CN1537582A - Shenqi Gankang granule contg. ginseng and ast4ragalus mongholicus for treating liver disease, and its prepn. method - Google Patents
Shenqi Gankang granule contg. ginseng and ast4ragalus mongholicus for treating liver disease, and its prepn. method Download PDFInfo
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- CN1537582A CN1537582A CNA031182887A CN03118288A CN1537582A CN 1537582 A CN1537582 A CN 1537582A CN A031182887 A CNA031182887 A CN A031182887A CN 03118288 A CN03118288 A CN 03118288A CN 1537582 A CN1537582 A CN 1537582A
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Abstract
An improved Chinese medicine 'Shenqi Gankang granule' for treating the acute or chronic hepatitis is prepared through extracting volatile oil from Chinese angelica root, extracting from milk thistle and schisandra fruit in alcohol, decocting the dregs and others, concentrating, drying, adding auxiliary, granulating and drying. Its advantages are high curative effect and high safety.
Description
Technical field
This invention relates to the particulate processing technology technical field of Chinese patent medicine, relates in particular to ginseng and astragalus hepar kang 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, the particulate original dosage form of ginseng and astragalus hepar kang is the ginseng and astragalus hepar kang capsule, 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 one half-dozen fine powder in the prescription, two flavor alcohol reflux such as half and Herba Silybi mariani are made thick paste, and medicinal residues and Radix Codonopsis etc. three are distinguished the flavor of and decocted with water, and make thick paste, add above-mentioned thick paste, Radix Angelicae Sinensis fine powder and Radix Et Caulis Acanthopanacis Senticosi extractum, mixing, drying, pulverize, granulate, drying, promptly encapsulated.This dosage form dose is big, one time 5, dysphagia, 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 by comparison, also has onset advantage rapidly.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.
Summary of the invention
The purpose of this invention is to provide a kind of ginseng and astragalus hepar kang 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, ginseng and astragalus hepar kang granule and preparation method comprise the steps:
1.1 the particulate prescription of ginseng and astragalus hepar kang is formed
Herba Artemisiae Scopariae 750-2250g Radix Codonopsis 375-1255g Herba Silybi mariani 375-1255g
Fructus Schisandrae Chinensis 375-1255g Radix Angelicae Sinensis 500-1500g Radix Astragali 750-2250g
Radix Et Caulis Acanthopanacis Senticosi extractum 50-150g right amount of auxiliary materials is made 1000 bags altogether.
Its optimum formula is:
Herba Artemisiae Scopariae 1500g Radix Codonopsis 750g Herba Silybi mariani 750g
Fructus Schisandrae Chinensis 750g Radix Angelicae Sinensis 1000g Radix Astragali 1500g
Radix Et Caulis Acanthopanacis Senticosi extractum 100g
Right amount of auxiliary materials is made 1000 bags altogether.
1.2 the particulate preparation technology of ginseng and astragalus hepar kang
Technology one, will write out a prescription in seven flavor medicine be up to the standards standby respectively; Radix Angelicae Sinensis is got half amount and is ground into fine powder, and all the other half amounts and Herba Silybi mariani, Fructus Schisandrae Chinensis powder are broken into coarse powder, add 60-95% ethanol extraction 2-3 time, merge extractive liquid,, filter, filtrate recycling ethanol is condensed into thick paste, medicinal residues after Radix Codonopsis, Herba Artemisiae Scopariae, the Radix Astragali and the alcohol extraction decoct with water 2-3 time, collecting decoction filters, and filtrate is condensed into thick paste, add above-mentioned thick paste and Radix Angelicae Sinensis fine powder and Radix Et Caulis Acanthopanacis Senticosi extractum, stir, vacuum drying is ground into fine powder, with the appropriate amount of auxiliary materials mixing, make granule, drying, granulate, packing, promptly.
Technology two, will write out a prescription in seven flavor medicine be up to the standards standby respectively; Radix Angelicae Sinensis is got half amount and is ground into fine powder, and all the other half amounts and Herba Silybi mariani, Fructus Schisandrae Chinensis powder are broken into coarse powder, add 60-95% ethanol extraction 2-3 time, merge extractive liquid,, filter, filtrate recycling ethanol is concentrated into an amount of, medicinal residues after Radix Codonopsis, Herba Artemisiae Scopariae, the Radix Astragali and the alcohol extraction decoct with water 2-3 time, and collecting decoction filters, filtrate is concentrated in right amount, and with above-mentioned alcohol extract and Radix Et Caulis Acanthopanacis Senticosi extractum mixing, drying is made dried cream powder, add above-mentioned Radix Angelicae Sinensis fine powder and appropriate amount of auxiliary materials mixing, make granule, drying, granulate, packing, promptly.
Technology three, will write out a prescription in seven flavor medicine be up to the standards standby respectively; Radix Angelicae Sinensis, Herba Silybi mariani, Fructus Schisandrae Chinensis powder are broken into coarse powder, add 60-95% ethanol extraction 2-3 time, merge extractive liquid,, filter, filtrate recycling ethanol is concentrated in right amount, and the medicinal residues after Radix Codonopsis, Herba Artemisiae Scopariae, the Radix Astragali and the alcohol extraction decoct with water 2-3 time, collecting decoction filters, and filtrate is condensed into in right amount, with above-mentioned alcohol extract and Radix Et Caulis Acanthopanacis Senticosi extractum mixing, drying is made dried cream powder, with the appropriate amount of auxiliary materials mixing, make granule, 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 dissolving of ethanol; Herba Silybi mariani, Fructus Schisandrae Chinensis powder are broken into coarse powder, add 60-95% ethanol extraction 2-3 time, merge extractive liquid,, filter, filtrate recycling ethanol is concentrated in right amount, and medicinal residues after Radix Codonopsis, Herba Artemisiae Scopariae, common stilbene and the alcohol extraction and Radix Angelicae Sinensis extract the medicinal residues behind the volatile oil, decoct with water 2-3 time, collecting decoction filters, and filtrate is concentrated in right amount, with above-mentioned alcohol extract and Radix Et Caulis Acanthopanacis Senticosi extractum mixing, dried cream is made dried cream powder, with above-mentioned Radix Angelicae Sinensis volatile oil clathrate and appropriate amount of auxiliary materials mixing, built in becoming granule, dry, spray adds Radix Angelicae Sinensis volatile oil, mixing, and packing is promptly.
1.3 by the technology gained is granule
The added adjuvant of ginseng and astragalus hepar kang granule can be: 30 POVIDONE K 30 BP/USP
30, any or multiple mixing in the micropowder silica gel, starch, dextrin, sucrose, steviosin, Aspartane, magnesium stearate, essence etc. uses.
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 secondary, is 8 times of amounts for the second time, 2 hours for the first time, and 1.5 hours for the second time.
The alcohol extraction condition is in the technology: with 60-95% ethanol is solvent, adopts and refluxes or the percolation extraction, best for being solvent with 95% ethanol, adds 8 times of amount solvent refluxings and extracts secondary, 2 hours first time, 1.5 hours for the second time.
Radix Angelicae Sinensis powder is broken into fine powder in the technology one or two, is generally 80-160 purpose fine powder, and the best is that superfine powder is broken into 200-300 purpose fine powder.
The relative density of thick paste is 1.10-1.45 (60 ℃) in the technology one, and best relative density is 1.36-1.38 (60 ℃).
In the technology in four the condition of enclose be: 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: 9 (ml/g), the ratio of volatile oil and hydroxyl beta-schardinger dextrin-is 1: 2-10 (ml/g), optimal proportion are 1: 6 (ml/g).
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 (60 ℃), and inlet temperature is 160-180 ℃, and leaving air temp is 100 ℃.
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, the particulate quality control standard of ginseng and astragalus hepar kang further improves on the capsular basis of original ginseng and astragalus hepar kang among the present invention, former dosage form has the thin layer of Radix Angelicae Sinensis, the Radix Astragali to differentiate on differentiating, now kept, and increased the thin layer of Fructus Schisandrae Chinensis 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 Artemisiae Scopariae on the assay, and increased to Radix Angelicae Sinensis 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
This invention optimum implementation 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 dissolving of ethanol; Herba Silybi mariani, Fructus Schisandrae Chinensis powder are broken into coarse powder, add 60-95% ethanol extraction 2-3 time, merge extractive liquid,, filter, filtrate recycling ethanol is concentrated in right amount, and medicinal residues after Radix Codonopsis, Herba Artemisiae Scopariae, common stilbene and the alcohol extraction and Radix Angelicae Sinensis extract the medicinal residues behind the volatile oil, decoct with water 2-3 time, collecting decoction filters, and filtrate is concentrated in right amount, with above-mentioned alcohol extract and Radix Et Caulis Acanthopanacis Senticosi extractum mixing, dried cream is made dried cream powder, with above-mentioned Radix Angelicae Sinensis volatile oil clathrate and appropriate amount of auxiliary materials mixing, built in becoming granule, dry, spray adds Radix Angelicae Sinensis volatile oil, mixing, and packing is promptly.
Claims (8)
1, a kind of ginseng and astragalus hepar kang granule and preparation method is characterized in that:
(1) will write out a prescription in seven flavor medicine be up to the standards standby respectively; Radix Angelicae Sinensis is got half amount and is ground into fine powder, all the other half amounts and Herba Silybi mariani, Fructus Schisandrae Chinensis powder are broken into coarse powder, add 60-95% ethanol extraction 2-3 time, merge extractive liquid, filters, filtrate recycling ethanol, be concentrated in right amount, the medicinal residues after Radix Codonopsis, Herba Artemisiae Scopariae, the Radix Astragali and the alcohol extraction decoct with water 2-3 time, collecting decoction, filter, filtrate concentrate/is condensed into thick paste, and with above-mentioned alcohol extract and Radix Et Caulis Acanthopanacis Senticosi extractum mixing, drying is made dried cream powder, add above-mentioned Radix Angelicae Sinensis fine powder and appropriate amount of auxiliary materials mixing, make granule, drying, granulate, packing makes the ginseng and astragalus hepar kang granule.
(2) will write out a prescription in seven flavor medicine be up to the standards standby respectively; Radix Angelicae Sinensis, Herba Silybi mariani, Fructus Schisandrae Chinensis powder are broken into coarse powder, add 60-95% ethanol extraction 2-3 time, merge extractive liquid,, filter, filtrate recycling ethanol is concentrated in right amount, and the medicinal residues after Radix Codonopsis, Herba Artemisiae Scopariae, the Radix Astragali and the alcohol extraction decoct with water 2-3 time, collecting decoction filters, and filtrate is condensed into in right amount, with above-mentioned alcohol extract and Radix Et Caulis Acanthopanacis Senticosi extractum mixing, drying is made dried cream powder, with the appropriate amount of auxiliary materials mixing, make granule, drying, granulate, packing, promptly.
(3) 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 dissolving of ethanol; Herba Silybi mariani, Fructus Schisandrae Chinensis powder are broken into coarse powder, add 60-95% ethanol extraction 2-3 time, merge extractive liquid,, filter, filtrate recycling ethanol is concentrated in right amount, and medicinal residues after Radix Codonopsis, Herba Artemisiae Scopariae, common stilbene and the alcohol extraction and Radix Angelicae Sinensis extract the medicinal residues behind the volatile oil, decoct with water 2-3 time, collecting decoction filters, and filtrate is concentrated in right amount, with above-mentioned alcohol extract and Radix Et Caulis Acanthopanacis Senticosi extractum mixing, dried cream is made dried cream powder, with above-mentioned Radix Angelicae Sinensis volatile oil clathrate and appropriate amount of auxiliary materials mixing, built in becoming granule, dry, spray adds Radix Angelicae Sinensis volatile oil, mixing, and packing is promptly.
2, ginseng and astragalus hepar kang granule according to claim 1 and preparation method is characterized in that: the added adjuvant of ginseng and astragalus hepar kang granule can be: 30 POVIDONE K 30 BP/USP
30, any/multiple mixing in the micropowder silica gel, starch, dextrin, sucrose, steviosin, Aspartane, magnesium stearate, essence etc. uses.
3, ginseng and astragalus hepar kang granule according to claim 1 and preparation method, it is characterized in that: the alcohol extraction condition is in the technology: with 60-95% ethanol is solvent, adopt and reflux or the percolation extraction, best for being solvent with 95% ethanol, add 8 times of amount solvent refluxings and extract secondary, 2 hours for the first time, 1.5 hours for the second time.
4, ginseng and astragalus hepar kang granule according to claim 1 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 secondary, is 8 times of amounts for the second time, 2 hours for the first time, and 1.5 hours for the second time.
5, ginseng and astragalus hepar kang granule according to claim 1 and preparation method, it is characterized in that: Radix Angelicae Sinensis powder is broken into fine powder in the technology one or two, is generally 80-160 purpose fine powder, and the best is that superfine powder is broken into 200-300 purpose fine powder.
6, ginseng and astragalus hepar kang granule according to claim 1 and preparation method, it is characterized in that: in the technology in four the condition of enclose be: 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: 9 (ml/g), the ratio of volatile oil and hydroxyl beta-schardinger dextrin-is 1: 2-10 (ml/g), optimal proportion are 1: 6 (ml/g).
7, ginseng and astragalus hepar kang granule according to claim 1 and preparation method, it is characterized in that: drying can adopt vacuum drying or adopt spray drying in the technology, the vacuum drying temperature is controlled at 50-80 ℃, be 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, spray drying, inlet temperature is 100-200 ℃, leaving air temp is 50-150 ℃, best relative density is 1.08 (60 ℃), inlet temperature is 160-180 ℃, and leaving air temp is 100 ℃.
8, ginseng and astragalus hepar kang granule according to claim 1 and preparation method is characterized in that: have the thin layer of Fructus Schisandrae Chinensis to differentiate that have heavy metal limit must not cross 10/1000000ths, arsenic salt must not be crossed 2/1000000ths limit detection in quality standard control; The quantitative assay of Radix Angelicae Sinensis is arranged.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031182887A CN1537582A (en) | 2003-04-15 | 2003-04-15 | Shenqi Gankang granule contg. ginseng and ast4ragalus mongholicus for treating liver disease, and its prepn. method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031182887A CN1537582A (en) | 2003-04-15 | 2003-04-15 | Shenqi Gankang granule contg. ginseng and ast4ragalus mongholicus for treating liver disease, and its prepn. method |
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| CN1537582A true CN1537582A (en) | 2004-10-20 |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1981833B (en) * | 2005-12-05 | 2011-05-18 | 山东轩竹医药科技有限公司 | Medicinal composition of elutriate, virgate wormwood herb and and cape-jasmine |
| CN102240325A (en) * | 2010-05-11 | 2011-11-16 | 西安兆兴制药有限公司 | Traditional Chinese medicine dispersible tablet for treating hepatitis, and preparation method thereof |
| CN108310145A (en) * | 2018-03-29 | 2018-07-24 | 陕西省中医医院 | A kind of "Huazhi Fugan Granule" and preparation method thereof |
| CN112168896A (en) * | 2019-07-05 | 2021-01-05 | 黄胜昔 | Traditional Chinese medicine for treating liver hypofunction and liver injury and production method thereof |
-
2003
- 2003-04-15 CN CNA031182887A patent/CN1537582A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1981833B (en) * | 2005-12-05 | 2011-05-18 | 山东轩竹医药科技有限公司 | Medicinal composition of elutriate, virgate wormwood herb and and cape-jasmine |
| CN102240325A (en) * | 2010-05-11 | 2011-11-16 | 西安兆兴制药有限公司 | Traditional Chinese medicine dispersible tablet for treating hepatitis, and preparation method thereof |
| CN108310145A (en) * | 2018-03-29 | 2018-07-24 | 陕西省中医医院 | A kind of "Huazhi Fugan Granule" and preparation method thereof |
| CN112168896A (en) * | 2019-07-05 | 2021-01-05 | 黄胜昔 | Traditional Chinese medicine for treating liver hypofunction and liver injury and production method thereof |
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