CN100558385C - A kind of pharmaceutical composition for the treatment of irritable bowel syndrome, preparation and preparation method thereof - Google Patents
A kind of pharmaceutical composition for the treatment of irritable bowel syndrome, preparation and preparation method thereof Download PDFInfo
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- CN100558385C CN100558385C CNB200610066742XA CN200610066742A CN100558385C CN 100558385 C CN100558385 C CN 100558385C CN B200610066742X A CNB200610066742X A CN B200610066742XA CN 200610066742 A CN200610066742 A CN 200610066742A CN 100558385 C CN100558385 C CN 100558385C
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- irritable bowel
- treatment
- bowel syndrome
- parched
- oleum menthae
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- 235000013599 spices Nutrition 0.000 description 1
- 239000007921 spray Substances 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
- 239000004575 stone Substances 0.000 description 1
- 238000007920 subcutaneous administration Methods 0.000 description 1
- 239000000829 suppository Substances 0.000 description 1
- 239000004094 surface-active agent Substances 0.000 description 1
- 239000000375 suspending agent Substances 0.000 description 1
- 210000000115 thoracic cavity Anatomy 0.000 description 1
- 229940098465 tincture Drugs 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 230000000699 topical effect Effects 0.000 description 1
- 229940125725 tranquilizer Drugs 0.000 description 1
- 239000003204 tranquilizing agent Substances 0.000 description 1
- 239000003029 tricyclic antidepressant agent Substances 0.000 description 1
- 229960005345 trimebutine Drugs 0.000 description 1
- 239000000341 volatile oil Substances 0.000 description 1
- 238000010792 warming Methods 0.000 description 1
- 238000005303 weighing Methods 0.000 description 1
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- Medicines Containing Plant Substances (AREA)
Abstract
The invention discloses a kind of pharmaceutical composition for the treatment of irritable bowel syndrome, make: the Radix Paeoniae Alba (stir-fry) 65～70g, the Rhizoma Atractylodis Macrocephalae (stir-fry) 35～45g, Bulbus Allii Macrostemonis 35～45g, Semen Plantaginis 35～45g, Fructus Citri Sarcodactylis 35～45g, Oleum menthae 1～2ml by the raw material of following weight and volume.Advantage of the present invention is: prescription meets theory of Chinese medical science, has the clinical practice basis, the animal test results prompting is set upright in antidiarrheal, spasmolytic, pain relieving, calmness and spleen invigorating, medicine of the present invention has pharmacological action preferably aspect treatment irritable bowel syndrome diarrhoea, the stomachache, and clinical practice shows better therapeutic effect.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition for the treatment of irritable bowel syndrome, preparation and preparation method thereof, belong to the field of Chinese medicines.
Background technology
Irritable bowel syndrome (Irritable bowel syndrome, IBS) be a kind of common digestive system function disease, comprise that one group of stomachache, abdominal distention, bowl evacuation habit and stool character are unusual, continue or intermittently outbreak, and lack the syndrome that obvious morphology and biochemical abnormal change can be supported explanation, be characterized in the irritability of intestinal.Often be divided into diarrhea-type, constipation type and diarrhoea alternate type clinically.
The prevalence bibliographical information of IBS differs, and accounts for 20%～30% of all age group in developed countries such as Great Britain and Americas, accounts for 15%～20% of adult group.At western developed country, women IBS patient is obviously more than the male, and men and women's ratio is 1: 2～3.2, Eastern Europe, Asia and Africa and domestic be 1: 1～1.5.Because domestic male hospitalier is more than the women, so the M-F of document introduction may be than the reality number ratio height of falling ill.The age of onset half is at one's mid-30s, and the U.S. is then the highest with 45 years old～64 years old morbidity number.IBS patient's course of disease is long, and symptom continues or outbreak repeatedly, follows up a case by regular visits to 5 years symptom complete obiteration persons only 5%.Pan Guozong etc. adopt cluster, layering and simple random method, and 2486 adults of 18～70 years old have carried out questionnaire survey to the Beijing area.This age bracket is permanent resident population's 72.86%.The result shows that IBS crowd's prevalence that the Beijing area meets the Manning standard is 7.26%, and the prevalence that meets the Rome standard is 0.82%.Men and women's ratio is 1: 1.15, and difference does not have significance.The chromatographic analysis result shows, (10.5%) and suburb (6.14%) difference have significance (P＜0.001) to prevalence in the city.This research explanation, this ill colony number in Beijing is a lot, even only 20% seek medical advice, in Differential Diagnosis and handle consume human and material resources and medical expense also considerable, some patients have tendencies such as depression, hypochondriasis still more, and disease is had no end of misgivings, and run in many ways to seek medical advice.So this syndrome is the frequently-occurring disease and the commonly encountered diseases of significant.
At present primary disease still there is not certainly effectively Therapeutic Method.Although the curative effect of Drug therapy is also imprecise,, still advocate positive Drug therapy for the case of serious symptom.Mainly contain 1. analgesic: can use low dose of analgesics for the case of obstinate pain, but service time is unsuitable long.Because the life-time service analgesics has many serious side effects, as addiction or digestive tract damage etc.Therefore analgesic is only just used in suggestion when other treatment is invalid.2. anticholinergic: anticholinergic agents be used to very early treat IBS but its curative effect never by certainly.It is found that in recent years, take anticholinergic agents before the meal and can alleviate the stomachache that occurs after the meal.This may be to improve IBS patient's intestinal kinetics disorder because anticholinergic agents directly suppresses the gastrointestinal smooth muscle contraction.3. antidepressants: be used for patient based on chronic pain.Low dose of tricyclic antidepressant can be alleviated part patient's pain.But must be noted that this class side effects of pharmaceutical drugs, old people or have cardiopathic patient to use cautiously.4. calcium antagonist: pinaverium bromide (pinaverium bromide) is that a kind of selectively acting is in the gastrointestinal calcium ion antagonist.Many data show that it can suppress smooth muscle contraction and alleviate gastrointestinal symptom by adjusting the intestinal dynamic variation.5. diarrhea: loperamide can increase anal sphincter contraction force, lowers the colonic muscle electrical activity and prolongs the duration of runs of feces at small intestinal.Think that at present loperamide is that treatment is based on the comparatively ideal medicine of the IBS of diarrhoea.Because of it does not pass through blood brain barrier, so side effect is very little.Diphenoxylate also is a kind of medicine commonly used.6. other: other can be used to treat serious patient as gastro-kinetic agent, laxative.But laxative should be avoided using as far as possible, unless the patient's is obstinate.5-hydroxy tryptamine can neurally play an important role in regulating the sensory process of central nervous system to pain, and can directly influence colon motion and sensation, so selectivity medmain receptor agents may be helpful to IBS patient, and data is few at present.Disappearing the gallbladder ammonium can be in conjunction with too much cholate, may be that main patient is effective to diarrhoea.For spiritedness pressure, the IBS patient of anxiety, the Benzodiazepines tranquilizer has curative effect preferably.The sharp parathyrine releasing hormone analog of short property is treated the curative effect of functional digestive system disease and is affirmed not yet.
Because IBS is the colonic activity disorder due to the multiple factor is main syndrome, does not have a kind of medicine can alleviate all IBS symptoms fully at present as yet, the therefore main Comprehensive Treatment that adopts needs to observe principle of individuation.In this, this disease of Chinese medicine has bigger advantage.Chinese medicine is not seen the Chinese patent medicine listing that treatment irritable bowel syndrome diarrhea-type is arranged at present.Therefore, the Chinese medicine of developing a kind of effective treatment irritable bowel syndrome is very necessary.
Summary of the invention
First technical problem that the present invention will solve provides a kind of pharmaceutical composition for the treatment of irritable bowel syndrome.
Second technical problem that the present invention will solve provides the preparation of the pharmaceutical composition that contains above-mentioned treatment irritable bowel syndrome.
The 3rd technical problem that the present invention will solve provides a kind of preparation method for the treatment of the preparation of irritable bowel syndrome.
For achieving the above object, the present invention is by the following technical solutions:
A kind of pharmaceutical composition for the treatment of irritable bowel syndrome, make by the raw material of following weight and volume:
The Radix Paeoniae Alba (stir-fry) 65～70g Rhizoma Atractylodis Macrocephalae (stir-fry) 35～45g Bulbus Allii Macrostemonis 35～45g
Semen Plantaginis 35～45g Fructus Citri Sarcodactylis 35～45g Oleum menthae 1～2ml.
More than each flavor form when producing and can increase simultaneously or reduce according to corresponding proportion, can be as large-scale production with kilogram or with the ton or the unit of being upgraded to, small-scale production can be a unit with gram or milliliter also, weight or volume can increase or reduce pro rata.
At the pathological characteristic of irritable bowel syndrome diarrhea-type, the present invention has developed a kind of Chinese medicine for the treatment of symptoms such as stomachache, diarrhoea, abdominal distention, stool due to the irritable bowel syndrome be not well.
IBS belong to the traditional Chinese medical science stomachache, have loose bowels, category such as constipation, its cause of disease complexity, mostly being feelings will outside stimulates, at the interior weakness of the spleen and stomach that mostly is.It is angry to be worried, and for a long time strongly fragrant not understanding injures in liver, depression of liver-QI, and perverse and unreasonable manner is taken advantage of spleen, and temper is become estranged, and forms the card of disharmony between the liver and spleen.Therefore regulating qi-flowing for strengthening spleen is basic method of treatment.
With colic symptoms is main person, mostly is liver-spleen disharmony, and mechanism of qi retardance, treatment be when the depressed liver-energy dispersing and QI regulating pain relieving, normally operates to emphasis with what recover mechanism of qi, makes " general rule is not bitterly ".Owing to be not to see the pain pain relieving blindly, but at the reason that causes stomachache---mechanism of qi retardance and the measure taked, so method for effecting a permanent cure.With symptom of diarrhea is main person, and according to the pathogenesis of its incoordination between the liver and spleen, clinically tongxieyao formulas that adopt are the plus-minus treatment of basic side more, and it is intended to harmonizing the functional activities of vital QI, recovers catharsis, the fortuneization of spleen and the conduction function of large intestine of liver.The situation that the irritable bowel syndrome patient often has diarrhoea and constipation alternately to occur.Its pathogenesis still is stagnation of liver-QI with deficiency of the spleen, disorder of movement of QI, intestinal fortuneization mistake department, and treatment is a purpose to recover liver spleen function of intestinal canal.The constipation stage is sure not lavishment and rushes down the purgation product, and the diarrhoea stage can not be abused astringent therapy.
We are monarch drug with Radix Paeoniae Alba emergency easing the affected liver to relieve pain, and Rhizoma Atractylodis Macrocephalae invigorating spleen to remove dampness is a ministerial drug, and soil is able to healthy and vigorous and liver must not restrain and cuts down in making, and this two medicine is with the main idea that has embodied regulating the liver and spleen.Assistant is regulated the flow of vital energy with Fructus Citri Sarcodactylis, Bulbus Allii Macrostemonis, reaches the Chhnang of temper with the bar that helps irritability; The Semen Plantaginis diuretic is wet, and is pure and impure to divide, activating the spleen gas.Oleum menthae is the intestinal carminative, and fragrant odour can make to alleviate mucous membrane irritation and alleviate painful.This side's treating both the principal and secondary aspects of a disease meets the pathogenesis understanding of Chinese medicine to irritable bowel syndrome.
A kind of pharmaceutical composition for the treatment of irritable bowel syndrome, make by the raw material of following weight and volume:
The Radix Paeoniae Alba (stir-fry) 66～68g Rhizoma Atractylodis Macrocephalae (stir-fry) 38～42g Bulbus Allii Macrostemonis 38～42g
Semen Plantaginis 38～42g Fructus Citri Sarcodactylis 38～42g Oleum menthae 1.3-1.4ml.
The most preferred pharmaceutical composition crude drug of the present invention weight and volume is:
The Radix Paeoniae Alba (stir-fry) the 66.7g Rhizoma Atractylodis Macrocephalae (stir-fry) 40.0g Bulbus Allii Macrostemonis 40.0g
Semen Plantaginis 40.0g Fructus Citri Sarcodactylis 40.0g Oleum menthae 1.33ml.
The Radix Paeoniae Alba (stir-fry): this product is the processed product of the dry root of ranunculaceae plant Radix Paeoniae Paeonia Laitflora Pall..Radix Paeoniae Alba main product in Zhejiang, Sichuan, (Wan Bei) and other places, Anhui.This product should meet " the pertinent regulations under 78 pages of Radix Paeoniae Alba items of Chinese pharmacopoeia version in 2000.
The Rhizoma Atractylodis Macrocephalae (stir-fry): this product is the processed product of the dry stem of feverfew Rhizoma Atractylodis Macrocephalae Atractylodes macrocephala Koidz..Rhizoma Atractylodis Macrocephalae main product in Zhejiang, ground such as Anhui, Jiangxi, Hunan, Hubei.This product should meet " the pertinent regulations under 77 pages of Rhizoma Atractylodis Macrocephalae items of Chinese pharmacopoeia version in 2000.
Bulbus Allii Macrostemonis: this product is the dry bulb of liliaceous plant Allium macrostemon Allium macrostemon Bge or Chinese onion Allium chinensisG.Don.Main product is in northeast and ground such as Hebei, Jiangsu, Hubei.This product should meet " the pertinent regulations under 309 pages of Bulbus Allii Macrostemonis items of Chinese pharmacopoeia version in 2000.
Semen Plantaginis: this product is the dry mature seed of liliaceous plant Herba Plantaginis Plantago asiatica L. or Plantago depressa Willd Plantago depressaWilld..The former practises title " semen plantaginis major ", and the latter practises title " semen plantaginis minor "." semen plantaginis major " main product in Jiangxi, ground such as Henan, northeast, North China, southwest and East China also produces; " semen plantaginis minor " main product in Hebei, ground such as Liaoning, Shanxi, Sichuan, ground such as Heilungkiang, the Inner Mongol, Jilin, Qinghai, Shandong also produce.This product should meet " the pertinent regulations under 50 pages of Herba Plantaginis subitems of Chinese pharmacopoeia version in 2000.
Fructus Citri Sarcodactylis: this product is the dry fruit of rutaceae Fructus Citri Sarcodactylis Citrus medica L.var.sarcodactylis Swingle.Originate in Zhaoqing, Guangdong, high wanting, Guangxi Ling Le, Guanyang, big ground person such as new are called " FRUCTUS CITRI SARCODACTYLIS ".Originate in Hejiang, Sichuan, Jiangjin, Luxian County, and ground persons such as Yimen, Yunnan, Binchuan, new flat, E Shan claim " FRUCTUS CITRI SARCODACTYLIS from Sichuan of China ".In addition, also produce in Fujian, Zhejiang, Anhui.With Zhaoqing, Guangdong product quality optimum, be considered as authentic medicinal herbs.This product should meet " the pertinent regulations under 141 pages of Fructus Citri Sarcodactylis items of Chinese pharmacopoeia version in 2000.
Oleum menthae: this product is fresh bulb and the Ye Jing vapor distillation of labiate Herba Menthae Mentha haplocalyx Briq, and is freezing again, and part is taken off the volatile oil that brain processing obtains.This product should meet " the pertinent regulations under 310 pages of Oleum menthae items of Chinese pharmacopoeia version in 2000.
A kind of Chinese medicine preparation for the treatment of irritable bowel syndrome is made up of the pharmaceutical composition and the pharmaceutics acceptable auxiliary of treatment irritable bowel syndrome.
Can be according to known method in the pharmaceuticals industry, the above-mentioned pharmaceutical composition that obtains is made various different dosage forms after by the known method degerming.
According to the difference of route of administration, pharmaceutical composition of the present invention can be mixed be suitable in (in thoracic cavity, abdominal cavity, spinal cavity, intracranial and joint capsule) in intravenous, intramuscular, the body cavity, the tissue, the injectable solution or the dispersant of Intradermal or subcutaneous administration; Perhaps be suitable for powder agent, tablet, granule, pill, Emulsion, suspending agent, capsule, the tincture of oral administration; Perhaps be suitable for topical and pass through the spray of skin or mucosa absorption administration, refreshing agent, Emulsion, ointment, gel, buccal tablet or suppository or the like.
Dosage form of the present invention is preferably peroral dosage form, as tablet (conventional tablet, dispersible tablet, oral cavity disintegration tablet, effervescent tablet), powder agent, capsule (soft capsule, hard capsule, enteric coated capsule), granule (plain particles agent, effervescent granule), pill (honeyed pill, the watered pill or drop pill), oral liquid etc.
Wherein the acceptable dressing of pharmaceutics can use saccharides such as sucrose, lactose, galactose, and perhaps six carbon polyhydroxy-alcohols such as mannitol, sorbitol, and corn starch, gelatin, lipid, microcrystalline Cellulose, beta-schardinger dextrin-etc. are as carrier or excipient.In case of necessity, also can in these peroral dosage forms, add disintegrating agent, lubricant, buffer salt, coloring agent, sweeting agent, spice, dispersant and surfactant.
The present invention can adopt the Chinese medicine preparation conventional method to be prepared into any regular dosage form, for example these crude drug grind into powder mix homogeneously is made powder and takes after mixing it with water; Also can be with these medicines decocting together, the condensed water decocting liquid is made oral liquid then; But, preferably adopt following technology to extract, but this can not limit protection scope of the present invention to crude drug in order to make each crude drug of this medicine bring into play drug effect better.
A kind of method for preparing the granule for the treatment of irritable bowel syndrome comprises the steps:
The Radix Paeoniae Alba (stir-fry) 65～70g Rhizoma Atractylodis Macrocephalae (stir-fry) 35～45g Bulbus Allii Macrostemonis 35～45g
Semen Plantaginis 35～45g Fructus Citri Sarcodactylis 35～45g Oleum menthae 1～2ml;
(1) Radix Paeoniae Alba (stir-fry), the Rhizoma Atractylodis Macrocephalae (stir-fry), Bulbus Allii Macrostemonis, Semen Plantaginis and Fructus Citri Sarcodactylis five tastes medical material, soaked 1～2 hour, decoct secondary, add for the first time 8～12 times of water gagings and fry in shallow oil and carry 1～3 hour, add 6～10 times of water gagings for the second time and fry in shallow oil and carry 1～2 hour, filter, it is 1.30～1.34 (60 ℃ of heat are surveyed) thick paste that filtrate decompression is concentrated into relative density, 60 ℃ of vacuum dryings (0.08Mpa), be ground into fine powder, standby;
(2) get 6～10 times of beta-schardinger dextrin-s to the Herba Menthae oil mass and place mortar, add 2～5 times of water gagings and grind evenly, get Oleum menthae (being made into 50% Oleum menthae ethanol liquid in advance) then and slowly join in the mortar, ground 2～4 hours, 35～45 ℃ of dryings are pulverized, and are standby.Get above-mentioned water and carry dried cream powder, add Oleum menthae clathrate and an amount of lactose mixing,, cross 10～12 mesh sieves and make wet granular with 90% ethanol system soft material, low temperature (40 ℃) drying, granulate, promptly.
The administering mode of this medicine is oral, and every day 2-3 time, each 5 grams are equivalent to the crude drug amount and are about 11.33 grams.
Respectively with the constraint legal system be equipped with stress in rats diarrhoea model, the Radix Et Rhizoma Rhei oral medication prepares Mice with Spleen diarrhoea model.Anti-diarrhea effect of the present invention is studied, also the effect of aspects such as intestinal propulsion motion, analgesia, calmness and traditional Chinese medical science spleen invigorating is observed simultaneously with regard to medicine.Adopt the contrast of Chinese medicine GUCHANG ZHIXIE WAN or Western medicine dicetel sheet at the same time or separately.The result: 1. the constraint of pair rat caused stress suffer from diarrhoea and Radix Et Rhizoma Rhei due to Mice with Spleen diarrhoea anti-diarrhea effect is preferably all arranged, defecation frequency, loose stool rate and the loose stool degree of animal are reduced, the diarrhoea index significantly descends.Its effect strengthens with the increasing of dosage.2., binding constraint caused rat small intestine ahead running hyperfunction to the caused intestinal motility of neostigmine be too fast all certain antagonism, and the intestinal propulsion rate is descended.The intestinal test of exsomatizing also shows the smooth muscle tension force that can reduce intestinal tube, and can be to the intestinal smooth muscle spasm due to anti-acetylcholine and the histamine phosphate.3. the mice pain reaction that hot plate method and method of acetic acid are caused all has certain analgesic activity.4. tangible function of invigorating spleen is arranged, can improve the Mice with Spleen syndrome due to the Radix Et Rhizoma Rhei.Increase the body weight and the food-intake of animals with spleen deficiency.And mice swimming time is at low temperatures prolonged.5. the medicine of the present invention of doses has sedation, can reduce the mice voluntary activity.But collaborative syngignoscism is not obvious.With the Chinese medicine preparation GUCHANG ZHIXIE WAN of dose,equivalent relatively, medicine of the present invention to irritability diarrheal anti-diarrhea effect, alleviate that intestinal motility is hyperfunction, aspect analgesia and the sedation effect admittedly the intestinal ball certain advantage is arranged; Both act on quite to insufficiency of the spleen diarrheal antidiarrheal, the insufficiency of the spleen syndrome of improvement and physical strength reinforcing aspect.The antidiarrheal and the spasmolysis of dicetel are obvious, but do not have function of invigorating spleen.
Advantage of the present invention is: prescription meets theory of Chinese medical science, has the clinical practice basis, the animal test results prompting is set upright in antidiarrheal, spasmolytic, pain relieving, calmness and spleen invigorating, medicine of the present invention has pharmacological action preferably aspect treatment irritable bowel syndrome diarrhoea, the stomachache, and clinical practice shows better therapeutic effect.
The invention will be further described below in conjunction with the specific embodiment, and all this areas of doing according to the disclosure of invention are any to be equal to replacement, all belongs to protection scope of the present invention.
The specific embodiment
Embodiment 1. preparation granules
Prescription:
The Radix Paeoniae Alba (stir-fry) the 66.7g Rhizoma Atractylodis Macrocephalae (stir-fry) 40.0g Bulbus Allii Macrostemonis 40.0g Semen Plantaginis 40.0g Fructus Citri Sarcodactylis 40.0g Oleum menthae 1.33ml
Technology:
Preceding 5 flavor medicines were soaked 1.5 hours, decoct secondary, adding for the first time 10 times of water gagings fries in shallow oil and carries 2 hours, adding for the second time 8 times of water gagings fries in shallow oil and carries 1.5 hours, filter, it is 1.30～1.34 (60 ℃ of heat are surveyed) thick paste that filtrate decompression is concentrated into relative density, and 60 ℃ of vacuum dryings (0.08Mpa), be ground into fine powder, standby.Other gets 8 times of beta-schardinger dextrin-s to the Herba Menthae oil mass and places mortar, adds 4 times of water gagings and grinds evenly, gets Oleum menthae (being made into 50% Oleum menthae ethanol liquid in advance) then and slowly joins in the mortar, grinds 3 hours, and 40 ℃ of dryings are pulverized, and are standby.Get above-mentioned water and carry dried cream powder, add Oleum menthae clathrate and an amount of lactose mixing,, cross 10～12 mesh sieves and make wet granular with 90% ethanol system soft material, low temperature (40 ℃) drying, granulate, promptly.5 gram granules are equivalent to crude drug amount 11.34 grams.
Embodiment 2. preparation pills (concentrated pill)
The Radix Paeoniae Alba (stir-fry) the 65g Rhizoma Atractylodis Macrocephalae (stir-fry) 35g Bulbus Allii Macrostemonis 35g Semen Plantaginis 35g Fructus Citri Sarcodactylis 35g Oleum menthae 1ml.
Preceding 5 flavor medicines were soaked 1 hour, decocted secondary, added 10 times of water gagings for the first time and fried in shallow oil and carry 2 hours, add for the second time 8 times of water gagings and fry in shallow oil and carry 1.5 hours, filter, it is 1.30～1.34 (60 ℃ of heat are surveyed) thick paste that filtrate decompression is concentrated into relative density, 60 ℃ of vacuum dryings (0.08Mpa), be ground into fine powder, standby; Other gets 8 times of beta-schardinger dextrin-s to the Herba Menthae oil mass and places mortar, adds 4 times of water gagings and grinds evenly, gets Oleum menthae (being made into 50% Oleum menthae ethanol liquid in advance) then and slowly joins in the mortar, grinds 3 hours, and 40 ℃ of dryings are pulverized, and are standby; Get above-mentioned water and carry dried cream powder, add Oleum menthae clathrate and appropriate amount of auxiliary materials mixing, make ball, drying, polishing, promptly.
Embodiment 3. preparation powders
The Radix Paeoniae Alba (stir-fry) the 70g Rhizoma Atractylodis Macrocephalae (stir-fry) 45g Bulbus Allii Macrostemonis 45g Semen Plantaginis 45g Fructus Citri Sarcodactylis 45g Oleum menthae 2ml.
Preceding 5 flavor medicines were soaked 2 hours, decocted secondary, added 12 times of water gagings for the first time and fried in shallow oil and carry 2 hours, add for the second time 8 times of water gagings and fry in shallow oil and carry 1.5 hours, filter, it is 1.30～1.34 (60 ℃ of heat are surveyed) thick paste that filtrate decompression is concentrated into relative density, 60 ℃ of vacuum dryings (0.08Mpa), be ground into fine powder, standby; Other gets 8 times of beta-schardinger dextrin-s to the Herba Menthae oil mass and places mortar, adds 4 times of water gagings and grinds evenly, gets Oleum menthae (being made into 50% Oleum menthae ethanol liquid in advance) then and slowly joins in the mortar, grinds 3 hours, and 40 ℃ of dryings are pulverized, and are standby; Get above-mentioned water and carry dried cream powder, add Oleum menthae clathrate and appropriate amount of auxiliary materials mixing, drying adds starch and Pulvis Talci, pulverizes, and mixing sieves, promptly.
Pharmacodynamics test
1. animal:
The SD rat is provided by Shanghai west pul-Bi Kai laboratory animal company limited, the quality certification number No. 152.
The NIH mice is provided by Hunan College of Traditional Chinese Medicine's Experimental Animal Center, the quality certification number: moving word 20-001 number of the doctor of Hunan Province medical experiment the care of animal committee.
White big ear rabbit is provided by Hunan College of Traditional Chinese Medicine's Experimental Animal Center, the quality certification number: moving word 20-003 number of the doctor of Hunan Province medical experiment the care of animal committee.
Laboratory animal environment: a cleaning level environment, the quality certification number: No. 20002, the moving word of lake doctor.
2. medicine and reagent
Medicine of the present invention provides lot number by medicament teaching and research room of pharmaceutical college of Hunan College of Traditional Chinese Medicine: 20040820 according to the method preparation of embodiment 1.Every gram is equivalent to crude drug amount 3.5 grams.The clinical consumption of recommending is adult's crude drug amount every day 34.3 grams.During experiment in view of the above dosage be converted to the animal consumption, all establish high, medium and low three dosage, specifically see Table 1.
The dicetel sheet is produced by French Su Wei drugmaker, lot number: 20031008.Every contains pinaverium bromide 50mg.Consumption sees Table 1 during test.
GUCHANG ZHIXIE WAN is produced by Xi'an Efanggong Pharmaceutical Co., Ltd, lot number: 0406139.Consumption sees Table 1 during test.
Table 1. medicine of the present invention, dicetel sheet, GUCHANG ZHIXIE WAN pharmacodynamics test dosage
Annotate: table Chinese medicine dosage indication: drug dose of the present invention refers to the crude drug amount; Dicetel refers to contained pinaverium bromide content; GUCHANG ZHIXIE WAN is an amount of formulation;
The test of embodiment 4. anti-diarrhea effects---to the influence of stress in rats diarrhoea model
One. the foundation and the grouping of irritability diarrhoea animal model
According to document: Wang Haiyun, stone monarch outstanding person. the experimentation of peaceful intestinal soup treatment rat intestine irritable syndrome. Chinese Chinese medicine science and technology, 2003; 10 (5): 266; Xie Jianqun, Lu Xiong, Ma Jun, etc. spleen invigorating warming middle-JIAO method is to the experimentation of spleen-stomach deficiency-cold irritable bowel syndrome rat model somatostatin influence. Jiangxi College of Traditional Chinese Medicine journal, 2003; 15 (4): 56; Li Heguo, the whole intestinal spirit of Yu Jianer is to the gut hormone influence of spleen-stomach deficiency-cold at the Mus irritable bowel syndrome. He'nan University's journal (medical science version), 2002; 21 (3): 11 report has improvement slightly.Adopt constraint to add oral Folium Sennae legal system and be equipped with stress in rats diarrhoea model, animal has agitation to enrage performance, and diarrhoea incidence rate height and stability are better.
Get healthy do not have 70 of diarrhoea rats, body weight 180-220g, male and female half and half.By the layering of sex body weight, be divided into 7 groups at random, 10 every group.Be respectively normal control group, model control group, the high, medium and low dosage group of the present invention, dicetel group and GUCHANG ZHIXIE WAN group.Animal fasting (can't help water) is after 10 hours, and except that the normal control group, all the other each groups are all carried out modeling.
The 1st day, animal was twined both shoulders, two upper limb and the shirtfront that constraint bundlees rat with the wide medical proof fabric of about 2cm after gavaging 30% Folium Sennae solution immediately repeatedly.The single mice rearging cage of putting into is observed after 1 hour, and holostrome is covered with qualitative filter paper (grab, sting and stave filter paper for preventing animal, can add the more sparse thin wire gauze of one deck on filter paper) at the bottom of the cage.Cut off the adhesive plaster of constraint when being bound to 2 hours, make the rat activity that affranchises.Observe 2-5 hour behavior performance of rat back in bond and stool situation.Filter paper is per hour changed 1 time at the bottom of the cage.With this stress in rats diarrhoea situation before as administration.After observation in 5 hours finished, each treated animal was still concentrated by sex, the conventional raising.
Stress in rats diarrhoea result after the administration of 2-4 days difference observed and recordeds.Each group is all given the constraint of clothes Folium Sennae blended rubber cloth as preceding method earlier.Fetter administration after 1 hour.Be respectively: normal control group and model control group are given distilled water, and the high, medium and low dosage group of the present invention gives 12,6 respectively, 3g/kg medicine of the present invention, and dicetel and GUCHANG ZHIXIE WAN are given corresponding medicinal liquid respectively.Volume is 10ml/kg.After the administration the single cage of putting into of animal is observed.Cut off the constraint adhesive plaster after 1 hour, continue to observe.Observe after the administration general behavior performance and the stool situation of animal in 4 hours.All recovered to concentrate raising after every day, observation finished by the component sex.
Two. MAIN OUTCOME MEASURES
1. outward appearance of animal and behavior change: reach forward and backward animal general behavior of administration and active situation after the modeling.
2. stool situation: the statistics reference literature of stool situation: Zhou Gannan, Hu Zhihua, Wang Yaxian, etc. diarrhea of mouse Preparation of model and the exponential applied research of diarrhoea. Chinese herbal medicine, 1994,25 (4): 195; Xie Jianqun, Li Guoxia, Ma Guitong, etc. soothing liver and strengthening spleen soup to the mice exponential influence of stress suffering from diarrhoea. journal of shanghai Chinese medicine, 1999; (5): 26 method.
2-4 hour institute bowel movement total (inferior) is counted after observing the modeling of record rat Restraint Stress;
With filter paper have free from smutting during judge to do (shaping) just with rare (wetting) just;
Calculate dry stool and loose stool number respectively;
Animal institute passage of loose stools number is the loose stool rate of this animal with the ratio of total defecation number.
Measure the average stain diameter of each loose stool with ruler, judge the loose stool rank of each loose stool by following standard;
The product of loose stool rate and loose stool level then is the diarrhoea index of this animal.
Loose stool stain diameter (cm) loose stool rank
＜1 1
1-1.9 2
2-2.9 3
3-3.9 4
＞4 5
Three. result of the test
See Table 2 to shown in the table 4.Data uplink is the loose stool number in the table, following behavior loose stool rate; Dried (shaping) just has free from smutting during with rare (wetting) judgement just with filter paper is standard.
Loose stool rate is the ratio of institute's passage of loose stools number and total defecation number in the certain hour.
The comparison that table 2. different pharmaceutical influences rat Restraint Stress diarrhoea model loose stool number and loose stool rate (X ± SD, N=10)
(following table together): compare with normal group: ★ ★: P＜0.05, ★ ★ ★: compare with model group P＜0.01: ##:P＜0.05, ###:P＜0.01
Compare with dicetel:
*: P＜0.05,
* *: compare with GUCHANG ZHIXIE WAN P＜0.01: ++: P＜0.05, +++: P＜0.01
The comparison that table 3. different pharmaceutical influences rat Restraint Stress diarrhoea model loose stool degree (X ± SD, N=10)
The loose stool rank is judged measure the average stain diameter of each loose stool via ruler after.
The comparison that table 4. different pharmaceutical influences rat Restraint Stress diarrhoea model diarrhoea index (X ± SD, N=10)
Attached: diarrhoea index=loose stool rate * loose stool level
The test of embodiment 5. anti-diarrhea effects---to the influence of Mice with Spleen diarrhoea model
One. method:
Get 70 of healthy no diarrheal adult mices, male and female half and half are divided into 7 groups at random by the sex body weight, 10 every group.Be normal control group, model control group, the high, medium and low dosage group of the present invention, dicetel group and GUCHANG ZHIXIE WAN group.
Except that the normal control group, all the other each groups are all by document: the Li Yikui chief editor. herbal pharmacology experimental test methodology [M]. and Shanghai, Science and Technology of Shanghai publishing house, the 1st edition, 1991; 280 method is irritated stomach, every day 1 time, continuous 10 days with the Radix Et Rhizoma Rhei cooling bath 40ml/kg that contains crude drug amount 1g/ml.Each treated animal of modeling was all irritated stomach with the Folium Sennae soak 20ml/kg that contains crude drug amount 0.3g/ml in the 11st day.
Write down dry stool number, loose stool number and loose stool rank as stress the diarrhoea method observing animal diarrhoea situation method, and calculate the diarrhoea index to each mice in behind the Folium Sennae 5 hours.12-17 days, each group was irritated stomach by giving corresponding medicine every day for 1 time respectively.
Normal control group and model control group are distilled water, and the high, medium and low dosage of the present invention is respectively 16,8,4g/kg, and dicetel dosage is 40mg/kg, and the intestine-stabling and anti-diarrheal bolus quantities is 3g/kg.The 18th day except that the normal control group, all the other each group all as the 11st day method give the clothes Folium Sennae, obey the animal defecation situation in 5 hours behind the Folium Sennae with the method observation.
Two. observation index:
Dried (shaping) just has free from smutting during with rare (wetting) judgement just with filter paper is standard.
The loose stool rank judges that criterion sees Restraint Stress diarrhoea test method for details measure the average stain diameter of each loose stool via ruler after.
Diarrhoea index=loose stool rate * loose stool level
Three. result of the test:
Be shown in Table 5.
The comparison that table 5. different pharmaceutical influences Mice with Spleen diarrhoea model (X ± SD, N=10)
Compare with normal group: ★ ★: P＜0.05, ★ ★ ★: P＜0.01; Compare with model group: ##:P＜0.05, ###:P＜0.01
Compare with dicetel:
*: P＜0.05,
* *: P＜0.01; Compare with GUCHANG ZHIXIE WAN: ++: P＜0.05, +++: P＜0.01 (as follows)
6. pairs of bowel movement influences of embodiment test
One. the animal grouping: experimental animal is selected and is divided into groups with embodiment 4 and embodiment 5.
Two. test method: list of references: Xie Jianqun, Li Guoxia, Ma Guitong, etc. soothing liver and strengthening spleen soup to the mice exponential influence of stress suffering from diarrhoea. journal of shanghai Chinese medicine, 1999; (5): 26 and Li Yikui chief editor. herbal pharmacology experimental test methodology [M]. Shanghai, Science and Technology of Shanghai publishing house, the 1st edition, 1991; 321 pages.
1. neostigmine is caused the hyperfunction influence of mouse small intestine motion
Normal control group and model control group are irritated stomach to distilled water, the high, medium and low dosage group of the present invention gives 16,8 respectively, stomach is irritated in the medicine agent of the present invention of 4g/kg, dicetel group dosage is 40mg/kg, and GUCHANG ZHIXIE WAN gastric infusion dosage is 3g/kg, and volume is 40ml/kg.90min behind the gastric infusion, normal control group subcutaneous injection normal saline 5ml/kg, all the other each treated animals respectively the neostigmine injection 5ml/kg of subcutaneous injection 0.03mg/ml with the preparation mouse small intestine hyperfunction model that moves.Each group all uses 10% carbon powder paste (containing sodium carboxymethyl cellulose 10%) to irritate stomach behind the 15min.Put to death mice behind the 20min, take out whole small intestinals.Measure small intestinal total length and carbon powder forward position distance respectively, calculate the intestinal propulsion percentage rate according to a conventional method to pylorus.
2. to fettering the influence of stress rats intestinal ahead running: it is identical that each organizes being provided with of drug dose.Clothes Folium Sennae and constraint binding back 90min, normal control group and model control group are given distilled water respectively, the high, medium and low dosage group of the present invention is given the variable concentrations medicinal liquid of the present invention that contains 10% carbon powder respectively, positive control dicetel and intestine-stabling and anti-diarrheal medicinal liquid also all contain 10% carbon powder, irritate the long-pending 10ml/kg that is of body of stomach.Cut off the constraint adhesive plaster after the administration immediately, recover acting on one's own of animal.20min after the administration, disconnected neck is put to death rat, measures small intestinal total length and carbon powder front end distance, and calculates the propelling rate.
Three. result of the test:
Be shown in Table 6.
The comparison that table 6. different pharmaceutical influences the intestinal propulsion animal (X ± SD, N=10)
The influence of the stripped bowel movement of 7. pairs of rabbit of embodiment
One. the animal grouping:
Two. test method:
List of references: Qi Chen chief editor. herbal pharmacology research methodology [M]. Beijing, the People's Health Publisher, the 1st edition, 1993:439 and Li Junxia, Liu Xinguang, Xie Pengyan, etc. Trimebutine Maleate is to the stripped tensile regulating action mechanism of colonic smooth muscle of constraint stress rats. China's digestion magazine, 2003; 23 (11): 655.
Get the 2-3kg large ear rabbit, tap the head to cause and get killed.Take out the jejunum part rapidly, move into immediately after normal saline cleans a little in the fresh Tai Shi nutritional solution of oxygenation.Careful soft operation separates removes mesentery, and clean intestinal contents, and it is standby to put in the low temperature Tai Shi nutritional solution maintenance.About 2cm intestinal segment one joint of clip during test, the two ends binding.One end is fixed on the little hook in LQH isolated organ thermostatic bath bottom, and the other end links tonotransducer (L-1010 Shanghai red flag instrument plant, sensitivity 0.0mV/cm).Pen record intestinal segment motion tension variation curve.Preset tension force 400mg, the every 10-15min of Tai Shi nutritional solution changes once in the bath.In tyrode's solution, add variable concentrations and medicinal liquid, respectively the variation of the forward and backward intestinal segment voluntary activity of observed and recorded medication.Comprise the variation of tension force and motion frequency.To being viewed as of acetylcholine and histamine influence: in tyrode's solution, add a certain amount of acetylcholine or histamine respectively, cause the spastic contraction of intestinal segment, observe under acetylcholine or histamine's effect the influence that different medicinal liquids shrink intestinal segment respectively.
Three. result of the test:
See Table 7.
Table 7. the present invention to rabbit exsomatize intestinal smooth muscle tension force (mg) influence (X ± SD, N=6)
It in the table changing value.
▲ ▲ ▲: self cross-reference t check P＜0.01; ☆ ☆ ☆: compare P＜0.01 with the dicetel group.
The test of embodiment 8. analgesic effects
One. method:
1. the mice hot plate method is caused the influence of pain model
List of references: Qi Chen chief editor. herbal pharmacology research methodology [M]. Beijing, People's Health Publisher, the 1st edition, the method for 1993:377.
Get female mice, put into the large beaker bottom (keeping dry at the bottom of the beaker) that places 25 ± 0.5 ℃ of constant temperature water baths one by one, observe and write down mice from putting into the time (sec) that metapedes appears licking for 1 time in beaker to the, as the basic pain threshold of this Mus.All easy leapers, lick metapedes time＜5sec and＞30sec person is considered as nonconformingly, rejected.Get 70 of satisfactory mices, be divided into 7 groups after weighing at random, 10 every group.Survey and respectively organize each threshold of pain, animal basis once, the meansigma methods of getting twice basic threshold of pain is the preceding pain threshold of this animals administer.Each treated animal is gastric infusion respectively.Normal control group and model control group are given distilled water, and the high, medium and low dosage group of the present invention gives 16,8 respectively, the medicine of the present invention of 4g/kg, and the dicetel group is given the 40mg/kg dicetel, and the GUCHANG ZHIXIE WAN group is given clothes 3g/kg GUCHANG ZHIXIE WAN, and volume is 20ml/kg.After the last administration 15,30 and 60min survey each mice pain threshold respectively again.Animal occurs taking out at once when 60sec does not still have the metapedes of licking by 60sec to be calculated, and existing continuation is observed.Calculate the average threshold of pain of each treated animal different time sections, calculate according to a conventional method and respectively organize the forward and backward threshold of pain variation percentage rate of administration.
2. the influence of mice acetic acid twisting method pain reaction model
List of references: Qi Chen chief editor. herbal pharmacology research methodology [M]. Beijing, People's Health Publisher, the 1st edition, the method for 1993:378.
Experimental animal is selected and is divided into groups with embodiment 5.Normal control group and model control group are irritated stomach to distilled water, the high, medium and low dosage group of the present invention gives 16,8 respectively, the medicine of the present invention of 4g/kg is irritated stomach, dicetel group dosage is 40mg/kg, and GUCHANG ZHIXIE WAN gastric infusion dosage is 3g/kg, and volume is 20ml/kg.Administration every day 1 time, successive administration 6 days.60min after the last administration, normal control group intraperitoneal injection of saline 20ml/kg, all the other each treated animals are the glacial acetic acid solution 20ml/kg of lumbar injection 0.6% respectively.The required time of writhing response (being pain incubation period) appears for the 1st time in each animal after observing the injection glacial acetic acid, and turns round the body number of times in the 20min.Calculate the analgesia percentage rate of each medicine according to a conventional method.
Two. result of the test:
The results are shown in Table 8 and table 9 shown in.
Table 8. different pharmaceutical to hot plate method cause mice pain reaction influence comparison (X ± SD, N=10)
The comparison that table 9. different pharmaceutical influences mice acetic acid twisting method pain reaction (X ± SD, N=10)
The test of embodiment 9. function of invigorating spleen
One. method:
The NIH mice, other setting of animal groups and Radix Et Rhizoma Rhei cause the Mice with Spleen Preparation of model with embodiment 5.
Administration after the modeling, route of administration, dosage and time with test method with embodiment 8 " influence of mice acetic acid twisting method pain reaction model ".
The body weight and the food-intake situation of each treated animal after the modeling and after the administration respectively before the observed and recorded modeling.After the last administration animal dropped into water temperature and be in 15 ± 0.5 ℃ the water and swim.Haul oneself willingly in the entry beginning with stopwatch compute animal and sink to the swimming time of the time of the water surface to the nostril for this animal.
Two. the result:
See Table 10 and table 11 shown in.
Table 10. different pharmaceutical to Radix Et Rhizoma Rhei cause the comparison that Mice with Spleen model body ghost image rings (X ± SD, N=10)
Table 11. different pharmaceutical to Radix Et Rhizoma Rhei cause the influence of Mice with Spleen model food-intake and swimming time comparison (X ± SD, N=10)
The test of embodiment 10. sedations
One. method:
List of references: Wang Yu tail feather, Zhang Yan, Ai Ping, Deng. the particulate calmness of tranquilizing by nourishing the heart, hypnosis and resisting oxygen lack. Medical University Of Anhui's journal, 2003,38 (2): 118 and Qi Chen chief editor. herbal pharmacology research methodology [M]. Beijing, People's Health Publisher, the 1st edition, the described method of 1993:439.
1. to the influence of mice voluntary activity
60 of mices, male and female half and half are divided into 6 groups at random by the sex body weight, 10 every group.Be the high, medium and low dosage group of blank group, the present invention, diazepam group and GUCHANG ZHIXIE WAN group.After the grouping, under 20 ℃ of room temperatures, one by one each animal is put into inspection box, adapt to 5min earlier, the number of times that the two forelimbs of mice are upwards praised in the observed and recorded 5min is for making basic activity value then.Normal control group and model control group are irritated stomach to distilled water, the high, medium and low dosage group of the present invention gives 16,8 respectively, the medicine of the present invention of 4g/kg is irritated stomach, the diazepam group gives clothes 1mg/kg stable, and GUCHANG ZHIXIE WAN gastric infusion dosage is 3g/kg, and volume is 20ml/kg.Every day 1 time, successive administration 3 days.60min after the last administration measures the number of times that the two forelimbs of each Mus are upwards praised with method.
2. to the influence of sleep dosage down of mice pentobarbital sodium threshold
Inject the sleeping number of animals of each dosage in the observed and recorded 15min (the mice righting reflex loss reaches 1min person and is designated as sleeping animal) to mouse peritoneal with the various dose pentobarbital sodium.When pentobarbital sodium dosage is 45mg/kg as a result, sleeping animal number 7/8, sleeping rate 87.5%.When pentobarbital sodium dosage was 30mg/kg, animal mainly showed as movable the minimizing, sleeping animal number only 1/8, and sleeping rate is 12.5%.So with the 30mg/kg pentobarbital sodium is the sub-threshold dose of mice syngignoscism.
60 of mices, grouping, dosage and method are with test " to the influence of mice voluntary activity ".60min after the last administration, each treated animal be lumbar injection pentobarbital sodium 30mg/kg respectively.The sleeping number of animals of each dosage in the observed and recorded injection pentobarbital sodium 15min.
Two. result of the test:
Be shown in Table 12.
The comparison that table 12. different pharmaceutical influences the mice voluntary activity (X ± SD, N=10)
Claims (9)
1. pharmaceutical composition for the treatment of irritable bowel syndrome, make by the crude drug of following weight or volume:
Radix Paeoniae Alba (parched) 65～70g Rhizoma Atractylodis Macrocephalae (parched) 35～45g Bulbus Allii Macrostemonis 35～45g
Semen Plantaginis 35～45g Fructus Citri Sarcodactylis 35～45g Oleum menthae 1～2ml.
2. a kind of pharmaceutical composition for the treatment of irritable bowel syndrome according to claim 1, make by the crude drug of following weight or volume:
Radix Paeoniae Alba (parched) 66～68g Rhizoma Atractylodis Macrocephalae (parched) 38～42g Bulbus Allii Macrostemonis 38～42g
Semen Plantaginis 38～42g Fructus Citri Sarcodactylis 38～42g Oleum menthae 1.3～1.4ml.
3. a kind of pharmaceutical composition for the treatment of irritable bowel syndrome according to claim 1 and 2, make by the crude drug of following weight or volume:
Radix Paeoniae Alba (parched) 66.7g Rhizoma Atractylodis Macrocephalae (parched) 40.0g Bulbus Allii Macrostemonis 40.0g
Semen Plantaginis 40.0g Fructus Citri Sarcodactylis 40.0g Oleum menthae 1.33ml.
4. a Chinese medicine preparation for the treatment of irritable bowel syndrome is made up of the pharmaceutical composition and the pharmaceutics acceptable auxiliary of claim 1 or 2 described treatment irritable bowel syndromes.
5. a kind of Chinese medicine preparation for the treatment of irritable bowel syndrome according to claim 4, described dosage form is a peroral dosage form.
6. a kind of Chinese medicine preparation for the treatment of irritable bowel syndrome according to claim 5, described peroral dosage form is tablet, powder agent, capsule, granule, pill or oral liquid.
7. a kind of Chinese medicine preparation for the treatment of irritable bowel syndrome according to claim 4, described pharmaceutics acceptable auxiliary is sucrose, lactose, galactose, mannitol, sorbitol, corn starch, gelatin, lipid, microcrystalline Cellulose or beta-schardinger dextrin-.
8. a method for preparing the granule for the treatment of irritable bowel syndrome comprises the steps:
Radix Paeoniae Alba (parched) 65～70g Rhizoma Atractylodis Macrocephalae (parched) 35～45g Bulbus Allii Macrostemonis 35～45g
Semen Plantaginis 35～45g Fructus Citri Sarcodactylis 35～45g Oleum menthae 1～2ml;
(1) Radix Paeoniae Alba (parched), Rhizoma Atractylodis Macrocephalae (parched), Bulbus Allii Macrostemonis, Semen Plantaginis and Fructus Citri Sarcodactylis five tastes medical material, soaked 1～2 hour, decoct secondary, add for the first time 8～12 times of water gagings and fry in shallow oil and carry 1～3 hour, add 6～10 times of water gagings for the second time and fry in shallow oil and carry 1～2 hour, filter, it is 1.30～1.34 thick pastes that filtrate decompression is concentrated into 60 ℃ of heat survey relative densities, 60 ℃-0.08Mpa vacuum drying is ground into fine powder, and is standby;
(2) get 6～10 times of beta-schardinger dextrin-s to the Herba Menthae oil mass and place mortar, add 2～5 times of water gagings and grind evenly, get Oleum menthae then, be made into 50% Oleum menthae ethanol liquid in advance, slowly join in the mortar, ground 2～4 hours, 35～45 ℃ of dryings are pulverized, and are standby; Get above-mentioned water and carry dried cream powder, add Oleum menthae clathrate and an amount of lactose mixing,, cross 10～12 mesh sieves and make wet granular with 90% ethanol system soft material, 40 ℃ of cold drying, granulate, promptly.
9. a kind of method for preparing the granule for the treatment of irritable bowel syndrome according to claim 8 comprises the steps:
Radix Paeoniae Alba (parched) 66.7g Rhizoma Atractylodis Macrocephalae (parched) 40.0g Bulbus Allii Macrostemonis 40.0g
Semen Plantaginis 40.0g Fructus Citri Sarcodactylis 40.0g Oleum menthae 1.33ml;
Preceding 5 flavor medicines were soaked 1.5 hours, decocted secondary, added 10 times of water gagings for the first time and fried in shallow oil and carry 2 hours, add for the second time 8 times of water gagings and fry in shallow oil and carry 1.5 hours, filter, filtrate decompression is concentrated into 60 ℃ of heat, and to survey relative densities be 1.30～1.34 thick pastes, 60 ℃-0.08Mpa vacuum drying is ground into fine powder, and is standby; Other gets 8 times of beta-schardinger dextrin-s to the Herba Menthae oil mass and places mortar, adds 4 times of water gagings and grinds evenly, gets Oleum menthae then, is made into 50% Oleum menthae ethanol liquid in advance, slowly joins in the mortar, grinds 3 hours, and 40 ℃ of dryings are pulverized, and are standby; Get above-mentioned water and carry dried cream powder, add Oleum menthae clathrate and an amount of lactose mixing,, cross 10～12 mesh sieves and make wet granular with 90% ethanol system soft material, 40 ℃ of cold drying, granulate, promptly.
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| 肠易激综合症(IBS)的中医治疗五法. 陈文莉.山西中医学院学报，第6卷第2期. 2005 * |
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