CN1970071A - Preparation method of minipills of 'Xiao Chai Hu' - Google Patents
Preparation method of minipills of 'Xiao Chai Hu' Download PDFInfo
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- CN1970071A CN1970071A CN 200510101443 CN200510101443A CN1970071A CN 1970071 A CN1970071 A CN 1970071A CN 200510101443 CN200510101443 CN 200510101443 CN 200510101443 A CN200510101443 A CN 200510101443A CN 1970071 A CN1970071 A CN 1970071A
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Abstract
The invention discloses a process for making micro-pellets of bupleurum root with stabilized and controllable quality, the preparation also has the advantages of better pharmaceutical stability, longer effective period, shorter disintegration time, and quicker action.
Description
Technical field
The present invention relates to the new preparation process of minipills of ' Xiao Chai Hu ' agent, belong to field of traditional Chinese.
Background technology
Herba Sidae Rhombifoliae soup comes from the classic doctor of traditional Chinese medical science nationality treatise on Febrile Diseases, is made up of Radix Bupleuri, Radix Codonopsis, Fructus Jujubae, the Rhizoma Pinelliae, Radix Scutellariae, Rhizoma Zingiberis Recens, Radix Glycyrrhizae, is used for the treatment of alternate attack of chill and fever, and costa sternales is bitter full, and vexed happiness is told, diseases such as bitter taste in the mouth and dry throat.General dosage form has oral liquid, granule, tablet etc. at present.Little bupleurum particles (electuary) promptly is to be prepared from the Herba Sidae Rhombifoliae soup basis, now record in the 8th of the Sanitation Ministry medicine standard, but add a large amount of cane sugar powders in its technology, modern study shows, sucrose can produce harmful substance with composition generation chemical reactions such as some Chinese medicine protein, tannins, can decompose the some drugs effective ingredient, disturb some drugs to absorb, influence the final curative effect of medicine; While preparation sugar content height, big, the easy moisture absorption of volume makes troubles, and has increased the producing and selling cost for production, accumulating; This external preparation sugar content height is unsuitable for using with the patient of diseases such as diabetes, hypertension, obesity, thereby has retrained the clinical practice of little bupleurum particles (electuary).Little Radix Bupleuri sheet records in the 8th of the Sanitation Ministry medicine standard, the Herba Sidae Rhombifoliae soup ball records in the 12nd of the Sanitation Ministry medicine standard, Herba Sidae Rhombifoliae soup ball and little Radix Bupleuri sheet are because part medical material powder is directly to be used as medicine, the easy moisture absorption, grow microorganism, effect duration is short, and the disintegration time of soup ball and tablet is all longer, and onset is comparatively slow; The two all also has shortcomings such as dose is big, and child etc. are difficult for the person of swallowing and can't be suitable for.Patent 02125805.8 discloses the particulate preparation method of a kind of sugarless small radix bupleuri, and it is high and influence the scope of application to have solved the conventional particles sugar content, but does not solve easy moisture absorption spoilage problems, and mouthfeel is bad, and bitter in the mouth is unfavorable for patient's compliance of taking medicine.
Patent 03135466.1 discloses a kind of preparation method of small thorowax droplet, does not also solve easy moisture absorption spoilage problems.
Summary of the invention the objective of the invention is to the above-mentioned shortcoming at existing medicine Herba Sidae Rhombifoliae granule, Herba Sidae Rhombifoliae soup ball, little Radix Bupleuri sheet, provide a kind of technology simple, but buccal onset, the less relatively and taking convenience of dose, medicine stability is good, effect duration is longer relatively, and disintegration time is short, the i.e. new drug formulation minipills of ' Xiao Chai Hu ' of advantages such as disintegrate thereby onset be very fast fully basically about 3 minutes.
Micropill is meant the coccoid peroral dosage form of diameter less than 2.5mm, and coating behind medicine and the adjuvant mixing pill is made.Because micropill belongs to dosage decentralized preparation, a dosage unit is composed of multiple units, compare with the single dose dosage form, have many advantages: 1, can extensively be evenly distributed in the gastrointestinal tract behind the micropill clothes, because dosage inclines and dispersion, medicine increases at gastrointestinal surface distributed area, drug bioavailability is improved, thereby reduce the generation of drug resistance and the generation of toxic and side effects to greatest extent.2, the influence of the running unable to take food thing conveying rhythm and pace of moving things of pellet in gastrointestinal tract, even when sphincter of pylorus is closed, still can pass through pylorus, so micropill absorbs the influence that generally is not subjected to gastric emptying at gastrointestinal.3, the drug release behavior of micropill is a summation of forming each micropill drug release behavior of a dosage, and error or the defective unlikely drug release behavior generation to whole preparation of indivedual micropills in preparation has a strong impact on.Therefore repeatability, concordance aspect in vivo is better than tablet and capsule.
Technology contents
The object of the invention provides a kind of good stability, curative effect height, carries, the preparation method of the minipills of ' Xiao Chai Hu ' of taking convenience.
The present invention seeks to be achieved through the following technical solutions: the Radix Bupleuri in Radix Bupleuri, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens), Radix Scutellariae, Radix Codonopsis, Radix Glycyrrhizae, Rhizoma Zingiberis Recens, the Fructus Jujubae, Radix Scutellariae, Radix Codonopsis, Radix Glycyrrhizae and Fructus Jujubae are decocted with water 2～4 times, each 1～2 hour, collecting decoction filters, and filtrate is concentrated in right amount; Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens), Rhizoma Zingiberis Recens are according to fluid extract and extractum item---the percolation of F, make solvent with 60～80% ethanol, flood after 12～36 hours, slowly percolation, collect percolate, reclaim ethanol, merge, be concentrated into clear paste with above-mentioned concentrated solution, it is an amount of to add acceptable accessories, mixing is made through extruding ... round as a ball ... dry ... coating, promptly.
The medicine that the present invention makes is white or off-white color micropill.
Micropill of the present invention, the institute that had both had Herba Sidae Rhombifoliae soup is powerful, has the advantage of modern medicinal agents again, and is stable and controllable for quality.Technology of the present invention is simple, but the buccal onset, the less relatively and taking convenience of dose, medicine stability is good, effect duration is longer relatively, and advantage such as disintegration time is short thereby onset is very fast.
Embodiment one
Prescription: Radix Bupleuri 240g Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 120g Radix Scutellariae 90g Radix Codonopsis 90g Radix Glycyrrhizae 90g Rhizoma Zingiberis Recens 90g Fructus Jujubae
90g
Method for making: above seven flavors, Radix Bupleuri, Radix Scutellariae, Radix Codonopsis, Radix Glycyrrhizae and Fructus Jujubae decoct with water secondary, and each 1.5 hours, collecting decoction filtered, and filtrate is concentrated in right amount.Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens), Rhizoma Zingiberis Recens are according to fluid extract and extractum item---the THROUGH METHOD of F, make solvent with 70% ethanol, flood after 24 hours, with the speed of per minute 1～3ml seepage flow slowly, collect the about 3180ml of percolating fluid, reclaim ethanol, merge with above-mentioned concentrated solution, being concentrated into relative density is the clear paste of 1.32～1.35 (75～80 ℃).1 part of qinghuo reagent adds 1 part of mixing of adjuvant, makes micropill, drying; Dried micropill is placed in the coating pan, use the hydroxypropyl emthylcellulose coating, promptly.
Embodiment two
Prescription: Radix Bupleuri 240g Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 120g Radix Scutellariae 90g Radix Codonopsis 90g Radix Glycyrrhizae 90g Rhizoma Zingiberis Recens 90g
Fructus Jujubae 90g
Method for making: above seven flavors, Radix Bupleuri, Radix Scutellariae, Radix Codonopsis, Radix Glycyrrhizae and Fructus Jujubae decoct with water secondary, and each 1.5 hours, collecting decoction filtered, and filtrate is concentrated in right amount.Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens), Rhizoma Zingiberis Recens are according to fluid extract and extractum item---the THROUGH METHOD of F, make solvent with 70% ethanol, flood after 24 hours, with the speed of per minute 1～3ml seepage flow slowly, collect the about 3180ml of percolating fluid, reclaim ethanol, merge with above-mentioned concentrated solution, being concentrated into relative density is the clear paste of 1.32～1.35 (75～80 ℃).1 part of qinghuo reagent adds 1 part of mixing of adjuvant, makes micropill, drying; Dried micropill is placed in the coating pan, use the acrylic resin coating, promptly.
Claims (6)
1, a kind of preparation method of minipills of ' Xiao Chai Hu ', it is characterized in that this micropill is made up of Radix Bupleuri, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens), Radix Scutellariae, Radix Codonopsis, Radix Glycyrrhizae, Rhizoma Zingiberis Recens, Fructus Jujubae, wherein Radix Bupleuri, Radix Scutellariae, Radix Codonopsis, Radix Glycyrrhizae and Fructus Jujubae decoct with water 2～4 times, each 1～2 hour, collecting decoction, filter, filtrate is concentrated in right amount.Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens), Rhizoma Zingiberis Recens are made solvent according to fluid extract and extractum item--the percolation of-F with 60～80% ethanol, flood after 12～36 hours, slowly percolation is collected percolate, reclaims ethanol, merge with above-mentioned concentrated solution, be concentrated into clear paste, add acceptable accessories and add 0.5～5 part of adjuvant, mixing by 1 part of clear paste, pill, drying, coating, promptly.
2, according to the preparation method of the described minipills of ' Xiao Chai Hu ' of claim 1, it is characterized in that: the described pharmaceutically adjuvant of approval be microcrystalline Cellulose, starch, dextrin, Pulvis Talci, silicon dioxide, lactose, sucrose, polyvidone, Polyethylene Glycol, sweeting agent, pigment a kind of/multiple mixing uses.
3, according to the preparation method of the described minipills of ' Xiao Chai Hu ' of claim 1, it is characterized in that: described micropill preparation is to make micropill through extruding-round as a ball mode.The micropill coating adopt acrylic resin, cellulose and derivant thereof, polyvinyl alcohol a kind of/multiple mixing uses; Acceptable accessories be lactose, starch, cyclodextrin, microcrystalline Cellulose, carboxymethyl starch sodium, polyvinylpolypyrrolidone, Pulvis Talci, silicon dioxide, titanium dioxide, Polyethylene Glycol, flavoring agent, pigment a kind of/multiple mixing uses.
4, according to the preparation method of the described minipills of ' Xiao Chai Hu ' of claim 1, it is characterized in that: described micropill coating adopt acrylic resin, cellulose and derivant thereof, polyvinyl alcohol a kind of/multiple mixing uses; Acceptable accessories be lactose, starch, cyclodextrin, microcrystalline Cellulose, carboxymethyl starch sodium, polyvinylpolypyrrolidone, Pulvis Talci, silicon dioxide, titanium dioxide, Polyethylene Glycol, flavoring agent, pigment a kind of/multiple mixing uses.
5, according to the preparation method of the described minipills of ' Xiao Chai Hu ' of claim 1, it is characterized in that: the particle diameter of described minipills of ' Xiao Chai Hu ' is 0.4～2.5mm, optimum grain-diameter 0.7～1.5mm.The micropill of gained can directly use.
5, according to the preparation method of the described minipills of ' Xiao Chai Hu ' of claim 1, it is characterized in that: described micropill contains flavoring agent in coatings.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510101443 CN1970071A (en) | 2005-11-22 | 2005-11-22 | Preparation method of minipills of 'Xiao Chai Hu' |
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200510101443 CN1970071A (en) | 2005-11-22 | 2005-11-22 | Preparation method of minipills of 'Xiao Chai Hu' |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102309739A (en) * | 2010-07-02 | 2012-01-11 | 北京亚东生物制药有限公司 | Chinese medicinal composition dispersible tablets |
| CN102526391A (en) * | 2010-12-16 | 2012-07-04 | 天津中敖生物科技有限公司 | Livestock Chinese medicinal composition with refrigerating function and preparation method thereof |
| CN103961665A (en) * | 2014-05-07 | 2014-08-06 | 江西百神药业股份有限公司 | Preparation method of common goldenrop granules |
-
2005
- 2005-11-22 CN CN 200510101443 patent/CN1970071A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102309739A (en) * | 2010-07-02 | 2012-01-11 | 北京亚东生物制药有限公司 | Chinese medicinal composition dispersible tablets |
| CN102309739B (en) * | 2010-07-02 | 2013-07-24 | 北京亚东生物制药有限公司 | Chinese medicinal composition dispersible tablets |
| CN102526391A (en) * | 2010-12-16 | 2012-07-04 | 天津中敖生物科技有限公司 | Livestock Chinese medicinal composition with refrigerating function and preparation method thereof |
| CN103961665A (en) * | 2014-05-07 | 2014-08-06 | 江西百神药业股份有限公司 | Preparation method of common goldenrop granules |
| CN103961665B (en) * | 2014-05-07 | 2017-09-01 | 江西百神药业股份有限公司 | A kind of preparation method of Xiao Chai Hu granules |
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