CN1456229A - Preparation of donkey hide gelatin effervescent granules for nourishing blood - Google Patents

Preparation of donkey hide gelatin effervescent granules for nourishing blood Download PDF

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CN1456229A
CN1456229A CN 03118613 CN03118613A CN1456229A CN 1456229 A CN1456229 A CN 1456229A CN 03118613 CN03118613 CN 03118613 CN 03118613 A CN03118613 A CN 03118613A CN 1456229 A CN1456229 A CN 1456229A
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technology
radix
time
volatile oil
decocting
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CN 03118613
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毛友昌
毛晓敏
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Individual
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Abstract

An improved process for preparing Chinese medicine "Donkey-hide gelatin effervescent particles" for nourishing blood includes such steps as pulverizing donkey-hide gelatin, decocting, Chinese angelica root and white atractylodes rhizome for extracting volatile oil, decocting residual dregs along with 3 Chinese-medicinal materials including astragalus root, concentrating, spray drying, mixing volatile oil with cyclodextrin and drying, drying the effervescent agent and additive, mixing all together and granulating. Its advantage is high product quality.

Description

The preparation method of Liujiaobuxue effervescent granule
Technical field
This invention relates to the processing technology technical field of Chinese patent medicine effervescent granule, relates in particular to the preparation method of Liujiaobuxue effervescent granule.
Background technology
Effervescent granule is a kind of new form of Chinese drug, according to the relevant drug act of China, change dosage form as a kind of new drug research, former dosage form has LVJIAO BUXUE KELI, and listed in the 11st of the Drug Standard of Ministry of Public Health of the Peoples Republic of China " Chinese traditional patent formulation preparation ", form by Six-element Chinese medicine.The technology of former dosage form is: Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae are carried volatile oil, are condensed into thick paste behind the medicinal residues and the Radix Astragali, Radix Codonopsis, the Radix Rehmanniae Preparata decocting in water precipitate with ethanol, add Colla Corii Asini, Icing Sugar, volatile oil granulation, drying, packing.Though extract earlier volatile ingredient in the technology, in granulation, add most of loss in the dry run, and sugar content is too high, and the quality standard of control product quality is too low, indefiniteness quantitative target almost, uncontrollable product quality.Have the shortcoming that influences quality based on granule, we use the modern pharmaceutical technology this product technology are made significant improvement, form new preparation, guarantee the quality monitoring of product, improve drug effect, benefit the common people.
Summary of the invention
The preparation method that the purpose of this invention is to provide a kind of Liujiaobuxue effervescent granule is improved the quality of products and curative effect, increases the stability of product, and the Ms is more pleased to take to satisfy needs of medical treatment better.
The objective of the invention is such realization:
The preparation method of Liujiaobuxue effervescent granule comprises the steps:
One, the prescription of Liujiaobuxue effervescent granule is formed
Colla Corii Asini 2160g Radix Astragali 1800g Radix Codonopsis 1800g
Radix Rehmanniae Preparata 1200g Rhizoma Atractylodis Macrocephalae 900g Radix Angelicae Sinensis 600g
Right amount of auxiliary materials is made 1000 bags altogether.
Two, Liujiaobuxue effervescent granule preparation technology
Technology one cleans the Six-element medicine respectively, removes impurity, and it is standby to be up to the standards; Get Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae is ground into coarse powder/decoction pieces and carries out steaming and decocting, collect volatile oil and make the cyclodextrin of volatile oil clathrate standby, the residue and the Radix Astragali, Radix Codonopsis, Radix Rehmanniae Preparata coarse powder/decoction pieces decoct with water three times, 1.5 hours for the first time, second and third time each 1 hour, collecting decoction filters, filtrate is concentrated into the clear paste that relative density is 1.08-1.10 (75-80 a ℃), after the cooling, add ethanol and make the alcohol amount of containing be 50-55%, stir evenly, cooling, leave standstill, filter filtrate recycling ethanol, be concentrated into relative density and be 1.25 (75-80 ℃), standby; Colla Corii Asini is ground into fine powder, adds above-mentioned concentrated solution, mixing, and drying is pulverized, and adds effervescent and reaches the appropriate amount of auxiliary materials mixed pelletization in right amount, and drying adds the cyclodextrin of volatile oil clathrate, mixing, packing, quality inspection, packing, promptly.
Technology two cleans the Six-element medicine respectively, removes impurity, and it is standby to be up to the standards; It is standby that Colla Corii Asini is ground into fine powder; All the other Radix Astragali five kinds of Chinese medicine mixed powders are broken into coarse powder, add the water steaming and carry three times, and it is standby to collect volatile oil and water boiling liquid; Merge three times water boiling liquid, filter, filtrate is concentrated into the clear paste that relative density is 1.08-1.10 (75-80 a ℃), after the cooling, add ethanol and make the alcohol amount of containing be 50-55%, stir evenly cooling, leave standstill, filter, filtrate recycling ethanol, being concentrated into relative density is the concentrated solution of 1.05-1.15 (60 ℃), spray drying, it is standby to collect dried cream powder; Said extracted volatile oil adds an amount of cyclodextrin, and to make the cyclodextrin of volatile oil clathrate standby; Get dried cream powder, donkey-hide gelatin fine powder adds effervescent and reaches the appropriate amount of auxiliary materials mixed pelletization in right amount, drying adds the cyclodextrin of volatile oil clathrate, mixing, packing, quality inspection, packing, promptly.
Three, prepared by technology one, two is effervescent granule.
Added adjuvant can be in the technology: 30 POVIDONE K 30 BP/USP 30, any or multiple mixing in the micropowder silica gel, starch, dextrin, Aspartane, magnesium stearate, essence uses.
Five tastes medical material such as Radix Astragali is ground into coarse powder and was generally 5-20 purpose coarse powder in the technology, is preferably 10 order coarse powder or is cut into decoction pieces.
The Colla Corii Asini pulverizing medicinal materials becomes fine powder to be generally 60-120 purpose fine powder in the technology, is preferably 100 order fine powders.
Decocting boils in the technology, the condition of water steaming and decocting is: amount of water is doubly measured for 6-12 for the first time, and second and third time doubly measured for each 4-10, and the 1-4 hour first time of time of decoction/steaming and decocting, second and third time is each 0.5-2 hour.Best second and third time is 8 times of amounts for amount of water is 10 times of amounts for the first time, and best decoction/digestion time is for being 1.5 hours for the first time, and second and third time is each 1 hour.
The relative density that is condensed into clear paste in the technology is 1.05-1.12 (75-80 a ℃), and best relative density is 1.08-1.10 (75-80 a ℃).
The relative density that is condensed into concentrated solution in the technology is 1.05-1.15 (55-60 a ℃), and best relative density is 1.08 (55-60 ℃).
In the technology one behind the decocting in water precipitate with ethanol solution concentration to become the relative density of thick paste be 1.15-1.30 (75-80 ℃), best relative density is 1.25 (75-80 ℃).
The spray drying inlet temperature is 100-200 ℃ in the technology, and leaving air temp is 50-150 ℃, and best inlet temperature is 160 ℃, and leaving air temp is 100 ℃.
The temperature of particle drying is controlled at 60-90 ℃ in the technology, is preferably 80 ℃.
Cyclodextrin of volatile oil clathrate preparation in the technology: cyclodextrin can adopt a kind of in beta-schardinger dextrin-, the hydroxyl beta-schardinger dextrin-, the ratio of volatile oil and beta-schardinger dextrin-is 1: 5-15 (ml/g), optimal proportion is 1: 8 (ml/g), the ratio of volatile oil and hydroxyl beta-schardinger dextrin-is 1: 2-10 (ml/g), optimal proportion are 1: 5 (ml/g).
The condition of precipitate with ethanol is in the technology: contain alcohol and reach 45%-65%, left standstill under 0-15 ℃ 8-48 hour; Be preferably and contain alcohol amount and reach 50%-55%, left standstill 12 hours at 4-10 ℃.
The acid source of effervescent is a kind of or two kinds in citric acid, tartaric acid, the fumaric acid in the prescription, and carbon dioxide source is a kind of in sodium carbonate, sodium bicarbonate, the potassium carbonate or two kinds; Be preferably citric acid and sodium bicarbonate, its ratio is a sodium bicarbonate: citric acid is 0.8-1.1: 1.2-1.5, and getting is 1.0: 1.3, and consumption is that sodium bicarbonate is 3-10%, and citric acid is 5-15%, is preferably sodium bicarbonate 6%, and citric acid is 8%.
The quality control of this product mainly is discriminating, inspection, three aspects of assay, Six-element medicine in the prescription is all carried out thin layer differentiate; Heavy metal, arsenic salt are carried out limit examine, and be controlled at dispersing and dissolving in 5 minutes; Radix Angelicae Sinensis, the Radix Astragali are carried out quantitatively.
This invention its superiority compared with the prior art is: production technology more becomes fully rationally, quality standard improves comprehensively, makes product that the qualitative, quantitative control method of science be arranged, and makes the quality of product that guarantee arranged.
The specific embodiment
The optimum implementation of this invention is that the Six-element medicine is cleaned respectively, removes impurity, and it is standby to be up to the standards; It is standby that Colla Corii Asini is ground into fine powder; All the other Radix Astragali five kinds of Chinese medicine mixed powders are broken into coarse powder, add the water steaming and carry three times, and it is standby to collect volatile oil and water boiling liquid; Merge three times water boiling liquid, filter, filtrate is concentrated into the clear paste that relative density is 1.08-1.10 (75-80 a ℃), after the cooling, add ethanol and make the alcohol amount of containing be 50-55%, stir evenly cooling, leave standstill, filter, filtrate recycling ethanol, being concentrated into relative density is the concentrated solution of 1.05-1.15 (60 ℃), spray drying, it is standby to collect dried cream powder; Said extracted volatile oil adds an amount of cyclodextrin, and to make the cyclodextrin of volatile oil clathrate standby; Get dried cream powder, donkey-hide gelatin fine powder adds effervescent and reaches the appropriate amount of auxiliary materials mixed pelletization in right amount, drying adds the cyclodextrin of volatile oil clathrate, mixing, packing, quality inspection, packing, promptly.

Claims (1)

1, the preparation method of Liujiaobuxue effervescent granule is characterized in that it may further comprise the steps:
(1) Radix Astragali in the technology, Radix Codonopsis, Radix Rehmanniae Preparata, the Rhizoma Atractylodis Macrocephalae, the Radix Angelicae Sinensis five tastes be for being ground into 5-20 purpose coarse powder, and the best is that to be ground into 10 order coarse powder standby.
(2) in the technology, the Radix Astragali, Radix Codonopsis, Radix Rehmanniae Preparata, the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis five tastes decocting boil/and the condition of water steaming and decocting is: and amount of water is doubly measured for 6-12 for the first time, second and third time doubly measured for 4-10, the time of decoction/steaming and decocting is 1-4 hour for the first time, and second and third time respectively is 0.5-2 hour, and best amount of water is 10 times of amounts for the first time, second and third time respectively is 8 times of amounts, decoction/digestion time is 1.5 hours for the first time, and second and third time respectively is 1 hour, and collects volatile oil and steaming and decocting/cooking liquor simultaneously.
(3) relative density that the Radix Astragali, Radix Codonopsis, Radix Rehmanniae Preparata, the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis five kinds of Chinese medicine are condensed into clear paste in the technology is 1.05-1.12 (75-80 a ℃), and best relative density is 1.08-1.10 (75-80 a ℃), carries out precipitate with ethanol then.
(4) condition of precipitate with ethanol is in the technology: contain alcohol and reach 45%-65%, left standstill under 0-15 ℃ 8-48 hour; Be preferably and contain alcohol amount and reach 50%-55%, left standstill 12 hours at 4-10 ℃, filter then, filtered solution reclaims ethanol, reconcentration.
(5) relative density of the concentrated solution of the Radix Astragali, Radix Codonopsis, Radix Rehmanniae Preparata, the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis five kinds of Chinese medicine is 1.05-1.15 (55-60 a ℃) in the technology, and best relative density is 1.08 (55-60 ℃).
(6) the spray drying inlet temperature is 100-200 ℃ in the technology, and leaving air temp is 50-150 ℃, and best inlet temperature is 160 ℃, and leaving air temp is 100 ℃.
(7) temperature of particle drying is controlled at 60-90 ℃ in the technology, is preferably 80 ℃.
(8) cyclodextrin of volatile oil clathrate preparation in the technology: cyclodextrin can adopt a kind of in beta-schardinger dextrin-, the hydroxyl beta-schardinger dextrin-, the ratio of volatile oil and beta-schardinger dextrin-is 1: 5-15 (ml/g), optimal proportion is 1: 8 (ml/g), the ratio of volatile oil and hydroxyl beta-schardinger dextrin-is 1: 2-10 (ml/g), optimal proportion are 1: 5 (ml/g).
(9) used adjuvant is in the technology: any/multiple mixing in 30 POVIDONE K 30 BP/USP 30, micropowder silica gel, Aspartane, starch, dextrin, magnesium stearate, the essence is used.
(10) added effervescent in the technology, its acid source are a kind of in citric acid, tartaric acid, the fumaric acid/two kind, and carbon dioxide source is a kind of/two kind in sodium carbonate, sodium bicarbonate, the potassium carbonate; Be preferably citric acid and sodium bicarbonate, its ratio is a sodium bicarbonate: citric acid is 0.8-1.1: 1.2-1.5, and getting is 1.0: 1.3, and consumption is that sodium bicarbonate is 3-10%, and citric acid is 5-15%, is preferably sodium bicarbonate 6%, and citric acid is 8%.
(11) Colla Corii Asini porphyrize powder is standby in the technology.
(12) standby material, adjuvant, effervescent are fed intake on request make effervescent granule.
CN 03118613 2003-02-12 2003-02-12 Preparation of donkey hide gelatin effervescent granules for nourishing blood Pending CN1456229A (en)

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101342267B (en) * 2008-08-20 2010-05-12 李少平 Donkey-hide gelatin angelica polymorpha & hoantchy particle and method of preparing the same
CN101879302A (en) * 2010-06-24 2010-11-10 浙江省中医药研究院 Compound traditional Chinese medicine for treating slow arrhythmia and preparation method thereof
CN101623313B (en) * 2009-01-22 2011-08-17 九芝堂股份有限公司 Method for preparing traditional Chinese medicine preparation for tonifying blood
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
CN106266129A (en) * 2016-08-28 2017-01-04 浙江康恩贝制药股份有限公司 A kind of blue a kind of reed mentioned in ancient books granule preparing process

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101342267B (en) * 2008-08-20 2010-05-12 李少平 Donkey-hide gelatin angelica polymorpha & hoantchy particle and method of preparing the same
CN101623313B (en) * 2009-01-22 2011-08-17 九芝堂股份有限公司 Method for preparing traditional Chinese medicine preparation for tonifying blood
CN101879302A (en) * 2010-06-24 2010-11-10 浙江省中医药研究院 Compound traditional Chinese medicine for treating slow arrhythmia and preparation method thereof
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
CN106266129A (en) * 2016-08-28 2017-01-04 浙江康恩贝制药股份有限公司 A kind of blue a kind of reed mentioned in ancient books granule preparing process

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