CN1548091A - Leukocyte-increasing Radix astragali and donkey-hide gelatin Qijiao shengbai bolus and its prepn - Google Patents
Leukocyte-increasing Radix astragali and donkey-hide gelatin Qijiao shengbai bolus and its prepn Download PDFInfo
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- CN1548091A CN1548091A CNA031244297A CN03124429A CN1548091A CN 1548091 A CN1548091 A CN 1548091A CN A031244297 A CNA031244297 A CN A031244297A CN 03124429 A CN03124429 A CN 03124429A CN 1548091 A CN1548091 A CN 1548091A
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Abstract
The present invention discloses leukocyte-increasing Qijiao bolus and its preparation. The present invention relates to preparation form innovation on the basis of available capsule, and the medicine has the advantages of fast release speed, high bioavailability, less irritation, etc. The medicine has the functions of nourishing blood and benefiting vital energy, and is used in treating deficiency of both vital energy and blood and leucopenia with high curative effect.
Description
Technical field
This invention relates to the processing technology technical field of Chinese patent medicine pill, relates in particular to Qijiao shengbai bolus and preparation method.
Background technology
Pill is a kind of conventional dosage forms, because quick development of modern science and technology, the pharmacy structural establishment is brought in constant renewal in and is regenerated, the extensive use of the appearance of novel pellet processing machine and new adjuvant, for this ancient dosage form of medicine pill has shone youthful vigor, it has changed people to the traditional prejudice of traditional pill " black; big; thick ", it is fast that the pill that makes it to produce has drug release rate, the bioavailability height, zest is little, divided dose is accurate, take, advantage such as easy to carry, according to the relevant drug act of China, change dosage form as a kind of new drug research, original dosage form of Qijiao shengbai bolus is a stilbene glue paste capsule of rising white blood cell, has listed in national Bureau of Drugs Supervision's country's standard for traditional Chinese medicines compilation (terrestrial reference rises the GB tentative standard).The technology characteristics of former dosage form is: Radix Angelicae Sinensis powder is broken into fine powder in the prescription, and the five tastes such as Fructus Jujubae decoct with water, and filters, and filtrate adds the Colla Corii Asini after the molten, is condensed into thick paste, adds above-mentioned fine powder, and mixing is granulated, and drying is encapsulated, promptly.This medicine dose is bigger, and dysphagia is especially to old person, and this pharmaceutically dosage form is single, and application forms still has only capsule, far can not satisfy people's medication demand, its quality standard still can further improve simultaneously, and pill also has the advantage of the rapid taking convenience of onset by comparison.Based on this, we use the modern pharmaceutical technology this product technology are done necessary improvement, form new preparation, and the control criterion that improves the quality simultaneously guarantees the quality monitoring of product, and the raising drug effect is benefited the common people.This is significant to inheriting and develop motherland's medicine legacy.
Summary of the invention
The purpose of this invention is to provide a kind of Qijiao shengbai bolus and preparation method, improve the quality of products and curative effect, increase the stability of product, enrich medicine variety, to satisfy and to ensure people's medication demand better.
1. Qijiao shengbai bolus and preparation method comprise the steps:
1.1 the prescription of Qijiao shengbai bolus is formed
Fructus Jujubae 375-625g Colla Corii Asini 375-625g Radix Lespedezae Buergeri 562.5-937g
Excessive sheep 562-937g Radix Sophorae Flavescentis 375-625g Radix Astragali 1125-1875g
Radix Angelicae Sinensis 375-625g
Right amount of auxiliary materials is made 1000g altogether.
Its optimum formula is:
Fructus Jujubae 450-500g Colla Corii Asini 450-500g Radix Lespedezae Buergeri 675-750g Herba Epimedii 675-750g
Radix Sophorae Flavescentis 450-500g Radix Astragali 1350-1500g Radix Angelicae Sinensis 450-500g
Right amount of auxiliary materials is made 1000g altogether.
1.2 the preparation technology of Qijiao shengbai bolus
Technology one, will write out a prescription in seven flavor medicine be up to the standards standby respectively; Radix Angelicae Sinensis powder is broken into fine powder; Ground spices such as all the other Fructus Jujubaes are broken into coarse powder/be cut into decoction pieces, decoct with water 2-3 time, and collecting decoction filters, filtrate adds the Colla Corii Asini after the molten, stirs evenly, and is condensed into thick paste/concentrate drying and makes dried cream powder, adds above-mentioned Radix Angelicae Sinensis fine powder and appropriate amount of auxiliary materials mixing, make ball, drying, promptly.
Technology two, will write out a prescription in seven flavor medicine be up to the standards standby respectively; Colla Corii Asini, Radix Angelicae Sinensis powder are broken into fine powder; Ground spices such as all the other Fructus Jujubaes are broken into coarse powder/be cut into decoction pieces, decoct with water 2-3 time, and collecting decoction filters, and filtrate is condensed into thick paste/concentrate drying and makes dried cream powder, adds fine powder and appropriate amount of auxiliary materials such as above-mentioned Radix Angelicae Sinensis, and mixing is made ball, drying, promptly.
Technology three, will write out a prescription in seven flavor medicine be up to the standards standby respectively; Herba Epimedii, Radix Angelicae Sinensis powder are broken into coarse powder, use the 60-95% ethanol extraction, and extracting solution filters, reclaim ethanol, be concentrated in right amount, the coarse powder/decoction pieces of four flavors such as medicinal residues and Fructus Jujubae, Radix Sophorae Flavescentis, Radix Lespedezae Buergeri, the Radix Astragali decocts with water 2-3 time, collecting decoction filters, and filtrate adds the Colla Corii Asini after the molten, stir evenly, be concentrated in right amount, merge with above-mentioned alcohol extract, mixing, concentrate drying is made dried cream powder, adds the appropriate amount of auxiliary materials mixing, make ball, drying, promptly.
Technology four, will write out a prescription in seven flavor medicine be up to the standards standby respectively; Radix Angelicae Sinensis extracts volatile oil, make clathrate or standby with an amount of anhydrous alcohol solution, Herba Epimedii is ground into coarse powder, uses the 60-95% ethanol extraction, extracting solution filters, reclaim ethanol, be concentrated in right amount, the coarse powder/decoction pieces of above-mentioned Radix Angelicae Sinensis, Herba Epimedii medicinal residues and Fructus Jujubae, Radix Sophorae Flavescentis, Radix Lespedezae Buergeri, the Radix Astragali decocts with water 2-3 time, collecting decoction, filter, filtrate adds the Colla Corii Asini after the molten, stirs evenly, be concentrated to an amount of, merge with above-mentioned alcohol extract, mixing, drying is made dried cream powder, with above-mentioned Radix Angelicae Sinensis volatile oil clathrate and appropriate amount of auxiliary materials mixing, make ball, drying, promptly.Or above-mentioned dried cream powder and appropriate amount of auxiliary materials mixing, make ball, drying sprays into above-mentioned Radix Angelicae Sinensis volatile oil, promptly.
1.3 the ball by above-mentioned technology gained is a Qijiao shengbai bolus.
The ball of gained can wrap film-coat in the technology, the film-coat material adopt stomach dissolution type film-coat pre-mixing agent (Opadry), hydroxypropyl cellulose, polyvinylpyrrolidone, hydroxypropyl emthylcellulose, polyvinyl alcohol, methylcellulose a kind of/multiple mixing uses.
Used adjuvant can be that one or more mixing such as sucrose, lactose, starch, beta-schardinger dextrin-, HP-, microcrystalline Cellulose, hydroxypropyl cellulose, carboxymethylstach sodium, Aspartane, polyvinylpolypyrrolidone, 30 POVIDONE K 30 BP/USP 30 are used in the technology.
The particle diameter of the ball of gained is 0.5-6mm in the technology, and optimum grain-diameter is 1.5-4mm.
In the technology ball of gained can directly use or the capsulae vacuus of packing in use.
The ball drying can adopt vacuum drying, fluid bed drying, lyophilization etc. in the technology.
Need be ground into the medical material of fine powder in the technology, can routine be ground into 80-160 purpose fine powder or superfine powder is broken into 200-300 purpose fine powder.
Coarse powder/the be cut into medical material of decoction pieces need be ground in the technology, 5-30 purpose coarse powder/be cut into decoction pieces can be routine be ground into.Be preferably and be ground into 10-20 order coarse powder.
The condition that decocting boils in the technology is: amount of water is that 6-15 doubly measures for the first time, and second and third time doubly measured for 4-10, decocts each 1-3 hour 2-3 time.Best amount of water is 10 times of amounts for the first time in order to decoct three times, and second and third time is 8 times of amounts, 2 hours for the first time, and 1.5 hours for the second time, 1 hour for the third time.Medicinal residues such as Radix Angelicae Sinensis can add when second fries in shallow oil with frying in shallow oil in the technology three, four.
The relative density of thick paste is 1.15-1.40 (80 ℃) in the technology, and best relative density is 1.30 (80 ℃).
Alcohol extraction process adopts heating reflux method or percolation to extract for being solvent with 60-95% ethanol in the technology three, four, and is best for being solvent with 70% ethanol, adds 10 times of amount ethanol, reflux, extract, 2 times, each 2 hours.
The extract drying can adopt vacuum drying or spray drying in the technology, and the vacuum drying temperature is controlled at 50-80 ℃, is preferably 60 ℃.Spray drying is for to be concentrated to the concentrated solution that relative density is 1.05-1.15 (60 ℃) with extracting solution, and spray drying, inlet temperature are 100-200 ℃, leaving air temp is 50-150 ℃, best relative density is 1.08-1.10 (60 ℃), and inlet temperature is 160-180 ℃, and leaving air temp is 80-100 ℃.
In the technology extracting solution filter also can adopt centrifugal, the conventional filtration, ultrafiltration filters after adding clarifier, method such as ultrafiltration again after adding clarifier and filtering.
2. quality control standard of the present invention is mainly aspect discriminating, inspection, assay.
This product is further to improve on the basis of original stilbene glue paste capsule of rising white blood cell, former dosage form has the thin layer of Radix Angelicae Sinensis, Radix Sophorae Flavescentis, the Radix Astragali, Herba Epimedii to differentiate on differentiating, now kept, and increased the thin layer of Fructus Jujubae has been differentiated, former dosage form does not have the limit examine of arsenic salt, heavy metal on checking, now increased heavy metal limit and must not cross 10/1000000ths, arsenic salt must not cross 2/1000000ths; Former dosage form has carried out quantitatively now being kept to Herba Epimedii on the assay, and increased to Radix Sophorae Flavescentis quantitatively.
This invention is dosage form technological innovation on existing capsular basis, and quality standard has new raising again, to improving the quality of products significant meaning is arranged, and has enriched medicine variety, satisfies and ensured people's medication demand.
The specific embodiment
Optimum implementation of the present invention is: seven flavor medicine is up to the standards standby respectively in will writing out a prescription; Radix Angelicae Sinensis powder is broken into fine powder; Ground spices such as all the other Fructus Jujubaes are broken into coarse powder, decoct with water 2 hours for the first time 3 times, 1.5 hours for the second time, 1 hour for the third time, collecting decoction, filter, filtrate adds the Colla Corii Asini after the molten, stirs evenly, be concentrated into relative density 1.08-1.10 (60 ℃), spray drying is made dried cream powder, adds above-mentioned Radix Angelicae Sinensis fine powder and appropriate amount of auxiliary materials mixing, makes ball, drying, promptly.
Claims (10)
1. Qijiao shengbai bolus and preparation method is characterized in that:
(1) will write out a prescription in Fructus Jujubae, Colla Corii Asini, Radix Lespedezae Buergeri, Herba Epimedii, Radix Sophorae Flavescentis, the Radix Astragali, Radix Angelicae Sinensis seven flavor medicine be up to the standards standby respectively; Radix Angelicae Sinensis powder is broken into fine powder; Ground spices such as all the other Fructus Jujubaes are broken into coarse powder/be cut into decoction pieces, decoct with water 2-3 time, and collecting decoction filters, filtrate adds the Colla Corii Asini after the molten, stirs evenly, and is condensed into thick paste/concentrate drying and makes dried cream powder, adds Radix Angelicae Sinensis fine powder and appropriate amount of auxiliary materials mixing, make ball, drying, promptly.
(2) will write out a prescription in Fructus Jujubae, Colla Corii Asini, Radix Lespedezae Buergeri, Herba Epimedii, Radix Sophorae Flavescentis, the Radix Astragali, Radix Angelicae Sinensis seven flavor medicine be up to the standards standby respectively; Colla Corii Asini, Radix Angelicae Sinensis powder are broken into fine powder; Ground spices such as all the other Fructus Jujubaes are broken into coarse powder/be cut into decoction pieces, decoct with water 2-3 time, and collecting decoction filters, and filtrate is condensed into thick paste/concentrate drying and makes dried cream powder, adds fine powder and appropriate amount of auxiliary materials such as Radix Angelicae Sinensis, and mixing is made ball, drying, promptly.
(3) will write out a prescription in Fructus Jujubae, Colla Corii Asini, Radix Lespedezae Buergeri, Herba Epimedii, Radix Sophorae Flavescentis, the Radix Astragali, Radix Angelicae Sinensis seven flavor medicine be up to the standards standby respectively; Herba Epimedii, Radix Angelicae Sinensis powder are broken into coarse powder, use the 60-95% ethanol extraction, and extracting solution filters, reclaim ethanol, be concentrated in right amount, the coarse powder/decoction pieces of four flavors such as medicinal residues and Fructus Jujubae, Radix Sophorae Flavescentis, Radix Lespedezae Buergeri, the Radix Astragali decocts with water 2-3 time, collecting decoction filters, and filtrate adds the Colla Corii Asini after the molten, stir evenly, be concentrated in right amount, merge with alcohol extract, mixing, concentrate drying is made dried cream powder, adds the appropriate amount of auxiliary materials mixing, make ball, drying, promptly.
(4) will write out a prescription in Fructus Jujubae, Colla Corii Asini, Radix Lespedezae Buergeri, Herba Epimedii, Radix Sophorae Flavescentis, the Radix Astragali, Radix Angelicae Sinensis seven flavor medicine be up to the standards standby respectively; Radix Angelicae Sinensis extracts volatile oil, make clathrate/standby with an amount of anhydrous alcohol solution, Herba Epimedii is ground into coarse powder, uses the 60-95% ethanol extraction, extracting solution filters, reclaim ethanol, be concentrated in right amount, the coarse powder/decoction pieces of Radix Angelicae Sinensis, Herba Epimedii medicinal residues and Fructus Jujubae, Radix Sophorae Flavescentis, Radix Lespedezae Buergeri, the Radix Astragali decocts with water 2-3 time, collecting decoction, filter, filtrate adds the Colla Corii Asini after the molten, stirs evenly, be concentrated to an amount of, merge with alcohol extract, mixing, drying is made dried cream powder, with Radix Angelicae Sinensis volatile oil clathrate and appropriate amount of auxiliary materials mixing, make ball, drying, promptly; Or dried cream powder and appropriate amount of auxiliary materials mixing, make ball, drying sprays into Radix Angelicae Sinensis volatile oil, promptly.
2. Qijiao shengbai bolus according to claim 1 and preparation method, it is characterized in that: the ball of gained can wrap film-coat, the film-coat material adopt stomach dissolution type film-coat pre-mixing agent (Opadry), hydroxypropyl cellulose, polyvinylpyrrolidone, hydroxypropyl emthylcellulose, polyvinyl alcohol, methylcellulose a kind of/multiple mixing uses; Used adjuvant can be sucrose, lactose, starch, beta-schardinger dextrin-, microcrystalline Cellulose, hydroxypropyl cellulose, carboxymethylstach sodium, Aspartane, polyvinylpolypyrrolidone, 30 1 kinds/multiple mixing use of 30 POVIDONE K 30 BP/USP.
3. Qijiao shengbai bolus according to claim 1 and preparation method is characterized in that: the particle diameter of the ball of gained is 0.5-6mm, and optimum grain-diameter is 1.5-4mm; The ball drying can adopt vacuum drying, fluid bed drying, lyophilization; The ball of gained can directly use/pack in the capsulae vacuus and use.
4. Qijiao shengbai bolus according to claim 1 and preparation method is characterized in that: need be ground into the medical material of fine powder, can routine be ground into 80-160 purpose fine powder, best superfine powder is broken into 200-300 purpose fine powder; Coarse powder/the be cut into medical material of decoction pieces need be ground into, 5-30 purpose coarse powder/be cut into decoction pieces can be routine be ground into, best for being ground into 10-20 order coarse powder.
5. Qijiao shengbai bolus according to claim 1 and preparation method, it is characterized in that: the condition that decocting boils is: amount of water is that 6-15 doubly measures for the first time, and second and third time doubly measured for 4-10, decocts 2-3 time, each 1-3 hour, best amount of water is 10 times of amounts for the first time in order to decoct three times, and second and third time is 8 times of amounts, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, medicinal residues such as Radix Angelicae Sinensis can add when second fries in shallow oil with frying in shallow oil.
6. Qijiao shengbai bolus according to claim 1 and preparation method is characterized in that: the relative density of thick paste is 1.15-1.40 (80 ℃), and best relative density is 1.30 (80 ℃).
7. Qijiao shengbai bolus according to claim 1 and preparation method is characterized in that: middle alcohol extraction process adopts heating reflux method/percolation to extract for being solvent with 60-95% ethanol, best for being solvent with 70% ethanol, add 10 times of amount ethanol, reflux, extract, 2 times, each 2 hours.
8. Qijiao shengbai bolus according to claim 1 and preparation method, it is characterized in that: the extract drying can adopt vacuum drying/spray drying, the vacuum drying temperature is controlled at 50-80 ℃, the best is 60 ℃, spray drying is for to be concentrated to the concentrated solution that relative density is 1.05-1.15 (60 ℃) with extracting solution, spray drying, inlet temperature is 100-200 ℃, leaving air temp is 50-150 ℃, best relative density is 1.08-1.10 (60 ℃), inlet temperature is 160-180 ℃, and leaving air temp is 80-100 ℃.
9. Qijiao shengbai bolus according to claim 1 and preparation method is characterized in that: extracting solution filter also can adopt centrifugal, the conventional filtration, ultrafiltration filters after adding clarifier, the method for ultrafiltration again after adding clarifier and filtering.
10. Qijiao shengbai bolus according to claim 1 and preparation method is characterized in that: have the thin layer of Fructus Jujubae to differentiate that have heavy metal must not cross 10/1000000ths, arsenic salt must not be crossed 2/1000000ths limit detection in the quality standard control among the present invention; The quantitative of Radix Sophorae Flavescentis arranged on the assay.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031244297A CN1548091A (en) | 2003-05-24 | 2003-05-24 | Leukocyte-increasing Radix astragali and donkey-hide gelatin Qijiao shengbai bolus and its prepn |
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| Application Number | Priority Date | Filing Date | Title |
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| CNA031244297A CN1548091A (en) | 2003-05-24 | 2003-05-24 | Leukocyte-increasing Radix astragali and donkey-hide gelatin Qijiao shengbai bolus and its prepn |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108760945A (en) * | 2018-08-24 | 2018-11-06 | 贵州汉方药业有限公司 | A kind of detection method of Qijiaoshenbai capsule |
| CN109266773A (en) * | 2017-07-14 | 2019-01-25 | 贵州汉方药业有限公司 | A kind of DNA bar code identification method of Qijiaoshenbai capsule raw medicinal material |
-
2003
- 2003-05-24 CN CNA031244297A patent/CN1548091A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109266773A (en) * | 2017-07-14 | 2019-01-25 | 贵州汉方药业有限公司 | A kind of DNA bar code identification method of Qijiaoshenbai capsule raw medicinal material |
| CN108760945A (en) * | 2018-08-24 | 2018-11-06 | 贵州汉方药业有限公司 | A kind of detection method of Qijiaoshenbai capsule |
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