CN1430999A - Chinese herbal medicine combination for treating disease of disorder of bowels's function and its product - Google Patents
Chinese herbal medicine combination for treating disease of disorder of bowels's function and its product Download PDFInfo
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Abstract
本发明涉及一种治疗肠功能紊乱疾病的中药组合物(irritable bowel syndrome，IBS)等肠功能紊乱疾病的中药复方组合物，以及这种中药复方组合物的剂型。申请人认为IBS常见和首要的原因是精神因素，以“整体观念”和“辨证施治”的原则，提供一种治疗肠易激综合征的中药组合物，包括：柴胡6－15克，白芍5－20，川芎3－10，白术6－20，茯苓6－12克，甘草5－20克。其剂型包括：组合物的提取物直接或经纯化分离后加入适当的药用辅料制备的颗粒剂、胶囊、片剂、口服液、注射剂类、经皮或经粘膜给药制剂、直肠给药的栓剂。本方案在治疗IBS方面已展现独特的效果和优势，有较好的前景。The invention relates to a traditional Chinese medicine compound composition for treating intestinal dysfunction diseases such as a traditional Chinese medicine composition (irritable bowel syndrome, IBS), and a dosage form of the traditional Chinese medicine compound composition. The applicant believes that the common and primary cause of IBS is mental factors, and based on the principle of "holistic concept" and "treatment based on syndrome differentiation", it provides a traditional Chinese medicine composition for treating irritable bowel syndrome, including: Bupleurum bupleurum 6-15 grams, Radix Paeoniae Alba 5-20, Rhizoma Chuanxiong 3-10, Atractylodes Rhizoma 6-20, Poria 6-12 grams, Licorice 5-20 grams. Its dosage forms include: granules, capsules, tablets, oral liquids, injections, transdermal or transmucosal administration preparations, rectal administration preparations prepared by adding the extract of the composition directly or after purification and separation with appropriate pharmaceutical excipients. suppositories. This program has demonstrated unique effects and advantages in the treatment of IBS, and has a good prospect.
Description
Technical field
The present invention relates to a kind of treatment irritable bowel syndrome (irritable bowel syndrome, IBS) the Chinese medicine compound compositions of disease such as bowel dysfunction such as grade, and the preparation of this Chinese medicine compound compositions.
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.At present this disease is still lacked effective Therapeutic Method, so be one of clinical common refractory disease.The IBS prevalence that studies show that American-European countries is about 20%, and annual neopathy rate is 1-2%, and M-F is about 1: 3.The relevant bibliographical information of China, IBS account for gastrointestinal tract special outpatient clinic amount 1/3, account for total crowd's about 15%.Because symptom shows effect repeatedly, long-term existence, to the patient live influence and the inconvenience that brings to work quite obvious, the cost of various inspections and treatment is more considerable.Modern medicine thinks that this disease and nerve, endocrine, immunomodulating system are closely related.Because IBS sickness rate height, external drugmaker falls over each other developing new drug more, but begs till the present, and treatment means is limited, does not still have this sick specific medicament of healing.And medicine is many from lax intestinal smooth muscle, excitement and antagonism neurotransmitter, anxiety, act on limited, usually be at disposing as single symptoms such as diarrhoea or constipation, mainly concentrating on adjusting, antidepressant, dynamics-promoting medicine treatment, calcium-channel antagonists and astringent treatment etc. to the intestinal microecology link.Clinical medicine commonly used mostly is and alleviates some symptom at present, is used for stomachache, the diarrhoea of irritable bowel syndrome as dioctahedral smectite (SEMECDA); The gastrointestinal dynamics-promoting medicine thing of treatment constipation symptom commonly used mainly contains motilium (domperidone, domperidone) is the peripheral nerve dopamine-receptor antagonist, cisapride (cisapride, prepulsid, prepulsid) be a kind of novel gastrointestinal dynamics-promoting medicine, by 5-hydroxy tryptamine (5-HT) not the multiple action of isoacceptor finish the motivator effect.Maleic acid is a kind of new chemical medicine for the treatment of irritable bowel syndrome that Novartis develops for adding thiophene sieve, and its indication is irritable bowel syndrome patient's symptoms such as stomachache, abdominal discomfort and constipation.For adding the cardiac toxicity that thiophene sieve does not have cisapride, littler than cisapride side effect.Shang Shi 5-hydroxytryptamine receptor blocker---alosetron treatment diarrhoea is main irritable bowel syndrome (D-IBS) in recent years.There are some researches show the sex difference of existence.Though above various kinds of drug can be alleviated some symptom of irritable bowel syndrome, in application, exist can't effect a radical cure, shortcomings such as side effect is big, individual variation is obvious, medical expense height.But because the primary disease morbidity relates to spirit, diet, consitution many aspects, in clinical practice, all there are one-sidedness and limitation, still can not satisfy clinical requirement.
IBS has been acknowledged as a kind of psychosomatic disease, is an overdetermined symptom grouping, relates to biology and social mentality's factors such as (comprising intense strain, patient's personality and behavior) in its cause of disease and morbidity.Prove: the pathogenic factor of IBS and Nervous and Mental Factors, the change of intestinal kinetics, eating and drinking without temperance, colon secretion are relevant with absorption function change, alteration of intestinal flora etc.
In the Ancient Times in China medical literature, to early existing a large amount of description and the records of etiology and pathogenesis, symptom and sign and the prophylactic treatment of IBS." organic conception " and the principles such as " determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs " of Chinese medical theory have clear superiority to such treatment of diseases.The basic research of IBS finds that IBS is because nervus centralis and autonomic nervous dysfunction can cause the motion of intestinal tube and secrete due to the dysfunction.IBS patient's intestinal movement is unusual, visceral sensitivity is too high is one of the important pathophysiological basis of IBS morbidity, and morbidity belongs to " having loose bowels " or the models such as " constipation " of the traditional Chinese medical science and raises.Theory of Chinese medical science thinks that primary disease is due to " insufficiency of the spleen excess of the liver ", insufficiency of the spleenly easily is edema with the liver involved insult gram, and the mechanism of qi harmony stagnates, abnormal ascending-descending of QI so that suffer from diarrhoea or constipation.China Chinese medicine medical institutions have adopted Chinese medicine that IBS has been carried out a large amount of exploration and practices.Carry out extensive work at aspects such as the medicine typing of IBS, Therapeutic Principle, the combination of Chinese and Western medicine, obtained good effect.The IBS typing is taked dispersing the stagnated live-QI to relieve the stagnation of QI, pressed down intestinal antidiarrheal; Sweetly lightly hold up spleen, yin nourishing to help fortune; Strengthening the body resistance, warming and invigorating the spleen and stomach; Strong gland damp eliminating, principle is dialectical treats for Qinghua reason intestinal etc., also all achieves tangible results.But report treatment IBS combination physical therapy, acupuncture-moxibustion are arranged, and add, certain curative effect is arranged with abdominal massaging, hot compress or ultrashort wave etc.Adopt Chinese medicine compound and hismanal, vitamin C etc. shared, therapy of combining Chinese and Western medicine IBS curative effect is also very remarkable.
Summary of the invention
The present invention has prescription in mind according to motherland's traditional medicine organic conception, principle with " organic conception " and " determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs ", take all factors into consideration multifactor in this symptom grouping pathogeny comprehensively, and a kind of Chinese medicine compound compositions for the treatment of bowel dysfunction diseases such as irritable bowel syndrome is provided, and the preparation of the preparation of this Chinese medicine compound compositions.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.The relevant applicant of this project 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, pathogenesis be liver lose dredge rush down, perverse and unreasonable manner violates spleen, causes disharmony between the liver and spleen; Or stagnation of QI due to depression of the liver, strongly fragrant fire-transformation of a specified duration, fire consumption body fluid, defeated cloth is lost in Tianjin, can not moisten large intestine, causes dysfunction of the spleen in transportation.The clinical constipation of seeing more, companion's anorexia, abdominal distention, the irritated xerostomia of psychentonia, few disease of waiting of sleeping.Fail to control as the state of an illness, course of disease delay causes weakness of the spleen and stomach, and fortuneization is unable, the biochemical weary source of QI and blood.Then have loose bowels and constipation replaces clinically toward visiting.The course of disease plays i.e. stomachache visible clinically morning to the end, borborygmus, has loose bowels, accompanies coldness of the body with chills, and the soreness of waist is soft, pale tongue with white fur, deep-thready pulse.Therefore, control from liver-spleen disharmony opinion, sum up depressed liver-energy dispersing and QI regulating, spleen invigorating bowel relieving on this basis, yin nourishing helps the Therapeutic Principle of fortune and square substantially through clinical verification.
The basic side of the Chinese medicine composition of above-mentioned treatment bowel dysfunction disease comprises:
Radix Bupleuri 6-15 gram
Radix Paeoniae Alba 5-20 gram
Rhizoma Chuanxiong 3-10 gram
Rhizoma Atractylodis Macrocephalae 6-20 gram
Poria 6-12 gram
Radix Glycyrrhizae 5-20 gram.
Further optimize above scheme: the recommendation consumption of basic prescription is:
Radix Bupleuri 8-12 gram
Radix Paeoniae Alba 9-12 gram
Rhizoma Chuanxiong 5-9 gram
Rhizoma Atractylodis Macrocephalae 9-15 gram
Poria 6-12 gram
Radix Glycyrrhizae 6-15 gram.
Below substantially can be not add other components, directly in clinical use.That is: the composition of said composition is above-mentioned prescription.Simultaneously also can on above-mentioned basic side's basis, increase other compositions, the component that can increase have in the following two class medicines any one or multiple:
1: Radix Codonopsis, Fructus Mume, Fructus Aurantii Immaturus, Radix Saposhnikoviae, Pericarpium Citri Reticulatae, Radix Pseudostellariae, Ramulus Cinnamomi, Rhizoma Cimicifugae, Semen Myristicae, Fructus Schisandrae Chinensis.
2: the Radix Astragali, Radix Ginseng, Radix Puerariae, Ramulus Uncariae Cum Uncis, Radix Angelicae Sinensis, Fructus Jujubae, Rhizoma Zingiberis Recens, Rhizoma Cyperi, the Rhizoma Pinelliae, Radix Curcumae.
For example: when being used for diarrhoea, constipation, stomachache, alternating diarrhea and constipation in various degree, can increase the Radix Aucklandiae 6 grams;
Be used for diarrhoea, stomachache, constipation, alternating diarrhea and constipation, and when significantly becoming thin, sleeping poor symptom in various degree, on basic side basis, increase a kind of in the following scheme combination of components: (1), increase Radix Pseudostellariae 10～18 grams, or, (2), Radix Pseudostellariae 10～18 grams, Pericarpium Citri Reticulatae, each 6 gram of Fructus Aurantii Immaturus; Or (3), Pericarpium Citri Reticulatae 6 grams～9 grams, or (4), Radix Scutellariae 9 grams, Radix Codonopsis 9 grams, Fructus Aurantii Immaturus 6 grams, Rhizoma Cimicifugae 3 grams, or (5), Pericarpium Citri Reticulatae, each 6 gram of Radix Codonopsis.
Be used for abdomen rise, suffer from abdominal pain, with obvious constipation, during diseases such as agitation, can increase: Radix Saposhnikoviae 6 grams, Semen Myristicae 6 grams, Radix Puerariae 9 grams, Fructus Schisandrae Chinensis 6 grams.
Be used for diarrhoea or constipation, and during with diseases such as obviously stomachache, fear of cold, increase a kind of in the following combination of components on basic side basis: (1), Fructus Mume 9 grams, Rhizoma Coptidis 3 grams, Ramulus Cinnamomi 3 grams, Radix Pseudostellariae 6 restrain; Or (2), Semen Myristicae 12 grams, Pericarpium Citri Reticulatae 6 grams, Ramulus Cinnamomi 6 grams, Rhizoma Coptidis 3 grams; Or (3), Ramulus Cinnamomi 9 grams, Pericarpium Citri Reticulatae 6 grams, Radix Curcumae 3 grams.
Being used for diarrhoea, constipation alternately rises, anorexia, when disease such as becoming thin, can increase: Radix Codonopsis 18 grams, Radix Platycodonis 9 grams, Rhizoma Coptidis 3 grams, the Radix Aucklandiae 3 grams, Fructus Crataegi 3 grams, Massa Medicata Fermentata 3 grams, Fructus Aurantii Immaturus 3 grams, Pericarpium Citri Reticulatae 3 grams with tangible abdomen.
The modern formulation of above Chinese medicine composition comprises:
1, the direct or purified suppository that separates granule that the back adds suitable pharmaceutic adjuvant preparation, capsule, tablet, oral liquid, parenteralia (subcutaneous, blood vessel, muscle administration), percutaneous or mucosal preparation, rectally of above extract.
2, above medicine adds granule, capsule, tablet, percutaneous or the mucosal preparation of suitable pharmaceutic adjuvant preparation, the suppository of rectally after crushed.
3, above extract direct or purified separation back and the direct ground product of medicine make up granule, capsule, tablet, percutaneous or the mucosal preparation of back preparation, the suppository of rectally.
The indication scope of this compositions: the gastrointestinal function disorder of people or other general newborn animal.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, other relevant diseases comprise: 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, gastropathy stomach discomfort etc.
The result of study of the animal pharmacodynamics of this compositions is as follows:
The defecation of 1 pair of model of spleen deficiency animal of drug efficacy study and the recovery of body weight and the influence of motilin.
The result of study of animal pharmacology: (1) influences experiment material 1.1 experimental drugs to the recovery of the defecation of model of spleen deficiency animal and body weight and motilin: plan side's (Radix Bupleuri 10 grams certainly, the Radix Paeoniae Alba 9 grams, Rhizoma Chuanxiong 6 grams, Radix Pseudostellariae 6 grams, the Rhizoma Atractylodis Macrocephalae 9 grams, Poria 9 grams, Radix Glycyrrhizae 6 grams).Concentrated solution decocts twice on request by prescription drug, is concentrated into 1 gram crude drug/ml (middle dosage) behind an amount of ethanol precipitation, 3 gram crude drug/ml (high dose), and 5 ℃ of storages are standby; 1.2 laboratory animal: the SD kind rat that grows up, 180～220g.2 experimental techniques, 2.1 grouping experiments
Matched group: get 10 of healthy rats, intraperitoneal injection of saline is an amount of, continuous 10 days.And in whenever
Day, 9:00,16:00 gavaged each 2ml of normal saline.Continuous 20 days, record was observed.
Model preparation: get rats by intraperitoneal injection reserpine injection 0.5mg kg
-1d
-1Continuous 10 days.
9:00,16:00 gavage each 2ml of normal saline every day.
Natural recovering group: 10 of delivery type rats, 9:00,16:00 gavage each 2ml of normal saline every day.
Continuous 10 days.
From plan side's low dose group: 10 of delivery type rats, 9:00,16:00 gavage from plan side dense every day
Each 2ml of liquid (1g/ml) that contracts, continuous 10 days.
From plan side's high dose group: 10 of delivery type rats, 9:00,16:00 gavage from plan side dense every day
Each 2ml of liquid (3g/ml) that contracts, continuous 10 days.
The positive drug matched group: 10 of delivery type rats, in every day 9:00,16:00 with 1g Kg
-1Agent
Amount gavages the dioctahedral smectite suspension, continuous 10 days.2.2 judge index as a result
The model situation is observed: engender in various degree diarrhoea, crissum dirt behind the modeling rat injection reserpine
Dirty.To the tenth day all a large amount of loose stools of each group, appetite descended.
Index is selected: write down situations such as each treated animal body weight, appetite, feces.Selecting the sings and symptomses such as time of animal appetite, body weight, recovery normal defecation is judge index.The results are shown in Table 1, table 2.Other gets motilin (MTL) and is the auxiliary judgment index.Observe the mucosa injury situation of gastrointestinal tissue simultaneously.Each treated animal experiment finishes back fasting 16 hours, and sacrificed by decapitation is got intestinal juice, blood plasma, jejunum, the freezing preservation of inferior colliculus cerebral tissue, presses kit method and measures MTL, the results are shown in Table 3.Get gastrointestinal tissue, naked eyes, light microscopic, transmission electron microscope observing mucosa injury situation the results are shown in Table 4.2.4 adopt two groups of t check carrying out statistical analysiss between the date processing mean in twos.3 results
Middle and high dosage can significantly improve body weight (P＜0.05) and the appetite (P＜0.05) of animal pattern from plan side's group and positive drug matched group, and plan side's group is significantly increased by (P＜0.05) (table 1, table 2) than the positive drug matched group certainly. middle and high dosage all can accelerate to improve the disorderly symptom of animal defecation from plan side's group, positive drug matched group, from rapid-action in dioctahedral smectite (table 3) with side's group.Middle and high dosage significantly improves MTL content (P＜0.05) (table 4) in animal pattern body fluid and the tissue from intending Fang Zuneng.Middle and high dosage all can obviously recover model drug to gastrointestinal mucosa cells injury (table 5) from plan side's group and positive drug matched group.
This result of study shows: animal model has tangible diarrhoea, loose stool, feces viscous not well, degradation symptom under appetite, body weight, the MTL.But there is no gastrointestinal mucosa before and after the medication obviously damages.Can obviously improve the general situation of reserpinization rat model (body weight, appetite, defecation) (P＜0.05) from plan side and dioctahedral smectite, intend to significantly improve MTL content (P＜0.05) in animal pattern body fluid and the tissue certainly; At aspects such as general situation, normal defecation recovery natural law, MTL significant advantage (P＜0.05) is all arranged than the dioctahedral smectite matched group from plan side's treatment group.Recover aspects such as natural law, body weight, MTL at defecation than dioctahedral smectite matched group be significantly improved (P＜0.05) from plan side's treatment group.Pretend medicine for treatment, help patient's rehabilitation for IBS.(2) to the research at the drug effect position of gastrointestinal motility regulating action.Method: adopt intestine in vitro to observe from of the influence of the different extract parts in plan side to the isolated small intestines of rabbits motion.Material 11 trial drugs boil twice through decocting from the side's of plan medicine, 30 minutes/each, filter, centrifugal, after concentrating, behind different organic solvent extractions, tell the molten position of water extraction alcohol, chloroform extract, chloroform extract 1, chloroform extract 2, ethyl acetate extract, ethyl acetate extract 1, ethyl acetate extract 2, ethyl acetate extract 3, n-butanol portion 1, n-butanol portion 2, the insoluble position of n-butyl alcohol, be mixed with debita spissitudo with distilled water during test and use.
Sketch map is separated at the different chemical position
Chinese medicine compound
↓
Water extraction
The molten position of ↓ water extracting alcohol ← water extract → ether position
↓
Insoluble part → the chloroform extract of ether → chloroform extract 2, chloroform extract 1
↓
Insoluble part → the ethyl acetate extract of chloroform → ethyl acetate extract 1, ethyl acetate extract 2,
Ethyl acetate extract 3
↓
Ethyl acetate part → n-butanol portion → n-butanol portion 1, n-butanol portion 2
↓
Rabbit, body weight 20～2.5kg plant in the insoluble position of n-butyl alcohol 13 animal New Zealand.The preparation reference literature method of 14 method isolated small intestines of rabbits, desk-top self-balancing recorder is traced curve movement, observe the variation of administration front and back intestinal tube curve movement: 1. relatively from the influence of each extract part of plan side to the duodenum spontaneous activity, 5 minutes intestinal tube shrinkage amplitudes suppress percentage rate after the calculating administration.2. at barium chloride (BaCl
2, 20% 0.1ml) cause on the basis of the tetanic property of rat small intestine in vitro contraction, observe the antagonism of each sample, obtain intestinal tube tension force height is suppressed percentage rate.3. cause the antagonism of observation sample on the obvious basis that suppresses of rat small intestine in vitro at adrenalin hydrochloride (0.1ml), obtain medicine intestinal tube shrinkage amplitude increment rate.The influence of 2.1 pairs of rabbit duodenums of 2 results spontaneous activity
From plan side's water extract, the molten position of water extraction alcohol the stripped duodenum spontaneous activity of rabbit is the inhibition influence, shows as shrinkage amplitude and reduce, frequency reduces, and tension force descends.Dosage hour mainly shows shrinkage amplitude and reduces, and frequency and tension variation are not obvious.Above dosage suppresses percentage rate to the intestinal tube shrinkage amplitude and is respectively 69.0 ± 27.3% (n=10) and 81.4 ± 12.0% (n=10).Spontaneous activity is inhibition influence to duodenum from plan side's ethyl acetate extract, chloroform extract, n-butanol extraction position, act on similarly to the water extract, mainly shows as the shrinkage amplitude minimizing.When dosage was big, frequency reduced to some extent, and tension force slightly descends, and its action intensity is relevant with dosage.The three compares, and ethyl acetate is suitable with the chloroform extract action intensity, a little less than the n-butanol portion effect.The insoluble position of n-butyl alcohol is not obvious to duodenum spontaneous activity effect.2.2 the effect of antagonism acetylcholine, barium chloride
From plan side's water extract (35mg/ml), the water extraction molten position of alcohol (35mg/ml) acetylcholine, barium chloride are caused that the contraction of the tetanic property of intestinal tube all has obvious antagonism, mainly shows as tensile force and obviously descends.Antagonism percentage rate to acetylcholine is respectively 66.9 ± 11.3% (n=10), 70.1 ± 9% (n=10); Antagonistic rate to barium chloride is respectively 53.4 ± 11.2% (n=10), 48.5 ± 9.6% (n=10).From plan side's ethyl acetate extract, chloroform extract, n-butanol portion acetylcholine is caused that the contraction of the tetanic property of intestinal tube all has tangible antagonism, the tension force that mainly shows as intestinal tube obviously descends, and action intensity is relevant with dosage.The three compares, and the action intensity of chloroform extract and ethyl acetate extract is suitable, a little less than the effect of n-butanol portion.
Chloroform extract 1, chloroform extract 2, ethyl acetate extract 1, ethyl acetate extract 2 have the effect of tangible antagonism acetylcholine, barium chloride, and action intensity all significantly strengthens than chloroform extract or ethyl acetate extract.Ethyl acetate extract 3 does not have this effect.N-butanol portion 2 pairs of acetylcholine, barium chlorides cause that the contraction of the tetanic property of intestinal tube all has obvious antagonism, but intensity a little less than, be lower than chloroform extract or ethyl acetate extract.2.3 adrenolytic
From plan side's water extract, n-butanol portion, the insoluble position of n-butyl alcohol epinephrine is caused that the obvious inhibition of rat small intestine in vitro all shows certain antagonism, antagonistic rate is respectively 23.8 ± 8.4%, 13.5 ± 53%, 12.7 ± 4.7% (n=10), mainly show as add reagent after, shrinkage amplitude has certain increasing.Ethyl acetate extract, chloroform extract, the molten position of water extraction alcohol all do not have the antiadrenergic drug effect.
1 pair of epinephrine of n-butanol portion causes that the obvious inhibition of rat small intestine in vitro shows intensive antagonism, and action intensity is than the remarkable enhancing of n-butanol portion.2 pairs of epinephrines of n-butanol portion cause that the obvious inhibition of rat small intestine in vitro do not have antagonism.3 discuss clinical being used in various degree gastrointestinal motility disorder (show as the hyperfunction of gastrointestinal motility or weaken) from plan sides.The method that we adopt Chemical Decomposition and drug efficacy study to combine is studied.The result shows that tentatively spontaneous activity is the inhibition influence to isolated small intestines of rabbits for the side's of plan chloroform extraction position, ethyl acetate extract, n-butanol portion, water extract certainly.Cause that at acetylcholine or barium chloride all there is antagonism at above-mentioned position on the basis of the tetanic property of rat small intestine in vitro contraction, wherein stronger with chloroform extract, ethyl acetate extract effect.No matter the insoluble position of n-butyl alcohol is all not have tangible influence to the spontaneous activity of small intestinal or to the effect of acetylcholine, barium chloride.Cause that at epinephrine except that n-butanol portion had certain adrenolytic, all the other positions did not have this effect on the obvious basis that suppresses of rat small intestine in vitro.
FF chloroform extract 1, chloroform extract 2, ethyl acetate extract 1, the ethyl acetate extract 2 of each effective site after further separating shows acetylcholine, barium chloride caused the more intensive antagonism of the tetanic property of intestinal tube contraction; 1 pair of epinephrine of FF n-butanol portion causes the more intensive antagonism of obvious inhibition of rat small intestine in vitro.
The appetite of each treated animal changes after table 1 medication
*P＜0.05vs natural recovering group, aP＜0.05vs positive drug matched group
Each treated animal body weight change of table 2
*P＜0.05vs natural recovering group, aP＜0.05vs positive drug matched group
Table 3 defecation state observation
| Group | Feces recovery normal time (my god) |
| Matched group | |
| Natural recovering group | ????11 |
| From plan side's high dose group | ????5 |
| Dosage group in plan side | ????5 |
| The positive drug matched group | ????7 |
Table 4 MTL is changes of contents group blood plasma intestinal juice hypothalamus jejunum tissue in animal body fluid and tissue
Ng/L ng/L ng/L ng/L matched group 231.14 ± 77.28 624.05 ± 29.47 32.94 ± 59.72 ± 5.05
2.18 natural recovering group 168.75 ± 31.40 483.57 ± 41.26 20.17 ± 41.62 ± 4.91
5.40 high agent 255.08 ± 610.39 ± 28.62 ± 55.21 ± amount in plan side group 29.59 certainly
*46.29
*3.66
*7.27
*A is agent 220.61 ± 654.96 ± 30.57 ± 68.40 ± amount group 51.42 in plan side
*30.51
*7.04
*4.25
*The a positive drug shines group 27.93 to 192.31 ± 499.35 ± 38.16 18.73 ± 3861 ± 3.19
*5.17
*P＜0.05vs natural recovering group; AP＜0.05vs positive drug matched group
The damage of table 5 gastrointestinal mucosa is observed the normal normal mucosa epithelial cell of the normal normal natural recovering group of group naked eyes light microscopic Electronic Speculum matched group and is arranged loose, few
Measuring the normal normal mucosa epithelial cell of the natural recovering group that comes off arranges loose, few
Amount comes off approaching from the normal normal mucosa epithelial cell of the side's of plan high dose group
Matched group, it is approaching not have the normal normal mucosa epithelial cell of dosage group that comes off in plan side
Matched group, it is approaching not have the normal normal mucosa epithelial cell of positive drug matched group that comes off
Matched group, not having comes off faces urine use observation
Irritable bowel syndrome (IBS) is common digestive tract non-organic disease, and clinical symptoms is with irregular stomachache, abdominal distention, diarrhoea, and the stool character changes and defecation frequency increases and is main performance, and existing still do not have an ideal Therapeutic Method.The medicine of clinical treatment IBS is the alleviation at a certain symptom basically at present, as analgesic (as calcium ion antagonist), diarrhea and gastrointestinal tract dynamia medicine etc.At also not having certain clear and definite medicine can cure this situation of IBS at present, so should adopt the principle of Comprehensive Treatment to the treatment of IBS.The invention provides the compound (Radix Bupleuri 10 grams, the Radix Paeoniae Alba 9 grams, Rhizoma Chuanxiong 6 grams, Radix Pseudostellariae 6 grams, the Rhizoma Atractylodis Macrocephalae 9 grams, Poria 9 grams, Radix Glycyrrhizae 6 grams) of Chinese medicine, take dispersing the stagnated live-QI to relieve the stagnation of QI, press down intestinal antidiarrheal; The sweet light Therapeutic Principle who holds up spleen, yin nourishing to help fortune carries out prescription.On the basis of theory of Chinese medical science and pharmacological evaluation, through our 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: by the irritable bowel syndrome case choice criteria of the whole nation, Chengdu in 1986 chronic diarrhea academic discussion formulation.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 33 examples in the case, women's 17 examples; Be divided into treatment and organize 40 examples, matched group 10 examples.Two groups close in sex, age, clinical manifestation, and comparability is arranged.Treatment group: use from plan side's potion every day.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
Organize from plan side: 40 examples, produce effects 21 examples (52.5%), effective 12 examples (30%), invalid 7 examples (17.5%), total effective rate 82.5％。Matched group 20 examples, produce effects 5 examples (25%), effective 7 examples (35%), invalid 8 examples (40%), total effective rate 60%.Curative effect is higher than dioctahedral smectite from plan side, 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.
This compositions is representing unique effect and advantage aspect the IBS in treatment, tally with the national condition sturdy basis and prospect preferably of exploitation treatment IBS modern Chinese medicine from the Chinese medicine clinical proved recipe.
The specific embodiment
Embodiment 1: Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9, Rhizoma Chuanxiong 6, the Rhizoma Atractylodis Macrocephalae 9, Poria 9 grams, Radix Glycyrrhizae 6 grams.
Embodiment 2: Radix Bupleuri 10 grams, the Radix Paeoniae Alba 9, Rhizoma Chuanxiong 6, the Rhizoma Atractylodis Macrocephalae 6, Poria 6 grams, Radix Glycyrrhizae 3 grams.
Embodiment 3: Radix Bupleuri 12 grams, the Radix Paeoniae Alba 9, Rhizoma Chuanxiong 6, Radix Pseudostellariae 10, the Rhizoma Atractylodis Macrocephalae 6, Poria 3, Radix Glycyrrhizae 5 grams.
Embodiment 4: Radix Pseudostellariae 18, the Radix Paeoniae Alba 15, Rhizoma Chuanxiong 15, Radix Bupleuri 10 grams, the Rhizoma Atractylodis Macrocephalae 15, Poria 9 grams, Radix Glycyrrhizae 9 grams.
Embodiment 5: Radix Bupleuri 12 grams, the Radix Paeoniae Alba 9, Rhizoma Chuanxiong 6, Radix Pseudostellariae 10, the Rhizoma Atractylodis Macrocephalae 6, Poria 3, Radix Glycyrrhizae 5 grams.Pericarpium Citri Reticulatae 6, Fructus Aurantii Immaturus 6.)
Embodiment 6: Radix Bupleuri 10 grams, the Radix Paeoniae Alba 15, Rhizoma Chuanxiong 5, the Rhizoma Atractylodis Macrocephalae 20, Poria 15 grams, Radix Glycyrrhizae 8 grams.
Embodiment 7: Radix Bupleuri 10 grams, the Radix Paeoniae Alba 15, Rhizoma Chuanxiong 5, the Rhizoma Atractylodis Macrocephalae 20, Poria 15 grams, Radix Glycyrrhizae 8 grams.Pericarpium Citri Reticulatae.
Embodiment 8: Radix Bupleuri 12, Radix Scutellariae 9, Radix Codonopsis 9, Radix Glycyrrhizae 6, Fructus Aurantii Immaturus 6, the Radix Paeoniae Alba 12.
Embodiment 9: Radix Bupleuri 9 grams, and the Radix Paeoniae Alba 18,, the Rhizoma Atractylodis Macrocephalae 12, Poria 6 grams, Radix Glycyrrhizae 9 grams.Pericarpium Citri Reticulatae 9
Embodiment 10: the Rhizoma Atractylodis Macrocephalae 9, the Radix Paeoniae Alba 6, Pericarpium Citri Reticulatae 6, Radix Codonopsis 6, Radix Glycyrrhizae 4.5, Poria 3.
Embodiment 11: the Rhizoma Atractylodis Macrocephalae 12, the Radix Paeoniae Alba 9, Radix Saposhnikoviae 6, Semen Myristicae 6, Fructus Evodiae 6, Fructus Schisandrae Chinensis 6, Radix Glycyrrhizae 3, Poria 9.
Embodiment 12: the Radix Paeoniae Alba 15, Radix Glycyrrhizae 9, Poria 6, Fructus Mume 9, Rhizoma Coptidis 3, Ramulus Cinnamomi 3, Radix Pseudostellariae 6.
Embodiment 13: the Radix Paeoniae Alba 20, Radix Glycyrrhizae 9, Ramulus Cinnamomi 9, the Rhizoma Atractylodis Macrocephalae 9, Poria 9, Pericarpium Citri Reticulatae 6, Radix Curcumae 3.
Embodiment 14: Radix Codonopsis 18, the Rhizoma Atractylodis Macrocephalae 9, Poria 9 grams, Radix Glycyrrhizae 6 grams.Radix Platycodonis 9, Rhizoma Coptidis 3, the Radix Aucklandiae 3, Fructus Crataegi 3, Massa Medicata Fermentata 3, Fructus Aurantii Immaturus 3, Pericarpium Citri Reticulatae 3.
Embodiment 15: the Radix Paeoniae Alba 18, the Rhizoma Atractylodis Macrocephalae 15, Semen Myristicae 12, Rhizoma Chuanxiong 6, Pericarpium Citri Reticulatae 6, Radix Glycyrrhizae 6, Ramulus Cinnamomi 3, Rhizoma Coptidis 3.
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