CN103735685B - The traditional Chinese medicine extraction compositions for the treatment of FGID or intestinal irritable syndrome, preparation method and in the application of preparing in medicine - Google Patents

Abstract

The traditional Chinese medicine extraction compositions for the treatment of FGID or intestinal irritable syndrome, preparation method and in the application of preparing in medicine. Each component adopts bulk drug extract, does is weight ratio: Rhizoma Atractylodis Macrocephalae extract I? 3 ~ 29, Rhizoma Atractylodis Macrocephalae extract II? 18 ~ 57, radix paeoniae alba extraction 13 ~ 53, dried orange peel extracts 6 ~ 32, Radix Saposhnikoviae extract 2 ~ 27. Rhizoma Atractylodis Macrocephalae extract I is the way of distillation or supercritical extraction extract; Rhizoma Atractylodis Macrocephalae extract II is water extract; Radix paeoniae alba extraction is ethanol extract; Dried orange peel extracts is ethanol extract; Radix Saposhnikoviae extract water extraction is got or supercritical extract. The present invention has overcome the traditional view of " Chinese medicine compound prescription decoct altogether or always extract be better than each medicinal material extract respectively ", is processed and has significantly been improved pharmacological effect, the quality control of the composition of being more convenient for by the optimum organization of each medicinal substances extract. The composition for the treatment of FGID of the present invention or intestinal irritable syndrome has produced beyond thought effect.

Description

The traditional Chinese medicine extraction compositions for the treatment of FGID or intestinal irritable syndrome, preparation method and in the application of preparing in medicine

Technical field

The present invention relates to one and treat the Chinese medical extract of FGID (FGIDs) or intestinal irritable syndrome (IBS)The preparation method of composition of composition, this treatment FGID or intestinal irritable syndrome; And this treatment functionThe composition of gastroenteropathy or intestinal irritable syndrome answering in preparation treatment FGID or intestinal irritable syndrome medicineWith.

Background technology

FGID (FGIDs) is that a class has symptom of digestive tract, does not find on inspection organic disease or can notBy a class disease of digestive system of biochemical structure interpretation of anomaly. Patient often occur poor appetite, early full, stomachache, feel sick, vomiting,The symptoms such as abdominal distension, diarrhoea, constipation and difficult defecation. Comprise 28 kinds of diseases by current sorting technique, with functional dyspepsia FD(FD), IBS (IBS), functional consitipation (FC) are the most common.

Functional dyspepsia FD (FD) refers to has got rid of upper abdomen pain organic disease, that Alimentary Canal Function disorder causesPain or the uncomfortable clinical symptom group that waits, taking Abdeminal pain after the meal, belch, early full, apocleisis, feel sick, vomit clinical as main manifestationsSyndrome. Its illness rate is high, accounts for crowd's 20%, accounts for 60% ~ 70% of digestion special outpatient clinic. Illustrate extremely common multiple. FunctionProperty constipation (functionalconstipation, FC) is a kind of alimentary canal common disease, without significant organic pathology withThe functional dysporia of changing into feature, clinical manifestation is that defecation frequency reduces, ight soil is dry and hard, defecation effort. Along with dietThe change of structure and under the impact of the spirit many factors such as psychological, social, China FC illness rate rises gradually, serious shadowRing people's quality of life. Epidemiologic data shows that China's chronic constipation illness rate is up to 15%～20%, wherein just functionalSecretly occupy very large ratio. Intestinal irritable syndrome (irritablebowelSyndrome, IBS) is the non-device of common alimentary canalMatter bowel dysfunction disease, has the chronic clinical characters of outbreak repeatedly. Illness rate in adult is 10%～22%,Women is slightly common. Its main clinical manifestation is without the gastrointestinal symptoms such as the stomachache of organic disease, diarrhoea, constipation, its cause of diseaseIt is functional disturbances of gastrointestinal tract. At present such disease is still lacked to effective methods for the treatment of.

FGID is by the difference of classification, and its pathogenesis and pathologic, physiologic are slightly different, but generally speaking itsMechanism can be summarized as following some: gastroenteritic power abnormal, effect, the psychosocial factor of visceral, brain intestines axleDeng. Due to FGID pathogenesis more complicated, risk factor is more, and chemicals is often difficult to obtain satisfied treatmentEffect, there is the defects such as large, the easy recurrence of side effect in these medicines simultaneously. In recent years, traditional medicine occupies very in the treatment of this diseaseConsequence.

In the prior art, according to theory of traditional Chinese medical science and pharmacological effect, several treatment intestinal irritable syndromes are disclosedDrug regimen. For example:

Application number is 200810102114.1, and denomination of invention is " a kind of pharmaceutical composition for the treatment of liver-depression spleen-deficiency and diarrheaAnd preparation method thereof " patent a kind of Chinese medicine composition for the treatment of intestinal irritable syndrome and preparation method thereof is disclosed, this schemeProvide by five kinds of formula and formulation methods that Chinese medicine forms such as the bighead atractylodes rhizome, the root of herbaceous peony, dried orange peel, windproof, rattletops.

Application number be 200410014704.0 denominations of invention for " Chinese medicine composition for the treatment of bowel dysfunction disease andPreparation method " patent of invention in, applicant discloses a kind of Chinese medicine composition for the treatment of intestinal irritable syndrome, provides as followsFormula: 15 ~ 30 grams of the bighead atractylodes rhizomes, 8 ~ 25 grams of the root of herbaceous peonys, 5 ~ 20 grams of dried orange peels, windproof 5 ~ 20 grams. Or the volatilization of the bighead atractylodes rhizome, windproof, the root of herbaceous peonyOil ingredient; The bighead atractylodes rhizome, windproof, the alcohol extract component of the root of herbaceous peony together with dried orange peel; Vegetable oil is appropriate.

Application number is 200810217301.4, and denomination of invention is preparation method and the use of " tongxieyao formula " Chinese medical extractWay patent of invention in, applicant discloses the preparation method of " tongxieyao formula " Chinese medical extract, comprises the following steps: 1) withRhizoma atractylodis macrocephalae, stir-baked RADIX PAEONIAE ALBA, stir-fry dried orange peel and windproof be raw material, taking ethanolic solution or water as raw material described in solvent extraction, obtain extract;2) the concentrated extract obtaining to the volume of described extract is described raw material weight 6～9 times; 3) rare with 3～5 times of volume waterRelease the concentrate of acquisition, get supernatant; 4) described supernatant is adsorbed with macroporous resin column, collect ethanol elution part, obtainEthanol eluate; 5) concentrate and be dried the ethanol eluate obtaining, obtain described Chinese medical extract.

Application number be 200410014704.0 denominations of invention for " Chinese medicine composition for the treatment of bowel dysfunction disease andPreparation method " patent of invention in, applicant discloses a kind of Chinese medicine composition for the treatment of intestinal irritable syndrome, provides as followsFormula: 15 ~ 30 grams of the bighead atractylodes rhizomes, 8 ~ 25 grams of the root of herbaceous peonys, 5 ~ 20 grams of dried orange peels, windproof 5 ~ 20 grams. Or the volatilization of the bighead atractylodes rhizome, windproof, the root of herbaceous peonyOil ingredient; The bighead atractylodes rhizome, windproof, the alcohol extract component of the root of herbaceous peony together with dried orange peel; Vegetable oil is appropriate.

Application number is in the patent of invention of 200810053479.X denomination of invention for " medicine for the treatment of diarrhoea ", applicantA kind of medicine for the treatment of diarrhoea is disclosed, by the bighead atractylodes rhizome, the root of herbaceous peony, dried orange peel, the windproof various medicines of preparing as active ingredient, clinical controllingTreat acute and chronic diarrhea, cold-heat jumble, deficient and excessive syndromes appearing together card effectively.

Although the bighead atractylodes rhizome, the root of herbaceous peony, windproof, the plus-minus side of dried orange peel seen clinical treatment bowel dysfunction, functional dyspepsia FD,The diseases such as intestinal irritable syndrome, but because compound active principle is still not exclusively clear and definite, the not high reason of preparation technique, should in realityWith in exist that clinical efficacy is unstable, patient takes the problems such as inconvenience. These problems have seriously restricted the effect of compound.

General points of view thinks, the Chinese medicine compound prescription activity extract of clinical practice should be mixed to extract by raw medicinal material and obtainComposition, for example, adopt decocting or alcohol extract, obtains water-soluble extractive or alcohol dissolubility active component. It is multiple that traditional view is thoughtSide's medicinal material mixes the extract effect of extracting and is better than the combination of a kind of medicinal substances extract wherein or various medicinal substances extracts.

Summary of the invention

The object of this invention is to provide one and treat the Chinese medical extract of FGID or intestinal irritable syndrome (IBS)Composition. Said composition can be used for treating FGID, especially for treatment intestinal irritable syndrome. The present invention also will carryFor the preparation method of this composition; And this composition is at preparation treatment FGID or anti-intestinal irritable syndrome medicineIn application.

The technical scheme that completes foregoing invention task is: a kind of Chinese medicine for the treatment of FGID or intestinal irritable syndromeExtractive composition, the bulk drug of said composition is: the bighead atractylodes rhizome, the root of herbaceous peony, dried orange peel, windproof; It is characterized in that, described each component is to adoptWith the extract of each bulk drug, the weight ratio of each component is: Rhizoma Atractylodis Macrocephalae extract I(component one) 3 ~ 29, Rhizoma Atractylodis Macrocephalae extract II(groupDivide two) 18 ~ 57, radix paeoniae alba extraction (component three) 13 ~ 53, dried orange peel extracts (component four) 6 ~ 32, Radix Saposhnikoviae extract (component five)2~27。

More specifically, described treatment FGID or the traditional Chinese medicine extraction compositions of intestinal irritable syndrome, its spyLevy and be, in composition, the weight ratio of each component is: Rhizoma Atractylodis Macrocephalae extract I3 ~ 24, Rhizoma Atractylodis Macrocephalae extract II20 ~ 46, the root of herbaceous peony is extractedThing 15 ~ 47, dried orange peel extracts 6 ~ 27, Radix Saposhnikoviae extract 5 ~ 21.

More specifically and more optimize described treatment FGID or the combination of the Chinese medical extract of intestinal irritable syndromeThing, is characterized in that, the weight ratio of component is: Rhizoma Atractylodis Macrocephalae extract I3 ~ 10, Rhizoma Atractylodis Macrocephalae extract II23 ~ 37, radix paeoniae alba extraction 16~ 36, dried orange peel extracts 8 ~ 17, Radix Saposhnikoviae extract 5 ~ 17. The present invention adopts each bulk drug to extract respectively purifying, selective by eachThe combination of extracting section thing, proposes: " the optimum organization thing of Chinese medicine material extract, effect will be better than total extract or thick decocting liquid "The fact. Further optimize on this basis preparation method and raw material proportioning, realized best pharmacological effect. In addition, thisThe processing of bright employing extract combination, has significantly reduced clinical dosage, is convenient to various formulation preparations, is conducive to the quality control of compositionSystem, has solved the technical barrier of Chinese medicine compound prescription in preparation process. Experimental data proves, adopts composition treatment stomach of the present inventionBowel dysfunction or intestinal irritable syndrome can produce beyond thought effect.

In above scheme, described Rhizoma Atractylodis Macrocephalae extract I refers to that Rhizoma Atractylodis Macrocephalae adopts the way of distillation or supercritical extraction extraction placeThe extract obtaining after reason; After described Rhizoma Atractylodis Macrocephalae extract II refers to Rhizoma Atractylodis Macrocephalae or extracts I, the dregs of a decoction are after water extraction processThe extract obtaining; Described radix paeoniae alba extraction refers to the extract that white Peony Root obtains after ethanolic solution extraction process; InstituteThe dried orange peel extracts of stating refers to the extract that dried orange peel medicinal material obtains after ethanolic solution extraction process; Described Radix Saposhnikoviae extract isRefer to that windproof medicinal material adopts alcohol extract or water extraction is got or extract that supercritical extract obtains after processing.

More specifically, described Rhizoma Atractylodis Macrocephalae extract I refers to: Rhizoma Atractylodis Macrocephalae is ground into 16 ~ 20 order meal, adds 6 ~ 10 timesThe water soaking of amount weight ratio 2 ~ 4 hours, distillation is extracted 2 ~ 6 hours, and collecting distillation becomes Rhizoma Atractylodis Macrocephalae extract I, for subsequent use;Or

Get Rhizoma Atractylodis Macrocephalae and be ground into 16 ~ 20 order meal, adopt the extraction of supercritical carbon dioxide extracting device, extracting pressure 25 ~30MPa, 35 DEG C ~ 40 DEG C of extraction temperature, separating pressure 6 ~ 9MPa, 45 DEG C ~ 50 DEG C of separation temperatures. Carbon dioxide flow 27 ~33L/h, extraction time: 100 ~ 150min; Collect extract as Rhizoma Atractylodis Macrocephalae extract I, for subsequent use;

Described Rhizoma Atractylodis Macrocephalae extract II refers to: adopt bighead atractylodes rhizome meal (12 ~ 20 order) or extract the bighead atractylodes rhizome dregs of a decoction and the water after ILiquid, water extraction is got 2 times: extract 80 ~ 90 DEG C of temperature, each 1 hour, the water of 15 ~ 18 times of weight ratios, mixing speed in leaching process20～50rpm. Merge extract, filter, be concentrated into every milliliter containing 0.5g ~ 1.0g crude drug, get supernatant and add 3 ~ 4 times of amounts heavyAmount than 95% ethanol, leaves standstill, filter and obtain solid content, solid content directly become Rhizoma Atractylodis Macrocephalae extract II or dry after become the bighead atractylodes rhizome and carryGet thing II; Or,

Adopt bighead atractylodes rhizome meal (12 ~ 20 order) or extract the bighead atractylodes rhizome dregs of a decoction and the water liquid after I, the water extraction of 15 ~ 18 times of weight ratios gets 2Inferior: extract 80 ~ 90 DEG C of temperature, each 1 hour, mixing speed 20～50rpm in leaching process. Merge extract, filter, denseBe reduced to every milliliter of supernatant containing 0.05g～0.1g crude drug, through 0.05～0.2 μ m inorganic ceramic membrane microfiltration, filtrate decompression is concentratedTo the medicinal extract that relative density is 1.14 ~ 1.30, directly become Rhizoma Atractylodis Macrocephalae extract II or dry after become Rhizoma Atractylodis Macrocephalae extract II.

Described radix paeoniae alba extraction refers to: white Peony Root is ground into 12 ~ 20 order meal, 6 ~ 8 times of amount weight ratio 50% ~ 70% ethanolExtract each 1 ~ 1.5 hour 2 times. Extract filters, and merges, reclaim ethanol to every milliliter containing 0.2 ~ 0.5g crude drug, through in the utmost pointProperty or low pole macroporous resin adsorption after, adopt different concentration ethanol solution stepwise elution macroreticular resin, collect ethanol eluateThrough concentrated directly become radix paeoniae alba extraction or dry after become radix paeoniae alba extraction; Or

White Peony Root is ground into 12 ~ 20 order meal, and the water extraction of 8 ~ 10 times of amount weight ratios is got 2 times, each 1 ~ 1.5 hour. CarryGet liquid and filter, merge, be concentrated into every milliliter containing 0.2 ~ 0.5g crude drug, after Semi-polarity or low pole macroporous resin adsorption, adoptWith different concentration ethanol solution stepwise elution macroreticular resin, collect ethanol eluate through the concentrated radix paeoniae alba extraction or dry that directly becomesAfter dry, become radix paeoniae alba extraction.

Described stepwise elution step is: first extremely colourless with the water elution of 2～4 times of amount weight ratios, and be first to use low concentration(weight ratio 20～30%) ethanolic solution carries out after wash-out, then adopts weight ratio 50～70% ethanolic solutions to carry out wash-out.

Described dried orange peel extracts refers to: dried orange peel pulverizing medicinal materials becomes 16 ~ 20 order meal, 6 ~ 8 times of amount weight ratio 60% ~ 80% secondAlcohol, extracts each 0.5 ~ 1 hour 2 times. Extract filters, and merges, reclaim ethanol to every milliliter containing 0.2 ~ 0.5g crude drug, warpAfter Semi-polarity or low pole macroporous resin adsorption, adopt different concentration ethanol solution stepwise elution macroreticular resin, collect ethanol and washDe-liquid through concentrated directly become dried orange peel extracts or be dried after become dried orange peel extracts; Or

Dried orange peel pulverizing medicinal materials becomes 16 ~ 20 order meal, and 6 ~ 8 times of amount weight ratio 60% ~ 80% ethanol, extract each 0.5 ~ 12 timesHour. Extract filters, and merges, and reclaims ethanol to every milliliter of supernatant containing 0.05g ~ 0.1g crude drug, through 0.05 ~ 0.2 μ mInorganic ceramic membrane microfiltration, it is 1.14 ~ 1.30 medicinal extract that filtrate decompression is concentrated into relative density, directly becomes dried orange peel extractsOr become dried orange peel extracts after dry.

Described stepwise elution step is: first extremely colourless with the water elution of 2～4 times of amount weight ratios, and be first to use low concentration(weight ratio 20～30%) ethanolic solution carries out after wash-out, then adopts weight ratio 50～70% ethanolic solutions to carry out wash-out.

Described Radix Saposhnikoviae extract refers to: get appropriate windproof medicine materical crude slice, the decoctings of 8 ~ 10 times of amount weight ratios boil 2 times, each 1 littleTime. Extract filters, and merges 2 times filtrate, is concentrated into every milliliter containing 0.2 ~ 0.5g crude drug, through Semi-polarity or low pole macropore treeAfter fat absorption, adopt different concentration ethanol stepwise elution macroreticular resin, collecting ethanol eluate directly becomes windproof carrying through concentratingGet thing or dry after become Radix Saposhnikoviae extract; Or,

Windproof medicinal material is ground into 16 ~ 20 order meal, 6 ~ 8 times of amount weight ratio 50% ~ 70% ethanol, and hot reflux is extracted 2 times, everyInferior 1 hour. Extract filters, and merges 2 times filtrate, is concentrated into every milliliter containing 0.2 ~ 0.5g crude drug, large through Semi-polarity or low poleAfter the resin adsorption of hole, adopt different concentration ethanol stepwise elution macroreticular resin, collect ethanol eluate through concentrated directly become anti-Wind extract or dry after become Radix Saposhnikoviae extract; Or,

Windproof medicinal material is ground into 16 ~ 20 order meal, adopts supercritical carbon dioxide extracting: extracting pressure 25 ~ 30MPa, extractionGet 35 DEG C ~ 42 DEG C of temperature, separating pressure 6 ~ 9MPa, 45 DEG C ~ 50 DEG C of separation temperatures, extraction time: 100～180 minutes, folderBand agent 50% ethanol 100ml/100g, the extract obtaining directly become Radix Saposhnikoviae extract or dry after become Radix Saposhnikoviae extract.

Described different concentration ethanol solution stepwise elution step is: first colourless with being washed to of 2～4 times of amount weight ratios,Then first use low concentration (weight ratio 25～35%) ethanolic solution to carry out after wash-out, then adopt weight ratio 55～70% ethanol moltenLiquid carries out wash-out.

The present invention is the innovative development to Chinese medicine compound prescription, the reasonable combination of extract, and it is thick than compound that institute obtains compositionExtract has qualitative leap. The feature that can not only embody the many target spot performances of Chinese medicine drug effect, can make again active ingredient enrichment more, medicineReason effect and clinical efficacy strengthen, reduce clinical dosage, are convenient to various formulation preparations, and are beneficial to quality control level raising etc.Advantage.

Keeping on traditional Chinese medical science medicine law and principle basis, by medicinal material active ingredient is deeply screened, rationally application is existingGeneration extraction, refining, technology of preparing, can reject a large amount of unnecessary composition and disturbing factor, makes effect more have selectivity,Main pharmacodynamics effect is more outstanding; Secondly, can the side of making in chemical constituent substantially clear, can make formulation and the life of drug standardThe control of yield and quality is more pointed, and drug quality is stablized controlled more.

Repeatedly say, technical scheme of the present invention is taking Chinese herbal medicine as raw material, forms medicine with the extract of its special ratiosCompositions. A kind of Chinese medicine active principle composition for the treatment of gastrointestinal dysfunction or intestinal irritable syndrome. Described each component isAdopt the extract of each bulk drug, wherein, Rhizoma Atractylodis Macrocephalae extract I becomes component one; Rhizoma Atractylodis Macrocephalae extract II becomes component two; The root of herbaceous peonyExtract becomes component three; The extract of dried orange peel becomes component four; Windproof extract becomes component five.

Main distinction feature of the present invention is: each bulk drug is extracted respectively to purifying, combine selectively. , originallyInvention is abandoned that whole raw medicinal materials are decocted altogether or jointly extracts obtaining extract, carries for every kind of Chinese medicine material and adoptGet purifying and obtain extract, abandoned the ratio of original compound, but adopt, various extracts are optimized to combination, to reachBest technique effect. This is diverse with traditional scheme.

Described treatment FGID or the traditional Chinese medicinal components composition of intestinal irritable syndrome, is characterized in that, described inThe concrete composition of each component is:

Described Rhizoma Atractylodis Macrocephalae extract I is containing atractylone, sagittol, beta-elemene, atractylenolide Ⅰ, atractylenolide Ⅰ II, double blankArt lactone; Described Rhizoma Atractylodis Macrocephalae extract II is containing arginine; Described radix paeoniae alba extraction is containing Paeoniflorin, albiflorin, benzoylPaeoniflorin, Hydroxy peoniflorin; Described dried orange peel extracts is containing aurantiamarin, aurantiin, orange peel element, Nobiletin; Described is windproofExtract is containing cimicifugoside, macrotin, 5-O-methyl visamminol glycosides, hamaudol glycosides, Psoralen, bergapten, Imperatoria ostruthiumElement, xanthotoxin, Scopoletin, bergapten.

The technical scheme that completes second invention task of the application is that described treatment FGID or intestines easily swash and combineThe preparation method who closes the traditional Chinese medicine extraction compositions of disease, is characterized in that, step is as follows:

(1). get respectively and prepare Rhizoma Atractylodis Macrocephalae extract I, Rhizoma Atractylodis Macrocephalae extract II, radix paeoniae alba extraction, dried orange peel extracts, windproof extractionThing;

(2). take respectively the direct or dry thing of the medicinal extract of above five kinds of extracts by required share, for subsequent use;

. adopt preparation technique or auxiliary material to process above extract, comprise that application is cyclodextrin encapsulated, adopt disperse,Solubilising, protection against the tide, slowly-releasing, pulverize, sieve, mix;

(4). above five kinds of extracts are combined in required ratio, prepare medicine.

The preparation method of described treatment gastrointestinal dysfunction or the composition of intestinal irritable syndrome, is characterized in that,

In above scheme, the extraction of Rhizoma Atractylodis Macrocephalae extract I can adopt steam distillation or CO2 supercritical extraction to carryGet. Recommend adoption CO2 supercritical extraction extracts. Get Rhizoma Atractylodis Macrocephalae and be ground into 16 order meal, adopt supercritical carbon dioxide extractionGet device extraction, extracting pressure 26 ~ 28MPa, 36 DEG C ~ 38 DEG C of extraction temperature, separating pressure 6 ~ 8MPa, separation temperature 46 DEG C ~ 48DEG C. Carbon dioxide flow 27 ~ 33L/h, extraction time: 120min; Collect extract as Rhizoma Atractylodis Macrocephalae extract I, for subsequent use;

The extraction recommend adoption of Rhizoma Atractylodis Macrocephalae extract II: Rhizoma Atractylodis Macrocephalae is ground into 16 order meal, extracts 2 times, extracts temperature 85DEG C, each 1 hour, the water of 15 times of weight ratios, mixing speed 30rpm in leaching process. Merge extract, filter, be concentrated into everyMilliliter containing 1.0g crude drug, is got supernatant and is added 3 times of amount weight ratio 95% ethanol, leaves standstill, and filters and obtains solid content, becomes after dryRhizoma Atractylodis Macrocephalae extract II;

The extraction recommend adoption of radix paeoniae alba extraction: white Peony Root is ground into 20 order meal, 6 times of amount weight ratio 60% ethanol are carriedGet each 1 hour 2 times. Extract filters, and merges, and reclaims ethanol to every milliliter containing 0.2g crude drug, through Semi-polarity or low poleAfter macroporous resin adsorption, first extremely colourless with the water elution of 4 times of amount weight ratios, then first carry out with weight ratio 20% ethanolic solutionAfter wash-out, then adopt weight ratio 60% ethanolic solution to carry out wash-out. Collection ethanol eluate becomes the root of herbaceous peony and carries after concentrate dryingGet thing.

The extraction recommend adoption of dried orange peel extracts: dried orange peel pulverizing medicinal materials becomes 16 order meal, 6 times of amount weight ratio 70% ethanol are carriedGet each 1 hour 2 times. Extract filters, and merges, and reclaims ethanol to every milliliter containing 0.5g crude drug, through Semi-polarity or low poleAfter macroporous resin adsorption, first extremely colourless with the water elution of 4 times of amount weight ratios, then first wash with weight ratio 25% ethanolic solutionAfter de-, then adopt weight ratio 70% ethanolic solution to carry out wash-out. Collect ethanol eluate and after concentrate drying, become dried orange peel extractionThing.

The extraction recommend adoption of Radix Saposhnikoviae extract: windproof medicinal material is ground into 20 order meal, 6 times of amount weight ratio 60% ethanol,Hot reflux is extracted 2 times, each 1 hour. Extract filters, and merges 2 times filtrate, is concentrated into every milliliter containing 0.2g crude drug, the utmost point in warpProperty or low pole macroporous resin adsorption after, first with the water elutions of 3 times of amount weight ratios to colourless, then first use weight ratio 30% ethanolSolution carries out after wash-out, then adopts weight ratio 65% ethanolic solution to carry out wash-out. Collecting ethanol eluate directly becomes through concentratedRadix Saposhnikoviae extract.

While adopting macroreticular resin Purified Water extract, can adopt the macroporous absorbent resin of nonpolar or low pole. Institute is usedNonpolar macroporous adsorption resin recommend adoption D101, HPD100(Cangzhou Bao En Chemical Co., Ltd.), HP20, HP10, HP40(Mitsubishi changes into company, polystyrene based structures), XAD-1～XAD-5(RohmHass Amberlite of company series, benzeneEthene structure). H103, H107, X-5(crosslinked polystyrene type, Chemical Plant of Nankai Univ.). The low pole macroreticular resin that usesCan be AB-8, DS-401, HPD-450(crosslinked polystyrene type).

The dry of described extract or medicinal extract can adopt vacuum drying, or microwave drying, or spraying is dry, or fluid bedDry, or freeze drying.

The technical scheme that completes the 3rd invention task of the application is that described treatment FGID or intestines easily swash and combineClose the traditional Chinese medicine extraction compositions of disease and treat the application in FGID or anti-intestinal irritable syndrome medicine in preparation.

Described traditional medicine volatile oil composition is in the medicine of preparation treatment FGID or intestinal irritable syndromeApplication, can add corresponding auxiliary material to be prepared into various clinical medicine formulations, comprises oral formulations, non-intestinal drug delivery agent, skinMucosa delivery preparation, suction preparation, as tablet, capsule, granule, dripping pill, micropill, supensoid agent, mixture, injection, aerosolAgent, spray, inhalant, ointment, cataplasm, suppository, emulsion, gel.

Although the patent that application number is 200810217301.4,2004100147040,200810053479.X disclosesThis four traditional Chinese medicine thing can be used for treating intestinal irritable syndrome or diarrhoea, prepares respectively extract but the present invention proposes every kind of medicinal raw materialAfter the technical scheme that combines obviously in scheme different from the past, particularly the present invention program the portfolio ratio of extract becomeChange and preparation parameter change can make the active constituent content of the present composition and drug effect have beyond thought variation, can make thisThat invention composition becomes is high in technological content, steady quality and be easy to the medicine of controlling.

We have carried out clinical front pharmacy, pharmacology and the clinical research of system to the present invention program's composition, in pharmacyIn research, index composition in composition is carried out respectively to qualitative, quantitative research, adopted AAS, HPLC method or GCMethod, has set up the analytical method of science, makes in extract index component content as the technical indicator of quality evaluation.

In drug efficacy study, according to the clinical symptoms of FGID or intestinal irritable syndrome, design serial drug effectExperiment, has investigated pharmaceutical composition of the present invention. Result shows that pharmaceutical composition of the present invention can obviously improve Mice with Spleen sign, rightSpleen-deficient mouse has rehabilitation effect; Obviously antagonism intestines hyperfunction, improves intestines function and suppresses, and plays and regulates intestines function; RightRat gastrointestinal tract dysfunction has regulating action; And there are obvious pain relieving, antifatigue, anti-anoxic, an anti-stress effect. Research knotFruit points out composition of the present invention to FGID or the effect of being significantly improved of intestinal irritable syndrome tool.

The more important thing is the optimization of the Combinatorial Optimization of different extracts, preparation method and preparation parameter in the present invention programAll can make the bighead atractylodes rhizome, the root of herbaceous peony, dried orange peel, windproofly produce beyond thought effect for the prepared composition of raw material, particularly these twoPrioritization scheme use in conjunction can have more significant advantage, and concrete distinguishing characteristics illustrates respectively and experimental results show that as follows:

One, the prioritization scheme of " extract combination " of the present invention will produce beyond thought effect. In the present inventionThese five kinds of schemes that extract combines, are better than that arbitrary Chinese medicine or extract use separately or the pharmacological effect of other combination.Particularly, the scheme that these five kinds of extracts combine is better than decocting altogether or mixed extract of these four kinds of Chinese medicine materials. In addition, originallyInvent the method for preparing extractive and the combined treatment that adopt, significantly improved the preparation performance of composition, be applicable to various kinds of drugPreparation, and be conducive to the quality control of composition.

The present invention program has strengthened the effect of active principle, has avoided toxic and side effect. Experimental example can illustrate this belowBright advantage. The present invention program's combination matching all has effect same.

The drug effect comparison of the different preparation method's samples of experimental study 1

Experimental drug material, medicine, animal used as test etc. are provided by legitimate channels.

Medicine material:

The bighead atractylodes rhizome, the root of herbaceous peony, dried orange peel, windproof.

Sample preparation methods:

Rhizoma Atractylodis Macrocephalae extract I: get Rhizoma Atractylodis Macrocephalae and be ground into 16 order meal, adopt the extraction of supercritical carbon dioxide extracting device, extractionPressure power 26 ~ 28MPa, 36 DEG C ~ 38 DEG C of extraction temperature, separating pressure 8MPa, 48 DEG C of separation temperatures. Carbon dioxide flow 29~ 30L/h, extraction time: 120min; Collect extract as Rhizoma Atractylodis Macrocephalae extract I, in extract, contain atractylone, sagittol,Beta-elemene, atractylodes lactone, atractylenolide Ⅰ II, biatractylolide.

Rhizoma Atractylodis Macrocephalae extract II: Rhizoma Atractylodis Macrocephalae is ground into 16 order meal, water extraction is got 2 times, extracts 90 DEG C of temperature, each 1 littleTime, 15 times of water, mixing speed 30rpm in leaching process. Merge extract, filter, be concentrated into every milliliter containing 1.0g crude drug, getSupernatant adds 3 times of amount 95% ethanol, leaves standstill, and filters, and collecting solid content becomes Rhizoma Atractylodis Macrocephalae extract II, contains arginine in extract.

Radix paeoniae alba extraction: get appropriate white Peony Root, be ground into 20 order meal, 6 times of amount 70% ethanol, extract 2 times, each 1 littleTime. Extract filters, and merges, reclaim ethanol to every milliliter containing 0.2g crude drug, after D101 macroporous resin adsorption, adopt water,25% ethanol, 60% ethanol elution macroreticular resin, collect ethanol eluate, through concentrating, becoming radix paeoniae alba extraction after vacuum drying, carriesGet in thing containing Paeoniflorin, albiflorin, benzoylpaeoniflorin, Hydroxy peoniflorin.

Dried orange peel extracts: dried orange peel pulverizing medicinal materials becomes 16 order meal, 6 times of amount 70% ethanol, extract each 1 hour 2 times. ExtractLiquid filters, and merges, reclaim ethanol to every milliliter containing 0.5g crude drug, after D101 macroporous resin adsorption, adopt water, 25% ethanol,70% ethanol elution macroreticular resin, collects ethanol eluate, through concentrated, becomes dried orange peel extracts after vacuum drying, in extract, containsAurantiamarin, aurantiin, orange peel element, Nobiletin.

Radix Saposhnikoviae extract: windproof medicinal material is ground into 20 order meal, 6 times of amount weight ratio 60% ethanol, hot reflux is extracted 2 times,Each 1 hour. Extract filters, and merges 2 times filtrate, is concentrated into every milliliter containing 0.2g crude drug, through Semi-polarity or low pole macroporeAfter resin adsorption, adopt water, 30%, 65% ethanol elution macroreticular resin, collect ethanol eluate, through concentrated, after vacuum drying, becomeFor Radix Saposhnikoviae extract, in extract, contain cimicifugoside, 5-O-methyl visamminol glycosides, hamaudol glycosides, macrotin, Psoralen,Bergapten, Imperatorin, xanthotoxin, Scopoletin, bergapten.

Test sample:

Sample 1, Rhizoma Atractylodis Macrocephalae extract I5%, Rhizoma Atractylodis Macrocephalae extract II18%, radix paeoniae alba extraction 45%, dried orange peel extracts 27%,Radix Saposhnikoviae extract 5%.

Sample 2, Rhizoma Atractylodis Macrocephalae extract 8%, Rhizoma Atractylodis Macrocephalae extract II32%, radix paeoniae alba extraction 27%, dried orange peel extracts 20%, anti-Wind extract 13%;

Sample 3, compound decoction (compound water extract). 30 grams of the bighead atractylodes rhizomes, 20 grams of the root of herbaceous peonys, 15 grams of dried orange peels, windproof 10 grams. By instituteThe ratio of stating is got various medicinal materials, and the bighead atractylodes rhizome of wherein said share, windproof, dried orange peel add respectively 8 times of water soakings 2 hours, and water vapour steamsThe method of heating up in a steamer is extracted 5 hours, collects volatile oil for subsequent use; White Peony Root is soaked 2 hours, merges with the dregs of a decoction that extract after volatile oil,Decoct and extract twice, each 1.5 hours, 10 times water, merge extract, filter, and are evaporated to relative density and are 1.30Medicinal extract, medicinal extract mixes with volatile oil Direct Uniform, for subsequent use.

Sample 4, compound decoction (compound water extract). 30 grams of the bighead atractylodes rhizomes, 20 grams of the root of herbaceous peonys, 15 grams of dried orange peels, windproof 10 grams. By instituteThe ratio of stating is got various medicinal materials, and the medicinal raw material of described share is soaked 2 hours, and decocting boils 2 times, and each 10 times of amounts decoct 1.5Hour; Merge decocting liquid, above two filtered solutions merge, concentrated rear dry, for subsequent use.

Sample 5, compound ethanol extract. 30 grams of the bighead atractylodes rhizomes, 20 grams of the root of herbaceous peonys, 15 grams of dried orange peels,, get in described ratio by windproof 10 gramsVarious medicinal materials, the bighead atractylodes rhizome of wherein said share, windproof, dried orange peel add respectively 8 times of water soakings 2 hours, and steam distillation extracts 5Hour, collect volatile oil for subsequent use; White Peony Root adds 80% alcohol immersion 2 hours, merges 80% with the dregs of a decoction that extract after volatile oilAlcohol extract twice, each 1.5 hours, 8 times 80% ethanol, merges extract, filters, and is evaporated to relative density and is1.30 medicinal extract, medicinal extract mixes with volatile oil Direct Uniform, for subsequent use.

Each group of sample is made into debita spissitudo with distilled water, for subsequent use.

Dosage: low dose group: be equivalent to 1.5g crude drug/kg; Middle dosage group: be equivalent to 3.0g crude drug/kg; High doseGroup: be equivalent to 6.0g crude drug/kg.

Experimental example one, different adjustment effect to the rat gastrointestinal tract dysfunction due to reserpine:

1. animal and grouping: healthy adult male SD rat, random packet, every group of 10 raisings.

2. administration and experimental technique: the capacity physiological saline such as (1) Normal group lumbar injection, the capacity such as simultaneously gavage steamsHeat up in a steamer water; (2) model group: lumbar injection reserpine 0.5mg/kg such as gavages at the capacity distilled water simultaneously; (3) positive group: lumbar injectionReserpine 0.5mg/kg gavages Cerekinon 50mg/kg simultaneously; (4) sample sets: lumbar injection reserpine 0.5mg/kg, simultaneouslyGavage respectively the high, medium and low dosage of test sample. Each group successive administration two weeks. Ight soil and the sign of observing at any time rat change, andWeigh body weight, the food ration of rat every day. Collect following sample by MTL radioimmunoassay kits: blood plasma, jejunum tissue store standbySurvey. By t inspection between organizing between each administration group.

3. experimental result model group rat also occurs that after injection reserpine diarrhoea, appetite in various degree decline successively,Ight soil viscous is not well, constipation, apocleisis, become thin (P < 0.05, P < 0.01). With model group comparison, the present composition (sample 1, sampleProduct 2) height, the body weight of middle dosage group rat, food ration, thymus index, spleen index, motilin in plasma, jejunum homogenate MTL decline state(P < 0.05, P < 0.01) all significantly improves. Illustrate that the present composition has the function that regulates stomach and intestine. And of the present invention groupCompound (sample 1, sample 2) is high, middle dosage group is significantly better than and corresponding dose of other combined sample (sample 3, sample 4, sample 5)Amount group (P < 0.01). Middle dosage group the results are shown in Table 1 to functional disturbances of gastrointestinal tract rat MTL's.

The impact of table 1 on functional disturbances of gastrointestinal tract rat MTL (±S)

Group	Motilin in plasma	Jejunum homogenate MTL
			Normal group	175.16±14.12	541.27±31.28
Model group	48.14±12.51△	266.31±22.41△
			Positive group	131.25±13.31**	481.36±41.18**
1 group, sample	145.18±13.17**	477.22±31.17**
			2 groups, sample	153.27±16.48**	491.62±38.81**
3 groups, sample	57.37±16.22▽	268.17±30.41▽
			4 groups, sample	52.26±8.82▽	267.37±45.11▽
5 groups, sample	51.05±8.06▽	270.02±40.80▽

With control group comparison: △ P < 0.05. With model group comparison: * * P < 0.01;

With 1 group, sample or 2 groups of comparisons: ▽ P < 0.01.

Experimental example two, different adjustment effect to intestine movement function

Small intestine Promoting Experiment

1. animal and grouping: Kunming mouse, body weight 18～22g, random packet, every group of 10 raisings.

2. experimental technique: (1) Normal group: the capacity distilled water such as gavage; (2) model group: every day, the capacity such as gavage steamedHeat up in a steamer water; (3) positive group: Cerekinon 100mg/kg; (4) sample sets: gavage respectively the high, medium and low dosage of test sample. Each groupGavage gives corresponding medicine, continuously 7d. After last administration, except Normal group, the neostigmine each group of equal skin of mouse of loadingHemostasis neostigmine 1mg/kg; The atropine each group of equal hypodermic injection atropine of the mouse 5mg/kg that load. After 10min, all littleThe Azo-Blue solution 0.1ml/10g of the equal gavage 5% of mouse, puts to death after 15min, cuts open the belly rapidly and takes out stomach and intestine section, records Azo-BlueForward position is to the distance of pylorus, calculates it and account for the percentage of small intestine total length. By t inspection between organizing between each administration group.

3. experimental result shows: with model group comparison, high, the middle dosage group of the present composition (sample 1, sample 2) can be brightThe aobvious neostigmine mouse small intestine hyperfunction (P < 0.05) causing of loading that suppresses, improves the mouse small intestine function that atropine causesSuppressed state (P < 0.05), points out it to have dual regulation to intestines function. And present composition group (sample 1, sample 2)High, middle dosage group is significantly better than and other combined sample (sample 3, sample 4, sample 5) corresponding dosage group (P < 0.05), inDosage group the results are shown in Table 2.

Impact that table 2 advances neostigmine load/atropine load mouse small intestine (±S)

With control group comparison: △ P < 0.05. With model group comparison: * * P < 0.01. With 1 group, sample or 2 groups of comparisons: ▽ P＜0.05。

Experimental example three, anti-stress effect

1. animal and grouping: Kunming mouse, body weight 18～22g, random packet, every group of 10 raisings.

2. experimental technique: (1) Normal group: give isometric(al) physiological saline; (2) positive group: ginseng spleen-strengthening bolus2.0g/kg; (3) sample sets: gavage respectively the high, medium and low dosage of test sample. Each group gavage gives corresponding medicine, every day oneInferior, continuous five days, after last administration, after 60min, mouse is placed in to airtight wide-mouth bottle (built-in soda lime 20g). Record mouseTime-to-live. By t inspection between organizing between each administration group.

Experimental result shows: with model group comparison, the present composition (sample 1, sample 2) is high, middle dosage group can be remarkableExtend the mouse normobaric hypoxia time-to-live (P < 0.05), show that the present composition has obvious anti-stress effect. The present inventionComposition group (sample 1, sample 2) is high, middle dosage group is significantly better than and other combined sample (sample 3, sample 4, sample 5) phaseAnswer dosage group (P < 0.05), middle dosage group the results are shown in Table 3.

Table 3 to the effect of mouse normal pressure resistant anoxia (±S)

Group	The mouse survival time (min)
		Normal group	29.92±5.61
Positive group	41.17±6.16*
		1 group, sample	39.71±5.39*
2 groups, sample	40.28±4.28*
		3 groups, sample	28.19±3.35▽
4 groups, sample	27.8±4.66▽
		5 groups, sample	30.15±6.31▽

With Normal group comparison: * P < 0.05. With 1 group, sample or 2 groups of comparisons: ▽ P < 0.05.

Experimental example four, the regulating action emptying to rat stomach

1. animal and grouping: Kunming mouse, body weight 18～22g, random packet, every group of 10 raisings.

2. experimental technique: (1) Normal group: give isometric(al) physiological saline; Other group adopts the side of irregular nursingMethod, i.e. odd-numbered day feed, meets two fasting, to upset normal dietary, freely drinks water. In every liter of drinking water, add simultaneouslyThe hydrochloric acid 10ml of 10mol/L, to destroy the acid or alkali environment in stomach, starts administration on the 3rd week in modeling, is keeping modeling conditionIn constant situation, (2) positive group: (consumption is pressed 1ml/100g body weight to Domperidone aqueous solution gavage, and motilium tablet is (by Xi'anJanssen Pharmaceutical Co., Ltd., 10mg/ sheet, makes 0.4% the aqueous solution); (3) sample sets: gavage respectively test sample high,In, low dosage. Gavage gives corresponding medicine, once a day, and continuous 7 days. When each treated animal medication finishes, fasting 1d (noProhibit water), within the 2nd day, with phenol red paste gavage, (1ml/100g rat, phenol red concentration is that after 10%, 20min, femoral vein is got blood placeDead rat, cuts open the belly, ligation orifice of the stomach and stomach hole immediately. Take off whole stomach, with distilled water flushing gastric content, last constant volume is 6Ml then adds respectively the Ba (OH) of 0.15mol/L in each pipe₂2ml stirs and evenly mixs, and leaves standstill 10min, adds respectivelyEnter 5%ZnSO₄The 2ml 5min that vibrates, with the centrifugal 10min of 3000r/min, draws 4ml and adds 10%NaOH0.5mlMix, measure A value with spectrophotometer under 560nm wavelength, reference standard curve, finds residual phenol red content, stomach rowEmpty rate (%)=(the phenol red content of phenol red content/gavage in 1-stomach) × 10%, calculates gastric emptying. To between each administration group, enterT inspection between row group.

3 experimental results show: with model group comparison, the present composition (sample 1, sample 2) is high, middle dosage group can showWork obviously improves rat stomach Emptying Rate (P < 0.05). Present composition group (sample 1, sample 2) is high, middle dosage group is significantly excellentIn with other sample (sample 3, sample 4, sample 5) corresponding dosage group (P < 0.05), difference has statistical significance. Middle dosageGroup the results are shown in Table 4.

Table 4 impact emptying on Mouse Stomach (±S)

Group	Gastric emptying (A value)
		Normal group	1.42±0.79
Positive group	1.82±1.55*
		1 group, sample	1.74±1.62*
2 groups, sample	1.79±1.08*
		3 groups, sample	3.16±5.36▽
4 groups, sample	3.52±5.27▽
		5 groups, sample	3.02±6.04▽

With Normal group comparison: △ P < 0.05.

With model group comparison: * P < 0.05.

With 1 group, sample or 2 groups of comparisons: ▽ P < 0.05.

Experimental example five, impact on constipation dehydration Constipation Model mouse defecation

1. animal and grouping: Kunming mouse, body weight 18～22g, random packet, every group of 10 raisings.

2. experimental technique: except blank group, all the other are respectively organized mouse and prohibit water non-fasting 72h, cause constipation dehydration justSecret model. After modeling success, blank group, model control group give distilled water, and other respectively organize administration every day 1 time, and gavage is givenGive corresponding medicine, continuously 7d. (1) Normal group: the capacity distilled water such as gavage; (2) model group: every day, the capacity such as gavage steamedHeat up in a steamer water; (3) positive group: Macrogol 4000 powder (5.2g/Kg.d) group, positive control medicine gives 2 times of clinical equivalent amounts;(4) sample sets: gavage respectively the high, medium and low dosage of test sample. Within the 7th day, blank control group, model control group give distilled water and join2% the india ink suspension of putting, administration group gives to replace with liquid 2% india ink suspension of distilled water preparation,Administration volume 20ml/Kg, after administration puts into mouse mouse box, 1, every box, and the clean filter paper of underlay white, observed and recorded is everyMouse is discharged first time (min) and the 4h mouse of melaena and discharges melaena sum. By t inspection between organizing between each administration groupTest.

The impact of table 5 on constipation dehydration Constipation Model defecation

With control group comparison: △ P < 0.05. With model group comparison: * P < 0.05.

With 1 group, sample or 2 groups of comparisons: ▽ P < 0.05.

Experimental example six, impact on intestinal motility disorder Constipation Model mouse defecation

1. animal and grouping: Kunming mouse, body weight 18～22g, random packet, every group of 10 raisings.

Experimental technique: a little grinds by mouse self ight soil, adds physiological saline and makes 10% suspension, only every by 1ml/It gavage gives 1 time, and 72h, causes intestinal motility disorder Constipation Model continuously. Except blank group, all the other are respectively organized mouse and prohibitWater non-fasting 72h, causes constipation dehydration Constipation Model. After modeling success, blank group, model control group give distilled water,Other each group administrations every day 1 time, gavage gives corresponding medicine, continuously 7d. (1) Normal group: the capacity distilled water such as gavage;(2) model group: every day the capacity distilled water such as gavage; (3) positive group: Macrogol 4000 powder (5.2g/Kg.d) group is positive rightGive 2 times of clinical equivalent amounts according to medicine; (4) sample sets: gavage respectively the high, medium and low dosage of test sample. The 7th day blankGroup, model control group give 2% india ink suspension of distilled water configuration, and administration group gives to replace distilled water with liquid2% india ink suspension of preparation, administration volume 20ml/Kg, after administration puts into mouse mouse box, 1, every box, underThe clean filter paper of pad white, every mouse of observed and recorded is discharged first time (min) and the 4h mouse of melaena and discharges melaena sum.

Experimental result shows: with model control group comparison, the present composition (sample 1, sample 2) is high, middle dosage group is brightThe aobvious mouse defecation time that makes shortens, and defecation number increases, and present composition group (sample 1, sample 2) is high, middle dosage group is significantly excellentIn with other combined sample (sample 3, sample 4, sample 5) corresponding dosage group (P < 0.05), middle dosage group the results are shown in Table 6.

The impact of table 6 on intestinal motive force obstacle Constipation Model mouse defecation

Group	Arrange first the melena time (min)	Row's melena number/point in 4h
			Normal group	129.7±33.7	6.1 ±2.5
Model group	182.3±31.5△	3.6±2.8△
			Positive group	93.5±15.9*	13.8±4.1*
1 group, sample	118.2±19.7*	11.3±5.1*
			2 groups, sample	117.6±20.2*	12.7±4.7*
3 groups, sample	170.4±26.4▽	5.1±4.2▽
			4 groups, sample	174.1±34.7▽	4.1±2.3▽
5 groups, sample	169.4±42.2▽	3.6±2.9▽

With control group comparison: △ P < 0.05. With model group comparison: * P < 0.05.

With 1 group, sample or 2 groups of comparisons: ▽ P < 0.05.

The present invention's research also adopts serial effect experiment to investigate the total ethanol extract of other ratio compounds, thick decocting liquid(traditional decoction), herbal mixture material ratio comprises: 20 grams of the bighead atractylodes rhizomes, 20 grams of the root of herbaceous peonys, 15 grams of dried orange peels, windproof 10 grams; Or 30 grams of the bighead atractylodes rhizomes,20 grams of the root of herbaceous peonys, 15 grams of dried orange peels, windproof 20 grams; Or 30 grams of the bighead atractylodes rhizomes, 25 grams of the root of herbaceous peonys, 20 grams of dried orange peels, windproof 20 grams. Experimental technique is equal toDescribed herein, experimental result has also shown above identical trend. All results are all pointed out: the present composition is in bowel movementRegulate, regulate rat gastrointestinal tract dysfunction, pain relieving, antifatigue, anti-anoxic, anti-stress, the work such as gastric emptying adjusting, constipation adjustingBy aspect, be significantly better than being significantly better than total extract (traditional decoction or total ethanol extract) (P < 0.05, P < 0.01). The present inventionThe optimum organization proportioning of scheme all has effect same. Therefore optimum organization thing in the present invention program, is significantly better than compound and always extractsThe pharmacological effect of thing, prioritization scheme will produce beyond thought effect. Extract combination in the present invention program, always carries with medicinal materialGet thing and relatively have clear superiority, (1) can improve kind and the content of active component in product, comprise atractylone (Atractylon), sagittol (β-eudesmol), beta-elemene (β-elemene), atractylenolide Ⅰ(AtractylenolideI), atractylenolide Ⅰ II(AtractylenolideIII), biatractylolide (Biatractylolide), arginine (Arginine), Paeoniflorin (Paeoniflorin), albiflorin(albiflorin), benzoylpaeoniflorin (benzoylpaeoniflorin), Hydroxy peoniflorin (Oxypaeoniflora), orangeSkin glycosides (hesperidin), aurantiin (Naringin), orange peel element (Tangeretin), Nobiletin (Nobiletin),Cimicifugoside (Prim-O-glucosylcimifugin), 5-O-methyl visamminol glycosides (4'-O-beta-Glucopyranosyl-5-O-Methylvisamminol), hamaudol glycosides (Sec-O-Glucosylhamaudol), Psoralen esterElement (psoralen), bergapten (bergapten), Imperatorin (imperation), xanthotoxin(xanthotoxin), Scopoletin (scopoletin), bergapten (Bergapten) etc., be conducive to improve drug effect andControl quality. (2) can significantly reduce extract paste-forming rate, the proterties of improving extract, dispersiveness and mouldability, effectively solveLarge, the easy moisture absorption of viscosity of total extract, preparation need the difficult problems such as auxiliary material amount is large. Be convenient to further prepare various kinds of drug preparation or answerFor various medicine preparations. (3) improved the stability of final preparation. Above result has significantly been improved the character of product, is suitable forIn the preparation of various kinds of drug formulation, and the quality of guarantee composition. Following experimental example adopts the present invention program's method parameterPrepare different solid composites, investigate the effect of the present composition. Experimental technique is equal to described herein. Results suggest: livingProperty component content, extract the aspects such as paste-forming rate, appearance character, preparation adaptability, stability, the present composition has significantlyAdvantage.

The Active Components of the different preparation method's samples of experimental study 2 compares and preparation Performance

Laboratory sample is the same.

In the described bighead atractylodes rhizome, the analysis of active component or index components adopts gas chromatography, analysis condition: quartzy capillaryTubing string (30m × 0.25mm, 0.25 μ m). 7% diphenyl 93% dimethyl arlydene silicone copolymers, temperature programmingCondition: 70 DEG C of initial temperatures, keep being warming up to 290 DEG C of constant temperature 15min with the speed of 10 DEG C/min after 3min gasification room temperatureDegree: 240 DEG C, carrier gas: high-purity He, flow: 1.2ml/min.

In the described bighead atractylodes rhizome, the analysis of active component or index components adopts high performance liquid chromatography, and essential condition is: adoptWith octadecylsilane Bonded Phase silica gel be filler, chromatographic column (4.6mm × 250mm, 5 μ m); Acetonitrile-water is mobile phase ladderDegree wash-out, flow: 1mL/min; Column temperature: 30 DEG C, detect wavelength: 200 and 220nm.

In the described root of herbaceous peony, the analysis of active component or index components adopts high performance liquid chromatography, essential condition: adoptOctadecylsilane Bonded Phase silica gel is filler, and methanol-water-glacial acetic acid (35:65:0.1) is mobile phase, detects rippleLong: 230nm.

Gradient elution program: 0 ~ 30min, 40% ~ 10% acetonitrile; 30 ~ 45min, 10% acetonitrile.

In described dried orange peel, the analysis of active component or index components adopts high performance liquid chromatography, essential condition: adoptOctadecylsilane Bonded Phase silica gel is filler, and chromatographic column (4.6mm × 250mm, 5 μ are m); , acetonitrile-water is eluent gradientWash-out, flow: 1mL/min; Column temperature: 25, detect wavelength: 283 and 330nm dual wavelength detect. Gradient elution journeyOrder: 0 ~ 15min, 25% ~ 50% acetonitrile; 15 ~ 35min, 50% ~ 60% acetonitrile; 35 ~ 40min, 60% ~85% acetonitrile.

Described windproof middle active component or the analysis of index components adopt high performance liquid chromatography, essential condition: adoptOctadecylsilane Bonded Phase silica gel is filler, and (4.6mm × 150mm, m), acetonitrile-water is eluent gradient to 5 μ to chromatographic columnWash-out, 20～30% acetonitriles (0～10min), 30%～55% acetonitrile (11～25min); 55～65% acetonitriles (26～40min), 65%～80% acetonitrile (41～45min); 80～20% acetonitriles (51～60min), flow velocity: 1.0mL/min; DetectWavelength: 254nm; Column temperature: 30 DEG C.

The analysis comparison of active component or index components in the different extracts of table 7

Illustrate: in table, result is the content about composition in the prepared extract of 100g crude drug

The analysis comparison of table 8 composite preparation performance

Adopt technology of preparation method and the parameter in the present invention program, optimized to prepare extract, significantly improve in composition mainWant kind and the content of index components or active component, reduce and extract yield of extract, thereby be conducive to pharmaceutical dosage form preparation and trueProtect drug quality.

The each constituent optimization ratio in the present invention program of particularly applying combines, and can make the present composition have imaginaryLess than variation, be embodied in composition of the present invention and there is more significant drug effect advantage and clinical efficacy advantage.

If technology of preparation method parameter and Combinatorial Optimization ratio combine in employing the present invention program, advantage is more aobviousWork.

Following experimental example can illustrate advantage of the present invention, result show the present composition be better than the combination of other ratio (C～Or the composition (E～F) prepared of other method D). The present invention program's combination matching all has effect same, the present invention program'sPreparation parameter all has effect same.

The pharmacodynamics of experimental study 3 various combination ratios and preparation parameter sample compares and constituent analysis comparison:

Sample preparation methods:

The present invention program:

The sample A(present composition): Rhizoma Atractylodis Macrocephalae extract I6%, Rhizoma Atractylodis Macrocephalae extract II30%, radix paeoniae alba extraction 30%, dried orange peel extracts 20%, Radix Saposhnikoviae extract 14%.

The sample B(present composition): Rhizoma Atractylodis Macrocephalae extract I10%, Rhizoma Atractylodis Macrocephalae extract II25%, radix paeoniae alba extraction 35%,Dried orange peel extracts 25%, Radix Saposhnikoviae extract 5%.

Sample C: Rhizoma Atractylodis Macrocephalae extract I30%, Rhizoma Atractylodis Macrocephalae extract II15%, radix paeoniae alba extraction 10%, dried orange peel extracts 5%,Radix Saposhnikoviae extract 40%.

Sample D: Rhizoma Atractylodis Macrocephalae extract I2%, Rhizoma Atractylodis Macrocephalae extract II60%, radix paeoniae alba extraction 3%, dried orange peel extracts 5%, windproofExtract 30%.

Sample A ~ D preparation method:

Rhizoma Atractylodis Macrocephalae extract I: get appropriate Rhizoma Atractylodis Macrocephalae, be ground into 16 order meal, adopt supercritical carbon dioxide extracting device extractionGet extracting pressure 28MPa, 36 DEG C of extraction temperature, separating pressure 8MPa, 47 DEG C of separation temperatures. Carbon dioxide flow 31L/H, extraction time: 120min; Collecting extract becomes Rhizoma Atractylodis Macrocephalae extract I, contains atractylone, sagittol, β-olive in extractFragrant alkene, atractylodes lactone, atractylenolide Ⅰ II, biatractylolide.

Rhizoma Atractylodis Macrocephalae extract II: adopt the bighead atractylodes rhizome dregs of a decoction and the water extraction liquid that extract after Rhizoma Atractylodis Macrocephalae extract I, water extraction is got 2 times, extracts temperatureSpend 90 DEG C, each 1 hour, 8 times water, merge extract, filter, and are concentrated into every milliliter containing 1.0g crude drug, get supernatant and add 3Doubly measure 95% ethanol, leave standstill, filter, collecting solid content becomes Rhizoma Atractylodis Macrocephalae extract II, contains arginine in extract.

Radix paeoniae alba extraction: get appropriate white Peony Root, be ground into 20 order meal, 6 times of amount 70% ethanol, extract 2 times, each 1 littleTime. Extract filters, and merges, reclaim ethanol to every milliliter containing 0.5g crude drug, after D101 macroporous resin adsorption, adopt water,25% ethanol, 65% ethanol elution macroreticular resin, collect ethanol eluate, through concentrating, becoming radix paeoniae alba extraction after vacuum drying, carriesGet in thing containing Paeoniflorin, albiflorin, benzoylpaeoniflorin, Hydroxy peoniflorin.

Dried orange peel extracts: dried orange peel pulverizing medicinal materials becomes 20 order meal, 6 times of amount 70% ethanol, extract each 1 hour 2 times. ExtractLiquid filters, and merges, reclaim ethanol to every milliliter containing 0.5g crude drug, after D101 macroporous resin adsorption, adopt water, 25% ethanol,60% ethanol elution macroreticular resin, collects ethanol eluate, through concentrated, becomes dried orange peel extracts after vacuum drying, in extract, containsAurantiamarin, aurantiin, orange peel element, Nobiletin.

Radix Saposhnikoviae extract: get appropriate windproof medicine materical crude slice, decocting boils 2 times, each 1 hour. Extract filters, and merges 2 filtersLiquid, is concentrated into every milliliter containing 0.2g crude drug, after D101 macroporous resin adsorption, adopts water, 25%, 70% ethanol elution macropore treeFat, collects ethanol eluate, through concentrated, becomes Radix Saposhnikoviae extract after vacuum drying, in extract, ties up containing cimicifugoside, 5-O-methylThis ammiol glycosides, hamaudol glycosides, macrotin, Psoralen, bergapten, Imperatorin, xanthotoxin, Scopoletin, BuddhistHand mandarin orange lactone.

Sample E: Rhizoma Atractylodis Macrocephalae extract I6%, Rhizoma Atractylodis Macrocephalae extract II30%, radix paeoniae alba extraction 30%, dried orange peel extracts 20%, Radix Saposhnikoviae extract 14%.

Sample F: Rhizoma Atractylodis Macrocephalae extract I30%, Rhizoma Atractylodis Macrocephalae extract II10%, radix paeoniae alba extraction 10%, dried orange peel extracts 5%, anti-Wind extract 45%.

Sample E ~ F preparation method:

Rhizoma Atractylodis Macrocephalae extract I: get Rhizoma Atractylodis Macrocephalae, be ground into 20 order meal, adopt the extraction of supercritical carbon dioxide extracting device, extractionPressure power 23MPa, 30 DEG C of extraction temperature, separating pressure 8MPa, 50 DEG C of separation temperatures. Carbon dioxide flow 25L/h, extractionTime: 160min; Collect extract and become Rhizoma Atractylodis Macrocephalae extract I.

Rhizoma Atractylodis Macrocephalae extract II: adopt 20 order bighead atractylodes rhizome meal, water extraction is got 1 time, extracts 100 DEG C of temperature, each 3 hours, 8 timesWater, merges extract, filters, and is concentrated into every milliliter containing 0.3g crude drug, gets supernatant and adds 3 times of amount 95% ethanol, leaves standstill mistakeFilter, collecting solid content becomes Rhizoma Atractylodis Macrocephalae extract II.

Radix paeoniae alba extraction: get appropriate white Peony Root, be ground into 30 order meal, 6 times of amount 60% ethanol, extract 2 times, each 2 littleTime. Extract filters, and merges, reclaim ethanol to every milliliter containing 0.5g crude drug, after D101 macroporous resin adsorption, adopt water,80% ethanol elution macroreticular resin, collects 80% ethanol eluate, through concentrating, becoming radix paeoniae alba extraction after vacuum drying.

Dried orange peel extracts: dried orange peel pulverizing medicinal materials becomes 10 order meal, 10 times of amount 70% ethanol, extract each 1.5 hours 3 times.Extract filters, and merges, and recovery ethanol containing 0.5g crude drug, after D101 macroporous resin adsorption, adopts water, 70% to every milliliterEthanol elution macroreticular resin, collects ethanol eluate, through concentrated, becomes dried orange peel extracts after vacuum drying.

Radix Saposhnikoviae extract: get appropriate windproof medicine materical crude slice, decocting boils 1 time, each 0.5 hour. Extract filters, and is concentrated into every milliRise containing 0.2g crude drug, after D101 macroporous resin adsorption, adopt water, 70% ethanol elution macroreticular resin, collect ethanol eluate,Through concentrated, after vacuum drying, become Radix Saposhnikoviae extract.

Each group of sample is made into debita spissitudo with distilled water, for subsequent use.

Dosage: low dose group: be equivalent to 1.5g crude drug/kg; Middle dosage group: be equivalent to 3.0g crude drug/kg; High doseGroup: be equivalent to 6.0g crude drug/kg.

1, the different adjustment effect to the rat gastrointestinal tract dysfunction due to reserpine

Experimental technique, experiment reagent medicine, animal etc. are the same. Experimental result shows: model group rat is at injection reserpineAfter occur that successively diarrhoea in various degree, appetite decline,, even there is constipation, apocleisis in ight soil viscous, become thin and day by day increase the weight of (P <0.05, P < 0.01). With model group comparison, body weight, food ration, the thymus gland of optimized proportion composition group of the present invention (A, B) rat refer toNumber, spleen index, motilin in plasma, jejunum homogenate MTL decline state all significantly improve (P < 0.05, P < 0.01). And, thisBright optimized proportion combination object height, middle dosage group are significantly better than other sample sets (C～F) (P < 0.05).

2, the different adjustment effect to intestine movement function

Experimental technique, experiment reagent, medicine, animal etc. are the same. Experimental result shows: with model group comparison, the present invention is excellentChange ratio composition (A, B) is high, high, the middle dosage group of middle dosage group can obviously suppress the neostigmine mouse small intestine merit causing of loadingEnergy hyperfunction (P < 0.05), improves the suppressed state of mouse small intestine function (P < 0.05) that atropine causes, points out it to have intestines functionDual regulation. And, optimized proportion of the present invention combination object height, middle dosage group be significantly better than other sample sets (C～F) (P <0.05）。

3, anti-stress effect research

Experimental technique, experiment reagent medicine, animal etc. are the same. Experimental result shows: with model group comparison, and optimization of the present inventionRatio composition (A, B) is high, middle dosage group can the significant prolongation mouse normobaric hypoxia time-to-live (P < 0.05), shows the present inventionComposition has obvious anti-stress effect. And optimized proportion combination object height of the present invention, middle dosage group are significantly better than other sampleProduct group (C～F) (P < 0.05).

4, the impact experiment on intestinal motility disorder Constipation Model

Experimental technique, experiment reagent medicine, animal etc. are the same. Experimental result shows: result shows: with model group comparison,Optimized proportion composition of the present invention (A, B) is high, middle dosage group obviously makes mouse defecation time shorten, defecation number increase (P <0.05), show the tool constipation effect that improves significantly. And optimized proportion combination object height of the present invention, middle dosage group are significantly better thanOther sample sets (C～F) (P < 0.05).

The drug effect result of middle dosage group is relatively in table 9.

The pharmacological action comparison of the different samples of table 9

+: showing has obvious effect, and effect degree strengthens with+quantity.-: show without obvious effect.

Important activity composition or index components in each extract are measured respectively in this research, and assay method is the same, the results are shown in Table10. Result shows the composition (E～F) that the present composition is better than other method and prepares. The present invention program's optimum organization is joinedThan all there being effect same.

The analysis comparison (%) of active component or index components in the different extracts of table 10

Illustrate: in table, result is the content about composition in the prepared extract of 100g crude drug

We study discovery: in the present invention program, radix paeoniae alba extraction is prepared adopted stepwise elution and obtained in compositionContent and the kind of methods of glycosides obviously increases, impurity significantly reduces, and the pharmacologically active of the composition that obtains is obviously better thanSingle concentration ethanol eluted product. After optimal design, elution processes of the present invention ethanolic solution total amount used is resin volume6 ~ 8 times.

The index components comparison (%) of the radix paeoniae alba extraction that the different elution process of table 11 obtain

	Water, 20% ethanol, 60% ethanol stepwise elution	Water, 30% ethanol, 70% ethanol stepwise elution	50% ethanol elution	75% ethanol elution	95% ethanol elution
						Paeoniflorin	34.8%	31.3%	12.5%	19.7%	18.9%
Albiflorin	11.6%	10.3%	1.53%	0.95%	1.63%
						Benzoylpaeoniflorin	5.27%	5.12%	Do not detect	Do not detect	Do not detect
Hydroxy peoniflorin	4.72%	3.54%	Do not detect	Do not detect	Do not detect

We study discovery: in the present invention program, dried orange peel extracts is prepared adopted stepwise elution and obtained in extractContent and the kind of flavones ingredient obviously increases, impurity significantly reduces, and the pharmacologically active of the composition that obtains is obviously excellentIn single concentration ethanol eluted product. After optimal design, elution processes of the present invention ethanolic solution total amount used is resiniteLong-pending 6 ~ 8 times.

The dried orange peel extracts index components comparison (%) that the different elution process of table 12 obtain

	Water, 25% ethanol, 70% ethanol stepwise elution	Water, 30% ethanol, 70% ethanol stepwise elution	50% ethanol elution	75% ethanol elution	95% ethanol elution
						Aurantiamarin	43.7%	41.6%	3.61%	5.27%	8.23%
Nobiletin	7.26%	5.61%	0.14%	0.04%	0.04%
						Orange peel element	7.41 %	7.22%	Do not detect	0.15%	0.15%

We study and find in the present invention program that Radix Saposhnikoviae extract is prepared adopted stepwise elution and obtain in extractContent and the kind of chromone constituents and Coumarins composition obviously increases, impurity significantly reduces, and the composition that obtainsPharmacologically active be obviously better than single concentration ethanol eluted product. After optimal design, the ethanol that elution processes of the present invention is usedSolution total amount is 6 ~ 8 times of resin volume.

The Radix Saposhnikoviae extract index components comparison (%) that the different elution process of table 13 obtain

	Water, 30% ethanol, 65% ethanol stepwise elution	Water, 25% ethanol, 70% ethanol stepwise elution	50% ethanol elution	75% ethanol elution	95% ethanol elution
						Cimicifugoside	11.21%	11.16%	1.04%	1.57%	2.05%
5-O-methyl visamminol glycosides	2.52%	2.61%	Do not detect	0.32%	0.71%
						Psoralen	0.16%	0.12%	Do not detect	Do not detect	Do not detect
Imperatorin	0.42%	0.56%	Do not detect	0.085%	0.067%
						Xanthotoxin	0.16%	0.14%	0.03%	Do not detect	Do not detect

On the basis of a large amount of preclinical studies, select the functional digestion of some courses of disease more than 6 months notGood, functional consitipation, intestinal irritable syndrome case are tried out. Result shows: respectively organize medication and be showed no obvious adverse reaction. ThisInvention composition can significantly improve clinical symptoms: poor appetite, Abdeminal pain, belch, morning satisfy, suffer from abdominal pain, feel sick, vomit, suffer from abdominal painSignificantly reduce with malaise symptoms, function of intestinal canal improves (comprise that times of defecation is normal, stool proterties is improved), and effect is better. ThisThe total effective rate (more than 80%) of bright composition is significantly higher than the total effective rate (below 60%) of other composition or decoction. ThisThe optimum organization proportioning of bright scheme all has effect same.

Detailed description of the invention

Embodiment 1. treatment gastrointestinal dysfunction of the present invention and the composition of intestinal irritable syndrome and the system of preparation thereofStandby.

Sample preparation methods:

Rhizoma Atractylodis Macrocephalae extract I: get appropriate Rhizoma Atractylodis Macrocephalae, be ground into 20 order meal, add the water soaking 3 hours of 8 times of amounts,Steam distillation extracts 6 hours, and collecting distillation becomes Rhizoma Atractylodis Macrocephalae extract I. By Rhizoma Atractylodis Macrocephalae extract I, add 6 times of beta cyclodextrins,Grind 15min, for subsequent use after vacuum drying.

Rhizoma Atractylodis Macrocephalae extract II: adopt bighead atractylodes rhizome meal (16 order), water extraction is got 2 times, extracts 85 DEG C of temperature, and each 15 times of water, carryGet 1 hour time, mixing speed 30rpm. Merge extract, filter, be concentrated into every milliliter containing 1.0g crude drug, get supernatant and addEnter 3 times of amount 95% ethanol, leave standstill, filter, collecting solid content becomes Rhizoma Atractylodis Macrocephalae extract II.

Radix paeoniae alba extraction: get appropriate white Peony Root, be ground into 20 order meal, 6 times of amount 60% ethanol, extract 2 times, each 1 littleTime. Extract filters, and merges, reclaim ethanol to every milliliter containing 0.2g crude drug, after D101 macroporous resin adsorption, adopt water,20% ethanol, 60% ethanol elution macroreticular resin, collect ethanol eluate, through concentrating, becoming radix paeoniae alba extraction after vacuum drying.

Dried orange peel extracts: dried orange peel pulverizing medicinal materials becomes 20 order meal, 6 times of amount 70% ethanol, extract each 1 hour 2 times. ExtractLiquid filters, and merges, reclaim ethanol to every milliliter containing 0.5g crude drug, after D101 macroporous resin adsorption, adopt water, 25% ethanol,60% ethanol elution macroreticular resin, collects ethanol eluate, through concentrated, becomes dried orange peel extracts after vacuum drying.

Radix Saposhnikoviae extract: get appropriate windproof medicine materical crude slice, decocting boils 2 times, each 1 hour. Extract filters, and merges 2 filtersLiquid, is concentrated into every milliliter containing 0.2g crude drug, after D101 macroporous resin adsorption, adopts water, 25%, 70% ethanol elution macropore treeFat, collects ethanol eluate, through concentrated, becomes Radix Saposhnikoviae extract after vacuum drying.

Expanding dose by following part by weight gets it filled for subsequent use: Rhizoma Atractylodis Macrocephalae extract I3, and Rhizoma Atractylodis Macrocephalae extract II18, the root of herbaceous peony is carriedGet thing 13, dried orange peel extracts 6, Radix Saposhnikoviae extract 2. After each several part extract is mixed, add appropriate lactose, microcrystalline cellulose,Dolomol is made tablet.

The composition of embodiment 2. treatment intestinal irritable syndrome of the present invention and the preparation of preparation thereof.

Sample preparation methods:

Rhizoma Atractylodis Macrocephalae extract I: get Rhizoma Atractylodis Macrocephalae and be ground into 16 order meal, adopt the extraction of supercritical carbon dioxide extracting device, extractionPressure power 28MPa, 37 DEG C ~ 38 DEG C of extraction temperature, separating pressure 6MPa, 47 DEG C ~ 48 DEG C of separation temperatures. Carbon dioxide flow31 ~ 33L/h, extraction time: 120min; Collect extract as Rhizoma Atractylodis Macrocephalae extract I.

Rhizoma Atractylodis Macrocephalae extract II: adopt the bighead atractylodes rhizome dregs of a decoction and the water extraction liquid that extract after Rhizoma Atractylodis Macrocephalae extract I, water extraction is got 2 times, extracts temperatureSpend 90 DEG C, each 1 hour, 8 times water, merge extract, filter, and are concentrated into every milliliter containing 1.0g crude drug, get supernatant and add3 times of amount 95% ethanol, leave standstill, and filter, and collecting solid content becomes Rhizoma Atractylodis Macrocephalae extract II.

Radix paeoniae alba extraction: get appropriate white Peony Root, be ground into 20 order meal, 6 times of amount 70% ethanol, extract 2 times, each 1 littleTime. Extract filters, and merges, and reclaims ethanol to every milliliter containing 0.5g crude drug, through Semi-polarity or low pole macroporous resin adsorptionAfter, adopt water, 25% ethanol, 65% ethanol elution macroreticular resin, collect ethanol eluate, become white through concentrating, after vacuum dryingChinese herbaceous peony extract.

Dried orange peel extracts: dried orange peel pulverizing medicinal materials becomes 16 order meal, 6 times of amount 70% ethanol, extract each 1 hour 2 times. ExtractLiquid filters, and merges, and recovery ethanol,, adopts containing 0.5g crude drug to every milliliter after Semi-polarity or low pole macroporous resin adsorptionWater, 25% ethanol, 70% ethanol elution macroreticular resin, collect ethanol eluate, through concentrated, become dried orange peel and extract after vacuum dryingThing.

Radix Saposhnikoviae extract: get appropriate windproof medicine materical crude slice, decocting boils 2 times, each 1 hour. Extract filters, and merges 2 filtersLiquid, is concentrated into every milliliter containing 0.2g crude drug, after Semi-polarity or low pole macroporous resin adsorption, adopts water, 25%, 70% ethanol to washDe-macroreticular resin, collects ethanol eluate, through concentrated, becomes Radix Saposhnikoviae extract after vacuum drying.

Expanding dose by following part by weight gets it filled for subsequent use: Rhizoma Atractylodis Macrocephalae extract I29, and Rhizoma Atractylodis Macrocephalae extract II57, the root of herbaceous peony is carriedGet thing 53, dried orange peel extracts 32, Radix Saposhnikoviae extract 27. By each part mentioned above extract mix after add appropriate microcrystalline cellulose,Superfine silica gel powder, makes capsule.

The composition of embodiment 3 treatment intestinal irritable syndrome of the present invention and the preparation of preparation thereof.

Rhizoma Atractylodis Macrocephalae extract I: get appropriate Rhizoma Atractylodis Macrocephalae, be ground into 16 order meal, add the water soaking 3 hours of 8 times of amounts,Steam distillation extracts 6 hours, and collecting distillation becomes Rhizoma Atractylodis Macrocephalae extract I. Get above extract, add 6 times of amount beta cyclodextrins,Colloid mill grinds 30min, for subsequent use after abrasive material vacuum drying.

Rhizoma Atractylodis Macrocephalae extract II: adopt the bighead atractylodes rhizome dregs of a decoction and the water extraction liquid that extract after Rhizoma Atractylodis Macrocephalae extract I, water extraction is got 2 times, extracts temperatureSpend 90 DEG C, each 1 hour, 8 times water, merge extract, filter, and are concentrated into every milliliter containing 1.0g crude drug, get supernatant and add3 times of amount 95% ethanol, leave standstill, and filter, and collecting solid content becomes Rhizoma Atractylodis Macrocephalae extract II.

Radix paeoniae alba extraction: get appropriate white Peony Root, be ground into 20 order meal, 6 times of amount 70% ethanol, extract 2 times, each 1 littleTime. Extract filters, and merges, and reclaims ethanol to every milliliter containing 0.5g crude drug, through Semi-polarity or low pole macroporous resin adsorptionAfter, adopt water, 25% ethanol, 65% ethanol elution macroreticular resin, collect ethanol eluate, reclaim ethanol to every milli through Vacuum ConcentrationRise containing 2g crude drug and become radix paeoniae alba extraction.

Dried orange peel extracts: dried orange peel pulverizing medicinal materials becomes 20 order meal, 6 times of amount 70% ethanol, extract each 1 hour 2 times. ExtractLiquid filters, and merges, and recovery ethanol,, adopts containing 0.5g crude drug to every milliliter after Semi-polarity or low pole macroporous resin adsorptionWater, 25% ethanol, 60% ethanol elution macroreticular resin, collect ethanol eluate, through Vacuum Concentration reclaim ethanol to every milliliter containing 2gCrude drug becomes dried orange peel extracts.

Radix Saposhnikoviae extract: get appropriate windproof medicine materical crude slice, decocting boils 2 times, each 1 hour. Extract filters, and merges 2 filtersLiquid, is concentrated into every milliliter containing 0.2g crude drug, after Semi-polarity or low pole macroporous resin adsorption, adopts water, 25%, 70% ethanol to washDe-macroreticular resin, collects ethanol eluate, and reclaiming ethanol through Vacuum Concentration becomes Radix Saposhnikoviae extract to every milliliter containing 2g crude drug.

Expanding dose in following prescription ratio gets it filled for subsequent use: Rhizoma Atractylodis Macrocephalae extract I24, and Rhizoma Atractylodis Macrocephalae extract II20, the root of herbaceous peony is carriedGet thing 15, dried orange peel extracts 6, Radix Saposhnikoviae extract 5. Each part mentioned above extract is evenly mixed in proportion, adds appropriate amount of PEG,Prepare soft capsule.

Embodiment 4 is substantially the same manner as Example 1, but the ratio of each component is in composition: Rhizoma Atractylodis Macrocephalae extract I3, the bighead atractylodes rhizomeExtract II 46, radix paeoniae alba extraction 15, dried orange peel extracts 6, Radix Saposhnikoviae extract 21. Said composition adds microcrystalline cellulose, breastSugar, prepares capsule. All the other are with embodiment 1.

Embodiment 5 is substantially the same manner as Example 1, but the ratio of each component is in composition: Rhizoma Atractylodis Macrocephalae extract I10 is whiteArt extract II 20, radix paeoniae alba extraction 47, dried orange peel extracts 27, Radix Saposhnikoviae extract 27. Said composition adds honey, sucrose, systemStandby pill. All the other are with embodiment 1.

Embodiment 6 is substantially the same manner as Example 1, but the ratio of each component is in composition: Rhizoma Atractylodis Macrocephalae extract I10 is whiteArt extract II 37, radix paeoniae alba extraction 16, dried orange peel extracts 8, Radix Saposhnikoviae extract 17. Said composition adds polyethylene glycol(PEG), prepare pill. All the other are with embodiment 1.

Embodiment 7 is substantially the same manner as Example 1, but the ratio of each component is in composition: Rhizoma Atractylodis Macrocephalae extract I7, the bighead atractylodes rhizomeExtract II 23, radix paeoniae alba extraction 36, dried orange peel extracts 17, Radix Saposhnikoviae extract 5. Said composition adds sucrose, starch, preparationMicropill preparation. All the other are with embodiment 1.

Embodiment 8 is substantially the same manner as Example 1, but the ratio of each component is in composition: Rhizoma Atractylodis Macrocephalae extract I10 is whiteArt extract II 30, radix paeoniae alba extraction 20, dried orange peel extracts 8, Radix Saposhnikoviae extract 17. All the other are with embodiment 1.

Embodiment 9 is substantially the same manner as Example 1, but the ratio of each component is in composition: Rhizoma Atractylodis Macrocephalae extract I24 is whiteArt extract II 40, radix paeoniae alba extraction 25, dried orange peel extracts 15, Radix Saposhnikoviae extract 5. All the other are with embodiment 1.

Embodiment 10 is substantially the same manner as Example 2, but the ratio of each component is in composition: Rhizoma Atractylodis Macrocephalae extract I6 is whiteArt extract II 30, radix paeoniae alba extraction 16, dried orange peel extracts 10, Radix Saposhnikoviae extract 20. Said composition add microcrystalline cellulose,Lactose, prepares capsule. All the other are with embodiment 2.

Embodiment 11 is substantially the same manner as Example 2, but the ratio of each component is in composition: Rhizoma Atractylodis Macrocephalae extract I10 is whiteArt extract II 20, radix paeoniae alba extraction 25, dried orange peel extracts 25, Radix Saposhnikoviae extract 15. All the other are with embodiment 2.

Embodiment 12 is substantially the same manner as Example 2, but the ratio of each component is in composition: Rhizoma Atractylodis Macrocephalae extract I8 is whiteArt extract II 30, radix paeoniae alba extraction 30, dried orange peel extracts 16, Radix Saposhnikoviae extract 10. All the other are with embodiment 2.

Embodiment 13 is substantially the same manner as Example 2, but the ratio of each component is in composition: Rhizoma Atractylodis Macrocephalae extract I3 is whiteArt extract II 18, radix paeoniae alba extraction 45, dried orange peel extracts 20, Radix Saposhnikoviae extract 14. Said composition adds PEG, and preparation is drippedPill. All the other are with embodiment 2.

Embodiment 14 is substantially the same manner as Example 3, but the ratio of each component is in composition: Rhizoma Atractylodis Macrocephalae extract I20 is whiteArt extract II 28, radix paeoniae alba extraction 25, dried orange peel extracts 14, Radix Saposhnikoviae extract 20. Said composition adds appropriate flavouring,Prepare oral administration solution. All the other are with embodiment 3.

Embodiment 15 is substantially the same manner as Example 3, but the ratio of each component is in composition: Rhizoma Atractylodis Macrocephalae extract I7 is whiteArt extract II 25, radix paeoniae alba extraction 25, dried orange peel extracts 20, Radix Saposhnikoviae extract 8. Said composition adds Lip river to moor husky nurse, systemStandby emulsion. All the other are with embodiment 3.

Embodiment 16 is substantially the same manner as Example 1, but the preparation method of Rhizoma Atractylodis Macrocephalae extract I is: get Rhizoma Atractylodis Macrocephalae and be ground into20 order meal, adopt supercritical carbon dioxide extracting device extraction Baizhu volatile oil, extracting pressure 28MPa, and 37 DEG C of extraction temperature,Separating pressure 8MPa, 46 DEG C of separation temperatures. Carbon dioxide flow 27 ~ 28L/h, extraction time: 120min; Collect extractAs Rhizoma Atractylodis Macrocephalae extract I, for subsequent use; Getting supernatant, to be evaporated to relative density be 1.14 medicinal extract, and all the other are with embodiment 1.

Embodiment 17 is substantially the same manner as Example 2, but the raw materials of Rhizoma Atractylodis Macrocephalae extract II is white for adopting the way of distillation to extractThe bighead atractylodes rhizome dregs of a decoction after art extract I and water liquid. All the other are with embodiment 1.

Embodiment 18 is substantially the same manner as Example 1, but the preparation method of Rhizoma Atractylodis Macrocephalae extract II is: get Rhizoma Atractylodis Macrocephalae and be ground into12 order meal, water extraction is got 2 times, extracts 80 ~ 90 DEG C of temperature, each 1 hour, 15 times water, mixing speed 20rpm in leaching process.Merge extract, filter, be concentrated into every milliliter of supernatant containing 0.1g crude drug, through 0.05 μ m inorganic ceramic membrane microfiltration, filtrate subtractsIt is 1.20 medicinal extract that pressure is concentrated into relative density, becomes Rhizoma Atractylodis Macrocephalae extract II after dry. All the other are with embodiment 1.

Embodiment 19 is substantially the same manner as Example 1, but the preparation method of radix paeoniae alba extraction is: white Peony Root is ground into 16 ordersMeal, 10 times of water gagings extract 2 times, each 1 hour. Extract filters, and merges, and is concentrated into every milliliter containing 0.2g crude drug, warpAfter D101 macroporous resin adsorption, adopt water, 20% ethanol, 70% ethanol elution macroreticular resin, collect ethanol eluate, through concentrated,After vacuum drying, become radix paeoniae alba extraction. All the other are with embodiment 1.

Embodiment 20 is substantially the same manner as Example 2, but the preparation method of dried orange peel extracts is: dried orange peel pulverizing medicinal materials becomes 16 ordersMeal, 6 times of amount 80% ethanol, extract each 1 hour 2 times. Extract filters, and merges, reclaim ethanol to every milliliter containing 0.1gThe supernatant of crude drug, through 0.1 μ m inorganic ceramic membrane microfiltration, it is 1.20 medicinal extract that filtrate decompression is concentrated into relative density, dry afterBecome dried orange peel extracts. All the other are with embodiment 2.

Embodiment 21 is substantially the same manner as Example 2, but the preparation method of Radix Saposhnikoviae extract is: windproof medicinal material is ground into 20 ordersMeal, 6 times of amount 60% ethanol, hot reflux is extracted 2 times, each 1 hour. Extract filters, and merges 2 times filtrate, is concentrated into every milliRise containing 0.5g crude drug, after HP20 macroporous resin adsorption, adopt water, 30% ethanol, 65% ethanol elution macroreticular resin, collect ethanolEluent becomes Radix Saposhnikoviae extract after concentrate drying. All the other are with embodiment 2.

Embodiment 22 is substantially the same manner as Example 3, but the preparation method of Radix Saposhnikoviae extract is: windproof medicinal material is ground into 20 ordersMeal, adopts supercritical carbon dioxide extracting: extracting pressure 30MPa, 40 DEG C of extraction temperature, and separating pressure 6MPa, separates48 DEG C of temperature, extraction time: 150 minutes, entrainer 50% ethanol 100ml/100g, the extract obtaining directly becomes windproofExtract. All the other are with embodiment 3.

Embodiment 23 is substantially the same manner as Example 2, but radix paeoniae alba extraction adopts AB-8 macroreticular resin to process, all the otherWith embodiment 2.

Claims (6)

1. treat a traditional Chinese medicine extraction compositions for FGID or intestinal irritable syndrome, the bulk drug of said compositionFor: the bighead atractylodes rhizome, the root of herbaceous peony, dried orange peel, windproof; It is characterized in that, described each component is the extract that adopts each bulk drug, the weight of each componentAmount is than being: Rhizoma Atractylodis Macrocephalae extract I3 ~ 29, and Rhizoma Atractylodis Macrocephalae extract II18 ~ 57, radix paeoniae alba extraction 13 ~ 53, dried orange peel extracts 6 ~ 32, anti-Wind extract 2 ~ 27;

Described Rhizoma Atractylodis Macrocephalae extract I refers to: Rhizoma Atractylodis Macrocephalae is ground into 16 ~ 20 order meal, add the water soaking 2 of 6 ~ 10 times of amounts ~4 hours, distillation was extracted 2 ~ 6 hours, and collecting distillation becomes Rhizoma Atractylodis Macrocephalae extract I, for subsequent use; Or

Get Rhizoma Atractylodis Macrocephalae and be ground into 16 ~ 20 order meal, adopt the extraction of supercritical carbon dioxide extracting device, extracting pressure 25 ~30MPa, 35 DEG C ~ 40 DEG C of extraction temperature, separating pressure 6 ~ 9MPa, 45 DEG C ~ 50 DEG C of separation temperatures; Carbon dioxide flow 27 ~33L/h, extraction time: 100 ~ 150min; Collect extract as Rhizoma Atractylodis Macrocephalae extract I, for subsequent use;

Described Rhizoma Atractylodis Macrocephalae extract II refers to: Rhizoma Atractylodis Macrocephalae is ground into 12 ~ 20 order meal, or extracts white after Rhizoma Atractylodis Macrocephalae extract IThe art dregs of a decoction and water liquid, water extraction is got 2 times: extract 80 ~ 90 DEG C of temperature, each 1 hour, 15 ~ 18 times water, stir speed in leaching processDegree 20～50rpm; Merge extract, filter, be concentrated into every milliliter containing 0.5g ~ 1.0g crude drug, get supernatant and add 3 ~ 4 times of amountsWeight ratio 95% ethanol, leaves standstill, filter and obtain solid content, solid content directly become Rhizoma Atractylodis Macrocephalae extract II or dry after become the bighead atractylodes rhizomeExtract II; Or

Rhizoma Atractylodis Macrocephalae is ground into 12 ~ 20 order meal, or extracts the bighead atractylodes rhizome dregs of a decoction and water liquid after Rhizoma Atractylodis Macrocephalae extract I, and water extraction is got 2 times:Extract 80 ~ 90 DEG C of temperature, each 1 hour, 15 ~ 18 times water, mixing speed 20～50rpm in leaching process; Merge extract,Filter, be concentrated into every milliliter of supernatant containing 0.05g～0.1g crude drug, through 0.05～0.2 μ m inorganic ceramic membrane microfiltration, filtrateBe evaporated to relative density and be 1.14 ~ 1.30 medicinal extract, directly become Rhizoma Atractylodis Macrocephalae extract II or dry after become the bighead atractylodes rhizome and carryGet thing II;

Described radix paeoniae alba extraction refers to: white Peony Root is ground into 12 ~ 20 order meal, 6 ~ 8 times of amount weight ratio 50% ~ 70% alcohol extracts2 times, each 1 ~ 1.5 hour; Extract filters, and merges, reclaim ethanol to every milliliter containing 0.2 ~ 0.5g crude drug, through Semi-polarity orAfter low pole macroporous resin adsorption, adopt different concentration ethanol solution stepwise elution macroreticular resin, collect ethanol eluate through denseContracting directly become radix paeoniae alba extraction or dry after become radix paeoniae alba extraction; Or

White Peony Root is ground into 12 ~ 20 order meal, and 8 ~ 10 times of water gagings extract 2 times, each 1 ~ 1.5 hour; Extract filters, and closesAnd, be concentrated into every milliliter containing 0.2 ~ 0.5g crude drug, after Semi-polarity or low pole macroporous resin adsorption, adopt different concentration ethanolSolution stepwise elution macroreticular resin, collect ethanol eluate through concentrated directly become radix paeoniae alba extraction or be dried after become the root of herbaceous peony and carryGet thing;

Described stepwise elution step is: first using the water elution of 2～4 times of amounts to colourless, is first to use weight ratio 20～30% ethanolSolution carries out after wash-out, then adopts weight ratio 50～70% ethanolic solutions to carry out wash-out;

Described dried orange peel extracts refers to: dried orange peel pulverizing medicinal materials becomes 16 ~ 20 order meal, and 6 ~ 8 times of amount weight ratio 60% ~ 80% ethanol, carryGet each 0.5 ~ 1 hour 2 times; Extract filters, and merges, reclaim ethanol to every milliliter containing 0.2 ~ 0.5g crude drug, through Semi-polarity orAfter low pole macroporous resin adsorption, adopt different concentration ethanol solution stepwise elution macroreticular resin, collect ethanol eluate through denseContracting directly become dried orange peel extracts or dry after become dried orange peel extracts; Or

Dried orange peel pulverizing medicinal materials becomes 16 ~ 20 order meal, and 6 ~ 8 times of amount weight ratio 60% ~ 80% ethanol, extract each 0.5 ~ 1 hour 2 times;Extract filters, and merges, and reclaims ethanol to every milliliter of supernatant containing 0.05g ~ 0.1g crude drug, through the inorganic pottery of 0.05 ~ 0.2 μ mPorcelain membrane microfiltration, it is 1.14 ~ 1.30 medicinal extract that filtrate decompression is concentrated into relative density, directly becomes dried orange peel extracts or dryAfter become dried orange peel extracts;

Described stepwise elution step is: first using the water elution of 2～4 times of amounts to colourless, is weight ratio 20～30% ethanolic solutionsCarry out after wash-out, then adopt weight ratio 50～70% ethanolic solutions to carry out wash-out;

Described Radix Saposhnikoviae extract refers to: get appropriate windproof medicine materical crude slice, decocting boils 2 times, each 1 hour, and 8 ~ 10 times of water; Extract filterCross, merge 2 times filtrate, be concentrated into every milliliter containing 0.2 ~ 0.5g crude drug, after Semi-polarity or low pole macroporous resin adsorption, adoptDifferent concentration ethanol stepwise elution macroreticular resin, collect ethanol eluate through concentrated directly become Radix Saposhnikoviae extract or dry after one-tenthFor Radix Saposhnikoviae extract; Or

Windproof medicinal material is ground into 16 ~ 20 order meal, 6 ~ 8 times of amount weight ratio 50% ~ 70% ethanol, and hot reflux is extracted 2 times, and each 1Hour; Extract filters, and merges 2 times filtrate, is concentrated into every milliliter containing 0.2 ~ 0.5g crude drug, through Semi-polarity or low pole macropore treeAfter fat absorption, adopt different concentration ethanol stepwise elution macroreticular resin, collecting ethanol eluate directly becomes windproof carrying through concentratingGet thing or dry after become Radix Saposhnikoviae extract; Or

Windproof medicinal material is ground into 16 ~ 20 order meal, adopts supercritical carbon dioxide extracting: extracting pressure 25 ~ 30MPa, extraction temperatureSpend 35 DEG C ~ 42 DEG C, separating pressure 6 ~ 9MPa, 45 DEG C ~ 50 DEG C of separation temperatures, extraction time: 100～180 minutes, entrainer weightAmount is than 50% ethanol 100ml/100g, the extract obtaining directly become Radix Saposhnikoviae extract or dry after become Radix Saposhnikoviae extract;

Described different concentration ethanol solution stepwise elution step is: first colourless with being washed to of 2～4 times of amounts, and then first with heavyAmount is carried out after wash-out than 25～35% ethanolic solutions, then adopts weight ratio 55～70% ethanolic solutions to carry out wash-out.

2. the traditional Chinese medicine extraction compositions for the treatment of FGID according to claim 1 or intestinal irritable syndrome, itsBe characterised in that, the weight ratio of described each component is: Rhizoma Atractylodis Macrocephalae extract I3 ~ 24, Rhizoma Atractylodis Macrocephalae extract II20 ~ 46, radix paeoniae alba extraction15 ~ 47, dried orange peel extracts 6 ~ 27, Radix Saposhnikoviae extract 5 ~ 21.

3. the traditional Chinese medicine extraction compositions for the treatment of FGID according to claim 1 or intestinal irritable syndrome, itsBe characterised in that, the weight ratio of described each component is: Rhizoma Atractylodis Macrocephalae extract I3 ~ 10, Rhizoma Atractylodis Macrocephalae extract II23 ~ 37, radix paeoniae alba extraction16 ~ 36, dried orange peel extracts 8 ~ 17, Radix Saposhnikoviae extract 5 ~ 17.

4. according to the Chinese medical extract combination of the treatment FGID one of claim 1-3 Suo Shu or intestinal irritable syndromeThing, is characterized in that, the concrete composition of described each component is: described Rhizoma Atractylodis Macrocephalae extract I is containing atractylone, sagittol, β-elemiAlkene, atractylenolide Ⅰ, atractylenolide Ⅰ II, biatractylolide; Described Rhizoma Atractylodis Macrocephalae extract II is containing arginine; The described root of herbaceous peony is extractedThing is containing Paeoniflorin, albiflorin, benzoylpaeoniflorin, Hydroxy peoniflorin; Described dried orange peel extracts is containing aurantiamarin, shaddock pedGlycosides, orange peel element, Nobiletin; Described Radix Saposhnikoviae extract is containing cimicifugoside, macrotin, 5-O-methyl visamminol glycosides, last of the twelve Earthly Branches thatchPhenolic glycoside, Psoralen, bergapten, Imperatorin, xanthotoxin, Scopoletin, bergapten.

5. the preparation side of the traditional Chinese medicine extraction compositions for the treatment of FGID claimed in claim 1 or intestinal irritable syndromeMethod, is characterized in that, step is as follows:

(1). get respectively and prepare Rhizoma Atractylodis Macrocephalae extract I, Rhizoma Atractylodis Macrocephalae extract II, radix paeoniae alba extraction, dried orange peel extracts, Radix Saposhnikoviae extract;

(2). take respectively medicinal extract or the dry thing of above five kinds of extracts by required share, for subsequent use;

(3). adopt preparation technique or auxiliary material to process above extract, comprise that application is cyclodextrin encapsulated, dispersion, solubilising, protection against the tide, slowRelease, pulverize, sieve, mix;

(4). above five kinds of extracts are combined in required ratio, prepare medicine;

Described Rhizoma Atractylodis Macrocephalae extract I refers to: Rhizoma Atractylodis Macrocephalae is ground into 16 ~ 20 order meal, add the water soaking 2 of 6 ~ 10 times of amounts ~4 hours, distillation was extracted 2 ~ 6 hours, and collecting distillation becomes Rhizoma Atractylodis Macrocephalae extract I, for subsequent use; Or

Get Rhizoma Atractylodis Macrocephalae and be ground into 16 ~ 20 order meal, adopt supercritical carbon dioxide extracting device extraction Baizhu volatile oil, extraction is pressedPower 25 ~ 30MPa, 35 DEG C ~ 40 DEG C of extraction temperature, separating pressure 6 ~ 9MPa, 45 DEG C ~ 50 DEG C of separation temperatures; Carbon dioxide streamAmount 27 ~ 33L/h, extraction time: 100 ~ 150min; Collect extract as Rhizoma Atractylodis Macrocephalae extract I, for subsequent use;

Described Rhizoma Atractylodis Macrocephalae extract II refers to: Rhizoma Atractylodis Macrocephalae is ground into 12 ~ 20 order meal, or extracts white after Rhizoma Atractylodis Macrocephalae extract IThe art dregs of a decoction and water liquid, water extraction is got 2 times: extract 80 ~ 90 DEG C of temperature, each 1 hour, 15 ~ 18 times water, stir speed in leaching processDegree 20～50rpm; Merge extract, filter, be concentrated into every milliliter containing 0.5g ~ 1.0g crude drug, get supernatant and add 3 ~ 4 times of amountsWeight ratio 95% ethanol, leaves standstill, filter and obtain solid content, solid content directly become Rhizoma Atractylodis Macrocephalae extract II or dry after become the bighead atractylodes rhizomeExtract II; Or

Rhizoma Atractylodis Macrocephalae is ground into 12 ~ 20 order meal, or extracts the bighead atractylodes rhizome dregs of a decoction and water liquid after Rhizoma Atractylodis Macrocephalae extract I, and water extraction is got 2 times:Extract 80 ~ 90 DEG C of temperature, each 1 hour, 15 ~ 18 times water, mixing speed 20～50rpm in leaching process; Merge extract,Filter, be concentrated into every milliliter of supernatant containing 0.05g～0.1g crude drug, through 0.05～0.2 μ m inorganic ceramic membrane microfiltration, filtrateBe evaporated to relative density and be 1.14 ~ 1.30 medicinal extract, directly become Rhizoma Atractylodis Macrocephalae extract II or dry after become the bighead atractylodes rhizome and carryGet thing II;

Described radix paeoniae alba extraction refers to: white Peony Root is ground into 12 ~ 20 order meal, 6 ~ 8 times of amount weight ratio 50% ~ 70% alcohol extracts2 times, each 1 ~ 1.5 hour; Extract filters, and merges, reclaim ethanol to every milliliter containing 0.2 ~ 0.5g crude drug, through Semi-polarity orAfter low pole macroporous resin adsorption, adopt different concentration ethanol solution stepwise elution macroreticular resin, collect ethanol eluate through denseContracting directly become radix paeoniae alba extraction or dry after become radix paeoniae alba extraction; Or

White Peony Root is ground into 12 ~ 20 order meal, and 8 ~ 10 times of water gagings extract 2 times, each 1 ~ 1.5 hour; Extract filters, and closesAnd, be concentrated into every milliliter containing 0.2 ~ 0.5g crude drug, after Semi-polarity or low pole macroporous resin adsorption, adopt different concentration ethanolSolution stepwise elution macroreticular resin, collect ethanol eluate through concentrated directly become radix paeoniae alba extraction or be dried after become the root of herbaceous peony and carryGet thing;

Described stepwise elution step is: first using the water elution of 2～4 times of amounts to colourless, is first to use weight ratio 20～30% ethanolSolution carries out after wash-out, then adopts weight ratio 50～70% ethanolic solutions to carry out wash-out;

Described dried orange peel extracts refers to: dried orange peel pulverizing medicinal materials becomes 16 ~ 20 order meal, and 6 ~ 8 times of amount weight ratio 60% ~ 80% ethanol, carryGet each 0.5 ~ 1 hour 2 times; Extract filters, and merges, reclaim ethanol to every milliliter containing 0.2 ~ 0.5g crude drug, through Semi-polarity orAfter low pole macroporous resin adsorption, adopt different concentration ethanol solution stepwise elution macroreticular resin, collect ethanol eluate through denseContracting directly become dried orange peel extracts or dry after become dried orange peel extracts; Or

Dried orange peel pulverizing medicinal materials becomes 16 ~ 20 order meal, and 6 ~ 8 times of amount weight ratio 60% ~ 80% ethanol, extract each 0.5 ~ 1 hour 2 times;Extract filters, and merges, and reclaims ethanol to every milliliter of supernatant containing 0.05g ~ 0.1g crude drug, through the inorganic pottery of 0.05 ~ 0.2 μ mPorcelain membrane microfiltration, it is 1.14 ~ 1.30 medicinal extract that filtrate decompression is concentrated into relative density, directly becomes dried orange peel extracts or dryAfter become dried orange peel extracts;

Described stepwise elution step is: first using the water elution of 2～4 times of amounts to colourless, is weight ratio 20～30% ethanolic solutionsCarry out after wash-out, then adopt weight ratio 50～70% ethanolic solutions to carry out wash-out;

Described Radix Saposhnikoviae extract refers to: get appropriate windproof medicine materical crude slice, decocting boils 2 times, each 1 hour, and 8 ~ 10 times of water; Extract filterCross, merge 2 times filtrate, be concentrated into every milliliter containing 0.2 ~ 0.5g crude drug, after Semi-polarity or low pole macroporous resin adsorption, adoptDifferent concentration ethanol stepwise elution macroreticular resin, collect ethanol eluate through concentrated directly become Radix Saposhnikoviae extract or dry after one-tenthFor Radix Saposhnikoviae extract; Or

Windproof medicinal material is ground into 16 ~ 20 order meal, 6 ~ 8 times of amount weight ratio 50% ~ 70% ethanol, and hot reflux is extracted 2 times, and each 1Hour; Extract filters, and merges 2 times filtrate, is concentrated into every milliliter containing 0.2 ~ 0.5g crude drug, through Semi-polarity or low pole macropore treeAfter fat absorption, adopt different concentration ethanol stepwise elution macroreticular resin, collecting ethanol eluate directly becomes windproof carrying through concentratingGet thing or dry after become Radix Saposhnikoviae extract; Or

Windproof medicinal material is ground into 16 ~ 20 order meal, adopts supercritical carbon dioxide extracting: extracting pressure 25 ~ 30MPa, extraction temperatureSpend 35 DEG C ~ 42 DEG C, separating pressure 6 ~ 9MPa, 45 DEG C ~ 50 DEG C of separation temperatures, extraction time: 100～180 minutes, entrainer weightAmount is than 50% ethanol 100ml/100g, the extract obtaining directly become Radix Saposhnikoviae extract or dry after become Radix Saposhnikoviae extract;

Described different concentration ethanol solution stepwise elution step is: first colourless with being washed to of 2～4 times of amounts, and then first with heavyAmount is carried out after wash-out than 25～35% ethanolic solutions, then adopts weight ratio 55～70% ethanolic solutions to carry out wash-out.

6. the traditional Chinese medicine extraction compositions for the treatment of FGID claimed in claim 1 or intestinal irritable syndrome is controlled in preparationApplication in treatment functions gastroenteropathy or anti-intestinal irritable syndrome medicine.