CN106177062A - A kind of pharmaceutical composition treating irritable bowel syndrome and preparation method thereof - Google Patents

A kind of pharmaceutical composition treating irritable bowel syndrome and preparation method thereof Download PDF

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CN106177062A
CN106177062A CN201610750616.XA CN201610750616A CN106177062A CN 106177062 A CN106177062 A CN 106177062A CN 201610750616 A CN201610750616 A CN 201610750616A CN 106177062 A CN106177062 A CN 106177062A
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parts
preparation
irritable bowel
bowel syndrome
weight proportion
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王小伟
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Shanxi Ecross Hongtai Biotechnology Co Ltd
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Shanxi Ecross Hongtai Biotechnology Co Ltd
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Abstract

The present invention provides a kind of pharmaceutical composition treating irritable bowel syndrome, is made up of the raw material of following weight proportion: Chinese prescription 30 50%, probiotics preparation 40 60%.Described Chinese prescription is made up of following weight proportion medicine: the Radix Astragali 10 50 parts, Radix Bupleuri 5 20 parts, 8 30 parts of Poria, the Rhizoma Atractylodis Macrocephalae 5 15 parts, the Radix Paeoniae Alba 5 15 parts, Pericarpium Citri Reticulatae 3 20 parts, Semen Plantaginis 1 10 parts.Described probiotics preparation is made up of the probiotic bacteria of following weight proportion: clostridium butyricum 28 parts, bacillus acidophilus 15 parts, bacillus subtilis 15 parts.The preparation method of the pharmaceutical composition of above-mentioned treatment irritable bowel syndrome, comprises the following steps: a, making Chinese prescription；B, making probiotics preparation: c, making capsule or granule.The present invention, by drug matching prescription and probiotics preparation formulated in combination, fundamentally plays prevention and the curative effect for the treatment of irritable bowel syndrome.

Description

A kind of pharmaceutical composition treating irritable bowel syndrome and preparation method thereof
Technical field
The invention belongs to drug world, particularly relate to a kind of pharmaceutical composition treating irritable bowel syndrome and preparation side thereof Method.
Background technology
Irritable bowel syndrome (irritable bowel syndrome, IBs) refers to one group and includes stomachache, abdominal distention, row Just custom change and stool is abnormal, the urine performance such as just get rid of the organic disease that can cause these symptoms on inspection Clinical syndrome, sustainable existence or recurrent exerbation.Primary disease has developed into commonly encountered diseases, carries out questionnaire survey general population, has IBS symptom America and Europe is reported as 10%-20%, and one group of China Beijing is reported as 8.7%.
Irritable bowel syndrome mainly has diarrhea-type, constipation type, alternating diarrhea and constipation type and uncertain type, wherein with diarrhea-type Clinical most commonly seen.Prolonged and repeated outbreak of suffering from diarrhoea brings a lot of inconvenience to the life of patient, study and work, reduces patient's Quality of life.For irritable bowel syndrome, current medicine is mainly antibiosis anti-inflammatory drug, diarrhea, Chinese medicine, Tiny ecosystem system Agent etc., but curative effect is respectively weak, it is impossible to and treating both the principal and secondary aspects of a disease, the course for the treatment of is longer, easily recurs after treatment.
Doctor trained in Western medicine thinks that the easy syndrome of diarrhea-type intestinal belongs to multifactorial Physiological Psychology disease, stress, dietary factor stomach function regulating Intestinal infection all can cause it to occur, and in treatment, how employing improves gastrointestinal tract dynamia medicine, calcium-channel antagonists and regulation is planted Thing function of nervous system class medicine is suited the medicine to the illness Supporting Therapy, and effect is not satisfactory, and side effect is obvious.
And according to its clinical manifestation characteristic in Chinese medicine, belonging to " having loose bowels ", " stomachache " category, the cause of disease mostly is outside impression Evil, seven emotions discord and weakness of the spleen and stomach etc., sick position is at large intestine, dirty closely related with liver, spleen two.The traditional Chinese medical science thinks that stagnation of liver-QI with deficiency of the spleen is that it is main Wanting pathogenesis, or not temperance for food and drink the most insufficiency of the spleen by ferritic, overstrain internal injury causes weakness of the spleen and stomach；Or because of being unable to satisfy the wants, disgruntled nervous anxiety And cause depression of liver-QI, and spleen weakness, retention of water-damp in the body, clear QI failing to ascend, turbid QI failing to descend, form and have loose bowels, functional activity of QI being not smooth event " stomachache ", " abdominal distention ", " borborygmus ", " having loose bowels ".Therefore, treatment uses the prescription of soothing liver and strengthening spleen, invigorating the spleen and replenishing QI more, effect still can, but control The treatment time is longer, and short-term is extremely difficult to good result.
Microecology of intestinal tract research thinks that the Etiological of irritable bowel syndrome is enteric flora disturbance, and harmful bacteria increases Many, the toxin such as the ammonia of generation, scatol, indole increases, make the biological barrier of intestinal, Mucosal immunity, mechanical barrier or even Chemical barrier is the most impaired, is in sub-health state, and enteroscopy does not go out obvious organic damage, but intestinal now is resistance to By reduced capability, by some pessimal stimulations, will suffer from diarrhoea, constipation, abdominal distention, the symptom such as stomachache.And Tiny ecosystem probiotic bacteria Preparation main mechanism is by recovering intestinal microbial population balance, reduce harmful bacteria and the toxin of generation thereof, producing short-chain fat Intestinal mucosa is repaired in acid, thus recovers function of intestinal canal.Therefore, it can be seen that Tiny ecosystem probiotics preparation can solve rapidly intestinal The symptoms such as diarrhoea that group is disorderly to cause, stomachache, constipation, but liver-spleen disharmony etc. can not be solved and fundamentally cause enteric flora disturbance The cause of disease.
Therefore, finding energy relieving the pain caused by diseases rapidly and fundamentally cure irritable bowel syndrome, the medicine being free from side effects is The great difficult problem of clinical urgent needs.
Summary of the invention
In order to solve this difficult problem, the present invention provides a kind of pharmaceutical composition treating irritable bowel syndrome and preparation side thereof Method, by drug matching prescription and probiotics preparation formulated in combination, prescription is rigorous, compatibility science, evident in efficacy, and energy table is the most double to be controlled, Treat rapidly and fundamentally diarrhea irritable bowel syndrome.
For reaching above-mentioned purpose, the technical solution used in the present invention is a kind of drug regimen treating irritable bowel syndrome Thing, is made up of the raw material of following weight proportion: Chinese prescription 30-50%, probiotics preparation 40-60%.Described Chinese prescription by under Row weight proportion medicine forms: Radix Astragali 10-50 part, Radix Bupleuri 5-20 part, Poria 8-30 part, Rhizoma Atractylodis Macrocephalae 5-15 part, Radix Paeoniae Alba 5-15 Part, Pericarpium Citri Reticulatae 3-20 part, Semen Plantaginis 1-10 part.Described probiotics preparation is made up of the probiotic bacteria of following weight proportion: butanoic acid shuttle shape Bacillus cereus 2-8 part, bacillus acidophilus's 1-5 part, bacillus subtilis 1-5 part, total viable count is 5 × 107More than cfu/g.
The dosage form of aforementioned pharmaceutical compositions is oral formulations.
Above-mentioned oral formulations is capsule or granule.
The preparation method of the pharmaceutical composition of above-mentioned treatment irritable bowel syndrome, comprises the following steps:
A, making Chinese prescription: weigh above Chinese medicine component according to aforesaid weight proportion and be respectively crushed into coarse powder, add medical material total The water of weight 8 times amount, soaks 3h, and decocting time is 2h, decocts 2 times；Merge decoction liquor, filter；Filtrate is concentrated into 60 DEG C of phases Being the extractum of 1.10-1.15 to density, adding ethanol to alcohol content is 75%(v/v), stand 72 hours, take supernatant, reclaim second Alcohol, to concentrating, is spray dried to fine powder, standby；
B, making probiotics preparation: clostridium butyricum, bacillus acidophilus and bacillus subtilis are carried out respectively purebred Liquid culture, is then centrifuged liquid culture, collects bacterium mud, adds protective agent and carries out lyophilization, pulverizes and obtain probiotic bacteria Mycopowder；
C, making capsule: Chinese medicinal components and probiotics preparation are configured according to described composition weight proportioning, adds medicine auxiliary Material, makes capsule or makes granule and pack after mix homogeneously.
The effect of each component of the present invention is as follows:
The Radix Astragali: nature and flavor are sweet, tepor, return lung, spleen, liver, kidney channel；Air making-up and spleen enlivening, the normal and compatibility such as Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae；Pericarpium Citri Reticulatae regulate the flow of vital energy and Stomach, Chinese Angelica blood replonishing and battalion, with a small amount of Rhizoma Cimicifugae, Radix Bupleuri, help the yang-energy that principal agent sink with ascending.All medicines share, then taste are strong, Middle gas is sufficient；
Radix Bupleuri: nature and flavor are bitter, be slightly cold, returns liver, gallbladder meridian.There are reconciling superficies and interior, effect of soothing the liver yang invigorating；
Poria: slightly sweet flavor, property is flat, GUIXIN, lung, spleen, kidney channel.For edema oliguria, phlegm retention vertigo and palpitation, insufficiency of the spleen lack of appetite, loose stool has loose bowels, Irritability, palpitation with fear insomnia；
The Rhizoma Atractylodis Macrocephalae: bitter in the mouth, sweet, warm in nature.Return spleen, stomach warp.Invigorating the spleen and benefiting QI, dampness diuretic, hidroschesis, antiabortive.For insufficiency of the spleen lack of appetite, abdominal distention Have loose bowels, phlegm retention vertigo and palpitation, edema, spontaneous perspiration, frequent fetal movement；
The Radix Paeoniae Alba: diarrhea due to cold pathogen liver-fire, inverse gas, pain relieving in delaying are held back in acid；
Pericarpium Citri Reticulatae: bitter in the mouth, pungent, warm in nature.Return lung, spleen channel, regulating qi-flowing for strengthening spleen, drying dampness to eliminate phlegm.For distension and fullness in the abdomen, lack of appetite and vomiting, cough Abundant expectoration；
Semen Plantaginis: property sugariness is trembled with fear, diuretic is controlled heat-damp in summer dysentery, with Rhizoma Atractylodis Macrocephalae compatibility, is had effect of invigorating the spleen to arrest diarrhea, is used for treating insufficiency of the spleen Have loose bowels, oliguria；
Clostridium butyricum: can produce the short-chain fatty acid such as butanoic acid, repairs impaired intestinal mucosa；And have in promoting intestinal Benefit bacteria growing, suppression harmful bacteria breeding；
Bacillus acidophilus: one of people and animal intestinal normal flora, suppression harmful bacteria growth, promote intestinal beneficial bacteria growing, adjust The intestinal microecology system of whole disorder；
Bacillus subtilis: produce protease, lipase, amylase etc. and promote food digestion, consume oxygen in intestinal, promote to detest Oxygen growth of probiotics, adjusts disorderly intestinal microecology system.
Beneficial effects of the present invention is as follows: both may be used compared with above-mentioned formula simple Chinese medicine existing with on market and microbial ecological agent Inherently improve human body constitution with function of spleen and stomach regulating, the intestinal microecology system of disorder can be adjusted rapidly again, directly repair and be subject to The intestinal mucosa damaged, improves intestinal immunity, treating both the principal and secondary aspects of a disease, fundamentally plays prevention and the treatment for the treatment of irritable bowel syndrome Effect.
Detailed description of the invention
Embodiment 1:
A kind of pharmaceutical composition treating diarrhea type irritable bowel syndrome, is made up of the raw material of following weight proportion: Chinese prescription 40%, probiotics preparation 60%.Described Chinese prescription is made up of following weight proportion medicine: the Radix Astragali 20 parts, Radix Bupleuri 10 parts, Poria 15 parts, the Rhizoma Atractylodis Macrocephalae 10 parts, the Radix Paeoniae Alba 10 parts, Pericarpium Citri Reticulatae 10 parts, Semen Plantaginis 5 parts.Described probiotics preparation prescription is by following weight proportion Probiotic bacteria composition: clostridium butyricum 5 parts, bacillus acidophilus 3 parts, bacillus subtilis 2 parts, total viable count 2 × 107More than cfu/g.Above-mentioned strain purchasing channel is Chinese industrial Culture Collection, Clostridium butyricum (Clostridum butyricum) CICC deposit number 10390；Bacillus acidophilus (Lactobacillus acidophilus) CICC preservation volume Numbers 6082；Bacillus subtilis (Bacillus subtilis) CICC deposit number 10453.
The preparation method of the medicament composition capsule agent of above-mentioned treatment diarrhea type irritable bowel syndrome, comprises the following steps:
A, making Chinese prescription: weigh above Chinese medicine component according to aforesaid weight and be respectively crushed into coarse powder, add medical material gross weight The water of 8 times amount, soaks 3h, and decocting time is 2h, decocts 2 times；Merge decoction liquor, filter；Filtrate is concentrated into when 60 DEG C the closeest Degree is the extractum of 1.10-1.15, and adding ethanol to alcohol content is 75%(v/v), stand 72 hours, take supernatant, reclaim ethanol extremely Concentrate, be spray dried to fine powder, add auxiliary materials and mixing standby；
B, making probiotics preparation: above-mentioned probiotic composition each process for preparing strain thereof step: first will respectively take butanoic acid shuttle shape spore Bacillus, bacillus acidophilus and bacillus subtilis test tube slant strain one, be inoculated in each of 200ml/500ml triangular flask respectively From the culture medium that spreads cultivation in carry out purebred liquid culture 12h, wherein Clostridium butyricum and bacillus acidophilus carry out quiescent culture, hay Bacillus cereus carries out 120rpm concussion and cultivates, and cultivation temperature is all 37 DEG C；Cultivation is transferred in 100L fermentation tank after terminating respectively, Inoculum concentration be 1%, wherein Clostridium butyricum and bacillus acidophilus be Anaerobic culturel, be passed through nitrogen and carry out pressurize, 37 DEG C of incubation times 24 Little tank at present；Bacillus subtilis is aerobic cultivation, is passed through air, and ventilation is 3:1,37 DEG C of incubation times 24 hours, spore Rate 90% tank at present；Liquid culture after the cultivation of 3 kinds of bacterium being terminated respectively is squeezed into tube centrifuge 12000rpm and is centrifuged, and receives Collection bacterium mud, according to 1:1(w/v) add the protective agent such as defatted milk powder and carry out lyophilization, pulverize and obtain 3 kinds of probiotic bacteria mycopowder, add Enter adjuvant mix homogeneously and obtain probiotic bacteria mycopowder semi-finished product；
C, make capsule: be 40%:60% configuration by Chinese medicinal components and probiotics preparation according to weight proportion, add medicine auxiliary Material, makes capsule after mix homogeneously.Every crude drug amount 0.1g in Chinese medicine, probiotic bacteria content is more than 1 × 107cfu/g.Every day 3 times, each 2, one after each meal.
Embodiment 2:
A kind of pharmaceutical composition treating irritable bowel syndrome, is made up of the raw material of following weight proportion: Chinese prescription 45%, benefit Raw bacteria preparation 55%.Described Chinese prescription is made up of following weight proportion medicine: the Radix Astragali 30 parts, Radix Bupleuri 13 parts, 20 parts of Poria, The Rhizoma Atractylodis Macrocephalae 10 parts, the Radix Paeoniae Alba 10 parts, Pericarpium Citri Reticulatae 10 parts, Semen Plantaginis 5 parts.Described probiotics preparation prescription is by the probiotic bacteria of following weight proportion Composition: clostridium butyricum 4 parts, bacillus acidophilus 3 parts, bacillus subtilis 3 parts, total viable count is 5 × 107cfu/g Above, above-mentioned strain purchasing channel is Chinese industrial Culture Collection.
The preparation method of the medicament composition granule agent of above-mentioned treatment diarrhea type irritable bowel syndrome, comprises the following steps:
A, making Chinese prescription: with embodiment 1；
B, making probiotics preparation: with embodiment 2；
C, make granule agent: be 45%:55% configuration by Chinese medicinal components and probiotics preparation according to weight proportion, add medicine auxiliary Material, after mix homogeneously, cold drying, granulate, make granule and pack.Every crude drug amount 0.1g in Chinese medicine, probiotic bacteria content More than 1 × 107cfu/g.Three times a day, each 2, one after each meal.
Clinical trial
1, subjects: select 50 examples to diagnose clear and definite irritable bowel syndrome patients, age 20-68 according to Rome II diagnostic criteria Year, average 44 years old；
2, test method: treatment group oral Chinese medicine and probiotic combinations medicament capsule, every crude drug 0.1g in Chinese medicine, probiotic bacteria contains Amount is more than 1 × 107cfu/g；Three times a day, each 2, one after each meal, it is used in conjunction 15 days；
3, symptom score standard: with reference to " irritable bowel syndrome Chinese traditional medical diagnose National Consensus ".1. stomachache and abdominal distention degree are marked.Nothing Symptom is 0 point；Slight: to feel that having symptom is 1 point through prompting rear；Moderate: i.e. having symptom without prompting is 2 points；Severe: patient Main suit's cardinal symptom is 3 points.2. diarrhea frequency scoring: asymptomatic is 0 point；Slight: ＜ 3 times/day is 1 point；Moderate: 3～5 Times/day it it is 2 points；Severe: 6 times/day is 3 points.Using 1., 2. item total score as cardinal symptom mark
4, criterion of therapeutical effect:
Recovery from illness: symptom all disappears, function of intestinal canal is normal, and with examining, check is without exception；
Effective: symptom is clearly better, times of defecation significantly reduces, and feces character is close to normal；
Effective: symptom take a turn for the better, times of defecation has reduced, feces character improve, but not as good as effective substantially；
Invalid: symptom is without alleviating, and times of defecation, stool and defecation process are abnormal without improving；
5, result:
Integral contrast before and after 5.1 treatments: before and after's symptom average integral of taking medicine reduces to 1.25 from 5.48, difference 4.23 before and after treatment, Effect is obvious；
5.2 curative effects: after 15 days medication treatments, 26 examples of fully recovering, effective 16 examples, effective 5 examples, invalid 3 examples, total effective rate 94%.

Claims (2)

1. treat a pharmaceutical composition for irritable bowel syndrome, it is characterized in that being made up of the raw material of following weight proportion: Chinese medicine Prescription 30-50%, probiotics preparation 40-60%；Described Chinese prescription is made up of following weight proportion medicine: Radix Astragali 10-50 part, bavin 5-20 part recklessly, Poria 8-30 part, Rhizoma Atractylodis Macrocephalae 5-15 part, Radix Paeoniae Alba 5-15 part, Pericarpium Citri Reticulatae 3-20 part, Semen Plantaginis 1-10 part；Described prebiotic Bacteria preparation is made up of the probiotic bacteria of following weight proportion: clostridium butyricum 2-8 part, bacillus acidophilus's 1-5 part, hay bud Spore bacillus 1-5 part, total viable count is 5 × 107More than cfu/g.
2. treat a preparation method for the pharmaceutical composition of irritable bowel syndrome, it is characterized in that comprising the following steps:
A, making Chinese prescription: weigh above Chinese medicine component according to aforesaid weight proportion and be respectively crushed into coarse powder, add medical material total The water of weight 8 times amount, soaks 3h, and decocting time is 2h, decocts 2 times；Merge decoction liquor, filter；Filtrate is concentrated into 60 DEG C of phases Being the extractum of 1.10-1.15 to density, adding ethanol to alcohol content is 75%(v/v), stand 72 hours, take supernatant, reclaim second Alcohol, to concentrating, is spray dried to fine powder, standby；
B, making probiotics preparation: clostridium butyricum, bacillus acidophilus and bacillus subtilis are carried out respectively purebred Liquid culture, is then centrifuged liquid culture, collects bacterium mud, adds protective agent and carries out lyophilization, pulverizes and obtain probiotic bacteria Mycopowder；
C, making capsule: Chinese medicinal components and probiotics preparation are configured according to described composition weight proportioning, adds medicine auxiliary Material, makes capsule or makes granule and pack after mix homogeneously.
CN201610750616.XA 2016-08-30 2016-08-30 A kind of pharmaceutical composition treating irritable bowel syndrome and preparation method thereof Pending CN106177062A (en)

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CN110787190A (en) * 2019-12-17 2020-02-14 杨波 Compound probiotic composition with anti-aging effect and preparation method and application thereof
CN115400168A (en) * 2022-10-31 2022-11-29 云南中医药大学 A Chinese medicinal composition

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CN108524749A (en) * 2018-07-03 2018-09-14 正大青春宝药业有限公司 A kind of Chinese medicine composition and application for improving intestinal flora distribution
CN110787190A (en) * 2019-12-17 2020-02-14 杨波 Compound probiotic composition with anti-aging effect and preparation method and application thereof
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