof Pending CN117919365A (en)

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