CN1537575A - Granule contg. Radix astragalic, donkey-hide gelatin, rattletop and others for increasing leucocyte and its prepn. method - Google Patents

Granule contg. Radix astragalic, donkey-hide gelatin, rattletop and others for increasing leucocyte and its prepn. method Download PDF

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CN1537575A
CN1537575A CNA03118281XA CN03118281A CN1537575A CN 1537575 A CN1537575 A CN 1537575A CN A03118281X A CNA03118281X A CN A03118281XA CN 03118281 A CN03118281 A CN 03118281A CN 1537575 A CN1537575 A CN 1537575A
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drying
powder
angelicae sinensis
radix angelicae
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CNA03118281XA
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毛友昌
毛晓敏
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Abstract

An improved Chinese medicine 'Qijiao Shengbai granule' for treating dizziness, night sweat, leukocytopenia, etc is prepared through extracting in alcohol and decocting for part of raw materials, direct decocting for part of raw materials, collecting volatile oil and decocting for part of raw materials, pulverizing the rest, granulating, adding additive and volatile oil, and granulating again. Its advantages are high curative effect and high safety.

Description

Stilbene glue rises white granule and preparation method
Technical field
This invention relates to the particulate processing technology technical field of Chinese patent medicine, relates in particular to stilbene glue and rises white granule and preparation method.
Background technology
Granule is the pharmaceutical formulation of using always, according to the relevant drug act of China, change dosage form as a kind of new drug research, it is stilbene glue paste capsule of rising white blood cell that stilbene glue rises white particulate original dosage form, 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 granule is by comparison than also having onset advantage rapidly, based on this, we use the modern pharmaceutical technology this product technology are done necessary improvement, form new preparation, the control criterion that improves the quality simultaneously guarantees the quality monitoring of product, improve drug effect, benefit the common people.
Summary of the invention
The purpose of this invention is to provide a kind of stilbene glue and rise white granule 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, stilbene glue rises white particulate preparation method and comprises the steps:
1.1 rising white particulate prescription, stilbene glue forms
Fructus Jujubae 500-1500g Colla Corii Asini 500-1500g Radix Lespedezae Buergeri 700-2250g
Herba Epimedii 750-2250g Radix Sophorae Flavescentis 500-1500g Radix Astragali 1500-4500g
Radix Angelicae Sinensis 500-1500g
Right amount of auxiliary materials is made 1000 bags altogether.
Its optimum formula is:
Fructus Jujubae 1000g Colla Corii Asini 1000g Radix Lespedezae Buergeri 1500g Herba Epimedii 1500g
Radix Sophorae Flavescentis 1000g Radix Astragali 3000g Radix Angelicae Sinensis 1000g right amount of auxiliary materials is made 1000 bags altogether.
1.2 stilbene glue rises white particulate preparation technology
Technology one, will write out a prescription in seven flavor medicine be up to the standards standby respectively; Except that Colla Corii Asini, Radix Angelicae Sinensis powder is broken into fine powder; The five tastes such as all the other Fructus Jujubaes decoct with water collecting decoction 2-3 time, filter, filtrate adds the Colla Corii Asini after the molten, stirs evenly, be condensed into thick paste, add above-mentioned Radix Angelicae Sinensis fine powder and appropriate amount of auxiliary materials mixing, make granule, drying, granulate, packing or concentrate drying are made dried cream powder, add above-mentioned Radix Angelicae Sinensis fine powder and appropriate amount of auxiliary materials mixing, granulate drying, granulate, packing, 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; The five tastes such as all the other Fructus Jujubaes decoct with water 2-3 time, and collecting decoction filters, and concentrate drying is made dried cream powder, adds fine powder and appropriate amount of auxiliary materials such as above-mentioned Radix Angelicae Sinensis, and mixing is made granule, drying, and granulate, packing, 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, and reclaim ethanol, be concentrated in right amount, medicinal residues and Fructus Jujubae, Radix Sophorae Flavescentis, Radix Lespedezae Buergeri, the Radix Astragali decoct with water 2-3 time, and collecting decoction filters, filtrate adds the Colla Corii Asini after the molten, stirs evenly, and is concentrated into an amount of, merge with above-mentioned alcohol extract, mixing, drying is made dried cream powder, add the appropriate amount of auxiliary materials mixing, granulate drying, granulate, packing, 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, makes clathrate or standby with an amount of dissolve with ethanol, and Herba Epimedii is ground into coarse powder, use the 60-95% ethanol extraction, extracting solution filters, and reclaims ethanol, be concentrated in right amount 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 in right amount, merge mixing with above-mentioned alcohol extract, drying is made dried cream powder, with above-mentioned Radix Angelicae Sinensis volatile oil clathrate and appropriate amount of auxiliary materials mixing, granulates, drying, granulate, packing or with the appropriate amount of auxiliary materials mixing, granulate, drying, spray adds above-mentioned Radix Angelicae Sinensis volatile oil, mixing, packing, promptly.
1.3 by the technology gained is granule
Stilbene glue rises the added adjuvant of white granule: 30 POVIDONE K 30 BP/USP 30, any or multiple mixing in the micropowder silica gel, beta-schardinger dextrin-, hydroxyl beta-schardinger dextrin-, starch, dextrin, sucrose, steviosin, Aspartane, magnesium stearate, essence etc. uses.
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.
Need be ground into the medical material of coarse powder in the technology, can routine be ground into 5-40 purpose coarse powder.Best for being 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.
Drying can adopt vacuum drying or adopt 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 ℃.
The relative density of thick paste is 1.15-1.4 (80 ℃) in the technology one, and best relative density is 1.30 (80 ℃).
Concentrate in the technology and can adopt concentrating under reduced pressure or thin film concentration.
Extracting solution filters and also can adopt centrifugation method in the technology.
2, stilbene glue rises the further raising on the basis of original stilbene glue paste capsule of rising white blood cell of white particulate quality control standard among the present invention, 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 extracts volatile oil, makes clathrate or standby with an amount of dissolve with ethanol, and Herba Epimedii is ground into coarse powder, use the 60-95% ethanol extraction, extracting solution filters, and reclaims ethanol, be concentrated in right amount 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 in right amount, merge mixing with above-mentioned alcohol extract, drying is made dried cream powder, with above-mentioned Radix Angelicae Sinensis volatile oil clathrate and appropriate amount of auxiliary materials mixing, granulates, drying, granulate, packing or with the appropriate amount of auxiliary materials mixing, granulate, drying, spray adds above-mentioned Radix Angelicae Sinensis volatile oil, mixing, packing, promptly.

Claims (7)

1, a kind of stilbene glue rises white granule and preparation method, it is characterized in that:
(1) 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, and reclaim ethanol, be concentrated in right amount, medicinal residues and Fructus Jujubae, Radix Sophorae Flavescentis, Radix Lespedezae Buergeri, the Radix Astragali decoct with water 2-3 time, and collecting decoction filters, filtrate adds the Colla Corii Asini after the molten, stirs evenly, and is concentrated into an amount of, merge with above-mentioned alcohol extract, mixing, drying is made dried cream powder, add the appropriate amount of auxiliary materials mixing, granulate drying, granulate, packing makes stilbene glue and rises white granule.
(2) will write out a prescription in seven flavor medicine be up to the standards standby respectively; Radix Angelicae Sinensis extracts volatile oil, makes clathrate or standby with an amount of dissolve with ethanol, and Herba Epimedii is ground into coarse powder, use the 60-95% ethanol extraction, extracting solution filters, and reclaims ethanol, be concentrated in right amount 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 in right amount, merge mixing with above-mentioned alcohol extract, drying is made dried cream powder, with above-mentioned Radix Angelicae Sinensis volatile oil clathrate and appropriate amount of auxiliary materials mixing, granulates, drying, granulate, packing or with the appropriate amount of auxiliary materials mixing, granulate, drying, spray adds above-mentioned Radix Angelicae Sinensis volatile oil, mixing, packing, promptly.
(3) will write out a prescription in seven flavor medicine be up to the standards standby respectively; Except that Colla Corii Asini, Radix Angelicae Sinensis powder is broken into fine powder; The five tastes such as all the other Fructus Jujubaes decoct with water collecting decoction 2-3 time, filter, filtrate adds the Colla Corii Asini after the molten, stirs evenly, be condensed into thick paste, add above-mentioned Radix Angelicae Sinensis fine powder and appropriate amount of auxiliary materials mixing, make granule, drying, granulate, packing or concentrate drying are made dried cream powder, add above-mentioned Radix Angelicae Sinensis fine powder and appropriate amount of auxiliary materials mixing, granulate drying, granulate, packing, promptly.
(4) 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; The five tastes such as all the other Fructus Jujubaes decoct with water 2-3 time, and collecting decoction filters, and concentrate drying is made dried cream powder, adds fine powder and appropriate amount of auxiliary materials such as above-mentioned Radix Angelicae Sinensis, and mixing is made granule, drying, and granulate, packing, promptly.
2, stilbene glue according to claim 1 rises white granule and preparation method, it is characterized in that: stilbene glue rises the added adjuvant of white granule and can be: 30 POVIDONE K 30 BP/USP 30, any/multiple mixing in the micropowder silica gel, beta-schardinger dextrin-, hydroxyl beta-schardinger dextrin-, starch, dextrin, sucrose, steviosin, Aspartane, magnesium stearate, essence etc. uses.
3, stilbene glue according to claim 1 rises white granule and preparation method, it is characterized in that: the medical material that need be ground into fine powder in the technology, can routine be ground into 80-160 purpose fine powder/superfine powder and be broken into 200-300 purpose fine powder, need be ground into the medical material of coarse powder in the technology, can routine be ground into 5-40 purpose coarse powder.Best for being ground into 10-20 order coarse powder.
4, stilbene glue according to claim 1 rises white granule and preparation method, it is characterized in that: 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.
5, stilbene glue according to claim 1 rises white granule and preparation method, it is characterized in that: alcohol extraction process is for being solvent with 60-95% ethanol in the technology three, four, adopt heating reflux method or percolation to extract, best for being solvent with 70% ethanol, add 10 times of amount ethanol, reflux, extract, 2 times, each 2 hours.
6, stilbene glue according to claim 1 rises white granule and preparation method, it is characterized in that: drying can adopt vacuum drying/employing 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 ℃.
7, stilbene glue according to claim 1 rises white granule and preparation method, it is characterized in that: d has the thin layer of Fructus Jujubae to differentiate that have heavy metal limit must not cross 10/1000000ths, arsenic salt must not be crossed 2/1000000ths limit detection on quality inspection standard; The quantitative assay of Radix Sophorae Flavescentis is arranged.
CNA03118281XA 2003-04-15 2003-04-15 Granule contg. Radix astragalic, donkey-hide gelatin, rattletop and others for increasing leucocyte and its prepn. method Pending CN1537575A (en)

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103933119A (en) * 2014-04-23 2014-07-23 严斯文 Production method of oral solution for treating dizziness of old people
CN104172145A (en) * 2013-05-20 2014-12-03 山东东阿阿胶股份有限公司 Compound donkey-hide gelatin composition promoting blood health, and preparation method and application thereof
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

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104172145A (en) * 2013-05-20 2014-12-03 山东东阿阿胶股份有限公司 Compound donkey-hide gelatin composition promoting blood health, and preparation method and application thereof
CN103933119A (en) * 2014-04-23 2014-07-23 严斯文 Production method of oral solution for treating dizziness of old people
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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