CN114569670A

CN114569670A - Traditional Chinese medicine composition for treating constipation

Info

Publication number: CN114569670A
Application number: CN202210289655.XA
Authority: CN
Inventors: 赵琼; 黄勤挽; 刘茜玮; 邓媛
Original assignee: Chengdu University of Traditional Chinese Medicine
Current assignee: Chengdu University of Traditional Chinese Medicine
Priority date: 2022-03-23
Filing date: 2022-03-23
Publication date: 2022-06-03
Anticipated expiration: 2042-03-23
Also published as: CN114569670B

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 radix ophiopogonis, 5-12 parts of radix scrophulariae, 5-12 parts of fructus cannabis, 3-10 parts of immature bitter orange, 3-10 parts of mangnolia officinalis, 3-10 parts of radix pseudostellariae, 3-10 parts of radix paeoniae alba, 3-10 parts of bighead atractylodes rhizome and 3 parts of liquorice. The traditional Chinese medicine composition has the advantages of precise and appropriate compatibility of medicines, appropriate cold and warm properties, appropriate dryness-moistening properties, concurrent application of tonics and purgation, combination of tonics and purgation, effects of nourishing yin and moistening dryness, strengthening spleen and replenishing qi, and promoting qi circulation and relaxing bowels, has obvious effects on treating functional constipation, especially children functional constipation, and has strong practical application value.

Description

Traditional Chinese medicine composition for treating constipation

Technical Field

The invention particularly relates to a traditional Chinese medicine composition for treating constipation.

Background

Constipation is a common gastrointestinal disorder in pediatric clinics. The clinical manifestations are dry stool or even dry stool into balls, difficult constipation, irregular defecation time, more than 2 days interval time, or no defecation without defecation. The etiology of Constipation can be classified into three major categories, namely, organic Constipation, drug Constipation and Functional Constipation (FC). FC is a common functional gastrointestinal disorder in children, and is 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 the rise in recent years due to the difference of dietary structures and the change of living habits of the children. Repeated constipation of children patients for a long time can cause appetite reduction, psychogenic abnormality, immunity reduction and the like, such as gastrointestinal function, memory and intelligence development of children, even enuresis, incontinence of urine and the like, and seriously affect growth and development and physical and psychological health of children. If constipation in childhood is not treated effectively, about 25% of children to adults suffer from other digestive diseases, seriously affecting their quality of life.

Children FC can be classified into the following 3 types according to colonic dynamic pathogenesis: (1) slow Transit Constipation (STC): the transmission function of each segment of the proximal colon is weakened; (2) constipation with Outlet Obstruction (OOC): dynamic abnormalities exist in the anorectal region; (3) mixed Constipation (MC): both colonic transit obstruction and exit motility abnormalities are present. At present, the exact pathophysiological mechanism of child FC is unknown, and may be closely related to the abnormal action of the brain-intestine axis, the abnormal secretion of gastrointestinal hormone, the abnormal intestinal nervous system, the abnormal interstitial cell of Cajal, the change of neurotransmitter, the lack of colon power, the abnormal anorectal function, the change of intestinal microecological flora and the like. Risk factors for morbidity relate to genetic susceptibility, inadequate dietary fiber intake, inadequate water consumption, lack of exercise, psychopsychological factors, and the like.

The main treatment measures for treating FC in western medicine comprise drug treatment and non-drug treatment, wherein the drug treatment comprises laxatives, prokinetic agents, secretion promoters, microecologics and the like; non-drug therapies include general therapy, biofeedback, electrical stimulation therapy, surgery, and the like. The drug intervention is an important means for treating FC in children, but colon melanosis can be caused by taking irritant cathartic for a long time, the constipation is aggravated by damaging nerves between intestinal muscles, electrolyte disturbance can be caused by taking osmotic cathartic, and the application evidence of gastrointestinal prokinetic agents and secretagogues in functional constipation of children is not sufficient. The traditional Chinese medicine has a long history of treating infantile constipation and a definite curative effect, like the ephedra kernel pill, is a classic prescription for treating yang-stagnation constipation carried by Zhang Zhongjing in Shang Han miscellaneous disease treatise, integrates qi-moving, bowel-relaxing, heat-clearing and purgation, and yin-nourishing and intestine-moistening medicines, and becomes a classic representative prescription for treating constipation by a bowel-relaxing and constipation-relieving method. Although the traditional Chinese patent medicines clinically used for treating functional constipation of children at present are various in types, many medicines with strong purgative effect (such as fructus cannabis pills and the like) contain anthraquinone substances, such as rheum officinale, polygonum multiflorum, aloe, semen cassiae, polygonum cuspidatum and the like, side effects of diarrhea, abdominal pain and the like appear after a patient takes the traditional Chinese medicine, and the situations of blackening colon and aggravating constipation can also appear after long-term taking. In addition, some common Chinese patent medicines such as children's digestion-promoting oral liquid, immature bitter orange stagnation-removing pill, Wangshi Baochi pill, intestine-moistening granule, Shenling Baizhu powder and the like are derived from the meridian prescription, but the efficacy is relatively single, and the cause of children's constipation is complex, so that several efficacy medicines are often required to be used in combination. Therefore, a compound-type laxative Chinese patent medicine which does not contain anthraquinone substances, has definite curative effect and can also take the physiological and pathological characteristics of the infant's ' young yin and young yang ' into consideration is urgently needed in clinic.

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 radix ophiopogonis, 5-12 parts of radix scrophulariae, 5-12 parts of fructus cannabis, 3-10 parts of immature bitter orange, 3-10 parts of mangnolia officinalis, 3-10 parts of radix pseudostellariae, 3-10 parts of radix paeoniae alba, 3-10 parts of bighead atractylodes rhizome and 3 parts of liquorice.

Further, the medicine is prepared from the following raw materials in parts by weight:

8 parts of radix ophiopogonis, 8 parts of radix scrophulariae, 8 parts of fructus cannabis, 6 parts of immature bitter orange, 6 parts of mangnolia officinalis, 6 parts of radix pseudostellariae, 6 parts of radix paeoniae alba, 6 parts of rhizoma atractylodis macrocephalae and 3 parts of liquorice;

or:

5 parts of radix ophiopogonis, 5 parts of radix scrophulariae, 5 parts of fructus cannabis, 3 parts of immature bitter orange, 3 parts of mangnolia officinalis, 3 parts of radix pseudostellariae, 3 parts of radix paeoniae alba, 3 parts of rhizoma atractylodis macrocephalae and 3 parts of liquorice;

or:

10 parts of radix ophiopogonis, 10 parts of radix scrophulariae, 10 parts of fructus cannabis, 8 parts of immature bitter orange, 8 parts of mangnolia officinalis, 8 parts of radix pseudostellariae, 8 parts of radix paeoniae alba, 8 parts of rhizoma atractylodis macrocephalae and 3 parts of liquorice;

or:

12 parts of radix ophiopogonis, 12 parts of radix scrophulariae, 12 parts of fructus cannabis, 10 parts of immature bitter orange, 10 parts of mangnolia officinalis, 10 parts of radix pseudostellariae, 10 parts of radix paeoniae alba, 10 parts of rhizoma atractylodis macrocephalae and 3 parts of liquorice.

Further, the bighead atractylodes rhizome is raw bighead atractylodes rhizome; the Glycyrrhrizae radix is radix Glycyrrhizae Preparata.

Furthermore, the traditional Chinese medicine composition is a preparation prepared by taking medicinal powder of raw material medicines, or water or organic solvent extracts of the raw material medicines as active ingredients 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, the raw material medicines in the step (2) are added with water for extraction, the extract is concentrated, and pharmaceutically acceptable auxiliary materials or auxiliary components are added to obtain an oral preparation containing 1g of raw materials per 1ml or 3g of raw materials 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.

Further, the medicament is a medicament for treating functional constipation in children.

The radix ophiopogonis in the composition of the invention: sweet, slightly bitter and slightly cold. It enters heart, lung and stomach meridians. The efficacy is as follows: nourish yin, promote the production of body fluid, moisten lung and clear away heart-fire. Can be used for treating dry cough due to lung dryness, cough due to yin deficiency, pharyngitis, pharyngalgia, thirst due to body fluid consumption, internal heat, diabetes, vexation, insomnia, and constipation due to intestinal dryness. The ophiopogon root has the effects of enhancing the immunity of a human body and regulating intestinal flora, and the ophiopogon root polysaccharide MDG-1 can increase the quantity of intestinal probiotics of mice to a certain extent, particularly lactobacillus taiwan and lactobacillus murinus, and simultaneously improve the diversity of the intestinal flora and promote the proliferation of the intestinal probiotics.

Figwort root: sweet, bitter, salty and slightly cold in flavor. It enters lung, stomach and kidney meridians. The efficacy is as follows: clear heat and cool blood, nourish yin to reduce fire, remove toxicity and dissipate nodulation. Can be used for treating heat entering nutrient-blood, toxic heat generating macula, fever damaging yin, crimson tongue with polydipsia, body fluid deficiency constipation, bone steaming, overstrain cough, conjunctival congestion, pharyngalgia, diphtheria, scab, carbuncle, swelling, and sore. Radix scrophulariae has antioxidant effect through dissociation of phenolic hydroxyl group and free radical, and can inhibit oxidative stress reaction causing constipation, so as to treat constipation, and its effective components harpagoside, iridoid glycoside, and phenylpropanoid glycoside can change symptoms of mouse model with yin deficiency, and can be used for treating constipation model with syndrome of yin deficiency and body fluid deficiency.

Fructus cannabis: sweet and mild in taste. It enters spleen, stomach and large intestine meridians. The efficacy is as follows: to moisten intestines and relax bowels. Can be used for treating constipation due to intestinal dryness caused by blood deficiency and body fluid deficiency. The fructus Cannabis contains essential oil, fatty acid and ester, steroid, cannabis phenol, flavone and glycoside, lignanoid amide, alkaloid, protein and amino acid, vitamin and microelement etc. as main active ingredients. The fatty acid and ester can stimulate intestinal mucosa, increase intestinal secretion, enhance intestinal peristalsis function, and reduce water absorption, thereby achieving the effect of relaxing bowels.

Immature bitter orange: bitter, pungent, sour and slightly cold. It enters spleen, stomach and large intestine meridians. The efficacy is as follows: break qi and remove food retention, resolve phlegm and disperse distention and fullness. Can be used for treating stagnation, abdominal distention, pain, dysentery, constipation, phlegm stagnation, qi stagnation, thoracic obstruction, and viscera prolapse. The immature bitter orange can obviously increase the tension of the stomach fundus smooth muscle, has the effects of promoting gastric motility and accelerating gastric emptying, can improve the contraction effect of the intestinal smooth muscle, enhances the tension and movement functions of the smooth muscle, and more quickly removes intestinal contents, thereby promoting defecation.

Magnolia bark: bitter, pungent and warm in flavor. It enters spleen, stomach, lung and large intestine meridians. The efficacy is as follows: dry dampness and dissolve phlegm, descend qi and remove fullness. Can be used for treating damp stagnation, abdominal distention, vomiting, diarrhea, food stagnation, qi stagnation, abdominal distention, constipation, phlegm retention, asthma, and cough. The main active ingredients of cortex Magnolia officinalis include magnolol, honokiol, xanthophyll, isoquinoline alkaloid, palmitone, quercetin, rutin, etc., and cortex Magnolia officinalis also contains saponin, tannin, and trace elements such as calcium, sodium, potassium, magnesium, iron, manganese, zinc, copper, etc. Magnolol and honokiol have antioxidant effect for scavenging peroxide and superoxide radical, and can be used for delaying aging, enhancing motion of stomach fundus smooth muscle, accelerating gastric emptying, relaxing duodenal smooth muscle, and relieving discomfort such as duodenal spasm caused by histamine.

Radix pseudostellariae: sweet, slightly bitter and neutral in taste. It enters spleen and lung meridians. The efficacy is as follows: to replenish qi, invigorate the spleen, promote the production of body fluid and moisten the lung. Can be used for treating spleen deficiency, asthenia, deficiency of both qi and yin, spontaneous perspiration, thirst, and dry cough due to lung dryness. Radix pseudostellariae can improve the abundance of beneficial bacteria in the intestinal tract, reduce the risk of intestinal tract diseases, recover the villus structure of the small intestine, effectively enhance the antioxidation level of the organism and simultaneously have the effect of protecting the intestinal tract.

White peony root: bitter and sour in taste, and slightly cold in nature. It enters liver and spleen meridians. The efficacy is as follows: nourish blood and regulate menstruation, astringe yin and check sweating, soften liver and relieve pain, and calm liver yang. Can be used for treating blood deficiency, sallow complexion, menoxenia, spontaneous perspiration, night sweat, hypochondriac pain, abdominal pain, limb spasm pain, headache, and vertigo. The total glucosides of paeony can promote colon movement by prolonging the contraction time of the smooth muscle and the transverse muscle of the colon of the guinea pig, and can also regulate the colon movement by acting on the enteric nervous system to enhance the contraction amplitude of the colon.

Raw rhizoma atractylodis macrocephalae: bitter, sweet and warm in taste. It enters spleen and stomach meridians. The efficacy is as follows: invigorate spleen, replenish qi, dry dampness, induce diuresis, stop sweating, prevent abortion, moisten intestines and relieve constipation. Can be used for treating spleen deficiency, anorexia, abdominal distention, diarrhea or constipation, phlegm retention, dizziness, palpitation, edema, spontaneous perspiration, and threatened abortion. The rhizoma Atractylodis Macrocephalae has effects of promoting the movement of digestive tract, enhancing the peristalsis of gastrointestinal tract, improving the transmission function of intestinal tract, and promoting defecation. Has effects in enhancing immunity, delaying aging, and resisting tumor.

Honey-fried licorice root: sweet and mild in taste. It enters heart, lung, spleen and stomach meridians. The efficacy is as follows: tonify spleen and stomach, replenish qi and recover pulse. Can be used for treating weakness of spleen and stomach, asthenia, palpitation, and intermittent pulse. Radix Glycyrrhizae Preparata has effects of resisting oxidation, resisting inflammation, and regulating immunity.

In the traditional Chinese medicine, the radix ophiopogonis is sweet and cold in flavor to nourish yin of lung and stomach, the radix scrophulariae is bitter and slightly cold in flavor to moisten the lower part, nourish yin and promote the production of body fluid, and the radix ophiopogonis and the radix scrophulariae are monarch medicines; fructus Cannabis, sweet in flavor and mild in property, can induce the food dregs to go out and recover the descending of stomach-qi; the bitter orange is bitter, pungent and slightly cold to promote qi circulation, remove food retention, remove food stagnation and relax bowels; the magnolia officinalis, bitter and pungent in flavor and warm energy dissipating powder can generate energy and act, can widen the middle energizer and resolve stagnation, is an essential drug for eliminating fullness, and is a ministerial drug together. The assistant radix pseudostellariae can tonify qi of lung and spleen, clear and nourish yin and promote the production of body fluid; the white peony root has the functions of nourishing blood, astringing yin, promoting fluid and blood generation, and can regulate the flow of the liver and smooth the defecation; raw Bai Zhu is sweet and warm in nature and can tonify middle-warmer energy of spleen and stomach; prepared licorice root, radix Glycyrrhizae Praeparata, as a guiding drug, can also tonify spleen and qi, and when spleen qi is vigorous, qi will ascend and descend orderly and the food will be accumulated. The whole formula has the effects of nourishing yin, moistening dryness, strengthening spleen, tonifying qi, promoting qi circulation and relaxing bowels.

The compatibility of medicines of the invention has four characteristics: firstly, increasing liquid and moving the boat to protect spleen yin; secondly, sour and sweet to transform yin, moisten and descend to purge and relax bowels; thirdly, stomach qi descending and harmonizing, and stagnation can be automatically eliminated; fourth, tonify and purge are applied simultaneously, so as to dredge the reinforcement. The traditional Chinese medicine composition has the advantages of being refined in medicine taste, free of toxic and side effects, low in cost, capable of effectively improving constipation symptoms of functional constipation (body fluid deficiency and intestinal dryness syndrome), traditional Chinese medicine symptoms and life quality, and low in adverse reaction of safety guarantee in longer-term use compared with the existing commonly used traditional Chinese medicine compound for treating constipation, especially suitable for children (especially young children), is a safe and effective traditional Chinese medicine composition for treating functional constipation, and has a good application prospect.

Obviously, many modifications, substitutions, and variations are possible in light of the above teachings of the invention, without departing from the basic technical spirit of the invention, as defined by the following claims.

The present invention will be described in further detail with reference to the following examples. This should not be understood as limiting the scope of the above-described subject matter of the present invention to the following examples. All the technologies realized based on the above contents of the present invention belong to the scope of the present invention.

Detailed Description

Example 1 preparation of a composition according to the invention

The formula is as follows: 8 parts of radix ophiopogonis, 8 parts of radix scrophulariae, 8 parts of fructus cannabis, 6 parts of immature bitter orange, 6 parts of magnolia officinalis, 6 parts of radix pseudostellariae, 6 parts of radix paeoniae alba, 6 parts of rhizoma atractylodis macrocephalae and 3 parts of liquorice.

The preparation method comprises the following steps: weighing the above raw materials at a certain ratio, decocting in water to obtain decoction, and making into 1g crude drug per 1 ml;

the preparation method comprises the following steps: weighing the above raw materials according to a certain proportion, mixing, soaking the medicine in water for 20-30 minutes (the water is covered on the medicine surface), decocting with strong fire, decocting with slow 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 15-20 min, filtering, and collecting filtrate. Mixing the two filtrates, concentrating to obtain fluid extract, adding adjuvant, and making into granule containing crude drug 3g per 1 g.

Example 2 preparation of the inventive Agents

The formula is as follows: 5 parts of radix ophiopogonis, 5 parts of radix scrophulariae, 5 parts of fructus cannabis, 3 parts of immature bitter orange, 3 parts of mangnolia officinalis, 3 parts of radix pseudostellariae, 3 parts of radix paeoniae alba, 3 parts of rhizoma atractylodis macrocephalae and 3 parts of liquorice.

The preparation method comprises the following steps: weighing the above materials at a certain ratio, decocting the materials in water to obtain decoction, and making into 1g crude drug per 1 ml;

Example 3 preparation of the inventive Agents

The formula is as follows: 10 parts of radix ophiopogonis, 10 parts of radix scrophulariae, 10 parts of fructus cannabis, 8 parts of immature bitter orange, 8 parts of mangnolia officinalis, 8 parts of radix pseudostellariae, 8 parts of radix paeoniae alba, 8 parts of rhizoma atractylodis macrocephalae and 3 parts of liquorice.

Example 4 preparation of the inventive Agents

The formula is as follows: 12 parts of radix ophiopogonis, 12 parts of radix scrophulariae, 12 parts of fructus cannabis, 10 parts of immature bitter orange, 10 parts of mangnolia officinalis, 10 parts of radix pseudostellariae, 10 parts of radix paeoniae alba, 10 parts of rhizoma atractylodis macrocephalae and 3 parts of liquorice.

The advantageous effects of the present invention will be described below by way of test examples

Test example 1 clinical study

1 data of

1.1 general data

The infant who is diagnosed as functional constipation in pediatric outpatient service of traditional Chinese medicine hospital affiliated to Chengdu traditional Chinese medicine university is diagnosed from 2 months in 2019 to 1 month in 2020. The study subjects were divided into 50 cases of the observation group and 50 cases of the control group by a simple randomization method (using a random number method) according to the treatment order.

1.2 diagnostic criteria

1.2.1 Western diagnostic standards

Referring to the roman IV standard for functional constipation, the following symptoms include at least 2, at least 1 episode per week for at least 1 month.

Children < 4 years of age have the following symptoms:

1) defecate for 1 time in 3 days or more.

2) There was a history of fecal retention.

3) There was a history of discharging large fecal masses.

4) There was a history of pain or difficulty in defecation during defecation.

5) Large pieces of stool are present in the rectum.

In the children who have performed defecation training, the following symptoms are required:

1) fecal incontinence is initiated at least once a week after the learning of voluntary defecation.

2) The large pieces of manure that may clog the toilet are discharged.

The infant is more than or equal to 4 years old, and on the premise that the irritable bowel syndrome diagnosis is not satisfied:

1) defecating for 1 time in 3 days or more;

2) fecal incontinence occurs at least once a week;

3) has the function of constipation retention posture or excessive self-suffocating excrement;

4) A history of pain or difficulty with defecation;

5) large fecal masses are present in the rectum;

6) the large pieces of manure that may clog the toilet are discharged.

1.2.2 Chinese medicine diagnostic standards

The standard is formulated according to the functional constipation diagnosis and treatment guideline and the traditional Chinese medicine pediatrics (2014, compiled by Wang Kongsu), and the standard is as follows:

the main symptoms are: difficult defecation, dry and hard stool and prolonged defecation interval

The secondary symptoms are as follows: abdominal distention, abdominal pain, poor appetite, dry mouth and little body fluid

Tongue pulse condition: a red tongue with little or dry coating and a thready and rapid pulse or purple-superficial stagnation of the fingerprint

The symptoms of the children patients meet the main symptoms, and have 2 or more symptoms, and can be diagnosed by combining tongue, pulse or fingerprint.

1.3 criteria for grouping

(1) The diagnosis standard accords with the Roman IV diagnosis standard and the Chinese medicine syndrome diagnosis standard of functional constipation, and the symptoms appear for at least 1 month;

(2) the age is less than or equal to 14 years old, and the nature is not limited;

(3) history of not taking relevant drugs (including treatment drugs and drugs causing constipation) within 2 weeks before treatment;

(4) the parents of the children suffer from informed consent.

1.4 exclusion criteria

(1) Organic constipation, endocrine diseases, metabolic diseases and other diseases accompanied by symptoms affecting diagnosis and judgment of therapeutic effect;

(2) non-authors, those with psychological disease;

(3) the treatment of the formonones is already accepted, or other treatment measures which can influence the effectiveness and safety of the observation experiment are adopted.

1.5 shedding criterion

(1) Automatically falling off;

(2) for some reason they cannot follow up as expected;

(3) the children patients and family members have poor compliance, and do not cooperate with self-stopping medicines or self-adding other treatment medicines in a non-specified range;

(4) the symptom of the children patients in the observation group or the control group is not obviously relieved after the follow-up visit for 1 week, and the patients should be immediately subjected to the anti-blocking medicines, such as the enema and the like, and quit;

(5) before the children patients in the observation group or the control group use the medicine, the times of automatic defecation are obviously increased, the stool character is in a dilute water sample, even the symptoms of abdominal pain and vomiting are serious, and the patients need to be reduced or stopped as required.

2 method

2.1 methods of treatment

1) The test group is used as follows:

the infant intestine-benefiting and bowel-relaxing formula is prepared from all traditional Chinese medicine decoction pieces in an outpatient clinic of traditional Chinese medicine hospital affiliated to Chengdu Chinese medicine university in Sichuan province, and the specific formula and dosage are shown in table 1. The decoction method comprises the following steps: soaking the raw materials in water for 20-30 min, decocting with strong fire, decocting with slow fire for 15-20 min, filtering, decocting with water for the second time, and mixing the two decoctions to obtain a daily dosage, wherein the dosages for different ages are shown in Table 1.

TABLE 1 specific drug composition and dosage (g)

The following addition and subtraction are carried out: the medicine is added or subtracted according to other accompanying symptoms and illness conditions of patients clinically. If the patient has no excrement for more than 3 days, anorexia and abdominal distention, 3-5g radix et rhizoma Rhei (decoction method: soaking in cold water for 30min, decocting with strong fire for 2min, and adding 1-3 spoon of medicinal liquid for administration, and taking for 2-3 days to reduce or stop middle-grade disease, and relieve constipation and emesis and abdominal pain; for patients with symptoms of constipation, halitosis, abdominal distention, etc., digestant medicines such as endothelium corneum Gigeriae Galli and Raphani semen can be optionally added according to infantile indigestion type to promote digestion and remove food stagnation; for feverish sensation in the palms and soles, restlessness, insomnia, scanty and brownish urine, Huang Qin and Lian Qiao can be added or the dose of rhubarb can be increased according to the situation to clear heat, purge fu-organs and relieve constipation; for those accompanied with difficulty in defecation, no defecation, bowel sound and flatulence, abdominal pain and no fixed position, fructus Aurantii Immaturus and cortex Magnolia officinalis can be used, or radix aucklandiae, fructus Toosendan and rhizoma corydalis can be added to regulate qi, soothe liver and relieve constipation; for those who have difficulty in getting rid of the bowels, lack of strength and no desire to speak and have a white face, radix Pseudostellariae and radix astragali are mainly used to tonify spleen and lung qi.

The taking method comprises the following steps: orally administered 3 times a day, once 10-150ml (< 1 year, 10-20 ml; 1-3 years, 20-60 ml; 3-6 years, 60-100 ml; > 6 years, 100-.

2) The drug administration of the control group is as follows:

fusong (the main component of the product is polyethylene glycol 4000, which is a mixture of ethylene oxide and water, and the auxiliary material is sorbitol.) 0.5-0.8 g/(kg. d), which is taken 3 times after meal.

2.2 Observation of content

The treatment course is 2 weeks, and the short-term curative effect and the long-term curative effect of the children are evaluated and compared by adding and comparing the quantitative scores of the main symptom signs and the minor symptoms of two groups of children before treatment, on the day when the treatment course is finished for 2 weeks, and after the treatment course is finished for 2 months for repeated diagnosis or telephone follow-up.

2.3 Observation index

2.3.1 general data index

Sex, age, course of constipation, Body Mass Index (BMI), etc. of the subject.

2.3.2 Main therapeutic index

Quantification standard of constipation main symptoms: the quantitative standard used in the research is drawn up according to the evaluation of constipation symptoms and curative effect and the Bristol feces scale, and the quantitative standard is respectively counted into 0 point, 1 point, 2 points and 3 points according to the frequency degree of difficult defecation, the feces character, the defecation time and the defecation frequency. (see Table 1 for details)

(1) Defecation is difficult: respectively counting 0 minute, 1 minute, 2 minutes and 3 minutes according to absence, occasional and frequent;

(2) Stool quality: 0, 1, 2 and 3 minutes respectively according to Bristol7-4, Bristol3, Bristol2 and Bristol 1;

(3) defecation time: respectively counting for 0min, 1 min, 2 min and 3 min for less than 10 min/time, 10-15 min/time, 15-20 min/time and more than 25 min/time;

(4) feeling of endless falling: respectively counting 0 minute, 1 minute, 2 minutes and 3 minutes according to absence, occasional and frequent;

(5) frequency: the amount is 0, 1, 2 and 3 points according to none, occasional and frequent.

Secondary symptom quantification criteria: abdominal distension and pain, poor appetite, dry mouth and fluid loss were quantified in stages according to the frequency of attack, i.e. none (0 min), occasional (1 min), occasional (2 min) and frequent (3 min). (see Table 2 for details)

TABLE 2 Constipation symptom and symptom quantitative score criteria

2.4 evaluation of therapeutic Effect

Refer to the symptom grading quantitative standard of general clinical research principles of new Chinese medicines (2015) and guidelines of clinical research of new Chinese medicines (2002): scoring is done before treatment and 2 weeks after treatment according to the score criteria.

And (4) healing, namely, the excrement is recovered to be normal, other symptoms and physical signs disappear or basically disappear, and the reduction rate of the syndrome score is more than or equal to 95%.

Has obvious effects that the stool quality and the defecation time interval are close to normal, other symptoms or physical signs are obviously improved, and the integral reduction rate of the syndrome is more than or equal to 70 percent and less than 95 percent.

Effective, the stool quality is slightly improved, or the stool time interval is reduced by one day compared with the previous one, other symptoms and physical signs are reduced, and the syndrome integral reduction rate is more than or equal to 30 percent and less than 70 percent.

The symptoms of the stool quality, the defecation time interval and other symptoms are not obviously improved or even aggravated, and the reduction rate of the syndrome score is less than 30 percent.

2.5 statistical methods

By IBMStatistical analysis was performed on the parameters before and after treatment by the SPSS Statistics 21.0 software. The measured data is expressed by mean + -standard deviation, self-pairing t test is adopted for comparison before and after treatment, two independent samples are adopted for comparison between groups, and X is adopted for classification²Tested and the difference is represented by p.

3. Results of clinical trial study

3.1 Baseline comparison

The baseline condition of the two groups of cases was compared from gender, age, and course.

3.1.1 comparison of gender and age of two groups

100 children patients qualified and included in the clinical study, 41 men and 59 women, with a male-female ratio of 1.44:1, had no significant gender difference. The sex of 2 groups of children patients has no significant difference (p is more than 0.05) and is comparable. See table 3.

Table 32 group gender comparison (example%)

The infants enrolled in this clinical study were 14 years old at the maximum, 0.25 years old at the minimum, with a mean age of 3.81 ± 2.77 years, and had no significant differences (p > 0.05) when compared to the ages of 2 groups of infants, as shown in table 4.

TABLE 42 group age comparison

Note that the sex and age comparison P of 2 groups of children patients are both greater than 0.05, which has no statistical significance and is comparable.

3.1.2 comparison of the course of two groups of Constipation

Through the matched t experiment, as shown in table 4, p is more than 0.05, and the disease course of 2 groups of children patients has no significant difference.

TABLE 52 comparison of disease progression

Note: the disease course comparison P of 2 groups of children patients is more than 0.05, has no statistical significance and is comparable.

3.2 comparison of therapeutic effects

3.2.1 in-group comparisons

3.2.1.1 Observation group before and after treatment integration comparison (Table 6)

TABLE 6 comparison of scores before and after treatment for the observation group

Note: through the matching t test, the integral comparison of the main symptoms and the secondary symptoms before and after the observation group treatment has statistical significance (p is less than 0.01), has extremely obvious difference, shows that the infantile constipation-relieving prescription has obvious curative effect on treating infantile constipation, and has outstanding curative effect on improving the main symptoms and the secondary symptoms.

3.2.1.2 comparison of integral before and after treatment of control group (Table 7)

TABLE 7 comparison of integral before and after treatment for control group

Note: through the matching t test, the integral comparison of the major symptoms and the minor symptoms before and after the treatment of the control group has statistical significance (p is less than 0.05), has obvious difference, can show that the Fusong has obvious curative effect on treating the infantile constipation, and has obvious effect on improving the major symptoms and the minor symptoms.

3.2.2 comparison between groups

3.2.2.12 group before and after treatment score comparison (Table 8)

TABLE 82 comparison of scores before and after treatment for infants in groups

Note: through variance test, the integral difference of the main symptoms and the integral difference of the secondary symptoms of the children patients in the observation group are better than those of the control group; the curative effect of the observation group on relieving the secondary symptoms of abdominal distension, anorexia and the like caused by constipation is better than that of the control group.

3.2.2.22 comparison of curative effects of infants (Table 9)

TABLE 92 comparison of the overall therapeutic effects of the infants

Note: warp X²Analysis shows that the overall curative effect of the 2 groups is significantly different (p is less than 0.05), as can be seen from table 9, the cure rates of the observation group and the control group are respectively 20.00% and 10.00%, the cure rates are respectively 62.00% and 36.00%, the cure rates of the observation group and the control group are statistically different (p is less than 0.05), and the curative effect of the child constipation treating prescription on the child constipation is better than that of the prednisone.

3.2.2.32 comparison of curative effects of children patients 2 months later (Table 10)

TABLE 102 comparison of long term treatment effect of children patients 2 months later

Note: the follow-up visit of 2 patients after 2 months, the total effective rate of the control group observation group is 84.00 percent and 76.00 percent respectively, the cure effect rate is 52.00 percent and 30.00 percent respectively, and the follow-up visit is carried out after X²Analysis shows that the total effective rate of the observation group is statistically significant (p is less than 0.05) compared with the control group, the healing efficiency of the observation group is significantly different (p is more than 0.05) compared with the control group, and the long-term curative effect of the observation group is better than that of the control group.

3.3 safety and Observation of adverse reactions

In the experimental process, only 1 patient child in the observation group has abdominal pain symptoms, pain appears around the umbilicus, the pain degree can be still tolerated, the abdominal pain is relieved after the drug is stopped, and severe adverse side reaction events such as abdominal pain, vomiting and the like do not appear in the rest patient children.

4. As a result, the

Clinical experiments are strictly screened, the total number of children patients with the syndrome of fluid deficiency and intestinal dryness is finally included in the group is 100, 50 children patients in an observation group and a control group are respectively subjected to statistical analysis on the general conditions of age, sex, course of disease and the like of the children patients, p is greater than 0.05, and the difference is not statistically significant and has comparability. After 2 weeks of treatment, the total effective rates of two groups of children are respectively 88% and 82%, the cure rates are respectively 16.00% and 12.00%, the cure rates are respectively 54.00% and 42.00%, and a paired t experiment shows that p is less than 0.05, which indicates that the curative effect of the observed group, namely the child intestine-benefiting and bowel-relaxing formula, is better than that of the control group; as seen from the follow-up result of 2 months, the total effective rate (84.00%) of the infant intestine-benefiting and bowel-relaxing formula is obviously higher than that (76.00%) of the Fusong. Comparing the integral difference values of the two groups between groups, wherein the integral difference value of the main symptom and the secondary integral difference value of the observation group are 7.00 +/-3.05 and 4.36 +/-1.88, the integral difference value of the main symptom 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 intestine-benefiting and bowel-relaxing prescription is obviously superior to that of the Fosong group (p is less than 0.05) no matter whether the stool character is changed, the defecation frequency is increased, or the secondary symptoms such as anorexia, halitosis, abdominal distension and abdominal pain caused by long-term constipation are relieved. Clinical studies have shown that: the infant intestine-benefiting and bowel-relaxing prescription has definite curative effect on infant constipation, is safe and reliable, and can be further deeply researched, popularized and used as an effective prescription for treating infant constipation.

5. Conclusion

The observation of the invention shows that the infantile intestine-benefiting and bowel-relaxing prescription has definite curative effect on infantile constipation, is safe and reliable, and can be further deeply researched, popularized and used as an effective prescription for treating infantile constipation.

The infant intestine-benefiting and bowel-relaxing prescription disclosed by the invention is composed of radix ophiopogonis, radix scrophulariae, fructus cannabis, immature bitter orange, mangnolia officinalis, radix pseudostellariae, radix paeoniae alba, raw rhizoma atractylodis macrocephalae and radix glycyrrhizae preparata. In the formula, radix ophiopogonis and radix scrophulariae are mainly used, wherein radix ophiopogonis is sweet and cold in nature and is used for nourishing yin of lung and stomach, radix scrophulariae is bitter and slightly cold in nature and is used for moistening yin and promoting fluid production, and the radix ophiopogonis and the radix scrophulariae are monarch drugs. Fructus Cannabis, sweet in flavor and mild in property, can induce the food dregs to go out and recover the descending of stomach-qi; the bitter orange is bitter, pungent and slightly cold to promote qi circulation, remove food retention, remove food stagnation and relax bowels; the magnolia officinalis, bitter and pungent in flavor and warm energy dissipating powder can generate energy and act, can widen the middle energizer and resolve stagnation, is an essential drug for eliminating fullness, and is a ministerial drug together. The assistant radix pseudostellariae can tonify qi of lung and spleen, clear and nourish yin and promote the production of body fluid; the white peony root has the functions of nourishing blood, astringing yin, promoting fluid and blood generation, and can regulate the flow of the liver and smooth the defecation; raw Bai Zhu is sweet and warm in nature and can tonify middle-warmer energy of spleen and stomach; prepared licorice root, radix Glycyrrhizae Praeparata, as a guiding drug, can also tonify spleen and qi, and when spleen qi is vigorous, qi will ascend and descend orderly and the food will be accumulated. 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 medicaments are proper in cold and warm, proper in dryness and dryness, and can tonify and purge simultaneously, so that the effects of nourishing yin, moistening dryness, strengthening spleen, tonifying qi, promoting qi circulation and relaxing the bowels are achieved. The compatibility of the traditional Chinese medicine composition for treating functional constipation conforms to the principle of 'monarch, minister, assistant and guide' of prescription compatibility, the medicine taste is refined, the physiological and pathological points of children are considered by the prescription medicine, and the traditional Chinese medicine composition has the advantages of high curative effect, no toxic or side effect, low cost and the like, and is particularly suitable for children. The selected raw material medicaments and the mixture ratio thereof are screened by tests, and the invention has the advantage of obvious 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 prospects. The traditional Chinese medicine composition can effectively improve constipation symptoms of functional constipation (body fluid deficiency and intestinal dryness syndrome), traditional Chinese medicine symptoms and life quality, and is high in safety and low in adverse reaction.

Claims

1. A traditional Chinese medicine composition for treating constipation is characterized in that: the traditional Chinese medicine is prepared from the following raw materials in parts by weight:

2. The traditional Chinese medicine composition according to claim 1, wherein: the traditional Chinese medicine is prepared from the following raw materials in parts by weight:

or:

5 parts of radix ophiopogonis, 5 parts of radix scrophulariae, 5 parts of fructus cannabis, 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 rhizoma atractylodis macrocephalae and 3 parts of liquorice;

or:

3. The traditional Chinese medicine composition according to claim 2, characterized in that: the bighead atractylodes rhizome is raw bighead atractylodes rhizome; the Glycyrrhrizae radix is radix Glycyrrhizae Preparata.

4. The Chinese medicinal composition according to any one of claims 1 to 3, wherein: the preparation is prepared by taking medicinal powder of raw material medicines, or water or organic solvent extracts of the raw material medicines as active ingredients and adding pharmaceutically acceptable auxiliary materials.

5. The traditional Chinese medicine composition according to claim 4, wherein: the preparation is an oral preparation; the oral preparation is solution, granule, pill, paste or capsule.

6. A method for preparing the Chinese medicinal composition of any one of claims 1 to 5, which comprises the following steps: the method comprises the following steps:

(1) weighing the raw materials according to the proportion of claim 1;

7. The method of claim 6, wherein: and (3) adding water into the raw material medicines in the step (2) for extraction, concentrating the extracting solution, and adding auxiliary materials or auxiliary components acceptable in medicines into the extracting solution to obtain an oral preparation containing 1g of crude medicines per 1ml or 3g of crude medicines per 1 g.

8. Use of the Chinese medicinal composition of any one of claims 1 to 6 in the preparation of a medicament for treating constipation.

9. Use according to claim 8, characterized in that: the medicine is used for treating functional constipation.

10. Use according to claim 8, characterized in that: the medicine is used for treating functional constipation of children.