CN1552356A - Sedative pill and preparing method thereof - Google Patents
Sedative pill and preparing method thereof Download PDFInfo
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- CN1552356A CN1552356A CNA031244777A CN03124477A CN1552356A CN 1552356 A CN1552356 A CN 1552356A CN A031244777 A CNA031244777 A CN A031244777A CN 03124477 A CN03124477 A CN 03124477A CN 1552356 A CN1552356 A CN 1552356A
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Abstract
A Chinese medicine 'Calming pill' for noushing blood and vital essence and calming is an improvement to existing 'Calming capsule'. Its preparing process is also disclosed. Its advantages are high curative effect, high release speed, and high biological utilization rate.
Description
Technical field
This invention relates to the processing technology technical field of Chinese patent medicine pill, relates in particular to Anshen Wan and preparation method.
Background technology
Pill is a kind of conventional dosage forms, because quick development of modern science and technology, pharmaceutical machine equipment 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 ", advantages such as the pill that makes it to produce has that drug release rate is fast, bioavailability is high, divided dose is accurate, takes, easy to carry, good looking appearance.According to the relevant drug act of China, changing dosage form needs as a kind of new drug research, and the original dosage form of Anshen Wan is: ANSHEN JIAONANG, and listed in the Drug Standard of Ministry of Public Health of the Peoples Republic of China (" Chinese traditional patent formulation preparation " the 20th), prescription is made up of eight flavor medicines.The technology features of former dosage form is that Semen Ziziphi Spinosae and Fructus Schisandrae Chinensis powder are broken into fine powder in the prescription, and Six-element decocting liquids such as all the other Rhizoma Chuanxiongs are condensed into thick paste, and drying and crushing and fine powder mixed pelletization incapsulate.This capsule adopts extraction process by water, and some liposoluble constituents are difficult for proposing, and quality standard is low, and this pharmaceutically dosage form is single simultaneously, far can not satisfy people's medication demand.Based on this, we use the modern pharmaceutical technology and mirror survey means are done necessary improvement to this product technology, form new preparation, improve the quality standard of product simultaneously, and the quality of product carried out overall monitor, thereby guarantee that product quality benefits 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 Anshen Wan and preparation method, improve the quality of products, satisfy needs of medical treatment better.
The objective of the invention is such realization:
1. Anshen Wan and preparation method comprise the steps:
1.1 the prescription of Anshen Wan is formed:
Semen Ziziphi Spinosae 80-160g Rhizoma Chuanxiong 94-188g Rhizoma Anemarrhenae 224-448g
Radix Ophiopogonis 184-368g Radix Polygoni Multiflori Preparata 64-128g Fructus Schisandrae Chinensis 194-388g
Radix Salviae Miltiorrhizae 260-520g Poria 194-388g
Right amount of auxiliary materials is made 1000g altogether.
Its optimum formula is:
Semen Ziziphi Spinosae 140g Rhizoma Chuanxiong 165g Rhizoma Anemarrhenae 392g 322g Radix Ophiopogonis
Radix Polygoni Multiflori Preparata 112g Fructus Schisandrae Chinensis 340g Radix Salviae Miltiorrhizae 455g Poria 340g
Right amount of auxiliary materials is made 1000g altogether.
1.2 Anshen Wan preparation technology
Technology one, with eight the flavor medicines clean respectively, remove impurity, it is standby to be up to the standards; Get Semen Ziziphi Spinosae, Fructus Schisandrae Chinensis powder is broken into fine powder; Six-elements such as remaining Rhizoma Chuanxiong are ground 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, with above-mentioned fine powder mixing, and pill, drying, promptly.
Technology two, with eight the flavor medicines clean respectively, remove impurity, it is standby to be up to the standards; Get Semen Ziziphi Spinosae, that Fructus Schisandrae Chinensis powder is broken into fine powder is standby; Six-element medicated powder such as all the other Rhizoma Chuanxiongs are broken into coarse powder/be cut into decoction pieces, add water steaming and decocting 2-3 time, collect volatile oil, become cyclodextrin of volatile oil clathrate or standby with an amount of anhydrous alcohol solution with cyclodextrin inclusion compound; Merge water and steam liquid, filter, filtrate is condensed into thick paste/concentrate drying and makes dried cream powder, adds above-mentioned fine powder, cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixing, and drying is made ball, promptly.Or above-mentioned thick paste/dried cream powder, above-mentioned fine powder and appropriate amount of auxiliary materials mixing, pill, drying, spray adds the volatile oil ethanol solution, promptly.
Technology three, with eight the flavor medicines clean respectively, remove impurity, it is standby to be up to the standards; Get Semen Ziziphi Spinosae, Fructus Schisandrae Chinensis, Rhizoma Chuanxiong, the Rhizoma Anemarrhenae, Radix Salviae Miltiorrhizae powder and be broken into coarse powder/be cut into decoction pieces, use the 60-95% ethanol extraction, extracting solution filters, and reclaims ethanol, is concentrated into standby in right amount; Coarse powder/the decoction pieces of three flavors such as medicinal residues and all the other Poria decocts with water 2-3 time, filters, and merging filtrate is concentrated in right amount, merges with above-mentioned alcohol extract, and be condensed into thick paste/concentrate drying and make dried cream powder, with the appropriate amount of auxiliary materials mixing, pill, drying, promptly.
1.3 by technology one, two, three prepared balls is Anshen Wan.
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, is preferably 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/be cut into decoction pieces, is generally 5～30 order coarse powder/be cut into decoction pieces, is preferably 10-20 order coarse powder.
The technology Chinese crude drug is ground into fine powder and was generally 80～160 order fine powders, and being preferably superfine powder, to be broken into 200～300 order fine powders standby.
The technology Chinese crude drug adds the secondary decocting and boils/and the condition of steaming and decocting is: and decoct 2-3 time, amount of water is that 6-12 doubly measures for the first time, and second and third time doubly measured for 4-8, and decocting time is 1-4 hour at every turn; Be preferably decoction 2 times, amount of water is 10 times of amounts for the first time, is 6 times of amounts for the second time, is 3 hours for the first time, is 2 hours for the second time.
The relative density of thick paste is 1.10～1.45 (60 ℃) in the technology, and best relative density is 1.28-1.33 (60 ℃).
The drying of extract can adopt vacuum drying or spray drying in the technology.The vacuum drying temperature is controlled at 50-80 ℃, and the best is 60 ℃.Spray drying is for to be condensed into the concentrated solution that relative density is 1.05-1.15 (60 ℃) with extracting solution, and spray drying, inlet temperature are 100-200 ℃, and leaving air temp is 50-150 ℃.Best relative density is 1.08-1.10 (60 ℃), and inlet temperature is 150-170 ℃, and leaving air temp is 80-100 ℃.
The cyclodextrin clathrate of volatile oil preparation in the technology, cyclodextrin can be adopted any in beta-schardinger dextrin-or the HP-; The ratio of volatile oil and beta-schardinger dextrin-is 1: 6-15ml/g, optimal proportion are 1: 10 (ml/g); The ratio of volatile oil and HP-is 1: 3-12ml/g, optimal proportion are 1: 5.5 (ml/g).
The condition of alcohol extraction is in the technology two: the ethanol with 60-95% is solvent, adopts percolation or heating reflux method to extract; Best for the ethanol with 95% is solvent, heating and refluxing extraction 2 times, stupid time 2 hours.
Filter in the technology to adopt and conventionally filter, centrifugal, ultrafiltration, add filtration/centrifugal/methods such as ultrafiltration behind the clarifier.
2. the control of this product quality standard has discriminating, inspection and three aspects of assay.
This product is dosage form technological innovation on the basis of former dosage form ANSHEN JIAONANG, increases Radix Salviae Miltiorrhizae, the lotus Radix Polygoni Multiflori, Fructus Schisandrae Chinensis, the Rhizoma Anemarrhenae, Semen Ziziphi Spinosae in the discriminating and carry out thin layer and differentiate on former only Rhizoma Chuanxiong basis simply; Increase heavy metal limit in the inspection and must not cross 10/1000000ths, arsenic salt must not cross 2/1000000ths; Former dosage form does not have quantitative target on the assay, now Radix Salviae Miltiorrhizae, Fructus Schisandrae Chinensis is carried out the content regulation.
This invention its superiority compared with the prior art is: production technology more becomes to improving rationally, keep better that stability improves greatly under the volatility active substance prerequisite, effect duration can reach more than 2 years, quality standard improves greatly, make product that the qualitative, quantitative control method of science be arranged, make the quality of product and curative effect that guarantee arranged.
The specific embodiment
The optimum implementation of this invention is that eight flavor medicines are cleaned respectively, removes impurity, and it is standby to be up to the standards; Get Semen Ziziphi Spinosae, that Fructus Schisandrae Chinensis powder is broken into fine powder is standby; Six-element medicated powder such as all the other Rhizoma Chuanxiongs are broken into coarse powder and add water steaming and decocting secondary, and 3 hours for the first time, 2 hours for the second time, collect volatile oil, become the cyclodextrin of volatile oil clathrate standby with beta-cyclodextrin inclusion compound; Merge water boiling liquid, filter, filtrate is condensed into relative density to 1.08～1.10 (60 ℃), and spray drying is collected dried cream powder, with above-mentioned fine powder, cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixing, pill, drying, coating, promptly.
Claims (10)
1. the preparation method of an Anshen Wan is characterized in that:
(1) Semen Ziziphi Spinosae, Rhizoma Chuanxiong, the Rhizoma Anemarrhenae, Radix Ophiopogonis, Radix Polygoni Multiflori Preparata, Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae, Poria eight flavor medicines are cleaned respectively, remove impurity, it is standby to be up to the standards; Get Semen Ziziphi Spinosae, Fructus Schisandrae Chinensis powder is broken into fine powder; Six-elements such as remaining Rhizoma Chuanxiong are ground 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, with the fine powder mixing, and pill, drying, promptly.
(2) Semen Ziziphi Spinosae, Rhizoma Chuanxiong, the Rhizoma Anemarrhenae, Radix Ophiopogonis, Radix Polygoni Multiflori Preparata, Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae, Poria eight flavor medicines are cleaned respectively, remove impurity, it is standby to be up to the standards; Get Semen Ziziphi Spinosae, that Fructus Schisandrae Chinensis powder is broken into fine powder is standby; Six-element medicated powder such as all the other Rhizoma Chuanxiongs are broken into coarse powder/be cut into decoction pieces, add water steaming and decocting 2-3 time, collect volatile oil, become cyclodextrin of volatile oil clathrate/standby with an amount of anhydrous alcohol solution with cyclodextrin inclusion compound; Merge water and steam liquid, filter, filtrate is condensed into thick paste/concentrate drying and makes dried cream powder, adds fine powder, cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixing, and drying is made ball, promptly; Or thick paste/dried cream powder, fine powder and appropriate amount of auxiliary materials mixing, pill, drying, spray adds the volatile oil ethanol solution, promptly.
(3) Semen Ziziphi Spinosae, Rhizoma Chuanxiong, the Rhizoma Anemarrhenae, Radix Ophiopogonis, Radix Polygoni Multiflori Preparata, Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae, Poria eight flavor medicines are cleaned respectively, remove impurity, it is standby to be up to the standards; Get Semen Ziziphi Spinosae, Fructus Schisandrae Chinensis, Rhizoma Chuanxiong, the Rhizoma Anemarrhenae, Radix Salviae Miltiorrhizae powder and be broken into coarse powder/be cut into decoction pieces, use the 60-95% ethanol extraction, extracting solution filters, and reclaims ethanol, is concentrated into standby in right amount; Coarse powder/the decoction pieces of three flavors such as medicinal residues and all the other Poria decocts with water 2-3 time, filters, and merging filtrate is concentrated in right amount, merges with alcohol extract, and be condensed into thick paste/concentrate drying and make dried cream powder, with the appropriate amount of auxiliary materials mixing, pill, drying, promptly.
2. according to described Anshen Wan 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; 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.
3. according to described Anshen Wan of claim 1 and preparation method, it is characterized in that: the particle diameter of the ball of gained is 0.5-6m, and optimum grain-diameter is 1-4mm; 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. according to described Anshen Wan of claim 1 and preparation method, it is characterized in that: pulverizing medicinal materials becomes coarse powder/be cut into decoction pieces, is generally 5～30 order coarse powder/be cut into decoction pieces, and the best was a 10-20 order coarse powder; Pulverizing medicinal materials becomes fine powder to be generally 80～160 order fine powders, and the best is standby for superfine powder is broken into 200～300 order fine powders.
5. according to described Anshen Wan of claim 1 and preparation method, it is characterized in that: medical material adds the secondary decocting and boils/and the condition of steaming and decocting is: and decoct 2-3 time, amount of water is that 6-12 doubly measures for the first time, and second and third time doubly measured for 4-8, and decocting time is 1-4 hour at every turn; Best amount of water is 10 times of amounts for the first time in order to decoct 2 times, is 6 times of amounts for the second time, is 3 hours for the first time, is 2 hours for the second time.
6. according to described Anshen Wan of claim 1 and preparation method, it is characterized in that: the drying of extract can adopt vacuum drying/spray drying, the vacuum drying temperature is controlled at 50-80 ℃, and the best is 60 ℃, and spray drying is for to be condensed into the concentrated solution that relative density is 1.05-1.15 (60 ℃) with extracting solution, spray drying, inlet temperature is 100-200 ℃, and leaving air temp is 50-150 ℃, and best relative density is 1.08-1.10 (60 ℃), inlet temperature is 150-170 ℃, and leaving air temp is 80-100 ℃.
7. according to described Anshen Wan of claim 1 and preparation method, it is characterized in that: the preparation of the cyclodextrin clathrate of volatile oil, cyclodextrin can be adopted any in beta-schardinger dextrin-/HP-; The ratio of volatile oil and beta-schardinger dextrin-is 1: 6-15ml/g, optimal proportion are 1: 10 (ml/g); The ratio of volatile oil and HP-is 1: 3-12ml/g, optimal proportion are 1: 5.5 (ml/g).
8. according to described Anshen Wan of claim 1 and preparation method, it is characterized in that: the condition of alcohol extraction is in 1 (2): the ethanol with 60-95% is solvent, adopts percolation/heating reflux method to extract; Best for the ethanol with 95% is solvent, heating and refluxing extraction 2 times, stupid time 2 hours.
9. according to described Anshen Wan 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; The relative density of thick paste is 1.10～1.45 (60 ℃), and best relative density is 1.28-1.33 (60 ℃).
10. according to described Anshen Wan of claim 1 and preparation method, it is characterized in that: the quality standard of this product is controlled at Radix Salviae Miltiorrhizae in the discriminating, the thin layer of the lotus Radix Polygoni Multiflori, Fructus Schisandrae Chinensis, the Rhizoma Anemarrhenae, Semen Ziziphi Spinosae is differentiated; Have heavy metal limit must not cross 10/1000000ths in the inspection, arsenic salt must not cross 2/1000000ths; The quantitative of Radix Salviae Miltiorrhizae, Fructus Schisandrae Chinensis arranged on the assay.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031244777A CN1552356A (en) | 2003-05-29 | 2003-05-29 | Sedative pill and preparing method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031244777A CN1552356A (en) | 2003-05-29 | 2003-05-29 | Sedative pill and preparing method thereof |
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| CN1552356A true CN1552356A (en) | 2004-12-08 |
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| CNA031244777A Pending CN1552356A (en) | 2003-05-29 | 2003-05-29 | Sedative pill and preparing method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105920315A (en) * | 2016-06-25 | 2016-09-07 | 丁常燕 | Traditional Chinese medicinal composition for treating tinnitus |
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2003
- 2003-05-29 CN CNA031244777A patent/CN1552356A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105920315A (en) * | 2016-06-25 | 2016-09-07 | 丁常燕 | Traditional Chinese medicinal composition for treating tinnitus |
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