CN114984160B

CN114984160B - Mongolian medicine for treating alcoholic liver disease

Info

Publication number: CN114984160B
Application number: CN202210630805.9A
Authority: CN
Inventors: 陈桂花; 周慧斌
Original assignee: Individual
Current assignee: Individual
Priority date: 2022-06-06
Filing date: 2022-06-06
Publication date: 2023-08-01
Anticipated expiration: 2042-06-06
Also published as: CN114984160A

Abstract

The invention discloses a Mongolian medicine for treating alcoholic liver disease, which comprises the following components: stigma croci Sativi, calculus bovis, fel Ursi powder, cornu Saigae Tataricae, carthami flos, saviae Miltiorrhizae radix, fructus Chebulae, radix Puerariae, fructus Schisandrae chinensis, lignum Santali albi, radix Ranunculi Ternati, herba Silybi Mariani, semen Nelumbinis, fructus Toosendan, semen Cassiae, folium Ginkgo, radix aucklandiae, radix Ophiopogonis, fructus Gardeniae, fructus Amomi rotundus, and Ginseng radix. The Mongolian medicine adopts a Mongolian medicine 'liver heat clearing, digestion promoting, detoxifying and kidney reinforcing' method to treat alcoholic liver disease, can effectively improve liver function and improve life quality of patients; can reduce or prevent alcoholic hepatitis from developing into alcoholic liver cirrhosis; the Mongolian medicine has the advantages of low price, easy popularization, no toxic or side effect after long-term administration, good treatment effect and low recurrence rate; solves the problems of extremely lack and no drug selection in the current alcoholic hepatitis drug treatment, and provides a new drug selection for clinic.

Description

Mongolian medicine for treating alcoholic liver disease

Technical field:

the invention relates to the field of pharmaceutical compositions, in particular to a Mongolian medicine for treating alcoholic liver diseases.

The background technology is as follows:

with the development of social economy, alcohol abuse, alcohol dependence and alcoholism have become common public health problems in countries around the world. Liver is the main part of alcohol metabolism and is also the main target organ of alcohol toxic action, and the incidence of alcoholic liver disease (alcoholic liver disease, ALD) caused by long-term drinking is increased year by year clinically, and the liver disease becomes another cause of liver injury after secondary viral hepatitis. Clinical diagnosis of alcoholic liver disease can be classified into the following categories according to liver function, imaging and histopathological examination results: mild alcoholic liver disease, alcoholic fatty liver, alcoholic hepatitis, alcoholic liver fibrosis, alcoholic cirrhosis, etc.

The common treatment methods in modern medicine mainly comprise alcohol withdrawal, nutrition support, drug treatment, liver transplantation and the like. However, there is no therapeutic drug which has definite curative effect and can be recommended for ALD, especially for alcoholic hepatitis, and the therapeutic drug is extremely deficient, and is in the non-drug selectable embarrassment, the overall therapeutic effect is not ideal, the toxic and side effects are large, and the cost is high, and the liver and kidney injury can be caused after long-term use.

The invention comprises the following steps:

the invention aims to provide a Mongolian medicine for treating alcoholic liver disease, which has definite curative effect, low cost and no side effect after long-term administration.

The invention is implemented by the following technical scheme: a Mongolian medicine for treating alcoholic liver disease comprises the following components in parts by weight: 0.1-0.5 part of stigma croci, 0.5-1 part of bezoar, 0.1-0.5 part of bear gall powder, 1-2 parts of antelope horn, 3-4 parts of safflower, 3-4 parts of red sage root, 3-4 parts of myrobalan, 3-4 parts of kudzuvine root, 3-4 parts of schisandra chinensis, 2-4 parts of red sandalwood, 2-3 parts of radix ranunculi ternati, 2-3 parts of silybum marianum, 2-3 parts of lotus seeds, 2-3 parts of szechwan chinaberry fruit, 1-2 parts of cassia seed, 1-2 parts of ginkgo leaf, 1-2 parts of costus root, 1-2 parts of dwarf lilyturf tuber, 1-2 parts of cape jasmine fruit, 1-2 parts of cardamon seed and 1-2 parts of ginseng.

Preferably, the Mongolian medicine for treating alcoholic liver disease is characterized by comprising the following components in parts by weight: 0.36 part of saffron, 0.72 part of bezoar, 0.45 part of bear gall powder, 1.2 part of antelope horn, 3.6 parts of safflower, 3.6 parts of red sage root, 3.6 parts of myrobalan, 3.6 parts of kudzuvine root, 3.6 parts of schisandra chinensis, 2.4 parts of red sandalwood, 2.4 parts of catclaw, 2.4 parts of silybum marianum, 2.4 parts of lotus seeds, 2.4 parts of szechwan chinaberry fruit, 1.8 parts of cassia seed, 1.8 parts of ginkgo leaf, 1.8 parts of costus root, 1.8 parts of dwarf lilyturf tuber, 1.8 parts of cape jasmine, 1.8 parts of cardamon seed and 1.8 parts of ginseng.

Further, the Mongolian medicine for treating alcoholic liver disease is any one of powder, watered pill, honeyed pill, capsule or granule.

The Mongolian medicine takes the saffron, the safflower, the bezoar, the bear gall powder and the antelope horn as main medicines, and the saffron and the safflower are sweet and slightly bitter in taste, cool in nature, blunt, soft, mild, heavy and firm, and have the effects of locking pulse, clearing liver heat, nourishing and strengthening body and relieving pain; bezoar is slightly bitter and slightly sweet, is cool, heavy, dull, mild and soft, and has the effects of clearing heat, detoxicating and calming; bear gall powder is bitter in taste, cool, dull, rough and dynamic, and has the effects of locking pulse, stopping bleeding, cleaning, improving eyesight, preserving, promoting vital energy and stopping diarrhea; the antelope horn has salty taste and flat nature and has the effects of drying pus, breaking blood fullness and stopping diarrhea.

The red sage root, the myrobalan, the kudzuvine root and the shizandra berry are taken as auxiliary medicines, and the red sage root has light, blunt and drastic taste and has the effects of clearing blood heat, eliminating dryness and stopping bleeding; the myrobalan has astringent taste, is flat, sharp and dry in nature, and has the effects of removing lesions, detoxifying and harmonizing voxels; pueraria is sweet and pungent in flavor and cool in nature, and has the effects of relieving muscle and allaying fever, promoting the production of body fluid and quenching thirst; fructus Schisandrae chinensis is sweet and sour in taste, has effects of relieving vomiting and diarrhea, and stimulating appetite, and is mild, dry, light, and coarse.

The pterocarpus santalinus, the radix ranunculi ternati, the silybum marianum, the lotus seeds and the szechwan chinaberry fruit are taken as adjuvant drugs, and the pterocarpus santalinus has the advantages of astringent and salty flavor, cool nature and dullness, and has the effects of clearing blood heat, calming qi and blood, promoting the subsidence of swelling and the like; the catclaw grass has sweet and pungent taste, warm nature and flat nature and has the efficacy of detoxification; silybum marianum is bitter in taste and cool in nature, and has the effects of clearing heat, promoting diuresis, soothing liver and promoting bile flow; the lotus seeds are pungent and astringent in taste and warm in nature, and have the effects of tonifying kidney, dispelling stomach and kidney cold, relieving diarrhea and eliminating yellow water; chuan Lian Zi is astringent, bitter, cool, light, dry and dull in nature, and has the effects of dispelling the heat of the Szechwan Chila, improving eyesight and relieving pain.

The medicines are semen Cassiae, folium Ginkgo, radix aucklandiae, radix Ophiopogonis, fructus Gardeniae, fructus Amomi rotundus, and Ginseng radix, and the semen Cassiae has stomach bitter, astringent, cool, coarse, dry, and sharp taste, and has effects of eliminating yellow water and nourishing; semen Ginkgo She Weigan, bitter and astringent, has effects of promoting blood circulation, removing blood stasis, dredging collaterals, relieving pain, eliminating turbid pathogen, and reducing blood lipid; the costus root has pungent and bitter taste, warm, greasy, coarse and light nature, and has the effects of dispelling the dry heat of the bus, calming the pulse of qi and blood, relieving stuffiness, harmonizing voxels, preserving and relieving pain; radix Ophiopogonis has bitter taste, cool nature, and has effects of dispelling Hila, removing toxic substances, clearing heat, and relieving swelling; gardenia is bitter in taste, cool, dull and rough in nature, and has the effects of clearing blood heat, improving eyesight, removing the dry Hirudo, nourishing and harmonizing voxels; the cardamon seed has pungent and bitter taste, warmth, greasiness, sharpness, light weight and dryness, and has the effects of dispelling kidney cold, relieving herry, helping stomach fire, promoting digestion, stimulating appetite and preventing vomiting; the ginseng has sweet and slightly bitter taste, warm nature and nourishing and tranquilizing effects.

The preparation method takes saffron, safflower, bezoar, bear gall powder and antelope horn as main medicines, and has the effects of clearing liver heat, removing toxicity, protecting liver and improving eyesight; the effects of clearing away blood heat, removing blood stasis, harmonizing voxels, stopping vomiting and diarrhea and stimulating appetite are added with the root of red-rooted salvia, myrobalan, kudzuvine root and shizandra berry; with the assistance of the pterocarpus santalinus, the radix ranunculi ternati, the silybum marianum, the lotus seed and the szechwan chinaberry fruit, the effects of clearing blood heat, detoxifying, calming the pulse, clearing heat, promoting diuresis, soothing liver, promoting bile flow and dispelling stomach and kidney cold are achieved; the medicament is prepared from cassia seed, ginkgo leaf, costus root, dwarf lilyturf tuber, cape jasmine fruit, cardamon seed and ginseng, has the effects of drying yellow water, nourishing, promoting blood circulation by removing blood stasis, dredging collaterals and relieving pain, dispelling the dry heat of the badada, helping stomach fire, promoting digestion and stimulating appetite and preventing vomiting, has reasonable formula, combines the medicaments, has the effects of clearing liver heat, detoxifying and protecting liver, is mainly used for treating fatty liver diseases, alcoholic hepatitis and the like, and has obvious effects.

The invention has the advantages that: the Mongolian medicine adopts a Mongolian medicine 'liver heat clearing, digestion promoting, detoxifying and kidney reinforcing' method to treat alcoholic liver disease, can effectively improve liver function and improve life quality of patients; can reduce or prevent alcoholic hepatitis from developing into alcoholic liver cirrhosis; the Mongolian medicine has the advantages of low price, easy popularization, no toxic or side effect after long-term administration and good treatment effect; solves the problems of extremely lack and no drug selection in the current alcoholic hepatitis drug treatment, and provides a new drug selection for clinic.

The specific embodiment is as follows:

the technical solutions of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention, and it is apparent that the described embodiments are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

Example 1: a Mongolian medicine for treating alcoholic liver disease is prepared by weighing the following raw materials in parts by weight: 0.72kg of saffron, 1.44kg of bezoar, 0.9kg of bear gall powder, 2.4kg of antelope horn, 7.2kg of safflower, 7.2kg of red sage root, 7.2kg of myrobalan, 7.2kg of kudzuvine root, 7.2kg of shizandra berry, 4.8kg of red sandalwood, 4.8kg of buttercup root, 4.8kg of silybum marianum, 4.8kg of lotus seeds, 4.8kg of szechwan chinaberry fruit, 3.6kg of cassia seed, 3.6kg of ginkgo leaf, 3.6kg of costus root, 3.6kg of dwarf lilyturf tuber, 3.6kg of cape jasmine, 3.6kg of cardamon seed and 3.6kg of ginseng. The weighed raw materials are entrusted to the International Mongolian medicine preparation center of International Mongolian medical hospital to be processed into water pills, and the specification is 200 mg/pill.

Example 2: a Mongolian medicine for treating alcoholic liver disease is prepared by weighing the following raw materials in parts by weight: 0.7kg of saffron, 1.4kg of bezoar, 0.8kg of bear gall powder, 3kg of antelope horn, 6kg of safflower, 6kg of red sage root, 6kg of myrobalan, 6kg of kudzuvine root, 6kg of shizandra berry, 7kg of red sandalwood, 5.6kg of buttercup root, 5.6kg of silybum marianum, 5.6kg of lotus seed, 5.6kg of szechwan chinaberry fruit, 2kg of cassia seed, 2kg of ginkgo leaf, 2kg of costustoot, 2kg of dwarf lilyturf tuber, 2kg of gardenia, 2kg of cardamon seed and 2kg of ginseng. The weighed raw materials are entrusted to the International Mongolian medicine preparation center of International Mongolian medical hospital to be processed into water pills, and the specification is 200 mg/pill.

The Mongolian medicine of the embodiment 1 and the embodiment 2 can also be prepared into powder, honeyed pills, capsules or granules by adopting the conventional method at present.

Clinical study of Mongolian medicine (Gu Ri Gu Muqing liver pill) for treating alcoholic liver disease for treating alcoholic hepatitis

The main purpose of the research is to investigate the effectiveness and safety of Mongolian medicine Gu Ri Gu Muqing liver pills by observing the clinical curative effect of the Mongolian medicine Gu Ri Gu Muqing liver pills on alcoholic hepatitis patients, and provide scientific basis for the clinical application of the Mongolian medicine Gu Ri Gu Muqing liver pills in future. The study protocol was randomized, control clinical study. 138 subjects were from the department of medical outpatient and hospitalization of the inner Mongolian Engineer Coli right wing Zhongqi Xietaimen town sanitary hospital.

2.1 methods of research

2.1.1 names and specifications of drugs for test

Group drug observation: the Mongolian medicine Guri Gu Muqing liver pill prepared according to the formula of the embodiment 1 of the invention has the following formulation: watered pills (200 mg/pill) are provided by the International Mongolian medicine preparation center of the International Mongolian medical Hospital.

Observations group two doses: the Mongolian medicine Guri Gu Muqing liver pill prepared according to the formula of the embodiment 2 of the invention has the following formulation: watered pills (200 mg/pill) are provided by the International Mongolian medicine preparation center of the International Mongolian medical Hospital.

Administration of the control group: liver protection tablet, dosage form: tablets, (0.35 g/tablet) were supplied by Heilongjiang sunflower pharmaceutical company, inc. (national medicine standard Z20003336).

2.1.2 random dispensing

The experimental study was performed as follows: and in the experimental study process, successively distributing drug numbers to patients meeting the group-entering standard according to the screening qualification sequence, and distributing drugs according to the drug numbers by a drug manager or researcher, and returning the rest drugs to the researcher or the drug manager.

2.1.3 methods of administration and courses of treatment

Observation group one: orally taking 15 pills once, 2 times a day, and delivering warm boiled water after breakfast and supper, wherein each treatment course is 6 weeks, and treating for 3 treatment courses;

observation group two: orally taking 15 pills once, 2 times a day, and delivering warm boiled water after breakfast and supper, wherein each treatment course is 6 weeks, and treating for 3 treatment courses;

control group: liver protection tablet, 4 tablets at a time, 2 times a day, warm boiled water delivery after breakfast and supper, 6 weeks of each treatment course, 3 treatment courses;

2.1.4 observations index

2.1.4.1 liver fibrosis index: liver function, blood lipid and liver fibrosis indexes including serum Hyaluronic Acid (HA), laminin (LN), type III procollagen (PC IV) and type IV Collagen (CIV) are checked by fasting blood sampling before and after treatment.

2.1.4.2B superb: b ultrasonic is respectively performed before and after the treatment, and classified into normal (-), mild (+); moderate (++) severe (+++).

2.1.5 therapeutic Standard

Referring to the national administration of Chinese medicine, in 2002, the guidelines for clinical study of New Chinese medicine (trial run) and related literature data, the judgment is made:

and (3) curing: the clinical symptoms completely disappear, the liver echo is basically recovered to be normal when the B ultrasonic examination is carried out, the liver function is recovered to be normal, the Total Cholesterol (TC) in serum is reduced by more than 20 percent, and the Triglyceride (TG) is reduced by more than 40 percent; the effect is shown: clinical symptoms basically or completely disappear, the grade of the echo condition of the liver is reduced by 1 level when the B ultrasonic examination is carried out, the liver function is recovered to be normal, the Total Cholesterol (TC) in serum is reduced by more than 10 to 20 percent, and the Triglyceride (TG) is reduced by more than 20 to 40 percent; the method is effective: the clinical symptoms are obviously improved, the grade of the echo condition of the liver is reduced by 1 grade or improved when the B ultrasonic examination is carried out, the liver function is basically normal and/or the serum Total Cholesterol (TC) is reduced by 10 to 20 percent, and the Triglyceride (TG) is reduced by 20 to 40 percent; invalidation: clinical symptoms and various examination results do not meet the above criteria.

2.1.6 statistical treatments

Statistical analysis is performed by SPSS 18.0 statistical software, the liver function curative effect data of the group is compared by t test, and the total curative effect data is compared by X-ray ² Checking, P<0.05, indicating significant differences, statistically significant.

2.2 results

2.2.1 clinical total curative effect of Mongolian medicine for dialectical treatment of alcoholic hepatitis

After 3 treatment courses, observing 40 cases of the 46 cases of the group, 4 cases of the group are cured, 1 case of the group is effective, 1 case of the group is ineffective, and the total effective rate is 97.83%; observing 38 cases of cure in group II 46, 2 cases of effective cases, 4 cases of effective cases, 2 cases of ineffective cases, and the total effective rate is 95.65%; in 46 cases of the control group, 10 cases are cured, 8 cases are effective, 15 cases are effective, 13 cases are ineffective, and the total effective rate is 71.74% (P is less than 0.01). The Mongolian medicine is suggested to treat alcoholic hepatitis by differentiation of symptoms and signs, and the clinical curative effect is obviously improved (see table 1).

Table 1, comparison of the total efficacy of the three groups

* Comparing the observation group I with the control group, wherein P is less than 0.01; observation group II was compared with control group, P < 0.01; % observations group one compared to observations group two, P < 0.05.

2.2.2 effects of Mongolian medical dialectical treatment on liver fibrosis of alcoholic liver disease

After 3 treatment courses, each group can improve alcoholic hepatitis liver fibrosis, but the improvement effect of the first observation group and the second observation group is obviously better than that of the control group, and the difference compared with the control group has statistical significance (P is less than 0.01); and the improvement effect of the first observation group is better than that of the second observation group, and the difference is statistically significant (P is less than 0.05). Prompting the Mongolian medicine to treat the alcoholic hepatitis by differentiation of symptoms and signs to obviously improve liver fibrosis of the alcoholic hepatitis patient (see table 2), wherein the data before and after the treatment of the control group in table 2 are the average value of the examination results of the patient in the control group; the pre-treatment and post-treatment data of observation group one are the mean of the examination results of the patient of observation group one; the pre-treatment and post-treatment data for the study group two are the mean of the results of the study on the study group two patients.

TABLE 2 influence of three groups on liver fibrosis

Comparison before and after treatment: * P < 0.05, < P < 0.01, < P < 0.001; observations group one compared to control group: ^※ p is less than 0.01; observations group two compared to control group: the #P is less than 0.01; observation group one compared to observation group two: % P < 0.05.

2.2.3 influence of Mongolian medical dialectical treatment on B-ultrasonic curative effect of alcoholic hepatitis

After 3 treatment courses, each group can improve the imaging index of the alcoholic hepatitis, but the improvement effect of the first observation group and the second observation group is obviously better than that of the control group, and the difference compared with the control group has statistical significance (P is less than 0.01); and the improvement effect of the first observation group is better than that of the second observation group, and the difference is statistically significant (P is less than 0.05). The Mongolian medicine dialectical treatment is suggested to be capable of remarkably improving the liver imaging change of the patient with alcoholic hepatitis (see table 3).

TABLE 3 influence of three groups of treatments on liver B-ultrasound efficacy before and after treatment

Comparison before and after treatment: * P < 0.05, < P < 0.01, < P < 0.001; observations group one compared to control group: ^※ p is less than 0.01; observations group two compared to control group: the #P is less than 0.01; observation group one compared to observation group two: % P < 0.05

The foregoing description of the preferred embodiments of the invention is not intended to be limiting, but rather is intended to cover all modifications, equivalents, alternatives, and improvements that fall within the spirit and scope of the invention.

Claims

1. The Mongolian medicine for treating alcoholic liver disease is characterized by comprising the following raw material medicines in parts by weight: 0.1-0.5 part of stigma croci, 0.5-1 part of bezoar, 0.1-0.5 part of bear gall powder, 1-2 parts of antelope horn, 3-4 parts of safflower, 3-4 parts of red sage root, 3-4 parts of myrobalan, 3-4 parts of kudzuvine root, 3-4 parts of schisandra chinensis, 2-4 parts of red sandalwood, 2-3 parts of radix ranunculi ternati, 2-3 parts of silybum marianum, 2-3 parts of lotus seeds, 2-3 parts of szechwan chinaberry fruit, 1-2 parts of cassia seed, 1-2 parts of ginkgo leaf, 1-2 parts of costus root, 1-2 parts of dwarf lilyturf tuber, 1-2 parts of cape jasmine fruit, 1-2 parts of cardamon seed and 1-2 parts of ginseng.

2. The Mongolian medicine for treating alcoholic liver disease according to claim 1, wherein the Mongolian medicine comprises the following raw materials in parts by weight: 0.36 part of saffron, 0.72 part of bezoar, 0.45 part of bear gall powder, 1.2 part of antelope horn, 3.6 parts of safflower, 3.6 parts of red sage root, 3.6 parts of myrobalan, 3.6 parts of kudzuvine root, 3.6 parts of schisandra chinensis, 2.4 parts of red sandalwood, 2.4 parts of catclaw, 2.4 parts of silybum marianum, 2.4 parts of lotus seeds, 2.4 parts of szechwan chinaberry fruit, 1.8 parts of cassia seed, 1.8 parts of ginkgo leaf, 1.8 parts of costus root, 1.8 parts of dwarf lilyturf tuber, 1.8 parts of cape jasmine, 1.8 parts of cardamon seed and 1.8 parts of ginseng.

3. The Mongolian medicine for treating alcoholic liver disease according to claim 1 or 2, wherein the Mongolian medicine is any one of powder, watered pill, honeyed pill, capsule or granule.