CN114569670B - Traditional Chinese medicine composition for treating functional constipation of children - Google Patents
Traditional Chinese medicine composition for treating functional constipation of children Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine composition for treating functional constipation, which is prepared from the following raw materials in parts by weight: 5-12 parts of dwarf lilyturf tuber, 5-12 parts of figwort root, 5-12 parts of hemp seed, 3-10 parts of immature bitter orange, 3-10 parts of magnolia officinalis, 3-10 parts of radix pseudostellariae, 3-10 parts of white paeony root, 3-10 parts of bighead atractylodes rhizome and 3 parts of liquorice. The traditional Chinese medicine composition has proper compatibility of medicines, is cold Wen Xiangshi, is suitable for moistening dryness, is applied together with reinforcing and reducing, is effective in nourishing yin and moistening dryness, strengthening spleen and tonifying qi, and promoting qi circulation and relaxing bowels, has obvious effect in treating functional constipation, especially functional constipation of children, and has stronger practical application value.
Description
Technical Field
The invention particularly relates to a traditional Chinese medicine composition for treating constipation.
Background
Constipation is a gastrointestinal disorder common to pediatrics. Clinically, the stool is dry and even forms balls, the constipation is difficult, the defecation time is irregular, the interval time is longer than 2 days, or the stool is not discharged when the stool is to be solved. According to the etiology, organic constipation, medicinal constipation and functional constipation (Functional Constipation, FC) can be classified into three categories. FC is a common functional gastrointestinal disorder in children, one of the most common causes of childhood visits, accounting for 29% of functional gastrointestinal disorders. In China, the incidence of constipation of children is on an increasing trend in recent years due to the deviation of the dietary structure and the change of life habits of children. The long-term repeated constipation of the children patients can cause appetite reduction, mental abnormality, immunity reduction and the like, such as the gastrointestinal function, the memory and the intelligence development of the children are influenced, and even enuresis, urinary incontinence and the like can be caused, so that the growth and the development and the physical and mental health of the children are seriously influenced. If constipation in childhood is not treated effectively, about 25% of infants get other digestive system diseases in adulthood, severely affecting their quality of life.
Children FC can be classified into the following 3 types according to colonic kinetic pathogenesis: (1) slow-transport constipation (STC): the transmission function of each segment of the proximal colon is weakened; (2) Outlet Obstruction Constipation (OOC): the anorectal region has a dynamic abnormality; (3) Constipation with Constipation (MC): there are both colonic transport disorders and outlet motility abnormalities. At present, the exact pathophysiological mechanism of the children FC is not known, and the mechanism is possibly closely related to the abnormal action of the brain intestinal axis, the abnormal secretion of gastrointestinal hormone, the abnormal enteric nervous system, the abnormal interstitial cells of Cajal, the change of neurotransmitters, the lack of colon power, the abnormal functions of rectum and anus, the change of intestinal microecological flora and the like. Risk factors for morbidity relate to genetic susceptibility, insufficient dietary fiber intake, insufficient drinking water, lack of locomotion, psychological factors, and the like.
The main therapeutic measures of western medicine treatment FC include drug treatment and non-drug treatment, wherein the drug treatment comprises purgative, prokinetic, secretagogue, microecological preparation and the like; non-drug therapies include general therapies, biofeedback, electrical stimulation therapies, surgery, and the like. The medicine intervention is an important means for treating the FC of children, but the chronic administration of the stimulating cathartic can cause colon blackening, damage the interintestinal nerves and aggravate constipation, the administration of the osmotic cathartic can cause electrolyte disturbance, and the application of gastrointestinal prokinetic agents and secretagogues in functional constipation of children is insufficient. The traditional Chinese medicine has long history of treating the infantile constipation and definite curative effect, such as hemp seed pills, is a classical prescription for treating the constipation caused by yang-qi stagnation, integrates qi-moving, viscera-purging, heat-clearing, purgation and yin-nourishing intestine-moistening medicines into a whole, and becomes a classical representative prescription for treating the constipation by a bowel-relaxing method. Although the traditional Chinese patent medicines for treating children functional constipation are various in clinical application at present, a plurality of medicines with strong purgation effect (such as hemp seed pills and the like) contain anthraquinone substances, such as rhubarb, fleece-flower root, aloe, cassia seed, giant knotweed, and the like, and after a few patients take the medicines, side effects of diarrhea, abdominal pain and the like appear, and colon blackening and constipation aggravation can also appear after long-term taking the medicines. In addition, some common Chinese patent medicines such as children food-resolving oral liquid, immature bitter orange stagnation-removing pills, wang's red-retention pills, intestine-moistening granules, ginseng, poria cocos and bighead atractylodes rhizome powder and the like are derived from the meridian prescription, but have relatively single efficacy, and the cause of the children constipation is complex, so that the medicines with several effects are often needed to be matched for use. Therefore, there is a need for a compound cathartic medicament which contains no anthraquinone substances, has definite curative effect and also has the physiological and pathological characteristics of children's ' young yin and young yang '.
Disclosure of Invention
In order to solve the problems, the invention provides a traditional Chinese medicine composition for treating constipation, which is prepared from the following raw materials in parts by weight:
5-12 parts of dwarf lilyturf tuber, 5-12 parts of figwort root, 5-12 parts of hemp seed, 3-10 parts of immature bitter orange, 3-10 parts of magnolia officinalis, 3-10 parts of radix pseudostellariae, 3-10 parts of white paeony root, 3-10 parts of bighead atractylodes rhizome and 3 parts of liquorice.
Further, the material is prepared from the following raw materials in parts by weight:
8 parts of dwarf lilyturf tuber, 8 parts of figwort root, 8 parts of hemp seed, 6 parts of immature bitter orange, 6 parts of magnolia officinalis, 6 parts of radix pseudostellariae, 6 parts of white paeony root, 6 parts of largehead atractylodes rhizome and 3 parts of liquorice;
or:
5 parts of dwarf lilyturf tuber, 5 parts of figwort root, 5 parts of hemp seed, 3 parts of immature bitter orange, 3 parts of magnolia officinalis, 3 parts of radix pseudostellariae, 3 parts of white paeony root, 3 parts of largehead atractylodes rhizome and 3 parts of liquorice;
or:
10 parts of dwarf lilyturf tuber, 10 parts of figwort root, 10 parts of hemp seed, 8 parts of immature bitter orange, 8 parts of magnolia officinalis, 8 parts of radix pseudostellariae, 8 parts of white paeony root, 8 parts of largehead atractylodes rhizome and 3 parts of liquorice;
or:
12 parts of dwarf lilyturf tuber, 12 parts of figwort root, 12 parts of hemp seed, 10 parts of immature bitter orange, 10 parts of magnolia officinalis, 10 parts of radix pseudostellariae, 10 parts of white paeony root, 10 parts of largehead atractylodes rhizome and 3 parts of liquorice.
Still further, the bighead atractylodes rhizome is raw bighead atractylodes rhizome; the Glycyrrhrizae radix is radix Glycyrrhizae Preparata.
Further, the preparation is prepared by taking medicinal powder of the raw material medicine or water or organic solvent extract of the raw material medicine as an active ingredient and adding pharmaceutically acceptable auxiliary materials.
Still further, the formulation is an oral formulation.
Further, the oral preparation is a solution, a granule, a pill, a paste or a capsule.
The invention also provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps:
(1) Weighing the raw materials according to the proportion;
(2) Grinding the raw materials into powder, or extracting with water or organic solvent, and adding pharmaceutically acceptable adjuvants or auxiliary components.
Further, extracting the raw materials in the step (2) with water, concentrating the extract, adding pharmaceutically acceptable auxiliary materials or auxiliary components, and obtaining an oral preparation containing 1g crude drug per 1ml or 3g crude drug per 1 g.
The invention finally provides application of the traditional Chinese medicine composition in preparing a medicine for treating constipation.
Further, the medicament is a medicament for treating functional constipation.
Still further, the medicament is a medicament for treating functional constipation in children.
Radix ophiopogonis in the composition of the invention: sweet, slightly bitter and slightly cold in taste. It enters heart, lung and stomach meridians. Efficacy: nourishing yin, promoting salivation, moistening lung, and clearing away heart-fire. Can be used for treating cough due to yin deficiency, cough due to fatigue, sore throat, fluid consumption, thirst, internal heat, diabetes, vexation, insomnia, constipation due to intestinal dryness. The ophiopogon japonicus has the effects of enhancing human immunity and regulating intestinal flora, and the ophiopogon japonicus polysaccharide MDG-1 can increase the number of the intestinal probiotics of mice to a certain extent, especially the taiwan lactobacillus and the lactobacillus murinus, improve the diversity of the intestinal flora and promote the proliferation of the intestinal probiotics.
Radix scrophulariae: sweet, bitter, salty and slightly cold in taste. It enters lung, stomach and kidney meridians. Efficacy: clearing heat and cooling blood, nourishing yin and reducing fire, and detoxicating and resolving hard mass. Can be used for treating heat entering nutrient blood, toxic heat, speckle, heat disease, yin injury, dark red tongue, polydipsia, constipation due to body fluid deficiency, bone steaming, cough, conjunctival congestion, pharyngalgia, diphtheria, scab, carbuncle, swelling, and sore. The radix scrophulariae can generate antioxidation through dissociation of phenolic hydroxyl groups and free radical ways, inhibit oxidative stress reaction causing constipation, so as to treat constipation, and the effective components of the radix scrophulariae, namely harpagoside, iridoid glycoside and phenylpropanoid glycoside, can change the symptoms of a yin deficiency mouse model, and have a treatment effect on a yin deficiency and body fluid impairment constipation model.
Fructus cannabis: sweet and flat in taste. Enter spleen, stomach and large intestine meridians. Efficacy: relaxing bowel. Can be used for treating constipation due to blood deficiency and fluid deficiency, and intestinal dryness. Fructus Cannabis contains volatile oil, fatty acid and esters, steroids, cannabinols, flavones and glycosides, lignan amides, alkaloids, proteins and amino acids, vitamins and microelements. The fatty acid and esters can stimulate intestinal mucosa, increase intestinal secretion, enhance intestinal peristalsis function, and reduce water absorption, thereby relieving constipation.
Immature bitter orange: bitter, pungent and sour taste and slight cold. Enter spleen, stomach and large intestine meridians. Efficacy: break qi, remove food retention, resolve phlegm and resolve distension and fullness. Can be used for treating stagnation, distention and pain, diarrhea, constipation, phlegm stagnation, qi stagnation, chest pain, chest stuffiness, and viscera prolapse. Fructus Aurantii Immaturus can obviously raise tension of smooth muscle at the fundus of stomach, has effects of promoting gastric motility and accelerating gastric emptying, and can improve contraction of smooth muscle in intestinal tract, enhance tension and exercise function of smooth muscle, and clear intestinal tract content more rapidly, thereby promoting defecation.
Cortex Magnoliae officinalis: bitter and pungent taste and warm. Enter spleen, stomach, lung and large intestine meridians. Efficacy: dry dampness and remove phlegm, and lower qi and remove fullness. Is used for treating damp stagnation, gastric fullness, vomiting and diarrhea, food stagnation, qi stagnation, abdominal distention, constipation, phlegm retention, asthma and cough. The major active ingredients in Magnolia officinalis include magnolol, honokiol, terpineol, isoquinoline alkaloid, palm ketone, quercetin, rutin, etc., and in addition, magnolia officinalis contains saponin, tannin and microelements such as calcium, sodium, potassium, magnesium, ferrum, manganese, zinc, copper, etc. The magnolol and honokiol have the antioxidant effect of eliminating peroxy and superoxide radicals, can delay aging, enhance movement of smooth muscle of stomach fundus, accelerate gastric emptying, relax smooth muscle of duodenum, and relieve discomfort such as duodenal spasm caused by histamine.
Radix pseudostellariae: sweet and slightly bitter in taste, and flat. Enter spleen and lung meridians. Efficacy: replenishing qi to invigorate the spleen, promoting fluid production and moistening the lung. Can be used for treating spleen deficiency, tiredness, inappetence, asthenia after illness, deficiency of qi and yin, spontaneous perspiration, thirst, and dry cough due to lung dryness. The radix pseudostellariae can improve the abundance of beneficial intestinal bacteria, reduce the risk of intestinal diseases, restore the villus structure of small intestine, effectively enhance the antioxidant level of organisms and have the effect of protecting the intestinal tract.
White peony root: bitter and sour in taste and slightly cold in nature. Enter liver and spleen meridians. Efficacy: nourishing blood, regulating menstruation, astringing yin, suppressing sweating, softening liver, relieving pain, and suppressing liver yang. Can be used for treating sallow complexion due to blood deficiency, menoxenia, spontaneous perspiration, night sweat, hypochondriac pain, abdominal pain, limb contracture pain, headache and dizziness. Radix Paeoniae alba total glycosides can promote colonic motility by prolonging the time of contraction of guinea pig colon smooth muscle transverse muscle, and can also regulate colonic motility by acting on enteric nervous system to enhance colonic contraction amplitude.
Raw white atractylodes rhizome: bitter and sweet in taste and warm in temperature. Enter spleen and stomach meridians. Efficacy: invigorating spleen, invigorating qi, eliminating dampness, promoting diuresis, stopping sweating, preventing abortion, and loosening bowel to relieve constipation. Can be used for treating spleen deficiency, anorexia, abdominal distention, diarrhea or constipation, phlegm retention, dizziness, palpitation, edema, spontaneous perspiration, and fetal movement. The raw bighead atractylodes rhizome has the effects of promoting gastrointestinal movement, enhancing gastrointestinal peristalsis, improving intestinal tract transmission function and promoting defecation. Can improve immunity, delay aging, and resist tumor.
Honey-fried licorice root: sweet and flat. It enters heart, lung, spleen and stomach meridians. Efficacy: tonify spleen and stomach, replenish qi and recover pulse. Can be used for treating weakness of spleen and stomach, listlessness, debilitation, palpitation, and pulse knot. Radix Glycyrrhizae Preparata has antioxidant, antiinflammatory, and immunity regulating effects.
In the invention, the dwarf lilyturf tuber is sweet and cold to nourish yin of lung and stomach, and the figwort root is bitter salty and slightly cold to nourish yin and promote the production of body fluid, and the dwarf lilyturf tuber and the figwort root are monarch drugs; fructus cannabis is sweet and flat and moistened to guide the flow of dregs and restore the circulation of stomach qi; bitter orange, bitter and pungent and slightly cold in order to promote qi circulation and remove food retention, remove stagnation and relieve constipation; magnolia officinalis and bitter Xin Wenneng powder can promote the development of energy, has the effects of relieving the stagnation of middle-jiao and stomach, is an essential drug for eliminating distension and fullness, and is an ministerial drug. With the assistance of radix pseudostellariae for tonifying qi of lung and spleen, the effects of nourishing yin and promoting fluid production are achieved during the clearing and tonifying; white peony root nourishes blood, astringes yin, and generates body fluid and blood mutually, and can regulate liver to dredge and release, and liver and wood strip can also help to smooth stool; raw white atractylodes rhizome is sweet and warm to invigorate spleen and stomach middle qi; prepared licorice root, radix Glycyrrhizae Praeparata regulates the actions of the other drugs, but also can tonify spleen and replenish qi, so spleen qi is hyperactivity, qi movement is ordered, accumulation of qi is reduced, so it is a guiding drug. The whole formula has the effects of nourishing yin, moistening dryness, strengthening spleen, tonifying qi, promoting qi circulation and relaxing bowels.
The compatibility of the invention is characterized in that: firstly, the liquid is added to move the boat, and the spleen yin is protected; secondly, sour and sweet, which can transform yin, moisten and reduce diarrhea to relieve constipation; thirdly, the stomach reduces qi and harmonizes, and stagnation is eliminated; fourthly, reinforcing and reducing are performed simultaneously, and the recipe is communicated with reinforcing. The traditional Chinese medicine composition has the advantages of being refined in compatibility of medicines, taking the physiological and pathological characteristics of children into consideration, being high in curative effect, free of toxic and side effects, low in cost, capable of effectively improving constipation symptoms, traditional Chinese medicine symptoms and quality of life of functional constipation (body fluid deficiency and intestine dryness syndrome), low in adverse effect due to safety guarantee and particularly suitable for children (especially young children) due to long-term use compared with traditional Chinese medicine compounds for treating constipation, and good in application prospect.
It should be apparent that, in light of the foregoing, various modifications, substitutions and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims.
The above-described aspects of the present invention will be described in further detail below with reference to specific embodiments in the form of examples. It should not be understood that the scope of the above subject matter of the present invention is limited to the following examples only. All techniques implemented based on the above description of the invention are within the scope of the invention.
Detailed Description
EXAMPLE 1 preparation of the composition of the invention
The formula comprises the following components: 8 parts of dwarf lilyturf tuber, 8 parts of figwort root, 8 parts of hemp seed, 6 parts of immature bitter orange, 6 parts of magnolia officinalis, 6 parts of radix pseudostellariae, 6 parts of white paeony root, 6 parts of largehead atractylodes rhizome and 3 parts of liquorice.
Preparation method (1): weighing the raw materials according to the proportion, adding water, decocting to obtain decoction, and preparing 1g crude drug per 1 ml;
preparation method (2): weighing the raw materials according to the proportion, mixing, soaking the raw materials in water for 20-30 minutes (the water is covered by the medicine surface), boiling with strong fire, decocting with small fire for 15-20 minutes, filtering, and collecting filtrate; decocting in water for the second time, decocting with strong fire, decocting with slow fire for 15-20min, filtering, and collecting filtrate. Mixing the filtrates, concentrating to obtain fluid extract, adding adjuvants, and granulating to obtain granule containing crude drug 3g per 1 g.
EXAMPLE 2 preparation of the medicament of the invention
The formula comprises the following components: 5 parts of dwarf lilyturf tuber, 5 parts of figwort root, 5 parts of hemp seed, 3 parts of immature bitter orange, 3 parts of magnolia officinalis, 3 parts of radix pseudostellariae, 3 parts of white paeony root, 3 parts of largehead atractylodes rhizome and 3 parts of liquorice.
Preparation method (1): weighing the raw materials according to the proportion, adding water into the medicines, decocting the medicines into decoction, and preparing 1g crude drug per 1 ml;
preparation method (2): weighing the raw materials according to the proportion, mixing, soaking the raw materials in water for 20-30 minutes (the water is covered by the medicine surface), boiling with strong fire, decocting with small fire for 15-20 minutes, filtering, and collecting filtrate; decocting in water for the second time, decocting with strong fire, decocting with slow fire for 15-20min, filtering, and collecting filtrate. Mixing the filtrates, concentrating to obtain fluid extract, adding adjuvants, and granulating to obtain granule containing crude drug 3g per 1 g.
EXAMPLE 3 preparation of the medicament of the invention
The formula comprises the following components: 10 parts of dwarf lilyturf tuber, 10 parts of figwort root, 10 parts of hemp seed, 8 parts of immature bitter orange, 8 parts of magnolia officinalis, 8 parts of radix pseudostellariae, 8 parts of white paeony root, 8 parts of largehead atractylodes rhizome and 3 parts of liquorice.
Preparation method (1): weighing the raw materials according to the proportion, adding water into the medicines, decocting the medicines into decoction, and preparing 1g crude drug per 1 ml;
preparation method (2): weighing the raw materials according to the proportion, mixing, soaking the raw materials in water for 20-30 minutes (the water is covered by the medicine surface), boiling with strong fire, decocting with small fire for 15-20 minutes, filtering, and collecting filtrate; decocting in water for the second time, decocting with strong fire, decocting with slow fire for 15-20min, filtering, and collecting filtrate. Mixing the filtrates, concentrating to obtain fluid extract, adding adjuvants, and granulating to obtain granule containing crude drug 3g per 1 g.
EXAMPLE 4 preparation of the medicament of the invention
The formula comprises the following components: 12 parts of dwarf lilyturf tuber, 12 parts of figwort root, 12 parts of hemp seed, 10 parts of immature bitter orange, 10 parts of magnolia officinalis, 10 parts of radix pseudostellariae, 10 parts of white paeony root, 10 parts of largehead atractylodes rhizome and 3 parts of liquorice.
Preparation method (1): weighing the raw materials according to the proportion, adding water into the medicines, decocting the medicines into decoction, and preparing 1g crude drug per 1 ml;
preparation method (2): weighing the raw materials according to the proportion, mixing, soaking the raw materials in water for 20-30 minutes (the water is covered by the medicine surface), boiling with strong fire, decocting with small fire for 15-20 minutes, filtering, and collecting filtrate; decocting in water for the second time, decocting with strong fire, decocting with slow fire for 15-20min, filtering, and collecting filtrate. Mixing the filtrates, concentrating to obtain fluid extract, adding adjuvants, and granulating to obtain granule containing crude drug 3g per 1 g.
The beneficial effects of the present invention are described below by test examples
Test example 1 clinical study
1 data
1.1 general data
The children with functional constipation are diagnosed by the pediatric outpatient department of the traditional Chinese medicine hospital attached to the university of adult Chinese medicine in the period from 2 months in 2019 to 1 month in 2020. Study subjects were divided into 50 observations and 50 controls by simple random (using random numbers) according to the order of treatment.
1.2 diagnostic criteria
1.2.1 Western diagnostic criteria
With reference to roman IV standard formulation for functional constipation, the following symptoms include at least 2 episodes at least 1 time per week for at least 1 month.
Children with the age of less than 4 years have the following symptoms:
1) Relieving constipation for 1 time for 3 days or more.
2) There is a history of fecal retention.
3) There was a history of the discharge of the fecal mass.
4) There is a history of pain or difficulty in defecation.
5) Large pieces of faeces are present in the rectum.
In infants who have been defecation trained, the following symptoms are also required:
1) The academic will have fecal incontinence at least once a week after voluntary defecation.
2) The large manure pieces which may clog the toilet are discharged.
Child patient of 4 years old or more, under the precondition of not meeting the diagnosis of irritable bowel syndrome:
1) Relieving constipation for 1 time for 3 days or more;
2) Fecal incontinence at least once weekly episodes;
3) Has the function of retention of stool or excessive autonomous hold-down of stool;
4) A history of bowel pain or difficulty;
5) The rectum has a large feces block;
6) The large manure pieces which may clog the toilet are discharged.
1.2.2 diagnostic criteria for TCM
The standard of the medical guideline for treating functional constipation and the standard of the medical science of traditional Chinese medicine (in 2014, wang is mainly compiled) are referred to as follows:
main symptoms are as follows: difficult discharge of the excrement, dry and hard excrement and prolonged excrement discharge interval
Secondary symptoms: abdominal distension, abdominal pain, poor appetite, dry mouth and less body fluid
Pulse condition of tongue: a red tongue with little or dry coating, a thready and rapid pulse or a purple-stagnant finger print
The infant symptoms are consistent with the main symptoms, 2 and more symptoms, and can be diagnosed by combining tongue, pulse or fingerprint.
1.3 group entry criteria
(1) Meets Roman IV diagnosis standard and traditional Chinese medicine syndrome waiting diagnosis standard of functional constipation, and symptoms appear for at least 1 month;
(2) Age is less than or equal to 14 years old, and sex is unlimited;
(3) No related history of medication (including therapeutic medication and medication responsible for constipation) was taken within 2 weeks prior to treatment;
(4) Parents of the infant know the consent.
1.4 exclusion criteria
(1) Organic constipation or other diseases such as endocrine and metabolic diseases, and the like, and affects diagnosis and treatment effect judgment;
(2) Non-collaborators, those suffering from psychological disorders;
(3) Futhon treatment has been accepted, or other treatments have been taken that may affect the effectiveness, safety of the observation trial.
1.5 drop criteria
(1) Automatically falling off;
(2) A follow-up cannot be expected for some reason;
(3) The compliance of the children patients and the family members is poor, and the children patients and the family members are not matched with the self-stopping medicine or the self-adding of other therapeutic medicines within a non-specified range;
(4) The following 1 week of the observation group or the control group of the infants has no obvious symptom relief, and the infants should be immediately treated with the anti-blocking drugs, such as enema, and the like, and exit;
(5) The number of automatic defecation times of the children patients in the observation group or the control group is obviously increased before the administration of the medicine, the stool characters are in a dilute water sample, and even the symptoms of abdominal pain and vomiting are serious, and the children patients need to be reduced or stopped as appropriate.
2 method
2.1 methods of treatment
1) Test group drug:
the recipe for benefiting intestines and relaxing bowels for children is prepared from all Chinese medicinal decoction pieces in the department of Traditional Chinese Medicine (TCM) hospital clinic belonging to the university of Chinese medicine in Sichuan province, and the specific recipe composition and dosage are shown in table 1. The decoction method comprises the following steps: soaking the medicines in water for 20-30 min, decocting with strong fire, decocting with slow fire for 15-20min, filtering, decocting with water for the second time, and mixing the two decoctions to obtain daily dosage, wherein the dosage for different ages is shown in table 1.
TABLE 1 specific pharmaceutical compositions and dosages (g)
Add-subtract with symptoms: clinically, add and subtract drugs according to other accompanying symptoms and diseases of patients. If the infant's stool is not relieved for more than 3 days, the infant can be added with 3-5g of wine-processed rhubarb (decoction method comprises soaking in cold water for 30min, boiling over strong fire for 2min, and taking alone, adding 1-3 soup spoon into the decoction for 2-3 days, wherein the infant is reduced or stopped, the stool is slightly abnormal, and emesis and abdominal pain even need to stop medicine); if the infant has the symptoms of acid and stink stool, halitosis, abdominal distention and the like, digestion-promoting medicines such as chicken's gizzard-skin, radish seeds and the like can be optionally added according to the type of infantile dyspepsia to promote digestion and remove food stagnation; for patients with febrile sensation in the palms and soles, vexation, insomnia, and scanty and dark urine, scutellariae radix and fructus forsythiae can be added, or radix et rhizoma Rhei can be added as appropriate to clear heat and relieve constipation; for cases with unsmooth stool, no desire to relieve constipation, borborygmus, flatulence, and abdominal pain, fructus Aurantii Immaturus and cortex Magnolia officinalis can be used, or radix aucklandiae, fructus Toosendan, and rhizoma corydalis can be added to regulate qi, sooth liver and relieve constipation; for cases of struggling with the face of the person who is in the toilet, debilitation and lazy speaking, radix pseudostellariae and radix astragali are used to tonify spleen and lung qi.
The administration method comprises the following steps: taken orally 3 times a day, 10-150ml at a time (< 1 year old, 10-20ml;1-3 years old, 20-60ml;3-6 years old, 60-100ml; > 6 years old, 100-150 ml).
2) Administration of the control group:
fusong (the main component of the product is polyethylene glycol 4000, which is a mixture formed by ethylene oxide and water-borne polymerization, and the auxiliary material is sorbitol) 0.5-0.8 g/(kg.d), and the product is taken after meals for 3 times.
2.2 viewing content
The treatment course is 2 weeks, and the near and long-term curative effects of the two groups of children patients are evaluated and compared by adding and comparing the quantitative scores of the main symptom signs and the secondary symptoms of the two groups of children patients before receiving the treatment, on the day of 2 weeks of treatment course end, 2 months of treatment course end or by telephone follow-up.
2.3 observations index
2.3.1 general data index
Sex, age, constipation course, body Mass Index (BMI), etc. of the subject.
2.3.2 main efficacy index
Quantification criteria for constipation cardinal symptoms: the quantitative standard used in the study was formulated by the Bristol stool scale with reference to constipation symptom and efficacy assessment, and 0 score, 1 score, 2 score, and 3 score were calculated according to the frequency of difficulty in defecation, stool characteristics, stool duration, and frequency, respectively. (see Table 1 for details)
(1) Difficult defecation: counting 0, 1, 2 and 3 points according to none, occasional, sometimes and frequently;
(2) And (3) stool quality: 0, 1, 2 and 3 points are counted according to Bristol7-4, bristol3, bristol2 and Bristol1 respectively;
(3) Defecation time: counting 0min, 1 min, 2min and 3 min for each time of less than 10 min/time, 10-15 min/time, 15-20 min/time and more than 25 min/time;
(4) The sense of falling inexhaustible: counting 0, 1, 2 and 3 points according to none, occasional, sometimes and frequently;
(5) Frequency: the number of the points is 0, 1, 2 and 3 in each of none, occasional, sometimes and frequently.
Secondary syndrome quantification criteria: abdominal distension and pain, poor appetite, dry mouth and less body fluid are quantified in stages according to the frequency of attacks, namely no (0 minutes), occasional (1 minute), sometimes (2 minutes) and often (3 minutes). (see Table 2 in particular)
TABLE 2 quantitative scoring criteria for constipation symptoms and symptoms
2.4 evaluation of efficacy
Reference is made to the criteria for quantitative classification of symptoms of "general principles of clinical research of New traditional Chinese medicine" (2015) and "guidelines of clinical research of New traditional Chinese medicine" (2002): scoring was performed on a scoring scale before treatment and 2 weeks after treatment.
The recovery is that the stool returns to normal, other symptoms and signs disappear or disappear basically, and the integral reduction rate of symptoms is more than or equal to 95 percent.
Has obvious effect that the stool quality and the stool time interval are close to normal, other symptoms or physical signs are obviously improved, and the integral reduction rate of symptoms is less than or equal to 70 percent and less than 95 percent.
The Chinese medicinal composition has the effects of slightly improving the stool quality, or reducing one day before the stool time interval, relieving other symptoms and signs, and reducing the integral rate of symptoms by 30 percent or less to 70 percent.
The disease is not effective, the stool quality, the defecation time interval and other symptoms are not obviously improved, even aggravated, and the integral rate of symptoms is less than 30 percent.
2.5 statistical methods
Statistical analysis was performed on each parameter before and after treatment by IBM SPSS Statistics 21.0.0 software. The measurement data is expressed by mean ± standard deviation, the self-pairing t test is adopted for comparison before and after treatment, the two independent sample t test is adopted for comparison between groups, and X is adopted for classification 2 The assay, variability is denoted by p.
3. Results of clinical trial study
3.1 baseline comparison
The baseline cases of the two groups of cases were compared from three aspects of gender, age, and course of disease.
3.1.1 comparison of gender and age of the two groups
100 children patients who qualify and are included in the clinical study, wherein 41 men and 59 women have a ratio of 1.44:1, and no obvious sex difference exists. The gender comparison of the group 2 infants has no significant difference (p > 0.05), and has comparability. See table 3.
Table 3 2 gender comparison (example%)
The infant age included in this clinical study was 14 years old at maximum, 0.25 years old at minimum, and the average age was 3.81±2.77 years old, with no significant differences (p > 0.05) in the group 2 infant age comparisons, as shown in table 4.
Table 42 age comparisons of groups
The gender and age comparison P of the group 2 infants are larger than 0.05, and the group 2 infants have no statistical significance and are comparable.
3.1.2 comparison of the course of constipation
The pairing t experiment shows that the disease course of the group of children with p > 0.05,2 is not significantly different as shown in table 4.
Table 52 group disease course comparison
Note that: the disease course comparison P of the group 2 children is larger than 0.05, and the children have no statistical significance and comparability.
3.2 comparison of efficacy
3.2.1 in-group comparisons
3.2.1.1.1 comparison of the integral before and after treatment of the observation group (Table 6)
Table 6 comparison of the integral before and after treatment of the observation group
Note that: the paired t test shows that the comparison of the major symptom and the minor symptom before and after the treatment of the group has statistical significance (p is less than 0.01), has extremely obvious difference, has obvious curative effect on treating the infantile constipation by the prescription for relaxing the bowels, and has outstanding curative effect on the improvement of the major symptom and the minor symptom.
3.2.1.2 comparison of the integration before and after treatment of the control group (Table 7)
Table 7 comparison of the integration before and after treatment of the control group
Note that: the comparison of the major symptom and the minor symptom of the control group before and after treatment by the paired t test has statistical significance (p is less than 0.05), has obvious difference, can be seen to have obvious curative effect on treating infantile constipation, and has obvious effect on improving major symptom and minor symptom.
3.2.2 group comparisons
3.2.2.1 Group 2 comparison of integration before and after treatment (Table 8)
Table 82 comparison of scores of infants before and after treatment
Note that: through variance test, the observed group infant is superior to the control group in terms of the integral difference value of the main symptoms and the integral difference value of the secondary symptoms after treatment; the curative effect of the observation group on relieving the secondary symptoms such as abdominal distension, anorexia and the like caused by constipation is better than that of the control group.
3.2.2.2 Group 2 children patients overall efficacy comparison (Table 9)
General efficacy comparison of infants with Table 9 2 group
Note that: warp X 2 Analysis of the total efficacy of the 2 groups showed significant differences (p < 0.05), as can be seen from Table 9, the cure rates of the observed group and the control group were 20.00% and 10.00% respectively, the cure rates of the observed group were 62.00% and 36.00% respectively, and the cure rates of the observed group were statistically compared with the control groupThe difference in science (p < 0.05) suggests that the treatment effect of the prescription for relaxing the bowels of children is better than that of foson.
3.2.2.3 Group 2 children patients with long-term efficacy comparison after 2 months (Table 10)
Table 10 group 2 children patients with long-term efficacy comparison after 2 months
Note that: the group 2 children patients are followed up after 2 months, the total effective rate of the group control observation groups is 84.00 percent and 76.00 percent respectively, the cure obvious efficiency is 52.00 percent and 30.00 percent, and the total effective rate of the group control observation groups is X-way 2 The total effective rate of the observation group is compared with that of the control group, the statistical significance is achieved (p is smaller than 0.05), the cure apparent rate of the observation group is obviously different from that of the control group (p is larger than 0.05), and the observation group is prompted to have better long-term curative effect than that of the control group.
3.3 safety and adverse reaction Observation
In the experimental process, only 1 infant in the observation group has symptoms of abdominal pain, pain appears around umbilicus, the pain degree can be tolerated, the abdominal pain is relieved after stopping the medicine, and the rest infants have no serious adverse side effects such as abdominal pain, vomiting and the like.
4. Results
Through strict screening, the clinical experiment finally includes 100 cases of children suffering from fluid deficiency and intestinal dryness syndrome in a group, 50 cases of children suffering from observation group and control group respectively, and the general conditions of the children suffering from fluid deficiency and intestinal dryness syndrome, such as age, sex, disease course and the like, are subjected to statistical analysis, p is greater than 0.05, and the differences are of no statistical significance and are comparable. After treatment for 2 weeks, the total effective rate of the two groups of infants is 88 percent and 82 percent respectively, the cure rate is 16.00 percent and 12.00 percent respectively, the cure rate is 54.00 percent and 42.00 percent respectively, and the paired t experiment shows that p is less than 0.05, which shows that the observed group, namely the infant intestine-benefiting and bowel-relaxing prescription has better curative effect than the control group; the follow-up result of 2 months shows that the total effective rate (84.00%) of the children intestine-tonifying and bowel-relaxing prescription is obviously higher than Yu Fusong (76.00%). The integral difference values of the two groups are compared between groups, the integral difference value of the main symptoms and the secondary integral difference value of the observed groups are 7.00+/-3.05 and 4.36+/-1.88, the integral difference value of the main symptoms and the secondary integral difference value of the control group are 5.54+/-3.20 and 3.00+/-2.18, and the treatment effect of the infant bowel-benefiting and relaxing prescription is obviously better than that of the Fusong group (p < 0.05) no matter changing the stool characters, increasing the defecation times or relieving the secondary symptoms such as anorexia, halitosis, abdominal distention and abdominal pain caused by long-term constipation. Clinical studies indicate that: the infant constipation treating prescription has a definite curative effect, is safe and reliable, and can be used as an effective prescription for treating infant constipation for further in-depth research and popularization.
5. Conclusion(s)
The invention observes that the prescription for treating the infantile constipation by the bowel-relaxing prescription is definite in curative effect, safe and reliable, and can be used as an effective prescription for treating the infantile constipation for further deep research and popularization.
The invention relates to a prescription for benefiting intestines and relaxing bowels for children, which consists of dwarf lilyturf tuber, figwort root, hemp seed, immature bitter orange, magnolia officinalis, radix pseudostellariae, white paeony root, raw largehead atractylodes rhizome and honey-fried licorice root. In the formula, dwarf lilyturf tuber and figwort root are used, wherein dwarf lilyturf tuber is sweet and cold to nourish yin of lung and stomach, figwort root is bitter salty and slightly cold to nourish yin and promote the production of body fluid, and the dwarf lilyturf tuber and figwort root are used as monarch drugs. Fructus cannabis is sweet and flat and moistened to guide the flow of dregs and restore the circulation of stomach qi; bitter orange, bitter and pungent and slightly cold in order to promote qi circulation and remove food retention, remove stagnation and relieve constipation; magnolia officinalis and bitter Xin Wenneng powder can promote the development of energy, has the effects of relieving the stagnation of middle-jiao and stomach, is an essential drug for eliminating distension and fullness, and is an ministerial drug. With the assistance of radix pseudostellariae for tonifying qi of lung and spleen, the effects of nourishing yin and promoting fluid production are achieved during the clearing and tonifying; white peony root nourishes blood, astringes yin, and generates body fluid and blood mutually, and can regulate liver to dredge and release, and liver and wood strip can also help to smooth stool; raw white atractylodes rhizome is sweet and warm to invigorate spleen and stomach middle qi; prepared licorice root, radix Glycyrrhizae Praeparata regulates the actions of the other drugs, but also can tonify spleen and replenish qi, so spleen qi is hyperactivity, qi movement is ordered, accumulation of qi is reduced, so it is a guiding drug. The whole formula has the effects of nourishing yin, moistening dryness, strengthening spleen, tonifying qi, promoting qi circulation and relaxing bowels.
The selected raw material medicine is cold Wen Xiangshi, is suitable for moistening dryness, is applied together with reinforcing and reducing, and is effective in nourishing yin and moistening dryness, strengthening spleen and tonifying qi, and promoting qi circulation and relaxing bowels. The traditional Chinese medicine composition for treating functional constipation has the compatibility conforming to the principle of compatibility of prescriptions of monarch, minister, assistant and guide, refined medicine taste, and compatible physiological and pathological points of children due to the prescription, has the advantages of high curative effect, no toxic or side effect, low cost and the like, and is especially suitable for children. The selected raw materials and the proportion between the raw materials are tested and screened, so that the invention has the advantage of remarkable effect. The preparation method is simple and easy to implement, is easy to accept by patients, is a safe and effective traditional Chinese medicine composition for treating functional constipation, and has good application prospect. The invention can effectively improve constipation symptoms, traditional Chinese medicine symptoms and life quality of functional constipation (body fluid deficiency and intestine dryness syndrome), and has high safety and low adverse reaction.
Claims (7)
1. A traditional Chinese medicine composition for treating children functional constipation is characterized in that: the composite material is prepared from the following raw materials in parts by weight:
8 parts of dwarf lilyturf tuber, 8 parts of figwort root, 8 parts of hemp seed, 6 parts of immature bitter orange, 6 parts of magnolia officinalis, 6 parts of radix pseudostellariae, 6 parts of white paeony root, 6 parts of raw largehead atractylodes rhizome and 3 parts of honey-fried licorice root;
or:
5 parts of dwarf lilyturf tuber, 5 parts of figwort root, 5 parts of hemp seed, 3 parts of immature bitter orange, 3 parts of magnolia officinalis, 3 parts of radix pseudostellariae, 3 parts of white paeony root, 3 parts of raw largehead atractylodes rhizome and 3 parts of honey-fried licorice root;
or:
10 parts of dwarf lilyturf tuber, 10 parts of figwort root, 10 parts of hemp seed, 8 parts of immature bitter orange, 8 parts of magnolia officinalis, 8 parts of radix pseudostellariae, 8 parts of white paeony root, 8 parts of raw largehead atractylodes rhizome and 3 parts of honey-fried licorice root;
or:
12 parts of dwarf lilyturf tuber, 12 parts of figwort root, 12 parts of hemp seed, 10 parts of immature bitter orange, 10 parts of magnolia officinalis, 10 parts of radix pseudostellariae, 10 parts of white paeony root, 10 parts of raw white atractylodes rhizome and 3 parts of honey-fried licorice root.
2. The traditional Chinese medicine composition according to claim 1, wherein: the preparation is prepared by taking medicinal powder of the raw materials or water or organic solvent extracts of the raw materials as active ingredients and adding pharmaceutically acceptable auxiliary materials.
3. The traditional Chinese medicine composition according to claim 2, wherein: the preparation is an oral preparation.
4. A Chinese medicinal composition according to claim 3, wherein: the oral preparation is solution, granule, pill, paste or capsule.
5. The method for preparing the traditional Chinese medicine composition of claim 1, which is characterized in that: it comprises the following steps:
(1) Weighing raw materials according to the proportion of claim 1;
(2) Grinding the raw materials into powder, or extracting with water or organic solvent, and adding pharmaceutically acceptable adjuvants or auxiliary components.
6. The method of manufacturing according to claim 5, wherein: extracting the raw materials in the step (2) with water, concentrating the extract, adding pharmaceutically acceptable auxiliary materials or auxiliary components, and obtaining an oral preparation containing 1g crude drug per 1ml or 3g crude drug per 1 g.
7. The use of the traditional Chinese medicine composition according to any one of claims 1-4 in preparing a medicament for treating functional constipation of children.
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| CN101797287A (en) * | 2010-04-16 | 2010-08-11 | 成都师创生物医药科技有限公司 | Purgative traditional Chinese medicine composition for strengthening spleen, replenishing qi, enriching blood and moisturizing intestine |
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| CN101130000A (en) * | 2007-08-27 | 2008-02-27 | 尹克华 | Traditional Chinese medicine for treating postoperative constipation |
| CN101797287A (en) * | 2010-04-16 | 2010-08-11 | 成都师创生物医药科技有限公司 | Purgative traditional Chinese medicine composition for strengthening spleen, replenishing qi, enriching blood and moisturizing intestine |
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