CN1552366A - Donkey hide gelatin and Chinese angelica nourishing blood pills and their preparation - Google Patents
Donkey hide gelatin and Chinese angelica nourishing blood pills and their preparation Download PDFInfo
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- CN1552366A CN1552366A CNA031245021A CN03124502A CN1552366A CN 1552366 A CN1552366 A CN 1552366A CN A031245021 A CNA031245021 A CN A031245021A CN 03124502 A CN03124502 A CN 03124502A CN 1552366 A CN1552366 A CN 1552366A
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Abstract
A Chinese medicine 'Aguiyangxue pill' for nourishing blood and Qi and treating poor constitution, amenorrhoea and morbid leukorrhea is an improvement to existing relative medicine in the form of particles. Its preparing process is also disclosed. Its advantages are high curative effect, high release speed and high biologic utilization rate.
Description
Technical field
This invention relates to the processing technology technical field of Chinese patent medicine pill, relates in particular to donkey hide gelatin and Chinese angelica nourishing blood pill and preparation method.
Background technology
Pill is a kind of conventional dosage forms, because the velocity of sound of modern science and technology development, pharmaceutical machine, equipment are brought in constant renewal in and are regenerated, the appearance of novel pellet processing machine, and the extensive use of new adjuvant, for this ancient dosage form of medicine pill has shone youthful vigor, it has changed the traditional prejudice of people to medicine pill " black, big, thick ", advantage such as the pill that makes it to produce has that drug release rate is fast, bioavailability is high, zest is little, divided dose is accurate, takes, easy to carry, good looking appearance; According to the relevant drug act of China, change dosage form as a kind of new drug research, original dosage form of donkey hide gelatin and Chinese angelica nourishing blood pill is: the EGUIYANGXUE granule, listed in the 12nd of the Drug Standard of Ministry of Public Health of the Peoples Republic of China " Chinese traditional patent formulation preparation ".The technology features of former dosage form is: except that Colla Corii Asini, eight flavors such as all the other Radix Angelicae Sinensis are used 60% ethanol percolate extraction in the prescription, and diacolation liquid recycling ethanol is concentrated in right amount, leaves standstill, and collects the grease of come-up; Medicinal residues water is carried and is concentrated into an amount of and above-mentioned concentrated solution mixing, adds the Colla Corii Asini solution that dissolves, and boils, and filters, and concentrates, granulate with sucrose, dextrin, and drying, spray adds above-mentioned grease, mixing, promptly.This granule supplementary product consumption is big, the sugar content height, and the people who is unsuitable for suffering from diabetes takes; And its quality standard controlling index is low, and dosage form is single, far can not satisfy people's medication demand.We use the modern pharmaceutical technology this product technology are improved based on this, form new preparation, and the standard that comprehensively improves the quality, and guarantee the quality monitoring of product, to improve drug effect, benefit the common people, and 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 donkey hide gelatin and Chinese angelica nourishing blood pill and preparation method, improve the quality of products and curative effect, increase the stability of product, satisfy needs of medical treatment better.
The objective of the invention is such realization:
1. donkey hide gelatin and Chinese angelica nourishing blood pill and preparation method comprise the steps:
1.1 the prescription of donkey hide gelatin and Chinese angelica nourishing blood pill is formed
Radix Angelicae Sinensis 1158-3088g Radix Codonopsis 72-192g Radix Paeoniae Alba 72-192g
Radix Glycyrrhizae (processed with honey) 36-96g Poria 72-192g Radix Astragali 72-192g
Radix Rehmanniae Preparata 72-192g Rhizoma Chuanxiong 36-96g Colla Corii Asini 72-792g
Right amount of auxiliary materials is made 1000g altogether.
Its optimum formula is:
Radix Angelicae Sinensis 1930-2002g Radix Codonopsis 120-168g Radix Paeoniae Alba 120-168g
Radix Glycyrrhizae (processed with honey) 60-84g Poria 120-168g Radix Astragali 120-168g
Radix Rehmanniae Preparata 120-168g Rhizoma Chuanxiong 60-84g Colla Corii Asini 120-168g
Right amount of auxiliary materials is made 1000g altogether.
1.2 donkey hide gelatin and Chinese angelica nourishing blood pill preparation technology
Technology one cleans nine flavor medicines respectively, removes impurity, and it is standby to be up to the standards.Except that Colla Corii Asini, eight flavor medicated powder such as all the other Radix Angelicae Sinensis are broken into coarse powder or are cut into decoction pieces, use the 50-95% ethanol extraction, and extracting solution reclaims ethanol, is concentrated in right amount, after leaving standstill, collects the grease of come-up, and device is preserved in addition; Medicinal residues decoct with water 1-2 time, filter, and filtrate is concentrated in right amount, with above-mentioned concentrated solution mixing, add the Colla Corii Asini solution after water dissolves, stir evenly, boiled 30 minutes, and filtered while hot, be condensed into thick paste/concentrate drying and make dried cream powder, with the appropriate amount of auxiliary materials mixing, pill, drying, spray adds above-mentioned grease, mixing, promptly.
Technology two cleans nine flavor medicines 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; Eight flavor medicated powder such as all the other Radix Angelicae Sinensis are broken into coarse powder or are cut into decoction pieces, use the 50-95% ethanol extraction, and extracting solution reclaims ethanol, is concentrated in right amount, after leaving standstill, collects the grease of come-up, and device is preserved in addition; Medicinal residues decoct with water 1-2 time, filter, and filtrate is concentrated in right amount, with above-mentioned concentrated solution mixing, are condensed into thick paste/concentrate drying and make dried cream powder, and with donkey-hide gelatin fine powder and appropriate amount of auxiliary materials mixing, pill, drying, spray adds above-mentioned grease, mixing, promptly.
Technology three cleans nine flavor medicines 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; Radix Angelicae Sinensis extracts volatile oil, and medicinal residues are standby; Above-mentioned volatile oil and an amount of cyclodextrin inclusion compound/standby with the ethanol solution dissolving; Seven flavor medicines such as all the other Radix Codonopsis are ground into coarse powder or are cut into decoction pieces, use the 50-95% ethanol extraction, and it is standby that extracting solution reclaims ethanol; Medicinal residues and above-mentioned Radix Angelicae Sinensis medicinal residues merge, decoct with water 1-2 time, decocting liquid filters, merge with the alcohol extract behind the above-mentioned recovery ethanol, be condensed into thick paste/concentrate drying and make dried cream powder, above-mentioned thick paste/dried cream powder and above-mentioned donkey-hide gelatin fine powder, cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixing, pill, drying, promptly.Or above-mentioned thick paste/dried cream powder and above-mentioned donkey-hide gelatin fine powder and appropriate amount of auxiliary materials mixing, pill, drying, spray adds above-mentioned volatile oil ethanol solution, promptly.
1.3 by technology one, two, three prepared balls is donkey hide gelatin and Chinese angelica nourishing blood pill.
The ball of gained can wrap film-coat in the technology, and the film-coat material adopts stomach dissolution type film-coat pre-mixing agent (Opadry), hydroxypropyl cellulose, polyvinylpyrrolidone, hydroxypropyl emthylcellulose, polyvinyl alcohol, one or more mixing of methylcellulose to use.
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 the best is 1-4mm.
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.
The technology Chinese crude drug is ground into coarse powder or is cut into decoction pieces for being ground into 5-30 purpose coarse powder or being cut into decoction pieces, and the best is a 10-20 purpose coarse powder.
The technology Chinese crude drug is ground into fine powder, is generally to be ground into 80-160 purpose fine powder, and the best is that superfine powder is broken into 200-300 purpose fine powder.
The condition of alcohol extraction is in the technology: with 50-95% ethanol is solvent, and reflux/percolation extracts; Best flooded 24 hours for being solvent with 60% ethanol, percolation is slowly collected 8 times of amounts liquid of filtering.
Cyclodextrin of volatile oil clathrate preparation in the technology: cyclodextrin can adopt a kind of in beta-schardinger dextrin-, the HP-, the ratio of volatile oil and beta-schardinger dextrin-is: 1: 5-15 (ml/g), optimal proportion is: 1: 9 (ml/g), the ratio of volatile oil and HP-is: 1: 3-10 (ml/g), optimal proportion is: 1: 6 (ml/g).
The condition that decocting boils in the technology is: decoct 1-2 time, amount of water is that the 4-12 of dose doubly measures, time 0.5-3 hour; The best is: decoct 1 time, amount of water is 10 times of amounts of dose, and the time is 1 hour.
The relative density of thick paste is 1.10-1.45 (75-80 a ℃) in the technology, and the best is relative density 1.30 (75-80 a ℃).
The drying of extract can adopt vacuum drying or adopt spray drying in the technology, and the vacuum drying temperature is controlled at 50-80 ℃, is preferably 60 ℃.The relative density of spray drying concentrated solution is 1.05-1.15 (55-60 a ℃); Inlet temperature is 100-200 ℃, leaving air temp 50-150 ℃; The best relative density of concentrated solution is 1.08-1.10 (60 ℃), and inlet temperature is 160-180 ℃, leaving air temp 80-100 ℃.
Filter in the technology to adopt and conventionally filter, centrifugal, ultrafiltration, add filtration/centrifugal/methods such as ultrafiltration behind the clarifier.
2. the quality control of this product mainly is: discriminating, inspection, three aspects of assay.
The quality standard of this product is improved comprehensively, former dose of dosage form has only the thin layer of a Radix Angelicae Sinensis to differentiate, the existing thin layer that has increased Radix Codonopsis, the Radix Astragali, the Radix Paeoniae Alba is differentiated; Increase heavy metal limit in the inspection and must not cross 10/1000000ths, arsenic salt must not cross 2/1000000ths; On assay, Radix Angelicae Sinensis has been carried out quantitatively.
This invention its superiority compared with the prior art is: production technology more becomes to improving rationally, and quality standard is much improved, and makes product that the qualitative, quantitative control method of science be arranged, and makes the quality of product and curative effect that guarantee arranged.
The specific embodiment
Embodiment 1: nine flavor medicines are cleaned respectively, remove impurity, it is standby to be up to the standards.Except that Colla Corii Asini, all the other Radix Angelicae Sinensis etc. eight flavor medicated powder are broken into coarse powder, and mixing is made solvent with 60% ethanol, floods 24 hours, and percolation is slowly collected 8 times of amounts liquid of filtering, and reclaims ethanol, are concentrated in right amount, after leaving standstill, collect the grease that floats, other device preservation; Medicinal residues decoct with water 1 time, 1 hour time, filter, and filtrate is concentrated in right amount, leaves standstill 24 hours.Incline and get above-mentioned two kinds of concentrated medicaments, mixing adds the Colla Corii Asini solution after water dissolves again, stir evenly, boiled 30 minutes, filter while hot, be concentrated into relative density 1.08-1.10 (55-60 ℃), spray drying is made dried cream powder, adds the appropriate amount of auxiliary materials mixing, pill, dry, spray adds above-mentioned grease, mixing, promptly.
Embodiment 2: nine flavor medicines are cleaned respectively, remove impurity, 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 Angelicae Sinensis etc. eight flavor medicated powder are broken into coarse powder, make solvent with 60% ethanol, floods 24 hours, and percolation is slowly collected 8 times of amounts liquid of filtering, and reclaims ethanol, are concentrated in right amount, after leaving standstill, collect the grease that floats, other device preservation; Medicinal residues decoct with water 1 time, 1 hour time, filter, and filtrate is concentrated in right amount, leaves standstill 24 hours.Incline and get above-mentioned two kinds of concentrated medicaments, mixing adds the Colla Corii Asini solution after water dissolves again, stir evenly, boiled 30 minutes, filter while hot, be concentrated into relative density 1.08-1.10 (55-60 ℃), spray drying is made dried cream powder, adds above-mentioned donkey-hide gelatin fine powder, appropriate amount of auxiliary materials mixing, pill, dry, spray adds above-mentioned grease, mixing, promptly.
Embodiment 3: nine flavor medicines are cleaned respectively, remove impurity, it is standby to be up to the standards.It is standby that Colla Corii Asini is ground into fine powder; Radix Angelicae Sinensis extracts volatile oil, and medicinal residues are standby; Above-mentioned volatile oil is standby with an amount of cyclodextrin inclusion compound; Seven flavor medicines such as all the other Radix Codonopsis are ground into coarse powder, make solvent with 60% ethanol, flood 24 hours, and percolation is slowly collected 8 times of amounts liquid of filtering, and reclaim behind the ethanol standby; The medicinal residues of medicinal residues and above-mentioned Radix Angelicae Sinensis merge, decoct with water 1 time, 1 hour time filtered, and the alcohol extract behind filtrate and the above-mentioned recovery ethanol merges, be concentrated into relative density 1.08-1.10 (55-60 ℃), spray drying is made dried cream powder, adds above-mentioned donkey-hide gelatin fine powder, cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixing, pill, drying, promptly.
Claims (10)
1, a kind of donkey hide gelatin and Chinese angelica nourishing blood pill and preparation method is characterized in that:
(1) Radix Angelicae Sinensis, Radix Codonopsis, the Radix Paeoniae Alba, Radix Glycyrrhizae, Poria, the Radix Astragali, Radix Rehmanniae Preparata, Rhizoma Chuanxiong, Colla Corii Asini nine flavor medicines are cleaned respectively, remove impurity, it is standby to be up to the standards; Except that Colla Corii Asini, eight flavor medicated powder such as all the other Radix Angelicae Sinensis are broken into coarse powder, use the 50-95% ethanol extraction, and extracting solution reclaims ethanol, is concentrated in right amount, after leaving standstill, collects the grease of come-up, and device is preserved in addition; Medicinal residues decoct with water 1-2 time, filter, and filtrate is concentrated in right amount, with the concentrated solution mixing, add the Colla Corii Asini solution after water dissolves, stir evenly, boiled 30 minutes, filter while hot, be condensed into thick paste/concentrate drying and make dried cream powder, with the appropriate amount of auxiliary materials mixing, pill, drying, spray adds grease, mixing, promptly.
(2) Radix Angelicae Sinensis, Radix Codonopsis, the Radix Paeoniae Alba, Radix Glycyrrhizae, Poria, the Radix Astragali, Radix Rehmanniae Preparata, Rhizoma Chuanxiong, Colla Corii Asini nine flavor medicines are cleaned respectively, remove impurity, it is standby to be up to the standards; It is standby that Colla Corii Asini is ground into fine powder; Eight flavor medicated powder such as all the other Radix Angelicae Sinensis are broken into coarse powder, use the 50-95% ethanol extraction, and extracting solution reclaims ethanol, is concentrated in right amount, after leaving standstill, collects the grease of come-up, and device is preserved in addition; Medicinal residues decoct with water 1-2 time, filter, and filtrate is concentrated in right amount, with the concentrated solution mixing, are condensed into thick paste/concentrate drying and make dried cream powder, and with donkey-hide gelatin fine powder and appropriate amount of auxiliary materials mixing, pill, drying, spray adds grease, mixing, promptly.
(3) Radix Angelicae Sinensis, Radix Codonopsis, the Radix Paeoniae Alba, Radix Glycyrrhizae, Poria, the Radix Astragali, Radix Rehmanniae Preparata, Rhizoma Chuanxiong, Colla Corii Asini nine flavor medicines are cleaned respectively, remove impurity, it is standby to be up to the standards; It is standby that Colla Corii Asini is ground into fine powder; Radix Angelicae Sinensis extracts volatile oil, and medicinal residues are standby; Volatile oil and an amount of cyclodextrin inclusion compound/standby with the ethanol solution dissolving; Seven flavor medicines such as all the other Radix Codonopsis are ground into coarse powder, use the 50-95% ethanol extraction, and it is standby that extracting solution reclaims ethanol; Medicinal residues and Radix Angelicae Sinensis medicinal residues merge, and decoct with water 1-2 time, and decocting liquid filters, merge with the alcohol extract behind the recovery ethanol, be condensed into thick paste/concentrate drying and make dried cream powder, thick paste/dried cream powder and donkey-hide gelatin fine powder, cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixing, pill, drying, promptly; Or thick paste/dried cream powder and donkey-hide gelatin fine powder and appropriate amount of auxiliary materials mixing, pill, drying, spray adds the volatile oil ethanol solution, promptly.
2. according to described donkey hide gelatin and Chinese angelica nourishing blood pill of 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.
3. according to described donkey hide gelatin and Chinese angelica nourishing blood pill of claim 1 and preparation method, it is characterized in that: used adjuvant can be sucrose, lactose, starch, beta-schardinger dextrin-, HP-, microcrystalline Cellulose, hydroxypropyl cellulose, carboxymethylstach sodium, Aspartane, polyvinylpolypyrrolidone, 30 1 kinds/multiple mixing use of 30 POVIDONE K 30 BP/USP.
4. according to described donkey hide gelatin and Chinese angelica nourishing blood pill of claim 1 and preparation method, it is characterized in that: the particle diameter of the ball of gained is 0.5-6mm, and the best is 1-4mm; The ball of gained can directly use/pack in the capsulae vacuus and use; The ball drying can adopt vacuum drying, fluid bed drying, lyophilization.
5. according to described donkey hide gelatin and Chinese angelica nourishing blood pill of claim 1 and preparation method, it is characterized in that: pulverizing medicinal materials becomes coarse powder for being ground into 5-30 purpose coarse powder, and the best is a 10-20 purpose coarse powder; Pulverizing medicinal materials becomes fine powder, is generally to be ground into 80-160 purpose fine powder, and the best is that superfine powder is broken into 200-300 purpose fine powder.
6. according to described donkey hide gelatin and Chinese angelica nourishing blood pill of claim 1 and preparation method, it is characterized in that: the condition of alcohol extraction is: with 50-95% ethanol is solvent, and reflux/percolation extracts; Best flooded 24 hours for being solvent with 60% ethanol, percolation is slowly collected 8 times of amounts liquid of filtering; The condition that decocting boils is: decoct 1-2 time, amount of water is that the 4-12 of dose doubly measures, time 0.5-3 hour; The best is: decoct 1 time, amount of water is 10 times of amounts of dose, and the time is 1 hour.
7. according to described donkey hide gelatin and Chinese angelica nourishing blood pill of claim 1 and preparation method, it is characterized in that: cyclodextrin of volatile oil clathrate preparation: cyclodextrin can adopt a kind of in beta-schardinger dextrin-, the HP-, the ratio of volatile oil and beta-schardinger dextrin-is: 1: 5-15 (ml/g), optimal proportion is: 1: 9 (ml/g), the ratio of volatile oil and HP-is: 1: 3-10 (ml/g), optimal proportion is: 1: 6 (ml/g).
8. according to described donkey hide gelatin and Chinese angelica nourishing blood pill of claim 1 and preparation method, it is characterized in that: the relative density of thick paste is 1.10-1.45 (75-80 a ℃), and the best is relative density 1.30 (75-80 a ℃); The drying of extract can adopt vacuum drying/employing spray drying, and vacuum drying concentrated solution relative density is 1.05-1.15 (55-60 a ℃), and temperature is controlled at 50-80 ℃, and the best is 60 ℃, and the spray drying inlet temperature is 100-200 ℃, leaving air temp 50-150 ℃; Best relative density is 1.08-1.10 (55-60 a ℃), and inlet temperature is 160-180 ℃, leaving air temp 80-100 ℃.
9. according to described donkey hide gelatin and Chinese angelica nourishing blood pill of claim 1 and preparation method, it is characterized in that: filtration can adopt and conventional filter, centrifugal, ultrafiltration, add the method for filtration/centrifugal/ultrafiltration behind the clarifier.
10. according to described donkey hide gelatin and Chinese angelica nourishing blood pill of claim 1 and preparation method, it is characterized in that: the quality standard of this product is controlled at the thin layer that Radix Codonopsis, the Radix Astragali, the Radix Paeoniae Alba are arranged in the discriminating and differentiates; Have heavy metal must not cross 10/1000000ths, arsenic salt must not be crossed 2/1000000ths limit detection; The quantitative of Radix Angelicae Sinensis arranged on assay.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031245021A CN1552366A (en) | 2003-06-03 | 2003-06-03 | Donkey hide gelatin and Chinese angelica nourishing blood pills and their preparation |
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| Application Number | Priority Date | Filing Date | Title |
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| CNA031245021A CN1552366A (en) | 2003-06-03 | 2003-06-03 | Donkey hide gelatin and Chinese angelica nourishing blood pills and their preparation |
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| CN1552366A true CN1552366A (en) | 2004-12-08 |
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| Application Number | Title | Priority Date | Filing Date |
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| CNA031245021A Pending CN1552366A (en) | 2003-06-03 | 2003-06-03 | Donkey hide gelatin and Chinese angelica nourishing blood pills and their preparation |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102579667A (en) * | 2011-12-21 | 2012-07-18 | 江西济民可信药业有限公司 | Preparation method of donkey-hide gelatin and Angelica blood-nourishing particles |
| CN106389724A (en) * | 2016-11-11 | 2017-02-15 | 东莞市百替生物科技有限公司 | Traditional Chinese medicine composition for treating qi and blood deficiency and preparation method thereof |
-
2003
- 2003-06-03 CN CNA031245021A patent/CN1552366A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102579667A (en) * | 2011-12-21 | 2012-07-18 | 江西济民可信药业有限公司 | Preparation method of donkey-hide gelatin and Angelica blood-nourishing particles |
| CN106389724A (en) * | 2016-11-11 | 2017-02-15 | 东莞市百替生物科技有限公司 | Traditional Chinese medicine composition for treating qi and blood deficiency and preparation method thereof |
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