CN100457169C - Medicine for treating chronic colitis and its preparing process - Google Patents

Medicine for treating chronic colitis and its preparing process Download PDF

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CN100457169C
CN100457169C CNB2005100442065A CN200510044206A CN100457169C CN 100457169 C CN100457169 C CN 100457169C CN B2005100442065 A CNB2005100442065 A CN B2005100442065A CN 200510044206 A CN200510044206 A CN 200510044206A CN 100457169 C CN100457169 C CN 100457169C
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fructus
spleen
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chronic colitis
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CN1907452A (en
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孙喜灵
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Abstract

The invention relates to a pharmaceutical composition for treating chronic colitis and process for preparation, wherein the composition comprises lotus seed 150 parts, amomum fruit 50 parts, coix seed 50 parts, poria cocos wolf 50 parts, evodia rutaecarpa 50 parts, white atractylodes rhizome 50 parts, common fennel fruit 50 parts, galangal 50 parts, cardamom 50 parts, nutgrass flatsedge rhizome 50 parts, root of pilose asiabell 150 parts, chebula fruit 50 parts, psoralea fruit 50 parts, licorice root 50 parts, pomegranate bark 50 parts, and schisandra fruit 50 parts.

Description

A kind of medicine for the treatment of chronic colitis and preparation method thereof
Technical field
The present invention relates to a kind of innerwear Chinese medicine preparation and preparation method thereof.Specifically, be a kind of medicine for the treatment of chronic colitis, be pure Chinese medicine, be mainly used in diseases such as abdominal distention that treatment chronic colitis spleen-kidney vacuity cold type occurs, stomachache, diarrhoea, the invention still further relates to the preparation method of this medicine.
Background technology
Chronic colitis is clinical frequently-occurring disease, belong in Chinese medicine have loose bowels, the category of disease such as stomachache.The medicine, particularly Chinese patent medicine of existing treatment chronic colitis are very few, and curative effect is not remarkable, and cure rate is low.
Summary of the invention
The present invention is intended to improve above-mentioned deficiency, and provides a kind of by the warm spleen of the kidney warming, relieving diarrhea with astringents, and the cold relieving removing dampness, regulating QI to relieve pain is treated the Chinese medicine preparation of chronic colitis, and its preparation method is provided.
In order to achieve the above object, the present invention has adopted following technical scheme.
A kind of medicine for the treatment of chronic colitis is characterized in that: formulated by following ten Six-element Chinese medicines: lotus seed kernel 150g, the Fructus Amomi 50g, Semen Coicis 50g, Poria 50g, Fructus Evodiae 50g, Rhizoma Atractylodis Macrocephalae (parched) 50g, Fructus Foeniculi 50g, Rhizoma Alpiniae Officinarum 50g, Fructus Amomi Rotundus 50g, Rhizoma Cyperi 50g, Radix Codonopsis 150g, Fructus Chebulae 50g, Fructus Psoraleae 50g, Radix Glycyrrhizae 50g, Pericarpium Granati 50g, the Fructus Schisandrae Chinensis 50g that remove the heart.
℃ first kind of preparation method: ten Six-element Chinese medicines are removed clean impurity, in circulating water, clean, put stainless steel disc hollow and do, put into electric oven again, below 80 ℃, oven dry, sterilization; The medical material that sterilization is good is inserted pulverizer, is ground into 100 orders, and the reuse super micron mill is ground into 200 order fine powders; Fine powder is inserted the abundant mix homogeneously of trough type mixing machine, oven dry below 80 ℃.
Second kind of preparation method: first group of medicine: go lotus seed kernel, Fructus Amomi, Semen Coicis, the Poria of the heart to be broken into 100 order fine powders, standby; Second group of medicine: other medical materials are through the carbon dioxide abstraction effective ingredient; With above-mentioned two groups of abundant mix homogeneously of medicine; Oven dry below 80 ℃.
Chinese herbal medicine of the present invention is according to traditional medicine and modern medicine analysis, and the property of medicine and pharmacological action are as follows.
Semen Nelumbinis: property is sweet, puckery, flat.Return spleen, kidney, heart channel.Spleen reinforcing antidiarrheal is arranged, the solid warp of kidney tonifying, the effect of tranquilizing by nourishing the heart.Pharmacological research shows that Semen Nelumbinis have the astringing intestine to stop diarrhea effect.
Fructus Amomi: property suffering, temperature.Return spleen, stomach warp.Removing dampness, circulation of qi promoting, warming middle-JIAO are arranged, antiabortive effect.Pharmacological research shows that Fructus Amomi has the effect of obvious antagonism ulcer to the rat pyloric ligation ulcer; Extracting solution can obviously make the shrinkage amplitude of guinea pig in vitro intestinal tube increase, and contraction frequency increases, and short preferably digestive tract power effect is arranged.
Semen Coicis: property is sweet, light, be slightly cold.Return spleen, stomach, lung meridian.Promoting diuresis to eliminate damp pathogen is arranged, spleen invigorating, eliminating impediment, heat clearing away expelling toxin.Pharmacological research shows that Semen Coicis has calmness, analgesic activity.
Poria: property is sweet, light, flat.Return spleen, kidney, heart channel.The effect that promoting diuresis to eliminate damp pathogen, spleen-benefiting mind-tranquilizing are arranged.Pharmacological research shows that Poria can obviously strengthen the activity of normal mouse lymphocyte to inductive breeder reaction of concanavalin A (ConA) and interleukin II.
Fructus Evodiae: property suffering, hardship, heat.Return spleen, stomach, Liver Channel.The effect that dispersing cold for relieving pain, the soothing the liver therapeutic method to keep the adverse QI flowing downwards, dampness are arranged.Pharmacological research shows, the contraction movement of the excited isolated rabbit intestinal of Fructus Evodiae decoct low concentration, and high concentration then significantly suppresses contraction movement; The effect of anti-hydrochloric acid gastric ulcer is arranged; Of short duration promotion bile secretion effect is arranged.
The Rhizoma Atractylodis Macrocephalae: property hardship, sweet, warm.Return spleen, stomach warp.Air making-up and spleen enlivening, dampness diuretic arranged, end gas, antiabortive effect.Pharmacological research shows, the promotion gastric emptying that Rhizoma Atractylodis Macrocephalae water decoction 10ml/kg (containing crude drug 0.25g/ml) can highly significant and the impetus of intestinal, enhancing gastroduodenal smooth muscle contraction that also can highly significant.Rhizoma Atractylodis Macrocephalae water decoction has protective effect to the carbon tetrachloride poisoning mouse liver injury, can reduce hepatic necrosis, promotes the hypertrophy of liver, and the alanine aminotransferase of rising is descended, and prevents that hepatic glycogen from reducing, and promotes the recovery of desoxyribose.
Fructus Foeniculi: property suffering, temperature.Return kidney, spleen, stomach, Liver Channel.The effect that cold relieving pain relieving, regulating qi-flowing for harmonizing stomach are arranged.Pharmacological research shows, the contraction movement that Fructus Foeniculi can remarkable excited isolated rabbit intestinal, and strengthen with concentration; To the gastric secretion suppression ratio is 38.9%, and shay ulcer or straining lasering type suppression ratio are respectively 34.9% or 33.8%; Can promote bile secretion.
Rhizoma Alpiniae Officinarum: property suffering, heat.Return spleen, stomach warp.The effect that warming middle-JIAO to relieve pain is arranged.Pharmacological research shows that Rhizoma Alpiniae Officinarum can promote gastric secretion; Water decoction can move by excited isolated rabbit intestinal tube; The calm antiinflammatory of energy, anti-hypoxia, antibacterial action.
Fructus Amomi Rotundus: property suffering, temperature.Return lung, spleen, stomach warp.The effect that removing dampness, circulation of qi promoting, warming middle-JIAO, preventing or arresting vomiting are arranged.Pharmacological research shows that Fructus Amomi Rotundus can make the gastric secretion of rat increase.
Rhizoma Cyperi: property suffering, little hardship, little sweet, flat.Return liver, tri-jiao channel.The effect that depressed liver-energy dispersing and QI regulating, menstruction regulating and pain relieving are arranged.Pharmacological research shows, that Rhizoma Cyperi has is analgesic, the town is painful, antiinflammatory, promoting digestion and removing stagnation effect.
Radix Codonopsis: property is sweet, flat.Return spleen, lung meridian.The effect that invigorating the spleen and replenishing QI is arranged, promote the production of body fluid and nourish blood.Pharmacological research shows that Radix Codonopsis can make macrophage quantity obviously increase, and cell volume increases, and phagocytic activity strengthens; Can cause that the isolated small intestines of rabbits tonicity raises; Can cause partly that the stomach motion increases and gastric emptying changes; Can damage by anti-gastric mucosa, have anti-gastric-ulcer and hepatoprotective effect; Have antibiotic, antiinflammatory, analgesic activity.
Fructus Chebulae: property hardship, acid, puckery, flat.Return lung, large intestine channel.Astringing intestine to stop diarrhea arranged, astringe the lung, the effect of the therapeutic method to keep the adverse QI flowing downwards, sore-throat relieving.Pharmacological research shows, the Fructus Chebulae can solidifying protein, and there is astriction in the mucosa ulcer that bacillary dysentery or enteritis are caused.Have antibiotic and anti-mycotic efficiency; The spasmolysis that smooth muscle is had the papaverine sample.
Fructus Psoraleae: property hardship, suffering, big temperature.Return kidney, spleen channel.Kidney invigorating and YANG supporting, controlling nocturnal emission with astringent drugs reducing urination, warming spleen and stopping diarrha effect are arranged.Pharmacological research shows, the intestine movement function that Fructus Psoraleae causes Radix Et Rhizoma Rhei is hyperfunction the obvious suppression effect.
Radix Glycyrrhizae: property is sweet, flat.Return lung, spleen, stomach, heart channel.The effect that invigorating the spleen and replenishing QI, nourishing the lung to arrest cough, relieving spasm to stop pain, the mitigation property of medicine are arranged.Pharmacological research shows, the secretion that the rat chronic gastric ulcer that the Radix Glycyrrhizae Dichlorodiphenyl Acetate brings out can not only gastric acid inhibitory equally also can promote ulcer healing.Normal contraction motion to the isolated rat ileum has the obvious suppression effect; Have antiinflammatory, blood fat reducing, hepatoprotective effect.
Pericarpium Granati: property acid, puckery, warm.Return stomach, large intestine channel.Relieving diarrhea with astringents, parasiticidal effect are arranged.Pharmacological research shows, Pericarpium Granati has antibiotic, antivirus action, clinical dysentery, diarrhoea, gastric and duodenal ulcers, the ulcerative colitis of being used for the treatment of.
Fructus Schisandrae Chinensis: property acid, temperature.Return lung, kidney, heart channel.The nourishing kidney of astringing the lung is arranged, the effect of the arresting sweating that promotes the production of body fluid, puckery Tianjin antidiarrheal, mind tranquilizing and the heart calming.Pharmacological research shows that Fructus Schisandrae Chinensis has the anti-liver injury effect; Antiulcer action is arranged; The ileum contraction that nicotine is caused has inhibitory action.
The present invention sheerly prepared from traditional Chinese medicines forms, and is a kind of Chinese medicine for oral administration.Fructus Psoraleae is worked hard hot in nature and the benefit gate of vitality in the side, is the key medicine of the native antidiarrheal of excessive fire benefit, so be monarch drug.Fructus Amomi Rotundus, Fructus Amomi warming the spleen kidney and relieving diarrhea with astringents; Fructus Evodiae, Fructus Foeniculi warming the spleen and stomach and dispelling cold and removing dampness, and be ministerial drug.Fructus Schisandrae Chinensis is the puckery product of temperature; The circulation of qi promoting of Rhizoma Alpiniae Officinarum cold expelling; The Radix Codonopsis air making-up and spleen enlivening, lotus seed kernel supplementing the kidney to control the nocturnal, spleen reinforcing antidiarrheal; The Rhizoma Atractylodis Macrocephalae (parched) air making-up and spleen enlivening, the dampness diuretic; The Semen Coicis spleen invigorating, eliminating dampness by diuresis.The Poria promoting diuresis to eliminate damp pathogen, spleen invigorating, mind tranquilizing and the heart calming.Rhizoma Atractylodis Macrocephalae invigorating the spleen and benefiting QI, dampness and in.The Rhizoma Cyperi regulating QI to relieve pain.Fructus Chebulae's relieving diarrhea with astringents.The Pericarpium Granati relieving diarrhea with astringents is only had blood in stool.The Radix Glycyrrhizae invigorating the spleen and replenishing QI, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription are messenger drug, and are adjuvant.So cooperate, then the kidney warming the spleen is warm, and cold-damp must be removed, and the stagnation of QI gets freely, and the solid fortuneization of large intestine is multiple, has loose bowels naturally to end, and all diseases are all healed.
The specific embodiment
In order to understand better and to implement, further specify the present invention below in conjunction with embodiment.
It below is preparation example.
Lotus seed kernel (removing the heart) 150g Fructus Amomi 50g Semen Coicis 50g Poria 50g
Fructus Evodiae 50g Rhizoma Atractylodis Macrocephalae (parched) 50g Fructus Foeniculi 50g Rhizoma Alpiniae Officinarum 50g
Fructus Amomi Rotundus 50g Rhizoma Cyperi 50g Radix Codonopsis 150g Fructus Chebulae 50g
Fructus Psoraleae 50g Radix Glycyrrhizae 50g Pericarpium Granati 50g Fructus Schisandrae Chinensis 50g
First kind of preparation method is: with above ten Six-elements, remove clean impurity, in circulating water, clean, put stainless steel disc hollow and do, and in the baking oven that discharges again, 80 ℃, oven dry.The medical material that sterilization is good is put pulverizer, is ground into 100 orders, and the reuse super micron mill is ground into 200 order fine powders.Fine powder is put the abundant mix homogeneously of trough type mixing machine, make the watered pill of every gram 10 balls, oven dry below 80 ℃, packing is promptly.
Second kind of preparation method is: first group of medicine: lotus seed kernel (removing the heart), Fructus Amomi, Semen Coicis, Poria are broken into 100 order fine powders, and be standby; Second group of medicine: other medical materials are through the carbon dioxide abstraction effective ingredient; With above-mentioned two groups of abundant mix homogeneously of medicine, make the watered pill of every gram 10 balls, oven dry below 80 ℃, packing is promptly.
[character] this product is the watered pill of yellowish-brown to pitchy; Feeble QI, mildly bitter flavor.
[discriminating] 1, get this product 5g, add ethyl acetate 40ml, supersound process 15 minutes filters, and filtrate evaporate to dryness, residue add ethyl acetate 1ml makes dissolving, as need testing solution.Other gets and mends event fat element, the plain reference substance of different benefit event fat, adds ethyl acetate and makes the mixed liquor that every 1ml contains 2mg, in contrast product solution.Test according to thin layer color popularize law (2000 editions pharmacopeia appendix viB), draw above-mentioned two kinds of each 2-4ul of solution, put respectively on same silica gel G plate, with hexane-ethyl acetate (4: 1) is developing solvent, launches, and takes out, dry, spray is put under the uviol lamp (365nm) with 10% potassium hydroxide methanol solution, inspects.In the test sample chromatograph, with the reference substance relevant position on, show two identical blue and white fluorescence speckles.
2, get this product 5g, add normal butane 10ml, supersound process 15 minutes filters, and filtrate evaporate to dryness, residue add ethyl acetate 1ml makes dissolving, as need testing solution.Other gets Rhizoma Atractylodis Macrocephalae control medicinal material 0.5g, makes reference substance solution with method.According to thin layer color popularize law (2000 editions pharmacopeia appendix viB) test, draw above-mentioned two kinds of each 10ul of solution, put respectively on same silica gel G plate, with petroleum ether-ethyl acetate (50: 1) is developing solvent, launches, and takes out, dry, spray is heated to clear spot with 5% vanillin sulfuric acid solution.In the test sample chromatograph, with the reference substance relevant position on, show identical speckle, and should show a pink speckle (atractylone).
[inspection]
Press every regulation relevant under the pill item (appendix IA of Pharmacopoeia of People's Republic of China version in 2000) inspection, dissolving time limit, content uniformity and moisture checked that three batch samples all comply with relevant regulations as a result, see Table 1:
Table 1: the checking experiment result of three batch samples
Figure C20051004420600071
The warm spleen of [function with cure mainly] the kidney warming, relieving diarrhea with astringents, cold relieving removing dampness, regulating QI to relieve pain.Be used for diseases such as abdominal distention that chronic colitis spleen-kidney vacuity cold type occurs, stomachache, diarrhoea
[consumption and usage] is oral, every day three times, each 6 the gram or follow the doctor's advice.
[specification] 6g/ bag
1, physical data
1.1 case history source:
Randomly draw chronic colitis patient 140 examples in proper order by prescription on individual diagnosis; Observation group's 100 examples wherein, matched group 40 examples; Be and be in hospital or clinic case.
1.2 clinical employing contrast random packet, double blind method, with case by sources, age, the course of disease, degree difference be divided into observation group and matched group.
1.3 patient age is at 25-61 between year, observation group's case 100 examples, male patient's 60 examples wherein, female patient 40 examples; Matched group case history 40 examples, male patient's 25 examples wherein, female patient 15 examples.Two groups of patient sources, age, the course of disease and the following tabulations of patient's type distribution situation:
Table 1 case source
Figure C20051004420600081
Learn to handle by statistics, P>0.05 is so think two groups of cases there was no significant differences of originating.
Table 2 liang group age distribution situation
Figure C20051004420600082
Wherein observation group's minimal ages is 25 years old, maximum 61 years old age, 44 years old mean age; Matched group minimal ages 26 years old, maximum 60 years old age, 43 years old mean age.Two groups of comparison patient ages do not have significant difference, P>0.05
Table 3 a liang group is suffered from chronic colitis patient course of disease distribution situation
Figure C20051004420600083
Wherein the elder of observation group's course of disease is 24 years, the shortest person 1 year, average 8.3 years.The matched group course of disease is the longest 23 years, and the shortest person half a year, average 8.1 years, two groups were not relatively had significant difference, P>0.05
Table 4 liang group patient tcm symptom situation relatively
Learn by statistics and handle, the main tcm symptom of P>0.05, two group patient compares no significant difference.
Table 5 liang group patient TCM Syndrome Type situation relatively
Figure C20051004420600092
Learn by statistics and handle P>0.05, two group patient's pattern of syndrome distribution there was no significant difference.
2, discuss
Chronic colitis is the one group of disease that is caused by multiple disease and reason, and the complicated touching difficulty of the state of an illness is more, belong in Chinese medicine have loose bowels, the category of disease such as stomachache.We for treatment colitis abdominal distention, have loose bowels, the general side of pain.Abdominal part feeling of distension and oppression, the pain that occurs with the spleen-kidney vacuity cold type, to have loose bowels be primary symptom.We cure mainly the spleen kidney and hindered by cold-damp and cause all diseases.Insufficiency of the spleen, transmitting and distributing the fluids is unfavorable, then endogenous dampness; The YANG QI deficiency of suffering from a deficiency of the kidney is then given birth in the cold-evil; Eating and drinking without temperance is arranged again, and cold-evil, damp are in outer intrusive body, and then impairment of the spleen kidney more causes having loose bowels.Cold having the property of coagulation is YIN pathogen, easily impairment of YANG gas; Moist sticky, easily block mechanism of qi, cause abnormal ascending-descending of QI, satisfy into distension pain, anorexia, extremity asthenia.Zhi Dangwen wherein, Xingqi gas dispels that it is cold, dry it is wet, and cold-damp must be removed, the stagnation of QI must be capable, the rehabilitation of spleen kidney, then abdominal distention, have loose bowels, pain explains by oneself.The kidney yang deficiency person, yang-energy is when to unlikely, and so cloudy QI exhaustion and descending is for having loose bowels.The insufficiency of kidney-YANG person, spleen is also not warm, and the fortuneization mistake is strong, so anorexia, chronic diarrhea is not healed.Wang Ang once said: " chronic diarrhea is all declined by kidney life fire, can not specialize in taste." therefore, the abdominal distention of having loose bowels pain is the spleen-kidney vacuity cold card, so can warm up spleen by the kidney warming, relieving diarrhea with astringents, the cold relieving removing dampness, regulating QI to relieve pain is a method of treatment.Fructus Psoraleae is worked hard hot in nature and the benefit gate of vitality in the side, is the key medicine of the native antidiarrheal of excessive fire benefit, so be monarch drug.Fructus Amomi Rotundus, Fructus Amomi warming the spleen kidney and relieving diarrhea with astringents; Fructus Evodiae, Fructus Foeniculi warming the spleen and stomach and dispelling cold and removing dampness, and be ministerial drug.Fructus Schisandrae Chinensis is the puckery product of temperature; The circulation of qi promoting of Rhizoma Alpiniae Officinarum cold expelling; The Radix Codonopsis air making-up and spleen enlivening, lotus seed kernel supplementing the kidney to control the nocturnal, spleen reinforcing antidiarrheal; The Rhizoma Atractylodis Macrocephalae (parched) air making-up and spleen enlivening, the dampness diuretic; The Semen Coicis spleen invigorating, eliminating dampness by diuresis.The Poria promoting diuresis to eliminate damp pathogen, spleen invigorating, mind tranquilizing and the heart calming.Rhizoma Atractylodis Macrocephalae invigorating the spleen and benefiting QI, dampness and in.The Rhizoma Cyperi regulating QI to relieve pain.Fructus Chebulae's relieving diarrhea with astringents.The Pericarpium Granati relieving diarrhea with astringents is only had blood in stool.The Radix Glycyrrhizae invigorating the spleen and replenishing QI, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription are messenger drug, and are adjuvant.So cooperate, then the kidney warming the spleen is warm, and cold-damp must be removed, and the stagnation of QI gets freely, and the solid fortuneization of large intestine is multiple, has loose bowels naturally to end, and all diseases are all healed.
In the 140 routine cases that extract, wherein 100 examples are organized 40 examples for treatment and are made as matched group, and the method for take to randomly draw in the statistics, double blinding being got is observed.Wherein enumeration data adopts X 2Check, ranked data adopt Ridit to analyze.With patient by sources, age, the course of disease, classification of diseases difference classify treatment group and matched group age all between 25 years old-61 years old, two groups do not have significant difference (P>0.05), relatively the course of disease, classification of diseases do not have significant difference (P>0.05) yet.Illustrate that grouping has reasonability, science.Two groups of traditional Chinese medical science sign integrated values all obviously lower, and the treatment group is compared with matched group and obviously is better than matched group.
This research with at random, double blinding dual analog contrast method carries out, the appraisement system of being formulated in " new Chinese medicine clinical guidance principle " is adopted in diagnostic criteria, the deviation of having avoided researcher and patient's subjective factors to cause has to greatest extent improved the credibility and the comparability of result of study.

Claims (2)

1, a kind of medicine for the treatment of chronic colitis is characterized in that: formulated by following ten Six-element Chinese medicines: lotus seed kernel 150g, the Fructus Amomi 50g, Semen Coicis 50g, Poria 50g, Fructus Evodiae 50g, Rhizoma Atractylodis Macrocephalae (parched) 50g, Fructus Foeniculi 50g, Rhizoma Alpiniae Officinarum 50g, Fructus Amomi Rotundus 50g, Rhizoma Cyperi 50g, Radix Codonopsis 150g, Fructus Chebulae 50g, Fructus Psoraleae 50g, Radix Glycyrrhizae 50g, Pericarpium Granati 50g, the Fructus Schisandrae Chinensis 50g that remove the heart.
2, the preparation method of the medicine of treatment chronic colitis as claimed in claim 1 is characterized in that: ten Six-element Chinese medicines removed clean impurity, in circulating water, cleans, put stainless steel disc hollow and do, put into electric oven again, and below 80 ℃, oven dry, sterilization; The medical material that sterilization is good is inserted pulverizer, is ground into 100 orders, and the reuse super micron mill is ground into 200 order fine powders; Fine powder is inserted the abundant mix homogeneously of trough type mixing machine, oven dry below 80 ℃.
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中药治疗慢性结肠炎临床体会. 梁琼芳,汤之明.河北中医,第26卷第6期. 2004
中药治疗慢性结肠炎临床体会. 梁琼芳,汤之明.河北中医,第26卷第6期. 2004 *

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