CN101700289A - Traditional Chinese medicine extract composition for treating gastrointestinal dysfunction or irritable bowel syndrome (IBS), and preparation method and applications thereof in preparation of medicaments - Google Patents
Traditional Chinese medicine extract composition for treating gastrointestinal dysfunction or irritable bowel syndrome (IBS), and preparation method and applications thereof in preparation of medicaments Download PDFInfo
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Abstract
The invention relates to a traditional Chinese medicine extract composition for treating gastrointestinal dysfunction or irritable bowel syndrome (IBS), and a preparation method and applications thereof in the preparation of medicaments. The traditional Chinese medicine extract composition comprises the following raw materials: 9-12g of radix bupleuri, 9-12g of paeonia lactiflora, 9-12g of atractylodes macrocephaia, 9-12g of tuckahoe, 3-6g of liquorice, 3-6 gof radix pseudostellariae and 3-6g of rhizoma ligustici wallichii. The invention is characterized in that all the components use extracts of raw medicinal drugs, wherein the volatile oil of atractylodes macrocephaia is component 1; the concentrated extract of water decocted liquid of atractylodes macrocephaia dregs after extracting the volatile oil and other drugs is component 2; and a proper amount of cyclodextrin is component 3. The invention overcomes the traditional viewpoint that the effect of the total extract or water decocted liquid of the traditional Chinese drugs is better than that of the partial extract, and selectively uses the volatile oil of the raw medicinal drugs. Through the combining treatment, the invention obviously improves the preparation performance of the extracts and ensures the quality of the composition. The traditional Chinese medicine extract composition for treating gastrointestinal dysfunction or irritable bowel syndrome (IBS) has unexpected effects by using the extracts.
Description
Technical field
The present invention relates to the preparation of compositions method of the compositions (Chinese medicine compound extract) of a kind of treatment gastrointestinal dysfunction or irritable bowel syndrome (IBS), this treatment gastrointestinal dysfunction or irritable bowel syndrome; And the application of the compositions of this treatment gastrointestinal dysfunction or irritable bowel syndrome in preparation treatment gastrointestinal dysfunction or anti-irritable bowel syndrome medicine.
Background technology
Gastrointestinal dysfunction is clinical common functional intestinal tract disease, accounts for 40～60% of gastroenteropathy.Wherein (irritable bowel Syndrome is common digestive tract non-organic bowel dysfunction disease IBS) to irritable bowel syndrome, has the chronic clinical characters of outbreak repeatedly.Prevalence in the adult is 10%～22%, and the women slightly sees more.Its main clinical manifestation is gastrointestinal symptoms such as the stomachache of no organic disease, diarrhoea, constipation, and its cause of disease is a functional gastrointestinal disorder.At present such disease is still lacked effective Therapeutic Method.
Because modern medicine is not clear and definite yet for its pathology and pathogenesis, the pathogeny more complicated, risk factor is more, and chemicals often is difficult to obtain satisfactory effect, and there are narrow, the defectives such as side effect big, easy recurrence of anti-IBS spectrum in these medicines simultaneously.In recent years, both at home and abroad, make traditional medicine in the treatment of primary disease, occupy very consequence more and more paying attention to conventional medicament aspect the development of anti-IBS medicine and the exploitation.
In the prior art, according to theory of Chinese medical science and pharmacological effect, the drug regimen of several treatment irritable bowel syndromes is disclosed.For example:
Close the product that tongxieyao formula adds Radix Codonopsis, Rhizoma Dioscoreae spleen invigorating (the Shaanxi traditional Chinese medical science, 1999,20:404 1) with Sini San; With Sini San, decoction of four noble drugs, the tongxieyao formula side of closing plus-minus (the Sichuan traditional Chinese medical science, 2000,18 (11): 41); Adopt flat stomach Sini San (Pericarpium Citri Reticulatae, the Radix Paeoniae Alba, Radix Bupleuri, Cortex Magnoliae Officinalis, Fructus Aurantii, Rhizoma Atractylodis, Radix Glycyrrhizae) plus-minus (traditional Chinese medical science forum, 2002,17 (3): 51 1 53); With XIAOYAO POWDER plus-minus treatment IBS (Hubei Journal of Traditional Chinese Medicine, 2002,24 (7) 1);
Application number is in the application for a patent for invention of 03112782.7 denomination of invention for " Chinese medicine composition and the preparation thereof of treatment bowel dysfunction disease ", the applicant discloses a kind of Chinese medicine composition for the treatment of irritable bowel syndrome, provide following prescription: Radix Bupleuri 6～15 grams, the Radix Paeoniae Alba 5～20 grams, Rhizoma Chuanxiong 3～10 grams, the Rhizoma Atractylodis Macrocephalae 6～20 grams, Poria 6～12 grams, Radix Glycyrrhizae 5～20 grams, Radix Pseudostellariae 10～18 grams.
Application number is 200410014337.4 denominations of invention for the patent disclosure of " Chinese medicine composition of treatment bowel dysfunction and preparation method thereof " a kind of Chinese medicine composition for the treatment of irritable bowel syndrome and preparation method thereof, this scheme provides by Radix Bupleuri 6～15 grams, the Radix Paeoniae Alba 5～20 grams, Radix Pseudostellariae 6～12 grams, prescription and formulation method that Radix Glycyrrhizae 5～20 grams are formed.
Though Radix Bupleuri, the Radix Paeoniae Alba, Rhizoma Chuanxiong, the Rhizoma Atractylodis Macrocephalae, Poria, the plus-minus side of medical materials such as Radix Glycyrrhizae and Radix Pseudostellariae has seen diseases such as clinical treatment bowel dysfunction, functional dyspepsia, irritable bowel syndrome, but because the compound recipe active substance is still not exclusively clear and definite, the not high reason of preparation technique exists the clinical efficacy instability, the patient takes problems such as inconvenience in actual applications.These problems have seriously restricted the effect of compound recipe.
General points of view thinks that the Chinese medicine compound activity extract of clinical practice should comprise the summation of volatility active component and the water-soluble active ingredient or the fat-soluble active ingredient of each medical material in the compound recipe.Traditional view even think the total extract or the various extract summation of each medical material in the direct employing compound recipe, effect is better than wherein one or more extracts.
Summary of the invention
The Chinese medicine compound extractive composition that the purpose of this invention is to provide a kind of treatment gastrointestinal dysfunction or irritable bowel syndrome (IBS).Said composition can be used for treating gastrointestinal dysfunction, especially for the treatment irritable bowel syndrome.The present invention also will provide this preparation of compositions method; And the application of this compositions in preparation treatment gastrointestinal dysfunction or anti-irritable bowel syndrome medicine.The present invention adopts volatile oil and the water extract in the crude drug partly to make up selectively, proposes: the fact of " the optimum organization thing of raw material of Chinese medicine extract, effect will be better than total extract or thick decocting liquid ".Further optimize preparation method and proportioning raw materials on this basis, realized optimum efficiency.In addition, the present invention adopts cyclodextrin and extract combination to handle, and has significantly improved the preparation performance of compositions, has solved the technical barrier of extract in the various pharmaceutical dosage form processes of preparation, and guarantees the quality of compositions.Experimental data proves, adopts combination treatment gastrointestinal dysfunction of the present invention or irritable bowel syndrome can produce beyond thought effect.
This project is the secondary innovation exploitation to Chinese medicine compound, the reasonable combination of extract, and resultant compositions has qualitative leap than the compound recipe crude extract.Can not only embody the characteristics of the many target spots of Chinese medicine performance drug effect, can make effective ingredient enrichment more again, pharmacological action and clinical efficacy strengthen, reduce clinical dosage, are convenient to various dosage forms preparations, and are beneficial to advantage such as quality control level raising.
Keeping on traditional Chinese medical science medicine law and the principle basis, by the medical material effective ingredient is deeply screened, the modern extraction of rational Application, refining, technology of preparing can have been rejected a large amount of unnecessary composition and interference factor, make effect have specificity more, the main pharmacodynamics effect is more outstanding; Secondly, can the side of making in chemical constituent clear substantially, can make the control of the formulation of drug standard and the quality of production more pointed, drug quality is stable and controllable more.
Technical scheme of the present invention is that the Chinese herbal medicine with special ratios is a raw material, constitutes pharmaceutical composition with its extract.The compositions of a kind of treatment gastrointestinal dysfunction or irritable bowel syndrome (IBS) (Chinese medicine compound extract), the raw material of said composition is made up of following medical material:
Radix Bupleuri 9～12 grams, the Radix Paeoniae Alba 9～12 grams, the Rhizoma Atractylodis Macrocephalae 9～12 grams, Poria 9～12 grams, Radix Glycyrrhizae 3～6 grams, Radix Pseudostellariae 3～6 grams, Rhizoma Chuanxiong 3～6 grams; It is characterized in that described each component adopts extracts of bulk drugs, wherein, the volatile oil of the described Rhizoma Atractylodis Macrocephalae becomes component one; The Rhizoma Atractylodis Macrocephalae medicinal residues behind the extraction volatile oil and the water extract of other medical materials become component two; Cyclodextrin is an amount of, becomes component three.
Main distinction feature of the present invention is: adopt the volatile oil in the crude drug selectively.That is, the present invention need abandon the volatile oil in the part material medicine, to reach the best techniques effect.This is diverse with traditional scheme.
In the above scheme, the Rhizoma Atractylodis Macrocephalae medicinal residues behind the extraction volatile oil of described component two and the water extract of other medical materials are meant:
Extract the Rhizoma Atractylodis Macrocephalae medicinal residues behind the volatile oil and the decocting liquid of other medical materials, being concentrated into relative density is the extractum of 1.14～1.30 (60 ℃), becomes component two after directly becoming component two or drying; Or
The Rhizoma Atractylodis Macrocephalae medicinal residues behind the extraction volatile oil and the decocting liquid of other medical materials, be concentrated into every milliliter of supernatant that contains 0.2～0.4g crude drug, macroporous adsorbent resin by nonpolar or low pole adsorbs, 50～80% ethanol-eluting resin columns, ethanol elution is concentrated into the extractum that relative density is 1.14～1.30 (60 ℃), becomes component two after directly becoming component two or drying; Or
The Rhizoma Atractylodis Macrocephalae medicinal residues behind the extraction volatile oil and the decocting liquid of other medical materials, be concentrated into every milliliter of supernatant that contains 0.05g～0.1g crude drug, through 0.05～0.2 μ m inorganic ceramic membrane microfiltration, filtrate decompression is concentrated into the extractum that relative density is 1.14～1.30 (60 ℃), becomes component two after directly becoming component two or drying.
More specifically, the raw material of preparation compositions can be made up of following medical material:
Radix Bupleuri 9～12 grams, the Radix Paeoniae Alba 9～12 grams, the Rhizoma Atractylodis Macrocephalae 9～12 grams, Poria 9～12 grams, Radix Glycyrrhizae 6 grams, Radix Pseudostellariae 6 grams, Rhizoma Chuanxiong 6 grams.
The Chinese medicine extraction compositions of treatment gastrointestinal dysfunction or irritable bowel syndrome is characterized in that described concrete composition is:
(1), the Rhizoma Atractylodis Macrocephalae medical material of described share, add the water logging bubble 2～4 hours of 6～10 times of amounts, extract 2～6 hours volatile oil, become component one; Or the Rhizoma Atractylodis Macrocephalae medical material of described share, adopt supercritical carbon dioxide extraction.Extracting pressure 30～35MPa, 40 ℃～45 ℃ of extraction temperature, carbon dioxide flow 27～33L/h, extraction time: 100～150min.Obtain Rhizoma Atractylodis Macrocephalae volatile oil and become component one.
(2), other medical materials of described share were soaked 2～4 hours, merge with the Rhizoma Atractylodis Macrocephalae medicinal residues behind the extraction volatile oil, decoct and extract twice, each 1～2 hour, 8～10 times water, merge extractive liquid,, filter, being concentrated into relative density is 1.06～1.10 (60 ℃), leaves standstill, and 8000～20000 rev/mins centrifugal, be evaporated to relative density and be 1.14～1.30 extractum, become component two after directly becoming component two or drying.Or
Other medical materials of described share were soaked 2～4 hours, merge with the Rhizoma Atractylodis Macrocephalae medicinal residues behind the extraction volatile oil, decoct and extract twice, each 1～2 hour, 8～10 times water, merge extractive liquid,, filter, be concentrated into every milliliter and contain 0.2～0.4g crude drug, centrifugal, get supernatant, the macroporous adsorbent resin by nonpolar or low pole adsorbs, 50～80% ethanol-eluting resin columns, collect ethanol elution, being evaporated to relative density is the extractum of 1.14～1.30 (60 ℃), becomes component two after directly becoming component two or drying.Or
Other medical materials of described share were soaked 2～4 hours, merge with the Rhizoma Atractylodis Macrocephalae medicinal residues behind the extraction volatile oil, decoct and extract twice, each 1～2 hour, 8～10 times water, merge extractive liquid,, filter, be concentrated into every milliliter and contain 0.05g～0.1g crude drug, centrifugal, get supernatant, through 0.2～0.05 μ m inorganic ceramic membrane microfiltration, filtrate decompression is concentrated into the extractum that relative density is 1.14～1.30 (60 ℃), directly or after the drying becomes component two.
(3), cyclodextrin is an amount of, becomes component three.
Wherein said cyclodextrin consumption is 4～8 times of volatile oil weight.
The Chinese medicine composition of described treatment irritable bowel syndrome is characterized in that, described more specifically composition is:
Atractylone content (Atractylon) is 30%～70% in the volatile oil of component one, and the weight yield of volatile oil is 0.5～2.5% of a Rhizoma Atractylodis Macrocephalae medical material weight;
The weight content of peoniflorin in the water extract of component two (Paeoniflorin) is 0.7%～5.5%, and the weight content of glycyrrhizic acid (Glycyrrhizic acid) is 0.7%～5.0% (in dry extract).The weight yield of water extract is 7%～28% (in a dry extract) of medical material weight.
Component three cyclodextrin consumptions are 4～8 times of volatile oil weight.
The preparation of compositions method of described treatment gastrointestinal dysfunction or irritable bowel syndrome may further comprise the steps:
(1), it is standby to get raw medicinal material by following composition by weight:
Radix Bupleuri 9～12 grams, the Radix Paeoniae Alba 9～12 grams, the Rhizoma Atractylodis Macrocephalae 9～12 grams, Poria 9～12 grams, Radix Glycyrrhizae 3～6 grams, Radix Pseudostellariae 3～6 grams, Rhizoma Chuanxiong 3～6 grams;
(2), get the Rhizoma Atractylodis Macrocephalae, extraction volatile oil.Collect volatile oil, medicinal liquid filters, and is standby;
(3), Radix Bupleuri, the Radix Paeoniae Alba, Rhizoma Chuanxiong, Poria, Radix Glycyrrhizae, Radix Pseudostellariae soaks, and merges with Rhizoma Atractylodis Macrocephalae medicinal residues, water extraction filters; More than two filtered solutions merge to concentrate;
(4), refining and edulcoration, concentrate, extractum;
(5), get volatile oil and add an amount of cyclodextrin, uniform mixing, standby.
(6), extractum, the direct uniform mixing of volatile oil or dry respectively back mix, promptly.
The preparation of compositions method of described treatment gastrointestinal dysfunction or irritable bowel syndrome is characterized in that it specifically is made up of following steps:
(1), get the Rhizoma Atractylodis Macrocephalae by the described quality component of claim 1, Radix Bupleuri, the Radix Paeoniae Alba, Rhizoma Chuanxiong, Poria, Radix Glycyrrhizae, Radix Pseudostellariae, standby;
(2), get Rhizoma Atractylodis Macrocephalae medical material, be ground into coarse powder or coarse powder, add the water logging bubble 2～4 hours of 6～10 times of amounts, the volatile oil that adopts steam distillation to extract 2～6 hours is collected volatile oil, aqueous extract filters, and is standby; Or
Get Rhizoma Atractylodis Macrocephalae medical material, suitably crushed after being dried becomes coarse powder or coarse powder, adopts supercritical carbon dioxide extraction device extraction Rhizoma Atractylodis Macrocephalae volatile oil, extracting pressure 30～35MPa, and extraction temperature 40 ℃～45 is resolved pressure 7～10MPa, resolution temperature: 40 ℃～45 ℃.CO2 flow 27～33L/h, the extraction time: 100～150min.
(3), the Radix Bupleuri of described share, the Radix Paeoniae Alba, Rhizoma Chuanxiong, Poria, Radix Glycyrrhizae, Radix Pseudostellariae was soaked 2～4 hours, merged with Rhizoma Atractylodis Macrocephalae medicinal residues, decoct and extract twice, each 1～2 hour, 8～10 times water, the gained extracting solution filters, and merges with Rhizoma Atractylodis Macrocephalae extracting solution.
(4), to be evaporated to relative density be 1.06～1.10 (60 ℃) to above medicinal liquid, leaves standstill, 8000～20000 rev/mins are centrifugal, being evaporated to relative density is the extractum of 1.14～1.30 (60 ℃).Or
Above medicinal liquid is evaporated to every milliliter and contains 0.2～0.4g crude drug, leave standstill, get supernatant, the macroporous adsorbent resin by nonpolar or low pole adsorbs, after absorption finishes, water flushing resin column, to nearly colourless the ending of water lotion, and then, collect ethanol elution with 50～80% ethanol-eluting resin columns, concentrating under reduced pressure is the extractum of 1.14～1.30 (60 ℃) to relative density.Or
Above medicinal liquid is evaporated to every milliliter and contains 0.05g～0.1g crude drug, leaves standstill, and 8000～20000 rev/mins centrifugal, gets supernatant, through 0.05～0.2 μ m AL
2O
3(filtrate decompression concentrates the inorganic ceramic membrane microfiltration, is the extractum of 1.15～1.30 (60 ℃) to relative density for 30 ℃ of temperature, operating pressure 0.15～0.20Mpa).
(5), get above volatile oil, it is an amount of to add cyclodextrin, mixes, and grinds 10～30min with colloid mill, will be after the abrasive material drying for mix with or directly for mixing usefulness.
(6), extractum directly or after dry is used for mixing.
(7), water extract part and volatile oil part uniform mixing, promptly.
The preparation of compositions method of described treatment gastrointestinal dysfunction or irritable bowel syndrome is characterized in that,
The extraction of described volatile oil adopts steam distillation to extract.Rhizoma Atractylodis Macrocephalae raw material soaking adopted 3～4 hours, added 8～10 times of water gagings, extracted 4～6 hours volatile oil.Get above volatile oil, the adding cyclodextrin is an amount of, mixes, and grinds 10～30min with colloid mill, will use or directly use for mixing for mixing after the abrasive material drying.
The extraction of described water extract adopts medicinal raw material to soak 3～4 hours, merges with Rhizoma Atractylodis Macrocephalae medicinal residues, and decoct and extract twice, each 1～2 hour, 8～10 times of water gagings, the gained extracting solution filters, and merges with Rhizoma Atractylodis Macrocephalae extracting solution; It is 1.08～1.10 (60 ℃) that above medicinal liquid is evaporated to relative density, and 4 ℃ leave standstill, and 8000～20000 rev/mins centrifugal, and concentrating under reduced pressure is the extractum of 1.14～1.20 (60 ℃) to relative density; Extractum directly or after dry is used for mixing;
In the above scheme, the extraction of volatile oil can be adopted steam distillation or CO2 supercritical fluid extraction.Recommend to adopt steam distillation, Rhizoma Atractylodis Macrocephalae raw material soaking 3 hours adds 8 times of water, extracts 6 hours.
The water extracting method parameter recommends to soak 4 hours, adds 10 times of water, each 1.5 hours.
Described aqueous extract process for purification can adopt methods such as membrane separation technique, ultrafiltration, high speed centrifugation, macroporous resin.Recommend to adopt supercentrifugation, 8000～20000 rev/mins of ultracentrifugation rotating speeds are recommended to adopt 20000 rev/mins.
When adopting macroporous resin Purified Water extract, can adopt the macroporous adsorbent resin of nonpolar or low pole.Employed nonpolar macroporous adsorption resin recommends to adopt D101, HPD100 (Cangzhou precious grace chemical industry company limited), HP20, HP10, (Mitsubishi changes into company to HP40, the polystyrene based structures), XAD-1～XAD-5 (the Rohm Hass Amberlite of company series, styrene structure).H103, H107, X-5 (crosslinked polystyrene type, Chemical Plant of Nankai Univ.).The low pole macroporous resin that uses can be AB-8, DS-401, HPD-450 (crosslinked polystyrene type).
The drying of described extract or extractum can adopt vacuum drying or spray drying or microwave drying.
Described cyclodextrin can be beta cyclodextrin or hydroxypropyl beta cyclodextrin or sulfobutyl-beta cyclodextrin, or the methyl beta cyclodextrin.
Chinese medicine extraction compositions of the present invention is characterized in that adding corresponding adjuvant and can be made into clinical acceptable all kinds of dosage forms.Described preparation comprises tablet, capsule, pill, granule, drop pill, pellet, aerosol, Emulsion, gel, microsphere, nanosphere, oral liquid, suspensoid, injection, mucocutaneous drug-delivery preparation and suppository.
Chinese medicine extraction compositions of the present invention is characterized in that can be used for preparing the medicine for the treatment of gastrointestinal dysfunction or anti-irritable bowel syndrome.
We have carried out clinical preceding pharmacy, pharmacology and the clinical research of system to the present invention program's compositions, in study of pharmacy, index composition in the compositions has been carried out qualitative, quantitative research respectively, adopt HPLC method or GC method, precision test, repeatability test, solvent stability test and application of sample recovery test have been carried out respectively, set up scientific analysis method, made in the extract index component content as the technical specification of quality evaluation.The product that makes the present composition become high in technological content, steady quality and be easy to control.
In drug efficacy study, according to the clinical symptoms of gastrointestinal dysfunction or irritable bowel syndrome, designed serial effect experiment, investigated pharmaceutical composition of the present invention.The result shows that pharmaceutical composition of the present invention can obviously improve the Mice with Spleen sign, has the rehabilitation effect to the spleen-deficient mice; Obviously the antagonism intestinal function is hyperfunction, improves intestinal function and suppresses, and plays the intestinal function effect of regulating; Dysfunction has regulating action to rat gastrointestinal tract; And tangible pain relieving, resisting fatigue, anti-hypoxia, anti-stress effect arranged.Result of study points out compositions of the present invention that gastrointestinal dysfunction or irritable bowel syndrome are had remarkable improvement effect.
The more important thing is that compare with relevant compositions, extract or compound medicine, the present composition has significant advantage.All to make Radix Bupleuri, the Radix Paeoniae Alba, Radix Glycyrrhizae, Radix Pseudostellariae, the Rhizoma Atractylodis Macrocephalae, Rhizoma Chuanxiong, Poria, Radix Pseudostellariae be that the prepared compositions of raw material produces beyond thought effect in the optimization of the optimization of extract part Combination Optimized, preparation parameter and material rate among the present invention program, particularly these three prioritization 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 " the Rhizoma Atractylodis Macrocephalae volatile oil part partly makes up with water extraction " of the present invention will produce beyond thought effect.The Rhizoma Atractylodis Macrocephalae volatile oil part partly makes up with water extract among the present invention program, is better than the pharmacological effect of the independent use in arbitrary position or other combination.Particularly, the combination of the volatile ingredient of Radix Bupleuri or Rhizoma Chuanxiong is unfavorable for the drug effect performance.In addition, the present invention adopts cyclodextrin and extract combination to handle, and has significantly improved the preparation performance of compositions, is applicable to the preparation of various kinds of drug, and guarantees the quality of compositions.
The present invention program has strengthened the effect of favourable component, has avoided the effect of unfavorable component.Following experimental example can illustrate advantage of the present invention.
Experimental drug material, medicine, laboratory animal etc. are provided by legitimate channels.
The medicine material combination:
Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Rhizoma Chuanxiong 6 grams, the Rhizoma Atractylodis Macrocephalae 9 grams, Poria 9 grams, Radix Glycyrrhizae 6 grams, Radix Pseudostellariae 6 grams.
Sample preparation methods:
Volatile oil part+beta-schardinger dextrin-: get the medicinal material coarse powder of recipe quantity, the water logging that adds 8 times of amounts was steeped 3 hours, 6 hours volatile oil of water vapour distillation, and volatile oil adds the beta-schardinger dextrin-of 6 times of amounts (w/w), grinds 20min, and 50 ℃ of vacuum dryings are standby;
The water extraction position: the medicinal residues that other medicinal raw materials of described share were soaked 4 hours and extracted behind the volatile oil merge, and decoct and extract 2 times, each 1.5 hours, 10 times of water, merge extractive liquid, filters, being evaporated to relative density is 1.09 (60 ℃), 4 ℃ left standstill 12 hours, and 20000 rev/mins centrifugal, and being evaporated to relative density is 1.15 (60 ℃), spray drying obtains dry extract, and is standby.
Compound decoction: the medicinal raw material of described share was soaked 4 hours, and decocting boils 2 times, and each 10 times of amounts decocted 1.5 hours; Merge decocting liquid, more than two filtered solutions merge and concentrate, be concentrated into every milliliter of medicinal liquid that contains the 1g crude drug, standby.
Supply test agent:
Combination 1, Rhizoma Atractylodis Macrocephalae volatile ingredient position+water extracting component position+beta cyclodextrin;
Combination 2, Radix Bupleuri volatile ingredient position+water extracting component position+beta cyclodextrin;
Combination 3, Rhizoma Chuanxiong volatile ingredient position+water extracting component position+beta cyclodextrin;
Combination 4, Radix Bupleuri volatile ingredient position+Rhizoma Chuanxiong volatile ingredient position+water extracting component position+beta cyclodextrin;
Combination 5, Rhizoma Atractylodis Macrocephalae volatile ingredient position+Radix Bupleuri volatile ingredient position+Rhizoma Chuanxiong volatile ingredient position+water extracting component position+beta cyclodextrin;
Combination 6, Rhizoma Atractylodis Macrocephalae volatile ingredient+beta cyclodextrin:
Combination 7, water extracting component position
Combination 8, compound decoction
As requested, each group sample is made into debita spissitudo with distilled water on demand, standby.
Dosage: low dose group: be equivalent to 1.5g crude drug/kg; Middle dosage group: be equivalent to 3.0g crude drug/kg; High dose group: be equivalent to 6.0g crude drug/kg.
Experimental example one, to the Different Effects of mice with spleen deficiency
1. animal and grouping: male mice in kunming, body weight 18～22g, random packet, every group of 10 raisings.(1) normal control group: irritate capacity distilled water such as stomach; (2) model group; (3) Ginseng Bolus for tonifying spleen's group: 2.0gkg
-1(4) sample: by the administration respectively of high, medium and low dosage.
2. administration and experimental technique: except that the normal control group, all the other each groups are all irritated stomach and are given 200% Radix Et Rhizoma Rhei decocting liquid, and 0.25ml/10g duplicates the Mice with Spleen model.Self-supporting Radix Et Rhizoma Rhei decocting liquid rose on the 5th day, and each organizes continuous one week of gastric infusion.The Azo-Blue solution of mouse stomach 5% after the last administration takes out the gastrointestinal section behind the execution mice, and the percentage ratio that it accounts for the small intestinal total length is calculated to the distance of pylorus in record Azo-Blue forward position.Take out each mouse thymus, spleen, weigh.A t check will be organized between each administration group.
3. result: after the model group mice gives Radix Et Rhizoma Rhei decocting liquid continuously, occur promptly that blink, lazy moving, loose stool, body weight obviously alleviate, ears back, loose stool, hair are withered, speckle with phenomenon such as Excreta, with normal control group comparing difference significantly (P＜0.05).Compare with model group, the present composition (combination 1) is high, middle dosage group all can obviously be improved above-mentioned insufficiency of the spleen sign, significantly increase body weight, increase mice with spleen deficiency spleen index, the thymus index (P＜0.05) of mice with spleen deficiency, illustrate that the present composition has spleen invigorating and regulates the gastrointestinal function.And the present composition (combination 1) is high, middle dosage group significantly is better than and other combined sample (combination 2～combination 8) corresponding dosage group (P＜0.05).Middle dosage group mice with spleen deficiency thymus index, spleen index the results are shown in Table 1.
The influence of table 1 pair mice with spleen deficiency thymus index, spleen index (X ± s)
Compare with matched group:
△P＜0.05.Compare with model group: * P＜0.05.Compare for 1 group with combination:
Experimental example two, to the different adjustment effect of the rat gastrointestinal tract dysfunction due to the reserpine
1. animal and grouping: healthy adult male SD rat, random packet, every group of 10 raisings.
2. administration and experimental technique: capacity normal saline such as (1) normal control group lumbar injection such as gavage simultaneously at the capacity distilled water; (2) model group: lumbar injection reserpine 0.5mg/kg such as gavages simultaneously at the capacity distilled water; (3) positive group: lumbar injection reserpine 0.5mg/kg gavages cerekinon 50mg/kg simultaneously; (4) sample sets: lumbar injection reserpine 0.5mg/kg gavages respectively simultaneously for the high, medium and low dosage of test agent.Each organizes two weeks of successive administration.The feces and the sign of observing rat at any time change, and body weight, the food ration of weighing every day rat.Collect following specimen by MTL radioimmunity test kit: blood plasma, jejunum tissue store to be equipped with and survey.A t check will be organized between each administration group.
3. in various degree diarrhoea, appetite decline also appear in experimental result model group rat successively behind the injection reserpine, and feces viscous is not well, constipation, anorexia, become thin (P＜0.05, P＜0.01).With model group relatively, the present composition (combination 1) height, the body weight of middle dosage group rat, food ration, thymus index, spleen index, motilin in plasma, jejunum homogenate MTL decline state all significantly improve (P＜0.05, P＜0.01).Illustrate that the present composition has the gastrointestinal of adjusting function.And the present composition (combination 1) is high, middle dosage group significantly is better than and other combined sample (combination 2～combination 8) corresponding dosage group (P＜0.01).In the dosage group functional gastrointestinal disorder rat MTL be the results are shown in Table 2.
The influence of table 2 couple functional gastrointestinal disorder rat MTL (X ± s)
Compare with matched group: △ P＜0.05.Compare with model group: * * P＜0.01.Compare for 1 group with combination:
The different adjustment effect of three pairs of intestine movement functions of experimental example
The intestinal propulsion experiment
1. animal and grouping: Kunming mouse, body weight 18～22g, random packet, every group of 10 raisings.
2. experimental technique: (1) normal control group: irritate capacity distilled water such as stomach; (2) model group: irritate capacity distilled water such as stomach every day; (3) positive group: cerekinon 100mg/kg; (4) sample sets: gavage respectively for the high, medium and low dosage of test agent.Each group is irritated stomach and is given corresponding medicine, continuously 7d.After the last administration, except that the normal control group, the neostigmine load is respectively organized the equal subcutaneous injection neostigmine of mice 1mg/kg; The atropine load is respectively organized the equal subcutaneous injection atropine of mice 5mg/kg.Behind the 10min, the Azo-Blue solution 0.1ml/10g that all mices are all irritated stomach 5% puts to death behind the 15min, cuts open the belly rapidly and takes out the gastrointestinal section, and the percentage ratio that it accounts for the small intestinal total length is calculated to the distance of pylorus in record Azo-Blue forward position.A t check will be organized between each administration group.
3. experimental result shows: compare with model group, present composition height, middle dosage group can obviously suppress the mouse small intestine hyperfunctioning (P＜0.05) that the neostigmine load causes, improve the mouse small intestine function that atropine causes and be subjected to press down state (P＜0.05), point out it that intestinal function is had dual regulation.And present composition group (combination 1) is high, middle dosage group significantly is better than and other combined sample (combination 2～combination 8) corresponding dosage group (P＜0.05), and middle dosage group the results are shown in Table 3.
The table 3 pair propulsive influence of neostigmine load/atropine load mouse small intestine (X ± s)
Compare with matched group: △ P＜0.05.Compare with model group: * * P＜0.01.Compare for 1 group with combination:
Experimental example four, anti-stress effect
Get Kunming mouse, male and female half and half, body weight 18～22g, random packet: (1) normal control group: give the isometric(al) normal saline; (2) positive group: Ginseng Bolus for tonifying spleen 2.0g/kg; (3) sample sets: gavage respectively for the high, medium and low dosage of test agent.Each group is irritated stomach and is given corresponding medicine, once a day, continuous five days, behind the 60min, mice is placed airtight wide mouthed bottle (built-in sodica calx 20g) after the last administration.The time-to-live of record mice.A t check will be organized between each administration group.
Experimental result shows: with model group relatively, the present composition (combination 1) but high, middle dosage group significant prolongation mice normobaric hypoxia time-to-live (P＜0.05) show that the present composition has tangible anti-stress effect.Present composition group (combination 1) is high, middle dosage group significantly is better than and other combined sample (combination 2～combination 8) corresponding dosage group (P＜0.05), and middle dosage group the results are shown in Table 4.
Table 4 pair mice normal pressure resistant anoxia effect (X ± s)
Compare with matched group: * P＜0.05.Compare for 1 group with combination:
The present invention's research also adopts serial effect experiment to investigate the pharmacologically active of the compositions of volatile oil and ethanol extraction, thick decocting liquid (traditional decoction) etc.Experimental technique is equal to described herein.Results suggest: aspect effects such as rehabilitation Mice with Spleen sign, adjusting bowel movement, the dysfunction of adjusting rat gastrointestinal tract, pain relieving, resisting fatigue, anti-hypoxia, anti-stress, the combination at bighead atractylodes rhizome volatile oil part and water extraction position (the present invention's combination) significantly is better than the combination (P＜0.05, P＜0.01) of any volatile oil part and alcohol extract part.The combination at bighead atractylodes rhizome volatile oil part and water extraction position (the present invention's combination) significantly is better than thick decocting liquid (traditional decoction) (P＜0.05, P＜0.01).
Therefore the Rhizoma Atractylodis Macrocephalae volatile oil part partly makes up with water extract among the present invention program, significantly is better than the pharmacological effect of the independent use in arbitrary position or other combination, and prioritization scheme will produce beyond thought effect.
The present invention discovers: adopt an amount of cyclodextrin in the compositions, (1) can improve the uniformity of compositions, makes volatile oil mix more even with water extraction position product.(2) can significantly improve the character of compositions, increase flowability, dispersibility and the mouldability of compositions, the viscosity that effectively solves water extract is big, easily the moisture absorption, preparation need difficult problems such as the adjuvant amount is big.Helping compositions further prepares the various kinds of drug preparation or is applied to various medication preparation.(3) stability of raising volatile oil main active atractylone.Above result has significantly improved the character of compositions, is applicable to the preparation of various kinds of drug, and guarantees the quality of compositions.Following experimental example adopts the present invention program's method parameter to prepare different solid composites, investigates the influence of cyclodextrin to compositions.Experimental technique is equal to described herein.Results suggest: at aspects such as the appearance character of compositions, preparation adaptability, atractylone stability, " beta cyclodextrin+Rhizoma Atractylodis Macrocephalae volatile oil+water extract combination " has significant advantage.
Table 5 cyclodextrin is to the influence of compositions character and stability
| Compositions | Character | The preparation adaptability | Room temperature is placed atractylone inspection after 3 months |
| Rhizoma Atractylodis Macrocephalae volatile oil+water extract+beta cyclodextrin | Powder surface is even, color and luster is consistent, good fluidity. | Compositions adding 20～25% microcrystalline Cellulose can be granulated smoothly, tabletting. | Qualitative detecting |
| Rhizoma Atractylodis Macrocephalae volatile oil+water extract+pregelatinized Starch (with beta cyclodextrin equivalent) | Powder body has caking, and color and luster is deep mixed. | Compositions adds 20～25% microcrystalline Cellulose, and viscosity is excessive, still can't granulate. | Do not detect |
| Rhizoma Atractylodis Macrocephalae volatile oil+water extract | Powder body has caking, and color and luster is deep mixed, and is mobile poor. | Compositions adds 20～25% microcrystalline Cellulose, and excessive, the poor compressibility of viscosity can't pelletizing press sheet. | Do not detect |
On the basis of a large amount of preclinical studies, select some courses of disease to try out in the irritable bowel syndrome case more than 6 months.The result shows: each is organized medication and there is no obvious adverse reaction.The present composition can significantly improve the IBS clinical symptoms: stomachache and malaise symptoms significantly reduce, and function of intestinal canal improves (comprise that times of defecation is normal, the stool character is improved), and effect is better.The total effective rate of the present composition (more than 80%) is significantly higher than the total effective rate (below 60%) of other compositions or decoction.
Two, the technology of preparing Parameter Optimization will produce beyond thought drug effect effect.The technology of preparing parameter of optimizing among the present invention program significantly improves in the extract must measuring of main effective ingredient atractylone, peoniflorin, saikoside, glycyrrhizic acid, can obviously increase the volatile oil yield, reduce the water extracted immersing paste yield, thereby guarantee pharmacological effect and help the pharmaceutical dosage form preparation.
Following experimental example can illustrate advantage of the present invention, and the present invention program's preparation method and parameter all have effect same.
The medicine material combination:
Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, Rhizoma Chuanxiong 6 grams, the Rhizoma Atractylodis Macrocephalae 9 grams, Poria 9 grams, Radix Glycyrrhizae 6 grams, Radix Pseudostellariae 6 grams.
Sample preparation methods:
The present invention program: get recipe quantity Rhizoma Atractylodis Macrocephalae medicinal material coarse powder, the water logging that adds 8 times of amounts was steeped 3 hours, 6 hours volatile oil of water vapour distillation, and volatile oil adds the beta-schardinger dextrin-of 6 times of amounts (w/w), grinds 20min, and 50 ℃ of vacuum dryings are standby; The medicinal residues that other medicinal raw materials of recipe quantity were soaked 4 hours and extracted behind the volatile oil merge, and decoct and extract 2 times, each 1.5 hours, 10 times of water, merge extractive liquid, filters, being evaporated to relative density is 1.09 (60 ℃), 4 ℃ left standstill 12 hours, and 20000 rev/mins centrifugal, and being evaporated to relative density is 1.15 (60 ℃), spray drying obtains extract powder, and is standby.
The parameter option A: get recipe quantity Rhizoma Atractylodis Macrocephalae medicinal material coarse powder, the water logging that adds 12 times of amounts was steeped 1 hour, 10 hours volatile oil of water vapour distillation, and volatile oil adds the beta-schardinger dextrin-of 3 times of amounts (w/w), grinds 30min, and 60 ℃ of vacuum dryings are standby; All the other same the present invention program.Medicinal residues behind the extraction volatile oil and other medical materials of described share are soaked the back and are decocted extraction, and medicinal raw material soaked 1 hour; 6 times of water; Extract 3 times; Each 0.5 hour.Merge extractive liquid, filters, and merge extractive liquid, filters, and being evaporated to relative density is 1.01 (60 ℃), and 6000 rev/mins centrifugal, and being evaporated to relative density is 1.12 (60 ℃), and spray drying obtains extract powder, and is standby.
The parameter option b: get recipe quantity Rhizoma Atractylodis Macrocephalae medicinal material coarse powder, the water logging that adds 4 times of amounts was steeped 6 hours, 1.5 hours volatile oil of water vapour distillation, and volatile oil adds the beta-schardinger dextrin-of 10 times of amounts (w/w), grinds 40min, and 50 ℃ of vacuum dryings are standby.Medicinal residues behind the extraction volatile oil and other medical materials of described share are soaked the back and are decocted extraction, and medicinal raw material soaked 6 hours; 14 times of water; Extract 1 time; Each 2.5 hours.Merge extractive liquid, filters, and merge extractive liquid, filters, and being evaporated to relative density is 1.13 (60 ℃), and 3000 rev/mins centrifugal, and being evaporated to relative density is 1.10 (60 ℃), and spray drying obtains extract powder, and is standby.
Measure must measuring of atractylone in the extract, peoniflorin, saikoside, glycyrrhizic acid.The weight that must measure content (the %) * extract that equals index components in the extract of index components the results are shown in Table 6.
The assay of atractylone adopts gas chromatography in the described volatile oil, analysis condition: quartz capillary column (30m * 0.25mm, 0.25 μ m).7% diphenyl, 93% dimethyl arlydene silicone copolymers, the temperature programming condition: 70 ℃ of initial temperatures, the speed with 10 ℃/min behind the maintenance 3min is warming up to 290 ℃ of constant temperature 15min, the vaporizer temperature: 240 ℃, carrier gas: high-purity He, flow: 1.2ml/min.
The mensuration that peoniflorin must be measured in the described extract adopts high performance liquid chromatography, essential condition: adopting octadecylsilane bonding phase silica gel is filler, and methanol-water-glacial acetic acid (35: 65: 0.1) is a mobile phase, detects wavelength: 230nm.
The mensuration that saikoside a must be measured in the described extract adopts high performance liquid chromatography, essential condition: adopting octadecylsilane bonding phase silica gel is filler, and acetonitrile-water (34: 66) is a mobile phase, detects wavelength: 210nm.
The mensuration that glycyrrhizic acid must be measured in the described extract adopts high performance liquid chromatography, and essential condition is: adopting octadecylsilane bonding phase silica gel is filler, and methanol-0.2mol/L ammonium acetate-acetic acid (67: 33: 1) is mobile phase, detects wavelength: 250nm.
The influence that the different preparation parameters of table 6 must be measured extract and index components
Three, the optimization of raw medicinal material ratio will produce beyond thought effect.
The present invention discovers: Radix Bupleuri, in the compound recipe that the Radix Paeoniae Alba, the Rhizoma Atractylodis Macrocephalae, Poria, Rhizoma Chuanxiong, Radix Glycyrrhizae, crown prince's SHENQI flavor are formed, the part by weight of Radix Bupleuri, the Radix Paeoniae Alba, the Rhizoma Atractylodis Macrocephalae, Poria four Chinese medicine material raw material and other three flavors medicinal raw material Radix Glycyrrhizae, Radix Pseudostellariae, Rhizoma Chuanxiong changes and will mainly contain effective component content and drug effect in the appreciable impact present composition.Prioritization scheme is: Radix Bupleuri 9-12g, Radix Paeoniae Alba 9-12g, Rhizoma Atractylodis Macrocephalae 9-12g, Poria 12-9g, Radix Glycyrrhizae 6-3g, Radix Pseudostellariae 6-3g, Rhizoma Chuanxiong 6-3g.By optimizing the part by weight of medical material, the present composition has significant more pharmacological action and reliable clinical efficacy.
Though application number is 03112782.7 patent of invention to be disclosed this seven flavor medicine thing and be used for the treatment of irritable bowel syndrome, the ratio that the present invention proposes raw material changes can make the active constituent content of the present composition and drug effect that beyond thought variation is arranged.
Following experimental example can illustrate advantage of the present invention, and the present invention program's proportioning raw materials all has effect same.
The medicine material combination:
The medicinal raw material proportioning of the present composition: Radix Bupleuri 9g, Radix Paeoniae Alba 9g, Rhizoma Atractylodis Macrocephalae 9g, Poria 9g Radix Glycyrrhizae 6g, Radix Pseudostellariae 6g, Rhizoma Chuanxiong 6g
Medicinal raw material proportioning A: Radix Bupleuri 6g, Radix Paeoniae Alba 6g, Rhizoma Atractylodis Macrocephalae 6g, Poria 6g, Rhizoma Chuanxiong 6g, Radix Glycyrrhizae 6g, Radix Pseudostellariae 6g
Medicinal raw material proportioning B: Radix Bupleuri 9g, Radix Paeoniae Alba 9g, Rhizoma Atractylodis Macrocephalae 9g, Poria 9g, Rhizoma Chuanxiong 2g, Radix Glycyrrhizae 2g, Radix Pseudostellariae 2g
Medicinal raw material proportioning C: Radix Bupleuri 9, the Radix Paeoniae Alba 9, the Rhizoma Atractylodis Macrocephalae 9, Poria 9, Rhizoma Chuanxiong 6, Radix Glycyrrhizae 6
Medicinal raw material proportioning D: Radix Bupleuri 9g, Radix Paeoniae Alba 9g, Radix Glycyrrhizae 6g, Radix Pseudostellariae 6g
Preparation method: get recipe quantity Rhizoma Atractylodis Macrocephalae medicinal material coarse powder, the water logging that adds 8 times of amounts was steeped 3 hours, 6 hours volatile oil of water vapour distillation, and volatile oil adds the beta-schardinger dextrin-of 6 times of amounts (w/w), grinds 20min, and 50 ℃ of vacuum dryings are standby; Other medicinal raw materials of recipe quantity were soaked 4 hours, merge with the medicinal residues behind the extraction volatile oil, decoct and extract each 1.5 hours 2 times, 10 times of water, merge extractive liquid, filters, and being evaporated to relative density is 1.09 (60 ℃), 4 ℃ left standstill 12 hours, 20000 rev/mins centrifugal, and being evaporated to relative density is 1.15 (60 ℃), and spray drying obtains extract powder.Volatile ingredient part, water extraction part in the compositions are fully mixed, be made into debita spissitudo with distilled water on demand, standby.
Adopt a plurality of effect experiments to investigate the pharmacological effect that different ratios of raw materials prepares compositions.Dosage is the same.
1, to the Different Effects research of mice with spleen deficiency
Experimental technique, experiment reagent medicine, animal etc. are the same.The result shows: compare with model group, medicinal raw material proportioning combination object height of the present invention, middle dosage group can obviously be improved above-mentioned insufficiency of the spleen sign, significantly increase body weight, increase mice with spleen deficiency spleen index, the thymus index (P＜0.05) of mice with spleen deficiency, illustrate that pharmaceutical composition of the present invention can obviously improve the Mice with Spleen sign, the spleen-deficient mice there is the rehabilitation effect, regulates the gastrointestinal function.And medicinal raw material proportioning of the present invention makes up object height, middle dosage group significantly is better than and medicinal raw material proportioning compositions A～D organizes (P＜0.05).
2, to the different adjustment effect of intestine movement function
Experimental technique, experiment reagent, medicine, animal etc. are the same.Experimental result shows: compare with model group, present composition height, middle dosage group can obviously suppress the mouse small intestine hyperfunctioning (P＜0.05) that the neostigmine load causes, improve the mouse small intestine function that atropine causes and be subjected to press down state (P＜0.05), point out it that intestinal function is had dual regulation.And medicinal raw material proportioning combination object height of the present invention, middle dosage group significantly are better than medicinal raw material proportioning A～D and organize (P＜0.05).
3, to the different adjustment effect of the rat gastrointestinal tract dysfunction due to the reserpine
Experimental technique, experiment reagent medicine, animal etc. are the same.Experimental result shows: diarrhoea, appetite that the model group rat occurs behind the injection reserpine in various degree successively descend, feces viscous, even constipation, anorexia appear, become thin and day by day increase the weight of (P＜0.05, P＜0.01).With model group relatively, the body weight of medicinal raw material proportioning compositions group rat of the present invention, food ration, thymus index, spleen index, motilin in plasma, jejunum homogenate MTL decline state all significantly improve (P＜0.05, P＜0.01).And medicinal raw material proportioning combination object height of the present invention, middle dosage group significantly are better than medicinal raw material proportioning A～D and organize (P＜0.05).
4, anti-stress effect research
Experimental technique, experiment reagent medicine, animal etc. are the same.Experimental result shows: with model group relatively, but present composition height, middle dosage group significant prolongation mice normobaric hypoxia time-to-live (P＜0.05) shows that the present composition has tangible anti-stress effect.And medicinal raw material proportioning combination object height of the present invention, middle dosage group significantly are better than medicinal raw material proportioning A～D and organize (P＜0.05).
Table 7 proportioning raw materials is to the influence of pharmacological action
| The medicinal raw material proportioning | Restitution to mice with spleen deficiency thymus index, spleen index | Restitution to gastrointestinal disturbance rat MTL | Adjusting restitution to intestine movement function | Chemistry is caused the analgesic activity of pain mice |
| Medicinal raw material proportioning of the present invention | ??+++ | ??+++ | ??+++ | ??+++ |
| Medicinal raw material proportioning A | ??- | ??+ | ??+ | ??- |
| Medicinal raw material proportioning B | ??+ | ??+ | ??- | ??+ |
| Medicinal raw material proportioning C | ??+ | ??- | ??+ | ??+ |
| Medicinal raw material proportioning D | ??- | ??+ | ??- | ??+ |
+: showing has obvious effect, and the effect degree strengthens with plus sige quantity.-: showing does not have obviously effect.
Must measuring of peoniflorin in the extract, saikoside, glycyrrhizic acid measured in this research.The weight that must measure content (the %) * extract that equals index components in the extract of index components.Assay method is the same, and the result shows that the present invention program's Chinese crude drug proportioning raw materials is better than other proportioning raw materials A～D.
The influence that table 8 proportioning raw materials must be measured index components in the extract
The specific embodiment
Embodiment 1. treatment gastrointestinal dysfunctions of the present invention and the compositions of irritable bowel syndrome and the preparation of preparation thereof.
Enlarging dose in following prescription ratio gets it filled standby: Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, the Rhizoma Atractylodis Macrocephalae 9 grams, Poria 9 grams, Radix Glycyrrhizae 6 grams, Radix Pseudostellariae 6 grams, Rhizoma Chuanxiong 6 grams.Get the Rhizoma Atractylodis Macrocephalae and be ground into coarse powder, the water logging that adds 8 times of amounts was steeped 3 hours, and 6 hours volatile oil of water vapour distillation is collected volatile oil, and medicinal liquid filters, and is standby.Other medical materials were soaked 4 hours in the prescription, merge with the Rhizoma Atractylodis Macrocephalae medicinal residues behind the extraction volatile oil, extract twice, each 1.5 hours, 10 times water, merge medicinal liquid, being concentrated into relative density is 1.09 (60 ℃), leaves standstill, and 20000 rev/mins centrifugal, get the supernatant concentrating under reduced pressure and (0.1Mpa) to relative density be 1.15 extractum, spray drying gets extract powder, and is standby.Get above volatile oil, add 6 times of beta cyclodextrins, grind 15min with colloid mill, standby behind the abrasive material vacuum drying.Above-mentioned volatile oil part, water extraction are partly added an amount of dextrin, magnesium stearate, and mixing granulation is made tablet.
The compositions of embodiment 2. treatment irritable bowel syndromes of the present invention and the preparation of preparation thereof.
Enlarging dose in following prescription ratio gets it filled standby: Radix Bupleuri 12 grams, the Radix Paeoniae Alba 12 grams, the Rhizoma Atractylodis Macrocephalae 12 grams, Poria 12 grams, Radix Glycyrrhizae 6 grams, Radix Pseudostellariae 6 grams, Rhizoma Chuanxiong 6 grams.Get the Rhizoma Atractylodis Macrocephalae and be ground into coarse powder, the water logging that adds 8 times of amounts was steeped 3 hours, and 6 hours volatile oil of water vapour distillation is collected volatile oil, and medicinal liquid filters, and is standby.Other medical materials of described share were soaked 4 hours, and the Rhizoma Atractylodis Macrocephalae medicinal residues merging with behind the extraction volatile oil decocts and extracts twice, each 1.5 hours, 10 times water merge medicinal liquid, filter, be concentrated into every milliliter and contain the 0.4g crude drug, centrifugal, get supernatant, adsorb by the D101 macroporous adsorbent resin, 50～80% ethanol-eluting resin columns, collect ethanol elution, be evaporated to relative density and be 1.30 extractum, standby.Get above volatile oil, add 6 times of amount beta cyclodextrins, grind 30min with colloid mill, standby behind the abrasive material vacuum drying.Above-mentioned volatile oil part, water extraction are partly added an amount of dextrin, Icing Sugar, and mixing granulation is made granule.
The compositions of embodiment 3 treatment irritable bowel syndromes of the present invention and the preparation of preparation thereof.
Enlarging dose in following prescription ratio gets it filled standby: Radix Bupleuri 12 grams, the Radix Paeoniae Alba 12 grams, the Rhizoma Atractylodis Macrocephalae 12 grams, Poria 12 grams, Radix Glycyrrhizae 6 grams, Radix Pseudostellariae 6 grams, Rhizoma Chuanxiong 6 grams.Get the Rhizoma Atractylodis Macrocephalae and be ground into coarse powder, the water logging that adds 8 times of amounts was steeped 3 hours, extracted 6 hours volatile oil, collected volatile oil, and medicinal liquid filters, and is standby.Other medical materials were soaked 4 hours in the prescription, with the Rhizoma Atractylodis Macrocephalae medicinal residues merging behind the extraction volatile oil, extracted twice, each 1.5 hours, 10 times water, and merge extractive liquid, filters, and is concentrated into every milliliter and contains the 0.1g crude drug, and is centrifugal, gets supernatant, through 0.2 μ m AL
2O
3(it is 1.15 extractum that filtrate decompression is concentrated into relative density to the inorganic ceramic membrane microfiltration, standby for 30 ℃ of temperature, operating pressure 0.15～0.20Mpa).Get above volatile oil, add 8 times of amount beta cyclodextrins, grind 20min with colloid mill, standby behind the abrasive material vacuum drying.Above-mentioned volatile oil part, water extraction are partly added an amount of adding PEG, the preparation soft capsule.
Embodiment 4 is substantially the same manner as Example 1, but the raw material of Chinese medicine proportioning of compositions is Radix Bupleuri 12 grams, the Radix Paeoniae Alba 12 grams, the Rhizoma Atractylodis Macrocephalae 12 grams, Poria 12 grams, Radix Glycyrrhizae 6 grams, Radix Pseudostellariae 6 grams, Rhizoma Chuanxiong 6 grams.Said composition adds microcrystalline Cellulose, lactose, the preparation capsule.All the other are with embodiment 1.
Embodiment 5 is substantially the same manner as Example 1, but the raw material of Chinese medicine proportioning of compositions is Radix Bupleuri 10 grams, the Radix Paeoniae Alba 10 grams, and the Rhizoma Atractylodis Macrocephalae 10 grams, Poria 10 grams, Radix Glycyrrhizae 6 grams, Radix Pseudostellariae 6 grams, Rhizoma Chuanxiong 6 grams, said composition adds Mel, sucrose, the preparation pill.All the other are with embodiment 1.
Embodiment 6 is substantially the same manner as Example 1, but the raw material of Chinese medicine proportioning of compositions is Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, and the Rhizoma Atractylodis Macrocephalae 9 grams, Poria 9 grams, Radix Glycyrrhizae 5 grams, Radix Pseudostellariae 5 grams, Rhizoma Chuanxiong 5 grams, said composition adds Polyethylene Glycol (PEG), the preparation drop pill.All the other are with embodiment 1.
Embodiment 7 is substantially the same manner as Example 1, but the raw material of Chinese medicine proportioning of compositions is Radix Bupleuri 10 grams, the Radix Paeoniae Alba 10 grams, and the Rhizoma Atractylodis Macrocephalae 10 grams, Poria 10 grams, Radix Glycyrrhizae 5 grams, Radix Pseudostellariae 5 grams, Rhizoma Chuanxiong 5 grams, said composition adds sucrose, starch, the preparation pellet.All the other are with embodiment 1.
Embodiment 8 is substantially the same manner as Example 1, but the raw material of Chinese medicine proportioning of compositions is Radix Bupleuri 11 grams, the Radix Paeoniae Alba 11 grams, and the Rhizoma Atractylodis Macrocephalae 11 grams, Poria 11 grams, Radix Glycyrrhizae 5 grams, Radix Pseudostellariae 5 grams, Rhizoma Chuanxiong 5 grams, said composition adds liquid paraffin, preparation Emulsion.All the other are with embodiment 1.
Embodiment 9 is substantially the same manner as Example 1, but the raw material of Chinese medicine proportioning of compositions is Radix Bupleuri 12 grams, the Radix Paeoniae Alba 12 grams, and the Rhizoma Atractylodis Macrocephalae 12 grams, Poria 12 grams, Radix Glycyrrhizae 5 grams, Radix Pseudostellariae 5 grams, Rhizoma Chuanxiong 5 grams, all the other are with embodiment 1.
Embodiment 10 is substantially the same manner as Example 1, but the raw material of Chinese medicine proportioning of compositions is Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, and the Rhizoma Atractylodis Macrocephalae 9 grams, Poria 9 grams, Radix Glycyrrhizae 4 grams, Radix Pseudostellariae 4 grams, Rhizoma Chuanxiong 4 grams, said composition adds microcrystalline Cellulose, lactose, the preparation capsule.All the other are with embodiment 1.
Embodiment 11 is substantially the same manner as Example 1, but the raw material of Chinese medicine proportioning of compositions is Radix Bupleuri 10 grams, the Radix Paeoniae Alba 10 grams, and the Rhizoma Atractylodis Macrocephalae 10 grams, Poria 10 grams, Radix Glycyrrhizae 4 grams, Radix Pseudostellariae 4 grams, Rhizoma Chuanxiong 4 grams, all the other are with embodiment 1.
Embodiment 12 is substantially the same manner as Example 1, but the raw material of Chinese medicine proportioning of compositions is Radix Bupleuri 12 grams, the Radix Paeoniae Alba 12 grams, and the Rhizoma Atractylodis Macrocephalae 12 grams, Poria 12 grams, Radix Glycyrrhizae 4 grams, Radix Pseudostellariae 4 grams, Rhizoma Chuanxiong 4 grams, said composition adds Polyethylene Glycol (PEG), preparation suppository.All the other are with embodiment 1.
Embodiment 13 is substantially the same manner as Example 1, but the raw material of Chinese medicine proportioning of compositions is Radix Bupleuri 12 grams, the Radix Paeoniae Alba 12 grams, and the Rhizoma Atractylodis Macrocephalae 12 grams, Poria 12 grams, Radix Glycyrrhizae 3 grams, Radix Pseudostellariae 3 grams, Rhizoma Chuanxiong 3 grams, all the other are with embodiment 1.
Embodiment 14 is substantially the same manner as Example 2, but the raw material of Chinese medicine proportioning of compositions is Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, the Rhizoma Atractylodis Macrocephalae 9 grams, Poria 9 grams, Radix Glycyrrhizae 6 grams, Radix Pseudostellariae 6 grams, Rhizoma Chuanxiong 6 grams.Said composition adds sweeting agent, the preparation oral liquid.All the other are with embodiment 2.
Embodiment 15 is substantially the same manner as Example 2, but the raw material of Chinese medicine proportioning of compositions is Radix Bupleuri 11 grams, the Radix Paeoniae Alba 11 grams, and the Rhizoma Atractylodis Macrocephalae 11 grams, Poria 11 grams, Radix Glycyrrhizae 6 grams, Radix Pseudostellariae 6 grams, Rhizoma Chuanxiong 6 grams, one of said composition component is the methyl beta cyclodextrin; Said composition adds crosslinked polypropylene diluted acid resin, the preparation gel.All the other are with embodiment 2.
Embodiment 16 is substantially the same manner as Example 2, but the raw material of Chinese medicine proportioning of compositions is Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, and the Rhizoma Atractylodis Macrocephalae 9 grams, Poria 9 grams, Radix Glycyrrhizae 5 grams, Radix Pseudostellariae 5 grams, Rhizoma Chuanxiong 5 grams, said composition adds white vaseline and prepares ointment.All the other are with embodiment 2.
Embodiment 17 is substantially the same manner as Example 2, but the raw material of Chinese medicine proportioning of compositions is Radix Bupleuri 10 grams, the Radix Paeoniae Alba 10 grams, the Rhizoma Atractylodis Macrocephalae 10 grams, Poria 10 grams, Radix Glycyrrhizae 5 grams, Radix Pseudostellariae 5 grams, Rhizoma Chuanxiong 5 grams; One of said composition component is a hydroxypropyl beta cyclodextrin; Said composition adds the Lip river and moors husky nurse, the preparation injection.All the other are with embodiment 2.
Embodiment 18 is substantially the same manner as Example 2, but the raw material of Chinese medicine proportioning of compositions is Radix Bupleuri 11 grams, the Radix Paeoniae Alba 11 grams, and the Rhizoma Atractylodis Macrocephalae 11 grams, Poria 11 grams, Radix Glycyrrhizae 5 grams, Radix Pseudostellariae 5 grams, Rhizoma Chuanxiong 5 grams, all the other are with embodiment 2.
Embodiment 19 is substantially the same manner as Example 2, but the raw material of Chinese medicine proportioning of compositions is Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, and the Rhizoma Atractylodis Macrocephalae 9 grams, Poria 9 grams, Radix Glycyrrhizae 4 grams, Radix Pseudostellariae 4 grams, Rhizoma Chuanxiong 4 grams, all the other are with embodiment 2.
Embodiment 20 is substantially the same manner as Example 2, but the raw material of Chinese medicine proportioning of compositions is Radix Bupleuri 10 grams, the Radix Paeoniae Alba 10 grams, and the Rhizoma Atractylodis Macrocephalae 10 grams, Poria 10 grams, Radix Glycyrrhizae 4 grams, Radix Pseudostellariae 4 grams, Rhizoma Chuanxiong 4 grams, all the other are with embodiment 2.
Embodiment 21 is substantially the same manner as Example 2, but the raw material of Chinese medicine proportioning of compositions is Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, and the Rhizoma Atractylodis Macrocephalae 9 grams, Poria 9 grams, Radix Glycyrrhizae 3 grams, Radix Pseudostellariae 3 grams, Rhizoma Chuanxiong 3 grams, all the other are with embodiment 2.
Embodiment 22 is substantially the same manner as Example 2, but the raw material of Chinese medicine proportioning of compositions is Radix Bupleuri 11 grams, the Radix Paeoniae Alba 11 grams, the Rhizoma Atractylodis Macrocephalae 11 grams, Poria 11 grams, Radix Glycyrrhizae 3 grams, Radix Pseudostellariae 3 grams, Rhizoma Chuanxiong 3 grams; One of said composition component is the sulfobutyl ether beta cyclodextrin; All the other are with embodiment 2.
Embodiment 23 is substantially the same manner as Example 2, but the raw material of Chinese medicine proportioning of compositions is Radix Bupleuri 12 grams, the Radix Paeoniae Alba 12 grams, and the Rhizoma Atractylodis Macrocephalae 12 grams, Poria 12 grams, Radix Glycyrrhizae 3 grams, Radix Pseudostellariae 3 grams, Rhizoma Chuanxiong 3 grams, all the other are with embodiment 2.
Embodiment 24 is substantially the same manner as Example 3, but the raw material of Chinese medicine proportioning of compositions is Radix Bupleuri 9 grams, the Radix Paeoniae Alba 9 grams, and the Rhizoma Atractylodis Macrocephalae 9 grams, Poria 9 grams, Radix Glycyrrhizae 6 grams, Radix Pseudostellariae 6 grams, Rhizoma Chuanxiong 6 grams, all the other are with embodiment 3.
Embodiment 25 is substantially the same manner as Example 3, but the raw material of Chinese medicine proportioning of compositions is Radix Bupleuri 12 grams, the Radix Paeoniae Alba 12 grams, and the Rhizoma Atractylodis Macrocephalae 12 grams, Poria 12 grams, Radix Glycyrrhizae 4 grams, Radix Pseudostellariae 4 grams, Rhizoma Chuanxiong 4 grams, all the other are with embodiment 3.
Embodiment 26 is substantially the same manner as Example 3, but the raw material of Chinese medicine proportioning of compositions is Radix Bupleuri 11 grams, the Radix Paeoniae Alba 11 grams, and the Rhizoma Atractylodis Macrocephalae 11 grams, Poria 11 grams, Radix Glycyrrhizae 3 grams, Radix Pseudostellariae 3 grams, Rhizoma Chuanxiong 3 grams, all the other are with embodiment 3.
Embodiment 27 is substantially the same manner as Example 1, steeps 2 hours but Rhizoma Atractylodis Macrocephalae coarse powder adds the water logging of 6 times of amounts, extracts 2 hours volatile oil.Other medical materials were soaked 2 hours in the prescription, extracted twice, each 1 hour, 8 times water, merge medicinal liquid, being concentrated into relative density is 1.06 (60 ℃), leaves standstill, 8000 rev/mins centrifugal, and getting supernatant, to be evaporated to relative density be 1.14 extractum, and all the other are with embodiment 1.
Embodiment 28 is substantially the same manner as Example 1, steeps 4 hours but Rhizoma Atractylodis Macrocephalae coarse powder adds the water logging of 10 times of amounts, extracts 4 hours volatile oil.Other medical materials were soaked 3 hours in the prescription, extracted twice, each 2 hours, 9 times water, merge medicinal liquid, being concentrated into relative density is 1.10 (60 ℃), leaves standstill, 10000 rev/mins centrifugal, and getting supernatant, to be evaporated to relative density be 1.30 extractum, vacuum drying.All the other are with embodiment 1.
Embodiment 28 is substantially the same manner as Example 1, is 1.08 (60 ℃) but extracting solution is concentrated into relative density, leaves standstill, and 8000 rev/mins centrifugal, and getting supernatant, to be evaporated to relative density be 1.20 extractum.All the other are with embodiment 1.
Embodiment 29 is substantially the same manner as Example 1, but adopts CO2 supercritical extraction extraction equipment to extract Rhizoma Atractylodis Macrocephalae volatile oil.Extracting pressure 30MPa, 40 ℃ of extraction temperature are resolved pressure 7MPa, resolution temperature: 40 ℃.CO2 flow 27L/h, extraction 100min.Collect Rhizoma Atractylodis Macrocephalae volatile oil.All the other are with embodiment 1.
Embodiment 30 is substantially the same manner as Example 2, contains the 0.2g crude drug but extracting solution is concentrated into every milliliter, and is centrifugal, gets supernatant, adsorbs by the HP20 macroporous resin, and it is 1.14 extractum that ethanol elution is evaporated to relative density, and all the other are with embodiment 2.
Embodiment 31 is substantially the same manner as Example 2, but aqueous extract is concentrated into every milliliter contains the 0.3g crude drug, centrifugal, get supernatant, adsorb by the AB-8 macroporous resin, it is 1.30 extractum that ethanol elution is evaporated to relative density, adopts the beta cyclodextrin of 8 times of amounts to handle volatile oil, and all the other are with embodiment 2.
Embodiment 32 is substantially the same manner as Example 3, contains the 0.05g crude drug but aqueous extract is concentrated into every milliliter, and is centrifugal, gets supernatant, through 0.05 μ m AL
2O
3(it is that 1.14 extractum is standby that filtrate decompression is concentrated into relative density to the inorganic ceramic membrane microfiltration for 30 ℃ of temperature, operating pressure 0.15～0.20Mpa).Volatile oil adds 4 times of amount beta cyclodextrins, grinds 10min with colloid mill, and standby behind the abrasive material vacuum drying, all the other are with embodiment 3.
Embodiment 33 is substantially the same manner as Example 3, contains the 0.1g crude drug but aqueous extract is concentrated into every milliliter, and is centrifugal, gets supernatant, through 0.1 μ m AL
2O
3(it is that 1.30 extractum is standby that filtrate decompression is concentrated into relative density to the inorganic ceramic membrane microfiltration for 30 ℃ of temperature, operating pressure 0.15～0.20Mpa).Volatile oil adds 8 times of amount beta cyclodextrins, grinds 30min with colloid mill, and standby behind the abrasive material microwave drying, all the other are with embodiment 3.
Embodiment 34 is substantially the same manner as Example 3, and is substantially the same manner as Example 1, but adopts CO2 supercritical extraction extraction equipment to extract Rhizoma Atractylodis Macrocephalae volatile oil.Extracting pressure 35MPa, 45 ℃ of extraction temperature are resolved pressure 10MPa, resolution temperature: 45 ℃.CO2 flow 33L/h, extraction 150min.Collect Rhizoma Atractylodis Macrocephalae volatile oil.All the other are with embodiment 3.
Claims (10)
1. Chinese medicine extraction compositions for the treatment of gastrointestinal dysfunction or irritable bowel syndrome, the raw material of said composition is made up of following medical material:
Radix Bupleuri 9～12 grams, the Radix Paeoniae Alba 9～12 grams, the Rhizoma Atractylodis Macrocephalae 9～12 grams, Poria 9～12 grams, Radix Glycyrrhizae 3～6 grams, Radix Pseudostellariae 3～6 grams, Rhizoma Chuanxiong 3～6 grams;
It is characterized in that described each component is to adopt extracts of bulk drugs, wherein, the volatile oil of the described Rhizoma Atractylodis Macrocephalae becomes component one; The Rhizoma Atractylodis Macrocephalae medicinal residues behind the extraction volatile oil and the water extract of other medical materials become component two; Cyclodextrin is an amount of, becomes component three.
2. the Chinese medicine extraction compositions of treatment gastrointestinal dysfunction according to claim 1 or irritable bowel syndrome is characterized in that, the Rhizoma Atractylodis Macrocephalae medicinal residues behind the extraction volatile oil of described component two and the water extract of other medical materials are meant:
Extract the Rhizoma Atractylodis Macrocephalae medicinal residues behind the volatile oil and the decocting liquid of other medical materials, be concentrated into relative density and be 1.14～1.30 extractum, become component two after directly becoming component two or drying; Or
The Rhizoma Atractylodis Macrocephalae medicinal residues behind the extraction volatile oil and the decocting liquid of other medical materials, be concentrated into every milliliter of supernatant that contains 0.2～0.4g crude drug, macroporous adsorbent resin by nonpolar or low pole adsorbs, 50～80% ethanol-eluting resin columns, it is 1.14～1.30 extractum that ethanol elution is concentrated into relative density, becomes component two after directly becoming component two or drying; Or
The Rhizoma Atractylodis Macrocephalae medicinal residues behind the extraction volatile oil and the decocting liquid of other medical materials, be concentrated into every milliliter of supernatant that contains 0.05g～0.1g crude drug, through 0.05～0.2 μ m inorganic ceramic membrane microfiltration, it is 1.14～1.30 extractum that filtrate decompression is concentrated into relative density, becomes component two after directly becoming component two or drying.
3. the Chinese medicine extraction compositions of treatment gastrointestinal dysfunction according to claim 1 or irritable bowel syndrome is characterized in that, the weight ratio of described raw material is:
Radix Bupleuri 9～12 grams, the Radix Paeoniae Alba 9～12 grams, the Rhizoma Atractylodis Macrocephalae 9～12 grams, Poria 9～12 grams, Radix Glycyrrhizae 6 grams, Radix Pseudostellariae 6 grams, Rhizoma Chuanxiong 6 grams.
4. according to the Chinese medicine extraction compositions of claim 1 or 2 or 3 described treatment gastrointestinal dysfunctions or irritable bowel syndrome, it is characterized in that the concrete composition of described each component is:
(1), the Rhizoma Atractylodis Macrocephalae medical material of described share, add the water logging bubble 2～4 hours of 6～10 times of amounts, extract 2～6 hours volatile oil, become component one; Or the Rhizoma Atractylodis Macrocephalae medical material of described share, adopt supercritical carbon dioxide extraction: extracting pressure 30～35MPa, 40 ℃～45 ℃ of extraction temperature, carbon dioxide flow 27～33L/h, extraction time: 100～150min; Obtain Rhizoma Atractylodis Macrocephalae volatile oil, become component one;
(2), other medical materials of described share were soaked 2～4 hours, merge with the Rhizoma Atractylodis Macrocephalae medicinal residues behind the extraction volatile oil, decoct and extract twice, each 1～2 hour, 8～10 times water, merge extractive liquid,, filter, being concentrated into relative density is 1.06～1.10, leaves standstill, and 8000～20000 rev/mins centrifugal, be evaporated to relative density and be 1.14～1.30 extractum, become component two after directly becoming component two or drying; Or
Other medical materials of described share were soaked 2～4 hours, merge with the Rhizoma Atractylodis Macrocephalae medicinal residues behind the extraction volatile oil, decoct and extract twice, each 1～2 hour, 8～10 times water, merge extractive liquid,, filter, be concentrated into every milliliter and contain 0.2～0.4g crude drug, centrifugal, get supernatant, the macroporous adsorbent resin by nonpolar or low pole adsorbs, 50～80% ethanol-eluting resin columns, collect ethanol elution, be evaporated to relative density and be 1.14～1.30 extractum, become component two after directly becoming component two or drying; Or
Other medical materials of described share were soaked 2～4 hours, merge with the Rhizoma Atractylodis Macrocephalae medicinal residues behind the extraction volatile oil, decoct and extract twice, each 1～2 hour, 8～10 times water, merge extractive liquid,, filter, be concentrated into every milliliter and contain 0.05g～0.1g crude drug, centrifugal, get supernatant, through 0.2～0.05 μ m inorganic ceramic membrane microfiltration, it is 1.14～1.30 extractum that filtrate decompression is concentrated into relative density, becomes component two after directly becoming component two or drying;
(3), described cyclodextrin consumption is 4～8 times of volatile oil weight, becomes component three.
5. the Chinese medicine extraction compositions of treatment gastrointestinal dysfunction according to claim 4 or irritable bowel syndrome is characterized in that, the concrete composition of described each component is:
Atractylone content is 30%～70% in the volatile oil of described component one, and the weight yield of volatile oil is 0.5～2.5% of a Rhizoma Atractylodis Macrocephalae medical material weight;
Peoniflorin is 0.7%～5.5% in the weight content of dry extract in the water extract of described component two, and glycyrrhizic acid is 0.7%～5.0% in the weight content of dry extract; Water extract is 7%～28% of a medical material weight in the weight yield of dry extract.
6. the Chinese medicine extract preparation of compositions method of described treatment gastrointestinal dysfunction of claim 1 or irritable bowel syndrome is characterized in that step is as follows:
(1), it is standby to get raw medicinal material by following composition by weight:
Radix Bupleuri 9～12 grams, the Radix Paeoniae Alba 9～12 grams, the Rhizoma Atractylodis Macrocephalae 9～12 grams, Poria 9～12 grams, Radix Glycyrrhizae 3～6 grams, Radix Pseudostellariae 3～6 grams, Rhizoma Chuanxiong 3～6 grams;
(2), get the Rhizoma Atractylodis Macrocephalae, extraction volatile oil.Collect volatile oil, medicinal liquid filters, and is standby;
(3), Radix Bupleuri, the Radix Paeoniae Alba, Rhizoma Chuanxiong, Poria, Radix Glycyrrhizae, Radix Pseudostellariae soaks, and merges with Rhizoma Atractylodis Macrocephalae medicinal residues, water extraction filters; More than two filtered solutions merge to concentrate;
(4), refining and edulcoration, concentrate, extractum;
(5), get volatile oil and add an amount of cyclodextrin, uniform mixing, standby.
(6), extractum, the direct uniform mixing of volatile oil or dry respectively back mix, promptly.
7. the Chinese medicine extract preparation of compositions method of treatment gastrointestinal dysfunction according to claim 6 or irritable bowel syndrome is characterized in that the weight ratio of described raw material is:
Radix Bupleuri 9～12 grams, the Radix Paeoniae Alba 9～12 grams, the Rhizoma Atractylodis Macrocephalae 9～12 grams, Poria 9～12 grams, Radix Glycyrrhizae 6 grams, Radix Pseudostellariae 6 grams, Rhizoma Chuanxiong 6 grams.
8. according to the Chinese medicine extract preparation of compositions method of claim 6 or 7 described treatment gastrointestinal dysfunctions or irritable bowel syndrome, it is characterized in that concrete steps are:
It specifically is made up of following steps:
(1), get the Rhizoma Atractylodis Macrocephalae by the described quality component of claim 1, Radix Bupleuri, the Radix Paeoniae Alba, Rhizoma Chuanxiong, Poria, Radix Glycyrrhizae, Radix Pseudostellariae, standby;
(2), get Rhizoma Atractylodis Macrocephalae medical material, be ground into coarse powder or coarse powder, add the water logging bubble 2～4 hours of 6～10 times of amounts, the volatile oil that adopts steam distillation to extract 2～6 hours is collected volatile oil, aqueous extract filters, and is standby; Or
Get Rhizoma Atractylodis Macrocephalae medical material, suitably crushed after being dried becomes coarse powder or coarse powder, adopts supercritical carbon dioxide extraction device extraction Rhizoma Atractylodis Macrocephalae volatile oil, extracting pressure 30～35MPa, and extraction temperature 40 ℃～45 is resolved pressure 7～10MPa, resolution temperature: 40 ℃～45 ℃.CO2 flow 27～33L/h, the extraction time: 100～150min;
(3), the Radix Bupleuri of described share, the Radix Paeoniae Alba, Rhizoma Chuanxiong, Poria, Radix Glycyrrhizae, Radix Pseudostellariae was soaked 2～4 hours, merged with Rhizoma Atractylodis Macrocephalae medicinal residues, decoct and extract twice, each 1～2 hour, 8～10 times water, the gained extracting solution filters, and merges with Rhizoma Atractylodis Macrocephalae extracting solution;
(4), to be evaporated to relative density be 1.06～1.10 to above medicinal liquid, leaves standstill, 8000～20000 rev/mins are centrifugal, concentrating under reduced pressure, relative density is 1.14～1.30 extractum; Or
Above medicinal liquid is evaporated to every milliliter and contains 0.2～0.4g crude drug, leave standstill, get supernatant, the macroporous adsorbent resin by nonpolar or low pole adsorbs, after absorption finishes, water flushing resin column, to nearly colourless the ending of water lotion, and then, collect ethanol elution with 50～80% ethanol-eluting resin columns, concentrating under reduced pressure is 1.14～1.30 extractum to relative density; Or
Above medicinal liquid is evaporated to every milliliter and contains 0.05g～0.1g crude drug, leaves standstill, and 8000～20000 rev/mins centrifugal, gets supernatant, through 0.05～0.2 μ m AL
2O
3The inorganic ceramic membrane microfiltration, filtrate decompression concentrates, and is 1.15～1.30 extractum to relative density;
(5), get above volatile oil, it is an amount of to add cyclodextrin, mixes, and grinds 10～30min with colloid mill, will be after the abrasive material drying for mix with or directly for mixing usefulness;
(6), extractum directly or after dry is used for mixing;
(7), water extract part and volatile oil part uniform mixing, promptly.
9. the Chinese medicine extract preparation of compositions method of treatment gastrointestinal dysfunction according to claim 8 or irritable bowel syndrome is characterized in that,
The extraction of described volatile oil adopts steam distillation to extract.Rhizoma Atractylodis Macrocephalae raw material soaking adopted 3～4 hours, added 8～10 times of water gagings, extracted 4～6 hours volatile oil.Get above volatile oil, the adding cyclodextrin is an amount of, mixes, and grinds 10～30min with colloid mill, will use or directly use for mixing for mixing after the abrasive material drying.
The extraction of described water extract adopts medicinal raw material to soak 3～4 hours, merges with Rhizoma Atractylodis Macrocephalae medicinal residues, and decoct and extract twice, each 1～2 hour, 8～10 times of water gagings, the gained extracting solution filters, and merges with Rhizoma Atractylodis Macrocephalae extracting solution; Above medicinal liquid is evaporated to relative density and is 1.08～1.10,4 ℃ and leaves standstill that 8000～20000 rev/mins centrifugal, and concentrating under reduced pressure is 1.14～1.20 extractum to relative density; Extractum directly or after dry is used for mixing;
10. the application of the Chinese medicine extraction compositions of described treatment gastrointestinal dysfunction of claim 1 or irritable bowel syndrome in preparation treatment gastrointestinal dysfunction or anti-irritable bowel syndrome medicine.
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| CN105998480B (en) * | 2016-05-16 | 2020-01-21 | 濮存海 | Traditional Chinese medicine extract for treating irritable bowel syndrome and preparation method thereof |
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