CN1579485B - Traditional Chinese medicinal composition for treating intestinal function disorder and its preparation method - Google Patents
Traditional Chinese medicinal composition for treating intestinal function disorder and its preparation method Download PDFInfo
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Abstract
The invention is a Chinese traditional medicine compound for treating intestines functions disorder. The compound includes following ingredients: bupleurum root 6-18g, white peony root 6-30g, pseudostellaria root 3-18g, liquorice 6-15g. The method can be used in clinic directly without adding ingredients; it also can use the extract of above mentioned medicines as medicine; the extract is: a. extract the volatile oil for backup from above mentioned compound; b. carries on extraction with water, alcohol, or other organic solution to above mentioned volatile oil compound; c. purifies and separates: water extracting liquid, vacuum condensing, and alcohol depositing, resin absorbing and exchanging, high speed eccentric process, and cyclodextrin packaging method; d. the extracts in above stepsare combined, and become medicine compound. There also can increase lagehead atractylodes, chuaniong rhizome, Tuckahoe, kudzu vine root, uncaria and other medicines; or some compounds such as shimida,and dopan ketone. The invention also provides a manufacturing method for above mentioned medicine.
Description
Technical field
The present invention relates to a kind of Chinese medicine compound compositions and modern preparation thereof for the treatment of the bowel dysfunction relevant disease, and the process for preparing this pharmaceutical composition.
Background technology
(irritable bowel syndrome is common digestive tract non-organic bowel dysfunction disease IBS) to irritable bowel syndrome, has the chronic clinical characters of outbreak repeatedly.Clinical symptoms show as abdominal discomfort (stomachache, abdominal distention) and intestinal movement unusual, changing (diarrhoea or constipation), stool character unusual (loose stool, Mucous Stool or scleroma are just), defecation frequency as bowl evacuation habit increases and is main performance, and continue to exist or intermittently outbreak, pathologic finding does not have specificity intestinal inflammatory lesion more, clinical diarrhea-type, constipation type, the alternate type of being divided into.Modern medicine thinks that pathogenic factor and Nervous and Mental Factors, the change of intestinal kinetics, eating and drinking without temperance, the colon secretion of IBS is relevant with absorption function change, alteration of intestinal flora etc., relate to biology and social mentality's factors such as (comprising intense strain, patient's personality and behavior) in its cause of disease and the morbidity, be acknowledged as a kind of psychosomatic disease.Treatment means is limited at present, how from lax intestinal smooth muscle, excitement and antagonism neurotransmitter, anxiety, acts on limited.And medicine usually is at disposing as single symptoms such as diarrhoea or constipation, mainly concentrate on adjusting, antidepressant, dynamics-promoting medicine treatment, calcium-channel antagonists and astringent treatment etc. to the intestinal microecology link, because the primary disease morbidity relates to spirit, diet, consitution many aspects, though above various kinds of drug can be alleviated some symptom of irritable bowel syndrome, in clinical practice, all there are one-sidedness and limitation, still can not satisfy clinical requirement.But in application, exist can't effect a radical cure, shortcomings such as side effect is big, individual variation is obvious, medical expense height.
03112782.7 number Chinese invention patent application discloses a kind of " Chinese medicine composition and the preparation thereof of treatment bowel dysfunction disease ", this scheme thinks that Nervous and Mental Factors is the primary cause of disease of bowel dysfunction, should provide following prescription with the principle of " organic conception " and " determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs ": Radix Bupleuri 6-15 gram, Radix Paeoniae Alba 5-20 gram, Rhizoma Chuanxiong-10 gram, Rhizoma Atractylodis Macrocephalae 6-20 gram, Poria 6-12 gram, Radix Glycyrrhizae 5-20 gram.The conception of this scheme and effect all are suitable for clinical practice, but rule of thumb, and Producer can wish this scheme is further simplified mostly, so as more to be suitable for industrialized great production prescription scheme and production technology.
Summary of the invention
Multifactor in comprehensively comprehensive this symptom grouping pathogeny of the present invention, and the Chinese medicine compound compositions of the treatment irritable bowel syndrome bowel dysfunction diseases such as (IBS) that provides.The clinical main performance diarrhoea of IBS, constipation, stomachache, alternating diarrhea and constipation; Companion anorexia, asthenia, poor, the agitation of becoming thin, sleep etc.Modern medicine is divided into diarrhea-type, constipation type, alternate type.This project inventor from theory of Chinese medical science, thinks that the common and primary reason of IBS is a Nervous and Mental Factors on the basis of clinical treatment and scientific research for many years.Patient is psychentonia, depression, morbidity or increase the weight of when irritated often, belongs to the traditional Chinese medical science " seven emotions " category that causes a disease, and sums up relevant Therapeutic Principle and square substantially through clinical verification on this basis.
The Chinese medicine composition of above-mentioned treatment bowel dysfunction comprises:
Radix Bupleuri 6-18 gram,
Radix Paeoniae Alba 6-30 gram,
Radix Pseudostellariae 6-18 gram,
Radix Glycyrrhizae 6-15 gram.
More than the used proportional quantities in basic side for alleviating, alleviate or cure relevant indication, regulate the various medical material amounts of intestines and stomach function and the ratio of drug regimen.Emergency weight according to clinical symptoms can adopt following ratio.
Basic side optimizes consumption 1:
Radix Bupleuri 12-18 gram,
Radix Paeoniae Alba 12-30 gram,
Radix Pseudostellariae 6-12 gram,
Radix Glycyrrhizae 6-12 gram.
Basic side optimizes consumption 2:
Radix Bupleuri 9-12 gram,
Radix Paeoniae Alba 9-12 gram,
Radix Pseudostellariae 6-12 gram,
Radix Glycyrrhizae 6-12 gram.
Below substantially can be so that following several embodiment to be arranged:
1, do not add any component, directly in clinical use: said composition is prescription;
2, with the extract of above-mentioned Chinese medicine composition as medicine;
3, on above-mentioned basic side's basis, increase other composition;
4, on the basis of the extract of above-mentioned Chinese medicine composition, increase other composition.
Above 2,3,4 are respectively described below:
Wherein " with the extract of above-mentioned Chinese medicine composition as medicine ", said " extract " is meant:
A, extraction volatile oil for backup from above mentioned compound;
B, the compositions behind the said extracted volatile oil is adopted water, ethanol or other organic solvent extraction;
Compositions behind c, water, ethanol or other organic solvent extraction adopts vacuum concentration, ethanol precipitation, resin absorption, resins exchange, the extract that technical method alone or in combination such as high speed centrifugation, cyclodextrin inclusion compound etc. obtains;
D, the extract of above steps is merged, become pharmaceutical composition.
Volatile oil part (composition combination one): prescription drug is through pulverizing the volatility oily material that the method for employing steam distillation extracts.Yield is the 0.5-3% of medical material weight.Wherein containing a plurality of components (by the content descending order) through the GC-MS analysis comprising:
Atractylone (Atractylon), atractylodes lactone A (Butenolide A), atractylodes lactone B (ButenolideB), ligustilide (ligustilide) and derivant thereof, 3-β-acetoxyl group atractylone (3-β-Acetoxyatractylon), celery alkane dienone (Selina-4 (14), 7 (11)-dien-8-one), group of Buddhists going together on a pilgrimage alkene, atractylol etc.The animal drug effect studies show that obviously to suppress the Small Intestine that causes because of neostigmine load mice hyperfunction, improving the Small Intestine that atropine causes is subjected to press down state: can significantly promote the normal mouse intestinal to advance, increase mice with spleen deficiency spleen index, thymus index, significantly reduce the mouse writhing number of times that causes by acetic acid.Experiment to the influence of the rat gastrointestinal tract dysfunction due to the reserpine: after the continuous modeling of rat reserpine, MTL level in body weight, food ration, thymus index, spleen index, blood plasma and the jejunum tissue homogenate and normal control group relatively significantly reduce (P＜0.01).The component of different parts, compositions extract administration group and model group comparison can improve above-mentioned condition to some extent, wherein the MTL level in body weight, food ration, thymus index, blood plasma and the jejunum tissue homogenate.The experiment of mucosa injury situation: the administration group of the component of different parts, compositions extract is compared with model group, and all there were significant differences (P＜0.05).
Dichloromethane extraction position component (composition combination two): prescription drug adopts dichloromethane to extract the compositions of the chemical constituent of gained behind the silica gel column chromatography from the insoluble part of petroleum ether.
Through HPLC, TLC, IR, NHR, MS, analyses such as UV wherein mainly contain studies on alkaloid constituents bag expansion more than 3 kinds: tetramethylpyazine--ligustrazine (ligustrazine, tetramethylpyrazine-TMP), isoleucyl-knot propylhomoserin lactams, perlolyrine (Perlolyrine).The animal drug effect studies show that obviously to suppress the Small Intestine that causes because of neostigmine load mice hyperfunction, improve the Small Intestine that atropine causes and be subjected to press down state: increase mice with spleen deficiency spleen index, thymus index, significantly reduce the mouse writhing number of times that causes by acetic acid.Experiment to the influence of the rat gastrointestinal tract dysfunction due to the reserpine: after the continuous modeling of rat reserpine, MTL level in body weight, food ration, thymus index, spleen index, blood plasma and the jejunum tissue homogenate and normal control group relatively significantly reduce (P＜0.01).The component of different parts, compositions extract administration group and model group comparison can improve above-mentioned condition to some extent, wherein the MTL level in body weight, food ration, thymus index, blood plasma and the jejunum tissue homogenate.The experiment of mucosa injury situation: the administration group of the component of different parts, compositions extract is compared with model group, and all there were significant differences (P＜0.05).
Ethyl acetate extraction position component: prescription drug adopts ethyl acetate to extract the compositions of the chemical constituent of gained behind the silica gel column chromatography from the insoluble part of dichloromethane.Totally two groups: EtOAC1 composition group and EtOAC2 composition group.
EtOAC1 (composition combination three): through HPLC, TLC, IR, NHR, MS, analyses such as UV wherein mainly contain 5 kinds of phenols chemical constituents.Ferulic acid (ferculic acid), cnidium lactone, chuanxingol (chuanxiongol), chrysophanol (chrysophanol), paeonol (paeonel).
The animal drug effect studies show that obviously to suppress the Small Intestine that causes because of neostigmine load mice hyperfunction, improving the Small Intestine that atropine causes is subjected to press down state: can significantly promote the normal mouse intestinal to advance, increase mice with spleen deficiency spleen index, thymus index, significantly reduce the mouse writhing number of times that causes by acetic acid.Experiment to the influence of the rat gastrointestinal tract dysfunction due to the reserpine: after the continuous modeling of rat reserpine, MTL level in body weight, food ration, thymus index, spleen index, blood plasma and the jejunum tissue homogenate and normal control group relatively significantly reduce (P＜0.01).The component of different parts, compositions extract administration group and model group comparison can improve above-mentioned condition to some extent, wherein the MTL level in body weight, food ration, thymus index, blood plasma and the jejunum tissue homogenate.The experiment of mucosa injury situation: the administration group of the component of different parts, compositions extract is compared with model group, and all there were significant differences (P＜0.05).
EtOAC2 (composition combination four).Through HPLC, TLC, IR, NHR, MS, analyses such as UV wherein mainly contain following chemical constituent.Saikogenin A-G (saikogenin A-G), enoxolone (glycyrrhetinic acid), Radix Glycyrrhizae aglycon (liquiritigenin), isoliquiritin unit (liquiritigenin), nimbecetin (Kaempferol), isoliquiritigenin (isoliquiritigenin), Quercetin (quercetin), isoquercitin (isoquercetin), isorhamnetin (isorhamnetin) etc.The animal drug effect studies show that obviously to suppress the Small Intestine that causes because of neostigmine load mice hyperfunction, improving the Small Intestine that atropine causes is subjected to press down state: can significantly promote the normal mouse intestinal to advance, increase mice with spleen deficiency spleen index, thymus index, significantly reduce the mouse writhing number of times that causes by acetic acid.Experiment to the influence of the rat gastrointestinal tract dysfunction due to the reserpine: after the continuous modeling of rat reserpine, MTL level in body weight, food ration, thymus index, spleen index, blood plasma and the jejunum tissue homogenate and normal control group relatively significantly reduce (P＜0.01).The component of different parts, compositions extract administration group and model group comparison can improve above-mentioned condition to some extent, wherein the MTL level in body weight, food ration, thymus index, blood plasma and the jejunum tissue homogenate.The experiment of mucosa injury situation: the administration group of the component of different parts, compositions extract is compared with model group, and all there were significant differences (P＜0.05).
The relevant component in n-butanol extraction position: prescription drug adopts the extraction of n-butyl alcohol from the insoluble part of ethyl acetate, the compositions of the chemical constituent of gained behind the silica gel column chromatography.Totally two groups: BuoH1 composition group and BuoH2 composition group.
BuoH1 (composition combination five): through HPLC, TLC, IR, NHR, MS, analyses such as UV wherein mainly contain flavone and glycoside thereof: puriri glycoside II, liquirtin (liquiritin), isoliquiritin (isoliquiritin), Neoliquiritin (neoliquiritin), isoliquiritigenin (isoliquiritigenin), globulariacitrin (Rutin), the glycoside of nimbecetin: Kaempferitrin (kaempferitrin), nimbecetin-7-rhamnoside (Kaempferol-7-rhamnoside), the Arabic glucoside of nimbecetin-3-0-α-L-furan-7-0-α-L-pyrans rhamnoside, narcissin (narcissin).The animal drug effect studies show that obviously to suppress the Small Intestine that causes because of neostigmine load mice hyperfunction, improving the Small Intestine that atropine causes is subjected to press down state: can significantly promote the normal mouse intestinal to advance, increase mice with spleen deficiency spleen index, thymus index, significantly reduce the mouse writhing number of times that causes by acetic acid.Experiment to the influence of the rat gastrointestinal tract dysfunction due to the reserpine: after the continuous modeling of rat reserpine, MTL level in body weight, food ration, thymus index, spleen index, blood plasma and the jejunum tissue homogenate and normal control group relatively significantly reduce (P＜0.01).The component of different parts, compositions extract administration group and model group comparison can improve above-mentioned condition to some extent, wherein the MTL level in body weight, food ration, thymus index, blood plasma and the jejunum tissue homogenate.The experiment of mucosa injury situation: the administration group of the component of different parts, compositions extract is compared with model group, and all there were significant differences (P＜0.05).
BuoH2 (composition combination six).Through HPLC, TLC, IR, NHR, MS, analyses such as UV wherein mainly contain Saponin or terpene glycoside chemical constituent: glycyrrhizic acid (glycyrrhizin), glycyrrhizin A-K (glycyrrhizin A-K), saikosaponin A-F (saikosaponin A-F), paeoniflorin (paeoniflorin), paeoniflorin (paeonin), peony lactone glycoside (albiforin), oxypaeoniflorin (oxypaeoniflorin), hydroxypaeoniflorin, benzoylpaeoniflorin (benzoylpaeoniflorin), paeonolide (paeonoside) Radix Pseudostellariae Saponin A (pseudostellarinoside A), point leaf gypsoside D (acutifoliside D).The animal drug effect studies show that obviously to suppress the Small Intestine that causes because of neostigmine load mice hyperfunction, improving the Small Intestine that atropine causes is subjected to press down state: can significantly promote the normal mouse intestinal to advance, increase mice with spleen deficiency spleen index, thymus index, significantly reduce the mouse writhing number of times that causes by acetic acid.Experiment to the influence of the rat gastrointestinal tract dysfunction due to the reserpine: after the continuous modeling of rat reserpine, MTL level in body weight, food ration, thymus index, spleen index, blood plasma and the jejunum tissue homogenate and normal control group relatively significantly reduce (P＜0.01).The component of different parts, compositions extract administration group and model group comparison can improve above-mentioned condition to some extent, wherein the MTL level in body weight, food ration, thymus index, blood plasma and the jejunum tissue homogenate.The experiment of mucosa injury situation: the administration group of the component of different parts, compositions extract is compared with model group, and all there were significant differences (P＜0.05).
Water-soluble component (composition combination seven): prescription drug adopts pure water to extract from the insoluble part of n-butyl alcohol, through ethanol precipitation, obtains total polysaccharides behind tannic acid or the ion exchange resin deproteinization, obtaining molecular weight through sephadex chromatography (Sephadex G-100) processing is 150000,120000,90000,46000,32000,15000 single component, hydrolysis is after paper chromatographic analysis detects galactose, glucose, rhamnose, arabinose, and galacturonic acid, glucuronic acid.Through HPLC, TLC, IR, NHR, MS, analyses such as UV wherein mainly contain pachymose (pachymic acid), pachyman (β-pachyman), the pachymaran (compositions of the polysaccharide macro-molecular composition of β-pachymaran), Angelica Polysaccharide (glycyrrizan UC).The animal drug effect studies show that obviously to suppress the Small Intestine that causes because of neostigmine load mice hyperfunction, improving the Small Intestine that atropine causes is subjected to press down state: can significantly promote the normal mouse intestinal to advance, increase mice with spleen deficiency spleen index, thymus index, significantly reduce the mouse writhing number of times that causes by acetic acid.Experiment to the influence of the rat gastrointestinal tract dysfunction due to the reserpine: after the continuous modeling of rat reserpine, MTL level in body weight, food ration, thymus index, spleen index, blood plasma and the jejunum tissue homogenate and normal control group relatively significantly reduce (P＜0.01).The component of different parts, compositions extract administration group and model group comparison can improve above-mentioned condition to some extent, wherein the MTL level in body weight, food ration, thymus index, blood plasma and the jejunum tissue homogenate.The experiment of mucosa injury situation: the administration group of the component of different parts, compositions extract is compared with model group, and all there were significant differences (P＜0.05).
Adopt following extraction scheme can obtain the various combination of above each component:
Extract E and component: the Chinese medicine compound compositions adopts water extraction, after suitably concentrating, adds Different concentrations of alcohol, and is centrifugal after leaving standstill, and gets supernatant concentration, obtains.Through HPLC, TLC, IR, NHR, MS, analyses such as UV wherein mainly contain composition combination two, three, four, five, six.The total solid yield is the 14-18% of medical material weight.
Extract S and component: the Chinese medicine compound compositions adopts water extraction, after suitably concentrating, through silicagel column repeatedly chromatography obtain the different composition of a plurality of polarity respectively and make up, through HPLC, TLC, IR, NHR, MS, analyses such as UV are respectively composition combination two, three, four, five, six, seven.
Extract L and component: the Chinese medicine compound compositions adopts water extraction, obtains a plurality of different compositions combinations through ion exchange column exchange absorption.Through HPLC, TLC, IR, NHR, MS, analyses such as UV wherein are respectively composition combination two, three, four, five.
Extract G and component: the Chinese medicine compound compositions adopts water extraction, after suitably concentrating, and after high speed centrifugation is handled, the component of water-soluble solution.Obtain a plurality of different compositions combinations.Through HPLC, TLC, IR, NHR, MS, analyses such as UV wherein are respectively composition combination two, three, four, five.The total solid yield is the 18-24% of medical material weight.
Extract D and component: the Chinese medicine compound compositions adopts water extraction, and eluting obtains a plurality of different compositions combinations behind absorption with macroporous adsorbent resin.Through HPLC, TLC, IR, NHR, MS, analyses such as UV wherein are respectively composition combination two, three, four, five, six, seven.The solid yield is the 2.0-7.0% of medical material weight.
Extract C and component: the Chinese medicine compound compositions adopts water extraction, after suitably concentrating, through high speed centrifugation, obtains different composition combinations after the hyperfiltration treatment, through HPLC, TLC, and IR, NHR, MS, analyses such as UV wherein are respectively combination two, three, four, five, six, seven.The total solid yield is the 10-15% of medical material weight.
Steam distillation thing and component: the volatility oily material that the Chinese medicine compound compositions adopts the method for steam distillation to extract, yield is the 1-3% of medical material weight.Wherein contain composition combination one through the GC-MS analysis.Store for future use through the beta-cyclodextrin inclusion compound solidification.
Need to prove: above-mentioned each component is the main component of described " extract ", and its actual constituent is not limited thereto, and should limit with its raw material and extracting method and be somebody's turn to do " extract ".
More than the 3rd, the 4th describedly " on above-mentioned basic side's basis, increase other composition; On the basis of the extract of above-mentioned Chinese medicine composition, increase other composition ", the component that can increase have in the following four class medicines any one or multiple.Plant-based medicine wherein can be that the corresponding plant of employing (plant species is as the criterion with the plant species of Chinese Pharmacopoeia regulation) is the various process of preparing Chinese medicine processed goods of feedstock production.
Increasable first kind medicine: the Rhizoma Atractylodis Macrocephalae, Rhizoma Chuanxiong, Poria, Fructus Aurantii Immaturus, Ramulus Cinnamomi, Pericarpium Citri Reticulatae, Radix Saposhnikoviae,, 1 flavor or 2 flavors or 3 flavors in the Radix Angelicae Sinensis, the Rhizoma Pinelliae, Rhizoma Coptidis, Radix Et Rhizoma Rhei, Radix Scutellariae, Cortex Albiziae, the consumption of each component is by the general consumption of pharmacopeia defined, or concrete prescription consumption below adopting.
Increase this quasi drugs and can constitute following each scheme:
Prescription 1～5 diarrhoea, constipation, stomachache, the alternating diarrhea and constipation that is mainly used in various degree.
1, Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams.
2, Radix Bupleuri 12 grams, the Radix Paeoniae Alba 12 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams.
3, Radix Bupleuri 15 grams, the Radix Paeoniae Alba 18 grams, Radix Pseudostellariae 9 grams, Radix Glycyrrhizae 9 grams.
4, Radix Bupleuri 12 grams, the Radix Paeoniae Alba 27 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 9 grams.
5, Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, the Rhizoma Atractylodis Macrocephalae 9 grams, Radix Glycyrrhizae 6 grams.
Prescription 6～10 diarrhoea, constipation, stomachache, the alternating diarrhea and constipations that are mainly used in various degree, and with diarrhoea, the pain symptom of heavier degree.
6, Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Rhizoma Chuanxiong 6 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams.
7, Radix Bupleuri 9 grams, the Radix Paeoniae Alba 18 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 9 grams, Pericarpium Citri Reticulatae 9 grams.
8, Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams, Fructus Aurantii Immaturus 9 grams.
9, Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams, Radix Scutellariae 9 grams.
10, Radix Bupleuri 9 grams, the Radix Paeoniae Alba 12 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams, Pericarpium Citri Reticulatae 6-9 gram, Radix Saposhnikoviae 6-9 gram.
Prescription 11～17 is mainly used in diarrhoea, constipation or alternating diarrhea and constipation, and symptom such as, agitation poor with sleeping in various degree.
11, Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams, the Rhizoma Atractylodis Macrocephalae 9 grams, Radix Saposhnikoviae 6-9 gram.
12, Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams, the Rhizoma Atractylodis Macrocephalae 9 grams, Rhizoma Coptidis 6-9 gram.
13, Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams, the Rhizoma Atractylodis Macrocephalae 9 grams, Poria 9 grams.
14, Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams, Cortex Albiziae 9 grams.
15, Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams, Fructus Aurantii Immaturus 6 grams.
16, Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams, Poria 9, the Rhizoma Atractylodis Macrocephalae 9 grams.
17, Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams, Rhizoma Chuanxiong 6 grams.
18, Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams, Radix Et Rhizoma Rhei 6 grams, the Rhizoma Pinelliae 3 grams.
Prescription 19～24 is mainly used in diarrhoea, constipation or alternating diarrhea and constipation, and with abdomen in various degree rise, symptoms such as anorexia, agitation
19, Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, the Rhizoma Atractylodis Macrocephalae 9 grams, Radix Glycyrrhizae 6 grams, Fructus Aurantii Immaturus 6 grams.
20, Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams, the Rhizoma Atractylodis Macrocephalae 9 grams, Rhizoma Coptidis 6-9 gram.
21, Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams, Pericarpium Citri Reticulatae 6 grams, Fructus Aurantii Immaturus 6 grams.
22, Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, the Rhizoma Atractylodis Macrocephalae 9 grams, Radix Glycyrrhizae 6 grams, Radix Scutellariae 9 grams, Pericarpium Citri Reticulatae 9 grams.
23, Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, the Rhizoma Atractylodis Macrocephalae 9 grams, Radix Glycyrrhizae 6 grams, Radix Saposhnikoviae 9 grams.
24, Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, the Rhizoma Atractylodis Macrocephalae 9 grams, Radix Glycyrrhizae 6 grams, Rhizoma Chuanxiong 6 grams, Poria 9 grams.
Prescription 25～28 is mainly used in diarrhoea, constipation or alternating diarrhea and constipation, and with diseases such as becoming thin in various degree, fear of cold.
25, Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, the Rhizoma Atractylodis Macrocephalae 9 grams, Radix Glycyrrhizae 6 grams, Rhizoma Chuanxiong 6 grams.
26, Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, the Rhizoma Atractylodis Macrocephalae 9 grams, Radix Glycyrrhizae 6 grams, Radix Angelicae Sinensis 6 grams, Rhizoma Coptidis 3 grams.
27, the Rhizoma Atractylodis Macrocephalae 9 grams, Poria 9 grams, Radix Glycyrrhizae 6 grams, Radix Bupleuri 6 grams, Radix Pseudostellariae 6 grams, the Radix Paeoniae Alba 12 grams, the Radix Astragali 9 grams.
28, Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, the Rhizoma Atractylodis Macrocephalae 9 grams, Radix Glycyrrhizae 6 grams, Ramulus Cinnamomi 6 grams.
The increasable second class medicine: the extract (assembly of the extract of the water of various pharmaceutical compositions, ethanol or organic solvent, a kind of and multiple extract or chemical constituent that can be certain or some drugs in the above first kind medicine.Extract combination body after the extract that comprises the combination of a kind of and multiple different pharmaceutical makes up once more.)
The extract of described certain or some drugs (also can be described as: " the chemical constituent combination of medicine opposed polarity and the chemical constituent combination of adopting different separation methods to obtain ") is meant: the water-soluble component in the insoluble position of n-butanol extraction component, n-butyl alcohol in the insoluble part of ethyl acetate extraction component, ethyl acetate in the insoluble part of dichloromethane extraction component, dichloromethane in volatile oil part, the aqueous extract position.See sketch map (Fig. 1).Purifies and separates drying: aqueous extract, vacuum concentration, ethanol precipitation, resin absorption, resins exchange, the component that technical method alone or in combination such as high speed centrifugation, cyclodextrin inclusion compound etc. obtains.See sketch map (Fig. 2).
Increasable the 3rd class medicine: the chemical compound that can be natural origin or synthetic.
For example, compositions adds one of following medicine: dioctahedral smectite (SEMECDA) 2-10g, domperidone (domperidone) 5-20mg, cisapride (cisapride) 1-20mg, for adding thiophene sieve (Tegaserod) 2-15mg, alosetron (Alosetron) 0.5-3mg, otilonium Bromide (Spasmomen) 50-200mg, pinaverium bromide (Pinaverum bromide) 50-200mg, Trimebutine Maleate (Trimebutine) 0.2-1.5g, butyric acid bacteria 40-200mg etc.
The preparation method of the above treatment bowel dysfunction Chinese medicine composition (and modern formulation), step is as follows:
1, above-mentioned composition is adopted water, ethanol or other organic solvent extraction;
2, the compositions behind above-mentioned water, ethanol or other organic solvent extraction is adopted one or more purifies and separates of following method: vacuum concentration, ethanol precipitation, resin absorption, resins exchange, high speed centrifugation, technical methods such as cyclodextrin inclusion compound obtain extract after handling;
3, above extract merges, direct or the purified again back of separating adds suitable pharmaceutic adjuvant, is prepared into granule, capsule, tablet, oral liquid, parenteralia (subcutaneous, blood vessel, muscle administration) respectively, through the suppository of skin or mucosal preparation, rectally; Perhaps set by step 4:
4, above medicine adds granule, capsule, tablet, percutaneous or the mucosal preparation of suitable pharmaceutic adjuvant preparation, the suppository of rectally after crushed.
The indication scope of above Chinese medicine composition:
People or other mammiferous gastrointestinal function disorder.Comprise:
1, the irritable bowel syndrome that brings out by Nervous and Mental Factors (bowel dysfunction).
2, by food or inflammation bring out irritable bowel syndrome (bowel dysfunction)
3, the clinical main performance diarrhoea of IBS, constipation, stomachache, alternating diarrhea and constipation; Companion anorexia, asthenia, poor, the agitation of becoming thin, sleep etc.Modern medicine is divided into diarrhea-type, constipation type.Clinical symptoms is with irregular stomachache, abdominal distention, diarrhoea, and the stool character changes and defecation frequency increases and is main performance.Get rid of other intestinal organic diseases: get rid of thyroid disease, diabetes, nephropathy, cardiovascular diseases, disease of hematopoietic system, ulcerative colitis, clone disease, chronic dysentery, peptic ulcer, chronic hepatitis, anus etc., prevent false positive.Stomachache before generally having following feature (1) is just alleviated after an action of the bowels; Enterokinesia obviously increases when (2) suffering from abdominal pain; (3) constipation or diarrhoea; (4) overall health of patients is general good or show with the general neurosis.(5) the spontaneous wriggling of colon is unusual, and intestinal sensitivity increases.(6) internal organs hyperpathia etc.
4, relevant disease comprises: functional bowel disorder (functional diarrhea, functional constipation), acute and chronic functional abdominal pain or abdominal distention or with the stomach symptom, periodically stomachache or abdominal distention, functional dyspepsia, stomachache stomach discomfort etc.
The result of study of the animal pharmacodynamics of the present composition (comprise the above, by extract or contain the various combination of chemicals):
Pharmacodynamic experiment is the result show:
1. to the component of the experiment different parts of mice with spleen deficiency influence, body weight, the food ration that the compositions extract can significantly increase mice with spleen deficiency to some extent, improve sign, loose stool level, increase mice with spleen deficiency spleen index, the thymus index of mice with spleen deficiency, regulate the gastrointestinal function of mice with spleen deficiency, relatively there were significant differences (P＜0.05) with model group.
2. to the experiment of the intestinal propulsion influence of mice neostigmine load/atropine load: it is hyperfunction that the component of different parts, compositions extract can obviously suppress the Small Intestine that causes because of neostigmine load mice to some extent, improve the Small Intestine that atropine causes and be subjected to press down state, relatively there were significant differences (P＜0.05) with model group, points out it that intestinal function is had dual regulation.
3. the experiment of the influence of the mouse writhing pain due to the Dichlorodiphenyl Acetate: the component of different parts, compositions extract can significantly reduce the mouse writhing number of times that is caused by acetic acid to some extent.
4. the experiment of the influence of the rat gastrointestinal tract dysfunction due to the reserpine: after the continuous modeling of rat reserpine, MTL level in body weight, food ration, thymus index, spleen index, blood plasma and the jejunum tissue homogenate and normal control group relatively significantly reduce (P＜0.01).The component of different parts, compositions extract administration group and model group comparison can improve above-mentioned condition to some extent, wherein the MTL level in body weight, food ration, thymus index, blood plasma and the jejunum tissue homogenate.
5. membrane damage situation experiment: the administration group of the component of different parts, compositions extract is compared with model group, and all there were significant differences (P＜0.05).
Experimental technique and result
One, the compositions extract is to the influence of mice with spleen deficiency:
Get 60 of Male Kunming strain mice, be divided into 6 groups at random.Except that the normal control group, all the other each groups all give Radix Et Rhizoma Rhei decocting liquid, duplicate the Mice with Spleen model.Continuous gastric infusion 6d.0.1g·kg
-1·d
-1。The component of different parts, compositions extract and model group are relatively organized a t check.Compare with positive drug group and model group, can significantly increase body weight, the food ration of mice with spleen deficiency to some extent, improve sign, loose stool level, increase mice with spleen deficiency spleen index, the thymus index of mice with spleen deficiency, regulate the gastrointestinal function of mice with spleen deficiency.The results are shown in Table 2.
Table 2 compositions extract is to the influence of mice with spleen deficiency (X ± S)
Compare with matched group:
△P＜0.05,
△ △P＜0.01.Compare with model group:
*P＜0.05,
*P＜0.01.
Two, the compositions extract is to the influence of the intestinal propulsion of mice neostigmine load/atropine load:
Get 60 of Kunming mouses, be divided into 6 groups at random by body weight.Gastric infusion, 5d continuously.Except that the normal control group, all the other respectively organize the equal subcutaneous injection neostigmine of mice 1mgkg
-1All mices are all irritated the carbon powder 0.1ml10g of stomach 5%
-1, putting to death cuts open the belly takes out the gastrointestinal section, and the percentage ratio that it accounts for the small intestinal total length is calculated to the distance of pylorus in record carbon ink forward position.The component at variant position, compositions extract and model group are relatively organized a t check.The intestinal propulsion experimental technique of atropine load removes model group and administration group subcutaneous injection atropine 5mgkg with the experiment of neostigmine load intestinal propulsion in addition
-1Load.The results are shown in Table 3.
Administration group and positive drug group and model group relatively, it is hyperfunction obviously to suppress the Small Intestine that causes because of neostigmine load mice to some extent, improves the Small Intestine that atropine causes and is subjected to press down state, points out it that intestinal function is had dual regulation.
Table 3 compositions extract is to the influence of the intestinal propulsion of mice neostigmine load/atropine load (X ± S)
Compare with matched group:
△P＜0.05,
△ △P＜0.01.Compare with model group:
*P＜0.05,
*P＜0.01.
Three, the influence of the mouse writhing pain due to the compositions extract Dichlorodiphenyl Acetate:
Get Kunming mouse, by the body weight grouping.The administration group is given and the different components extract respectively.After the last administration, the equal lumbar injection 0.6% acetum 0.2ml/ of each Mus, the writhing response number of times of appearance in the observation injection back 15min (abdominal part indent, stretching, extension hind leg, buttocks are raised), and calculate the analgesia percentage rate.The results are shown in Table 4.The component of different parts, compositions extract and positive drug group and model group relatively can significantly reduce the mouse writhing number of times that is caused by acetic acid to some extent.
The influence of the mouse writhing pain due to the table 4 compositions extract Dichlorodiphenyl Acetate (X ± S)
Compare with model group:
*P＜0.05
Four, the compositions extract is to the influence of the rat gastrointestinal tract dysfunction due to the reserpine:
Get the healthy adult male SD rat, be divided into 6 groups.Normal control group intraperitoneal injection of saline 5mlkg
-1D
-1, all the other respectively organize lumbar injection reserpine 0.5mgkg
-1D
-1, the component of different parts, compositions extract are given and the different components extract respectively simultaneously, and normal control group and model group are irritated stomach equal-volume distilled water, 1 d
-1.In the administration process, the feces and the sign of observing rat at any time change, and body weight, the food ration of weighing every day rat.Collect following specimen by MTL radioimmunity test kit behind the 14d continuously: blood plasma, jejunum tissue.Immediately take out each rat chest gland, spleen, weigh.Component, compositions extract and the model group at variant position are compared, organize a t check, the results are shown in Table 5, the continuous modeling of rat reserpine is after 14 days, MTL level in body weight, food ration, thymus index, spleen index, blood plasma and the jejunum tissue homogenate and normal control group relatively significantly reduce.MTL level in the body weight of the component of different parts, compositions extract, food ration, thymus index, blood plasma and the jejunum tissue homogenate is compared with model group, and notable difference is all arranged.
Table 5 compositions extract is to the influence of the rat gastrointestinal tract dysfunction due to the reserpine (X ± S)
Compare with matched group:
△P＜0.05,
△ △P＜0.01.Compare with model group: * P＜0.05, * * P＜0.01.
Five, the compositions extract is to the influence of the damage of gastrointestinal mucosa:
Get gastrointestinal tissue, naked eyes, light microscopic, transmission electron microscope observing mucosa injury situation the results are shown in Table 6.
The damage of table 6 gastrointestinal mucosa is observed
Clinical use is observed:
The compound that the invention provides Chinese medicine (comprises the above, by extract or contain the various combination of chemicals) on the basis of theory of Chinese medical science and pharmacological evaluation, through clinical observation, be used for the treatment of IBS and other gastrointestinal function disorders, effect is better.The result is as follows:
The selection of control drug:
In recent years there is the many cases clinical report to adopt dioctahedral smectite treatment IBS to obtain better effects, dioctahedral smectite all has the improvement effect to the multiple symptom of IBS, particularly aspect times of defecation and stool character, can be alleviated rapidly and improve at symptom after taking medicine, stool can recover normal after most patients 3-4 days.
The case choice criteria:
Select the 50 routine irritable bowel syndrome courses of disease the patient more than 1 month, case is selected: select to determine by Rome standard I I.All cases are through routine blood test, just routine, liver function, blood glucose, liver and gall pancreas B ultrasonic, fibro-colonoscope or intestinal barium agent radiography are got rid of organic disease.Clinical manifestation can be alleviated with stomachache behind abdominal distention, borborygmus, stomachache, the defecation based on diarrhoea.
Therapeutic process:
Male's 39 examples in the case, women's 31 examples; Be divided into treatment and organize 50 examples, matched group 20 examples.Two groups close in sex, age, clinical manifestation, and comparability is arranged.Treatment group: with the present invention's potion every day of writing out a prescription.2 week back doing well,improving person every days of treatment 2 times, 2 weeks of reuse.With the foundation of 4 weeks back clinical manifestation as the curative effect judgement.Matched group: dioctahedral smectite 3 restrains once, and every day 3 times, the course of treatment is the same.Be nonrandom grouping, treat have a blood test after 4 weeks routine, liver function, further consultation 1 time weekly in the therapeutic process understands that symptom changes, defecation character and number of times, looks into just conventional.
Efficacy evaluation
Produce effects: diarrhoea stops, and simultaneous phenomenon is obviously alleviated.Effectively: diarrhoea is obviously alleviated, and every day, defecation was 2 times, and simultaneous phenomenon takes a turn for the better.Invalid: as not reach above-mentioned standard.
The result observes
Prescription group of the present invention: 50 examples, produce effects 29 examples (58%), effective 12 examples (24%), invalid 9 examples (18%), total effective rate 82%.Matched group 20 examples, produce effects 4 examples (20%), effective 7 examples (35%), invalid 9 examples (45%), total effective rate 55%.The present invention's curative effect of writing out a prescription is higher than dioctahedral smectite, and treatment the fastest onset in plan side's is 5 days certainly.3 all stable curative effect show, stomachache and malaise symptoms significantly reduce, and function of intestinal canal improves (comprise that times of defecation and sense of urgency reduce, the stool character is improved), and the while was maintained during whole medication in doing well,improving appeared at around medication preceding.Invalid case extends the period of treatment and also can not improve curative effect, and two groups of medications there is no obvious adverse reaction, treatment back routine blood test, the equal no change of liver function.
Description of drawings
Fig. 1 separates sketch map for the different chemical position;
Fig. 2 is a process chart of the present invention.
The specific embodiment
Embodiment 1, writes out a prescription to be: Radix Bupleuri 6 grams, the Radix Paeoniae Alba 6 grams, Radix Pseudostellariae 3 grams, Radix Glycyrrhizae 6 grams.
Above-mentioned composition is adopted water, ethanol or other organic solvent extraction;
The purifies and separates drying: water or alcoholic acid extracting solution be through vacuum concentration, ethanol precipitation, resin absorption, resins exchange, high speed centrifugation, the extract that methods such as cyclodextrin inclusion compound obtain;
Above medicine adds granule, capsule, tablet, percutaneous or the mucosal preparation of suitable pharmaceutic adjuvant preparation, the suppository of rectally after crushed.
Embodiment 2, and is substantially the same manner as Example 1, but prescription is: Radix Bupleuri 18 grams, the Radix Paeoniae Alba 30 grams, Radix Pseudostellariae 18 grams, Radix Glycyrrhizae 15 grams.Preparation method changes into simultaneously:
Above-mentioned composition is adopted water, ethanol or other organic solvent extraction;
The purifies and separates drying: water or alcoholic acid extracting solution be through vacuum concentration, ethanol precipitation, resin absorption, resins exchange, high speed centrifugation, the extract that methods such as cyclodextrin inclusion compound obtain;
Direct or the purified back of separating of above extract adds suitable pharmaceutic adjuvant, is prepared into the suppository of granule, capsule, tablet, oral liquid, parenteralia, percutaneous or mucosal preparation, rectally respectively.
Embodiment 3, and is basic identical with embodiment 1 or 2, but prescription is: Radix Bupleuri 12 grams, the Radix Paeoniae Alba 12 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams.
Embodiment 4, and is basic identical with embodiment 1 or 2, but prescription is: Radix Bupleuri 18 grams, the Radix Paeoniae Alba 30 grams, Radix Pseudostellariae 12 grams, Radix Glycyrrhizae 12 grams.
Embodiment 5, and is basic identical with embodiment 1 or 2, but prescription is: Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams.
Embodiment 6, and is basic identical with embodiment 1 or 2, but prescription is: Radix Bupleuri 12 grams, the Radix Paeoniae Alba 12 grams, Radix Pseudostellariae 12 grams, Radix Glycyrrhizae 12 grams.
Embodiment 7, and is basic identical with embodiment 1 or 2, but prescription is: Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams.
Embodiment 8, and is basic identical with embodiment 1 or 2, but prescription is: Radix Bupleuri 12 grams, the Radix Paeoniae Alba 12 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams.
Embodiment 9, and is basic identical with embodiment 1 or 2, but prescription is: Radix Bupleuri 15 grams, the Radix Paeoniae Alba 18 grams, Radix Pseudostellariae 9 grams, Radix Glycyrrhizae 9 grams.
Embodiment 10, and is basic identical with embodiment 1 or 2, but prescription is: Radix Bupleuri 12 grams, the Radix Paeoniae Alba 27 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 9 grams.
Embodiment 11, and is basic identical with embodiment 1 or 2, but prescription is: Radix Bupleuri 12 grams, the Radix Paeoniae Alba 12 grams, Radix Pseudostellariae 6 grams, the Rhizoma Atractylodis Macrocephalae 9 grams, Radix Glycyrrhizae 6 grams.
Embodiment 12, and is basic identical with embodiment 1 or 2, but prescription is: Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Rhizoma Chuanxiong 6 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams.
Embodiment 13, and is basic identical with embodiment 1 or 2, but prescription is: Radix Bupleuri 9 grams, the Radix Paeoniae Alba 18 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 9 grams, Pericarpium Citri Reticulatae 9 grams.
Embodiment 14, and is basic identical with embodiment 1 or 2, but prescription is: Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams, Fructus Aurantii Immaturus 9 grams.
Embodiment 15, and is basic identical with embodiment 1 or 2, but prescription is: Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams, Radix Scutellariae 9 grams.
Embodiment 16, and is basic identical with embodiment 1 or 2, but prescription is: Radix Bupleuri 9 grams, the Radix Paeoniae Alba 12 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams, Pericarpium Citri Reticulatae 6-9 gram, Radix Saposhnikoviae 6-9 gram.
Embodiment 17, and is basic identical with embodiment 1 or 2, but prescription is: Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams, the Rhizoma Atractylodis Macrocephalae 9 grams, Radix Saposhnikoviae 6-9 gram.
Embodiment 18, and is basic identical with embodiment 1 or 2, but prescription is: Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams, the Rhizoma Atractylodis Macrocephalae 9 grams, Rhizoma Coptidis 6-9 gram.
Embodiment 19, and is basic identical with embodiment 1 or 2, but prescription is: Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams, the Rhizoma Atractylodis Macrocephalae 9 grams, Poria 9 grams.
Embodiment 20, and is basic identical with embodiment 1 or 2, but write out a prescription is: Radix Bupleuri 9 grams, and the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 restrain, Cortex Albiziae 9 restrains,
Embodiment 21, and is basic identical with embodiment 1 or 2, but prescription is: Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams, Fructus Aurantii Immaturus 6 grams.
Embodiment 22, and is basic identical with embodiment 1 or 2, but prescription is: Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams, Poria 9, the Rhizoma Atractylodis Macrocephalae 9 grams.
Embodiment 23, and is basic identical with embodiment 1 or 2, but prescription is: Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams, Rhizoma Chuanxiong 6 grams.
Embodiment 24, and is basic identical with embodiment 1 or 2, but prescription is: Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, the Rhizoma Atractylodis Macrocephalae 9 grams, Radix Glycyrrhizae 6 grams, Fructus Aurantii Immaturus 6 grams.
Embodiment 25, and is basic identical with embodiment 1 or 2, but prescription is: Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams, the Rhizoma Atractylodis Macrocephalae 9 grams, Rhizoma Coptidis 6-9 gram.
Embodiment 26, and is basic identical with embodiment 1 or 2, but prescription is: Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams, Pericarpium Citri Reticulatae 6 grams, Fructus Aurantii Immaturus 6 grams.
Embodiment 27, and is basic identical with embodiment 1 or 2, but prescription is: Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, the Rhizoma Atractylodis Macrocephalae 9 grams, Radix Glycyrrhizae 6 grams, Rhizoma Coptidis 6 grams, Pericarpium Citri Reticulatae 6 grams.
Embodiment 28, and is basic identical with embodiment 1 or 2, but prescription is: Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, the Rhizoma Atractylodis Macrocephalae 9 grams, Radix Glycyrrhizae 6 grams, Radix Saposhnikoviae 9 grams.
Embodiment 29, and is basic identical with embodiment 1 or 2, but prescription is: Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, the Rhizoma Atractylodis Macrocephalae 9 grams, Radix Glycyrrhizae 6 grams, Rhizoma Chuanxiong 6 grams.
Embodiment 30, and is basic identical with embodiment 1 or 2, but prescription is: Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, the Rhizoma Atractylodis Macrocephalae 9 grams, Radix Glycyrrhizae 6 grams, Radix Angelicae Sinensis, Rhizoma Coptidis 3 grams.
Embodiment 31, and is basic identical with embodiment 1 or 2, but prescription is: the Rhizoma Atractylodis Macrocephalae 9 grams, Poria 9 grams, Radix Glycyrrhizae 6 grams, Radix Bupleuri 6 grams, Radix Pseudostellariae 6 grams, the Radix Paeoniae Alba 12 grams, Radix Scutellariae 9 grams.
Embodiment 32, and is basic identical with embodiment 1 or 2, but prescription is: Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, the Rhizoma Atractylodis Macrocephalae 9 grams, Radix Glycyrrhizae 6 grams.
Embodiment 33, and is basic identical with embodiment 1 or 2, but prescription is: Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, the Rhizoma Atractylodis Macrocephalae 9 grams, Radix Glycyrrhizae 6 grams, Rhizoma Chuanxiong 6 grams, Poria 9 grams.
Embodiment 34, and is basic identical with embodiment 1 or 2, but prescription is: Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams.
With reference to Fig. 1, Fig. 2: above-mentioned composition is adopted water, ethanol or other organic solvent extraction;
Purifies and separates drying: aqueous extract, vacuum concentration, ethanol precipitation, resin absorption, resins exchange, high speed centrifugation, the extract that methods such as spray drying, vacuum drying, cyclodextrin inclusion compound obtain;
Adding is by the water of the Rhizoma Atractylodis Macrocephalae 9 grams, Rhizoma Chuanxiong 6 grams, Poria 9 grams or the compositions that ethanol extraction obtains.
Above medicine adds granule, capsule, tablet, percutaneous or the mucosal preparation of suitable pharmaceutic adjuvant preparation, the suppository of rectally after crushed.
Embodiment 35, and is basic identical with embodiment 34, but adds by the water of the Rhizoma Atractylodis Macrocephalae 9 grams, Fructus Aurantii Immaturus 9 grams or the compositions that extract obtains.
Embodiment 36, and is basic identical with embodiment 34, but adds by the water of Radix Saposhnikoviae 9 grams, Pericarpium Citri Reticulatae 9 grams or the compositions that extract obtains.
Embodiment 37, and is basic identical with embodiment 34, but adds the water extract by Rhizoma Coptidis, Fructus Aurantii Immaturus.
Embodiment 38, and is basic identical with embodiment 34, but adds by the Rhizoma Atractylodis Macrocephalae 9 grams, the n-butanol extract of Radix Saposhnikoviae 6-9 gram.
Embodiment 40, and is basic identical with embodiment 34, but adds the ethyl acetate extract by Fructus Aurantii Immaturus 6 grams.
Embodiment 41, and is basic identical with embodiment 34, but adds by Pericarpium Citri Reticulatae 6 grams, the water extract of Fructus Aurantii Immaturus 6 grams.
Embodiment 42, and is basic identical with embodiment 34, but adds the water extract by the Rhizoma Atractylodis Macrocephalae 9 grams, Rhizoma Chuanxiong 6 grams.
Embodiment 43, and is basic identical with embodiment 1 or 2.Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams.Above-mentioned composition is adopted water, ethanol or other organic solvent extraction;
Purifies and separates drying: aqueous extract, vacuum concentration, ethanol precipitation, resin absorption, resins exchange, high speed centrifugation, the extract that methods such as spray drying, vacuum drying, cyclodextrin inclusion compound obtain;
Add alosetron (Alosetron) 0.5-3mg,
Above medicine adds granule, capsule, tablet, percutaneous or the mucosal preparation of suitable pharmaceutic adjuvant preparation, the suppository of rectally after crushed.
Embodiment 44, and is basic identical with embodiment 43, but changes alosetron into domperidone (domperidone) 5-20mg.
Embodiment 45, and is basic identical with embodiment 43, changes alosetron into cisapride (cisapride) 1-20mg.
Embodiment 46, and is basic identical with embodiment 43, and alosetron is changed into for adding thiophene sieve (Tegaserod) 2-15mg.
Embodiment 47, and is basic identical with embodiment 43, changes alosetron into otilonium Bromide (Spasmomen) 50-200mg.
Embodiment 48, and is basic identical with embodiment 43, changes alosetron into pinaverium bromide (Pinaverumbromide) 50-200mg.
Embodiment 49, and is basic identical with embodiment 43, changes alosetron into Trimebutine Maleate (Trimebutine) 0.2-1.5g.
Embodiment 50, and is basic identical with embodiment 43, changes alosetron into butyric acid bacteria 40-200mg.
Embodiment 51, Radix Bupleuri 9 gram, and the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams, the Rhizoma Atractylodis Macrocephalae 9 grams, after crushed, 54000 grams, ten times of water, 100 ℃ are extracted twice, and each one hour, merge extractive liquid,, concentrating under reduced pressure (50 ℃, 0.1M) to relative density 1.07, add 95% ethanol and make solution contain alcohol amount to be 50%, 4 ℃ and to deposit 24 hours.Get the supernatant spray drying, total solid 8100 grams prepare various solid preparations; Or get supernatant obtaining liq preparation.
Embodiment 52, Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams, the Rhizoma Atractylodis Macrocephalae 9 grams are after crushed, 54000 grams, ten times of water, 100 ℃ are extracted twice, each one hour, merge extractive liquid,, successively, behind the cation exchange resin column (strong-acid type), and use PH5 respectively by anion-exchange resin column (weak base type).5 acetate buffer solutions, PH9.0 ammonia buffer solution elution, the eluent concentrating under reduced pressure (50 ℃ ,-0.1M), get total solid 1610 grams behind the vacuum drying, prepare various solid preparations; Or get concentrated solution obtaining liq preparation.
Embodiment 53, Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams, the Rhizoma Atractylodis Macrocephalae 9 restrain after crushed, and 54000 grams extract twice, each ten times of water for 100 ℃, one hour, merge extractive liquid, was successively by behind the macropore exchange resin column (AB-8), and use 20%, 40%, 60% respectively, 95% alcoholic solution eluting, the eluent concentrating under reduced pressure (50 ℃ ,-0.1Mpa), total solid 1730 grams behind the vacuum drying prepare various solid preparations; Or get concentrated solution obtaining liq preparation.
Embodiment 54, Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams, the Rhizoma Atractylodis Macrocephalae 9 grams are after crushed, 54000 grams extract twice, each ten times of water, one hour for 100 ℃, merge extractive liquid,, concentrating under reduced pressure (50 ℃ ,-0.1Mpa) to relative density 1.07-1.10, the centrifugal 20min of 4000～20000rpm, get total solid 10220 grams after getting the supernatant spray drying, prepare various solid preparations; Or get supernatant obtaining liq preparation.
Embodiment 55, with reference to Fig. 1, Fig. 2: Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams, the Rhizoma Atractylodis Macrocephalae 9 grams are after crushed, 54000 grams extract twice, each ten times of water, one hour for 100 ℃, merge extractive liquid,, concentrating under reduced pressure (50 ℃ ,-0.1Mpa) to relative density 1.07-1.10,4000～20000rpm, 20min gets the ultrafilter membrane of supernatant by 50000M or 10000M.Get the ultrafiltrate concentrating under reduced pressure (50 ℃ ,-0.1Mpa), after the spray drying total solid 7030 is restrained and is equipped with various solid preparations; Or get ultrafiltrate and prepare injection.
Embodiment 56, Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams, the Rhizoma Atractylodis Macrocephalae 9 restrain after crushed, and 54000 grams extract twice, each ten times of water for 100 ℃, one hour, merge extractive liquid,, (50 ℃ of concentrating under reduced pressure,-0.1Mpa) to relative density 1.35-1.40, add a small amount of silica gel and mix, adopt silicagel column, 20%, 40%, 60%, 95% alcoholic solution stepwise elution, (50 ℃ of each section eluent difference concentrating under reduced pressure,-0.1Mpa), obtain 130 grams behind the vacuum drying respectively, 320 grams, 570 grams, 598 gram solid contents prepare various solid preparations; Or get concentrated solution obtaining liq preparation.
Embodiment 57, Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Radix Pseudostellariae 6 grams, Radix Glycyrrhizae 6 grams, the Rhizoma Atractylodis Macrocephalae 54000 grams are after being ground into coarse granule, add ten times of water, water vapour distillation 5 hours is collected distillate, merge, in distillate, add Sal and make saturatedly, placed 24 hours, separate grease 25 and restrain, add 200 gram beta-schardinger dextrin-s, use milling treatment of colloid 30 minutes.Vacuum drying (50 ℃ ,-0.1Mpa).Obtain white solid 206 grams, prepare various solid preparations.
Embodiment 58, are raw material with basic side, get extract E and component as medicine: the Chinese medicine compound compositions adopts water extraction, after suitably concentrating, adds Different concentrations of alcohol, and is centrifugal after leaving standstill, and gets supernatant concentration, obtains.Through HPLC, TLC, IR, NHR, MS, analyses such as UV wherein mainly contain composition combination two, three, four, five, six.The total solid yield is the 14-18% of medical material weight.
Embodiment 59, with basic side is raw material, get extract S and component as medicine: the Chinese medicine compound compositions adopts water extraction, after suitably concentrating, through silicagel column repeatedly chromatography obtain the different composition combination of a plurality of polarity respectively, through HPLC, TLC, IR, NHR, MS, analyses such as UV are respectively composition combination two, three, four, five, six, seven.
Embodiment 60, are raw material with basic side, get extract L and component as medicine: the Chinese medicine compound compositions adopts water extraction, obtains a plurality of different compositions combinations through ion exchange column exchange absorption.Through HPLC, TLC, IR, NHR, MS, analyses such as UV wherein are respectively composition combination two, three, four, five.
Embodiment 61, are raw material with basic side, get extract G and component as medicine: the Chinese medicine compound compositions adopts water extraction, after suitably concentrating, and after the high speed centrifugation processing, the component of water-soluble solution.Obtain a plurality of different compositions combinations.Through HPLC, TLC, IR, NHR, MS, analyses such as UV wherein are respectively composition combination two, three, four, five.The total solid yield is the 18-24% of medical material weight.
Embodiment 62, are raw material with basic side, get extract D and component as medicine: the Chinese medicine compound compositions adopts water extraction, and eluting obtains a plurality of different compositions combinations behind absorption with macroporous adsorbent resin.Through HPLC, TLC, IR, NHR, MS, analyses such as UV wherein are respectively composition combination two, three, four, five, six, seven.The solid yield is the 2.0-7.0% of medical material weight.
Embodiment 63, with basic side is raw material, get extract C and component as medicine: the Chinese medicine compound compositions adopts water extraction, after suitably concentrating, through high speed centrifugation, obtain different composition combinations after the hyperfiltration treatment, through HPLC, TLC, IR, NHR, MS, analyses such as UV wherein are respectively composition combination two, three, four, five, six, seven.The total solid yield is the 10-15% of medical material weight.
Claims (4)
1. a Chinese medicine composition for the treatment of bowel dysfunction is characterized in that, crude drug composed as follows:
Radix Bupleuri 6-18 gram,
Radix Paeoniae Alba 6-30 gram,
Radix Pseudostellariae 6-18 gram,
Radix Glycyrrhizae 6-15 gram.
2. according to the Chinese medicine composition of the described treatment bowel dysfunction of claim 1, it is characterized in that: the proportioning of each crude drug is:
Radix Bupleuri 12-18 gram,
Radix Paeoniae Alba 12-30 gram,
Radix Pseudostellariae 6-12 gram,
Radix Glycyrrhizae 6-12 gram.
3. according to the Chinese medicine composition of the described treatment bowel dysfunction of claim 1, it is characterized in that: the proportioning of each crude drug is:
Radix Bupleuri 9-12 gram,
Radix Paeoniae Alba 9-12 gram,
Radix Pseudostellariae 6-12 gram,
Radix Glycyrrhizae 6-12 gram.
4. according to the Chinese medicine composition of claim 2 or 3 described treatment bowel dysfunctions, it is characterized in that: said Chinese medicine composition is that a kind of extraction in by the following method obtains:
Water extraction is adopted in the combination of crude drug, after suitably concentrating, after high speed centrifugation is handled, gets water-soluble component; Or
Water extraction is adopted in the combination of crude drug, after suitably concentrating, and the extract that after high speed centrifugation, hyperfiltration treatment, obtains.
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| CN101199639B (en) * | 2007-12-20 | 2011-12-14 | 北京天力正元医药技术开发有限公司 | Chinese medicine for treating irritable |
| KR101099004B1 (en) * | 2009-03-13 | 2011-12-28 | 주식회사 사이그린 | A composition for preventing or treating a gastrointestinal disease |
| CN101890082A (en) * | 2009-05-21 | 2010-11-24 | 张作光 | Medicinal composition for treating depression and manufacturing method thereof |
| CN101700289B (en) * | 2009-11-02 | 2012-02-15 | 南京师范大学 | Traditional Chinese medicine extract composition for treating gastrointestinal dysfunction or irritable bowel syndrome (IBS), and preparation method and applications thereof in preparation of medicaments |
| CN104984002B (en) * | 2015-06-16 | 2018-05-29 | 成都乾坤动物药业有限公司 | A kind of multi-functional Chinese and western medicinal composition for animals and preparation method thereof |
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