CN1552382A - Snow mountain stomach nourishing micro-pills and their preparation - Google Patents
Snow mountain stomach nourishing micro-pills and their preparation Download PDFInfo
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- CN1552382A CN1552382A CNA031245234A CN03124523A CN1552382A CN 1552382 A CN1552382 A CN 1552382A CN A031245234 A CNA031245234 A CN A031245234A CN 03124523 A CN03124523 A CN 03124523A CN 1552382 A CN1552382 A CN 1552382A
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Abstract
A Chinese medicine 'Xueshen Weibao micropill' for treating anorexia, indigestion, chronic gastritis and peptic ulcer is an improvement to existing relative medicine in the form of pill. 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 the making of Chinese patent medicine tablet, relates in particular to precious micropill of snow mountain stomach and preparation method.
Background technology
Pellet is a kind of new form of Chinese drug, according to the relevant drug act of China, changes dosage form as a kind of new drug research, and former dosage form snow mountain stomach medicine pill " Weibaowan " has been listed GB in.The technology characteristics of former dosage form is: eight flavors are ground into fine powder in the prescription, sieve, and mixing is with water pill, be drying to obtain.This medical instrument has the effect of invigorating the stomach and promoting digestion, dispersing cold for relieving pain, be used for the treatment of weakness of the spleen and stomach, cold coagulation dyspepsia, gastral cavilty distending pain, diet does not disappear, and chronic gastritis, the peptic ulcer person that sees the above-mentioned symptom, having significant curative effect, this pill is common water pill, every ball 1g, micropill have by comparison that drug release rate is fast, bioavailability is high, zest is little, divided dose is accurate, take, advantage such as easy to carry; And this pharmaceutically dosage form is single, and application forms has only pill a kind of, far can not satisfy people's medication demand; Pill is chewed clothes simultaneously, and mouthfeel is not good, and its quality standard still can further improve simultaneously, based on this, we use the modern pharmaceutical technology this product technology are done necessary improvement, form new preparation, and control criterion simultaneously improves the quality, guarantee the quality monitoring of product, improve drug effect, benefit the common people.
Summary of the invention
The purpose of this invention is to provide precious micropill of a kind of novel snow mountain stomach 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.
The objective of the invention is such enforcement:
1. precious micropill of snow mountain stomach and preparation method comprise the steps:
1.1 the prescription of the precious micropill of snow mountain stomach is formed
Calcitum rubrum 50～227g Fructus Piperis Longi 30～136g Radix Aucklandiae 20～92g
Pericarpium Granati 30～136g Fructus Crataegi 30～136g Radix Inulae 10～45g
Rhododendron 30～136g Fructus Chaenomelis 20～92g
Right amount of auxiliary materials is made 1000g altogether
Optimum formula:
Calcitum rubrum 204-227g Fructus Piperis Longi 122-136g Radix Aucklandiae 83-92g Pericarpium Granati 122-136g
Fructus Crataegi 122-136g Radix Inulae 40-45g Rhododendron 122-136g
Fructus Chaenomelis 83-92g right amount of auxiliary materials is made 1000g altogether
1.2 the preparation technology of the precious micropill of snow mountain stomach
Technology one, will write out a prescription in eight the flavor medicines be up to the standards standby respectively; Get eight flavor medicated powder and be broken into fine powder, add the right amount of auxiliary materials mixing, make micropill, drying, promptly.
Technology two, will write out a prescription in eight the flavor medicines be up to the standards standby respectively; Get plug water stone, Pericarpium Granati, Fructus Chaenomelis, that Fructus Crataegi powder is broken into fine powder is standby; Get Fructus Piperis Longi, the Radix Aucklandiae, Radix Inulae, Rhododendron and be ground into coarse powder/be cut into decoction pieces, extract volatile oil, volatile oil is with an amount of cyclodextrin inclusion compound/standby with an amount of anhydrous alcohol solution; Medicinal residues are ground into fine powder, with above-mentioned fine powder, cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixing, make micropill, drying, promptly.Or above-mentioned two kinds of fine powders and appropriate amount of auxiliary materials mixing, make micropill, drying, spray adds above-mentioned volatile oil ethanol solution, promptly.
Technology three, will write out a prescription in eight the flavor medicines be up to the standards standby respectively; Getting Mirabilitum crystallina, to be ground into fine powder standby; Fructus Piperis Longi, the Radix Aucklandiae, Radix Inulae, Rhododendron are ground into coarse powder/be cut into decoction pieces, extract volatile oil, and volatile oil is with cyclodextrin inclusion compound/standby with an amount of anhydrous alcohol solution; Coarse powder/decoction pieces of medicinal residues and Pericarpium Granati, Fructus Chaenomelis, Fructus Crataegi etc. decocts with water 2-3 time, and collecting decoction filters, filtrate is condensed into thick paste/concentrate drying and makes dried cream powder, with above-mentioned Mirabilitum crystallina fine powder, cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixing, makes micropill, drying, promptly.Or above-mentioned thick paste/dried cream powder, Mirabilitum crystallina fine powder and appropriate amount of auxiliary materials mixing, make micropill, drying, spray adds the volatile oil ethanol solution, promptly.
Technology four, will write out a prescription in eight the flavor medicines be up to the standards standby respectively; Getting Mirabilitum crystallina, to be ground into fine powder standby; All the other seven flavors are ground into coarse powder/be cut into decoction pieces and add water steaming and decocting 2-3 time, and collection volatile oil and water boiling liquid are standby; Gained volatile oil cyclodextrin inclusion compound/standby with an amount of ethanol solution dissolving; Water steams decocting liquid and merges, and filters, and filtrate is condensed into thick paste/concentrate drying and makes dried cream powder, with above-mentioned Mirabilitum crystallina fine powder, cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixing, makes micropill, drying, promptly.Or above-mentioned thick paste/dried cream powder, Mirabilitum crystallina fine powder and appropriate amount of auxiliary materials mixing, make micropill, drying, spray adds the volatile oil ethanol solution, promptly.
1.3 the micropill by the technology gained is the precious micropill of snow mountain stomach.
The micropill 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, methylcellulose etc., and one or more mix 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 micropill of gained is 0.5-6mm in the technology.The best is 1-4mm.
In the technology micropill of gained can directly use or the capsulae vacuus of packing in use.
The micropill drying can adopt vacuum drying, fluid bed drying, lyophilization etc. in the technology.
The technology Chinese crude drug is ground into fine powder, is generally 80-160 purpose fine powder, and it is standby that the best is that superfine powder is broken into 200-300 purpose fine powder.
Be ground into coarse powder/be cut into decoction pieces in the technology, be generally 5-40 purpose coarse powder/be cut into decoction pieces, the best was a 10-20 purpose coarse powder.
In the technology decocting boil/condition of steaming and decocting is: decoction/steaming and decocting 2-3 time, for the first time amount of water is that the 6-15 of dose doubly measures, second and third time doubly measured for the 4-10 of dose, decoction/digestion time is 1-4 hour, the best is: decoction/steaming and decocting 2 times, and amount of water is 10 times of amounts of dose for the first time, is 8 times of amounts of dose for the second time, 2 hours for the first time time, 1 hour for the second time.
The extract drying can adopt vacuum drying or spray drying in the technology.The vacuum drying temperature is controlled at 50-90 ℃, and the best is 60-70 ℃.Spray drying is 1.05-1.15 (55-60 a ℃) for extracting solution is condensed into relative density, and spray drying, inlet temperature are 100-200 ℃, and leaving air temp is 50-150 ℃.Best relative density is 1.08-1.10 (55-60 a ℃), and inlet temperature is 160-180 ℃, and leaving air temp is 80-100 ℃.
The relative density of thick paste is 1.15-1.45 (55-60 a ℃) in the technology, and best relative density is 1.30-1.34 (55-60 a ℃).
Cyclodextrin of volatile oil clathrate preparation in the technology: cyclodextrin can adopt any in beta-schardinger dextrin-, the HP-, the ratio of volatile oil and beta-schardinger dextrin-is 1: 6-16 (ml/g), optimal proportion is 1: 9.5 (ml/g), the ratio of volatile oil and HP-is 1: 3-12 (ml/g), optimal proportion are 1: 6 (ml/g).
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 standard of the precious micropill of snow mountain stomach has discriminating, inspection and three aspects of assay among the present invention.
The present invention further improves on the basis of original snow mountain stomach medicine pill " Weibaowan ", differentiating that the Central Plains dosage form has the thin layer of a physicochemical identification and Radix Inulae, Fructus Piperis Longi to differentiate, now give reservation, and increase is differentiated the thin layer of Fructus Crataegi, the Radix Aucklandiae, on assay, former dosage form has carried out quantitatively now being kept to Fructus Piperis Longi, and increased to Fructus Crataegi quantitatively.
The present invention is dosage form technological innovation on the basis of existing pill, and quality standard has new raising again, is of great importance to improving the quality of products, and has enriched medicine variety, satisfies and ensured people's medication demand.
The specific embodiment
Embodiment 1: eight flavor medicines are up to the standards standby respectively in will writing out a prescription; Get eight flavor medicated powder and be broken into fine powder, add the right amount of auxiliary materials mixing, make micropill, drying, promptly.
Embodiment 2: eight flavor medicines are up to the standards standby respectively in will writing out a prescription; Get plug water stone, Pericarpium Granati, Fructus Chaenomelis, that Fructus Crataegi powder is broken into fine powder is standby; Get Fructus Piperis Longi, the Radix Aucklandiae, Radix Inulae, Rhododendron and be ground into coarse powder, water steams the almost distillating extracting oil, and gained volatile oil is standby with an amount of cyclodextrin inclusion compound; Medicinal residues are ground into fine powder, with above-mentioned fine powder, cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixing, make micropill, drying, and coating, promptly.
Embodiment 3: eight flavor medicines are up to the standards standby respectively in will writing out a prescription; Getting Mirabilitum crystallina, to be ground into fine powder standby; Fructus Piperis Longi, the Radix Aucklandiae, Radix Inulae, Rhododendron are ground into coarse powder, water vapour distillation volatile oil, and volatile oil is standby with cyclodextrin inclusion compound; The coarse powder of medicinal residues and Pericarpium Granati, Fructus Chaenomelis, Fructus Crataegi etc. decocts with water 2 times, 2 hours for the first time, 1 hour for the second time, decocting liquid merged, filter, filtrate is concentrated into relative density 1.08-1.10 (55-60 ℃), and spray drying is made dried cream powder, with above-mentioned Mirabilitum crystallina fine powder, cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixing, make micropill, drying, coating, promptly.
Embodiment 4: eight flavor medicines are up to the standards standby respectively in will writing out a prescription; Getting Mirabilitum crystallina, to be ground into fine powder standby; All the other seven flavors add the water steaming and decocting 2 times, and 2 hours for the first time, 1 hour for the second time, gained volatile oil was standby with cyclodextrin inclusion compound; Water boiling liquid merges, and filters, and filtrate is concentrated into relative density 1.08-1.10 (55-60 ℃), and spray drying is made dried cream powder, with above-mentioned Mirabilitum crystallina fine powder, cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixing, makes micropill, drying, and coating, promptly.
Claims (10)
1. precious micropill of a snow mountain stomach and preparation method is characterized in that:
(1) will write out a prescription in Calcitum rubrum, Fructus Piperis Longi, the Radix Aucklandiae, Pericarpium Granati, Fructus Crataegi, Radix Inulae, Rhododendron, Fructus Chaenomelis eight flavor medicines be up to the standards standby respectively; Get eight flavor medicated powder and be broken into fine powder, add the right amount of auxiliary materials mixing, make micropill, drying, promptly.
(2) will write out a prescription in Calcitum rubrum, Fructus Piperis Longi, the Radix Aucklandiae, Pericarpium Granati, Fructus Crataegi, Radix Inulae, Rhododendron, Fructus Chaenomelis eight flavor medicines be up to the standards standby respectively; Get Mirabilitum crystallina, Pericarpium Granati, Fructus Chaenomelis, that Fructus Crataegi powder is broken into fine powder is standby; Get Fructus Piperis Longi, the Radix Aucklandiae, Radix Inulae, Rhododendron and be ground into coarse powder/be cut into decoction pieces, extract volatile oil, volatile oil is with an amount of cyclodextrin inclusion compound/standby with an amount of anhydrous alcohol solution; Medicinal residues are ground into fine powder, with fine powder, cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixing, make micropill, drying, promptly; Or two kinds of fine powders and appropriate amount of auxiliary materials mixing, make micropill, drying, spray adds the volatile oil ethanol solution, promptly.
(3) will write out a prescription in Calcitum rubrum, Fructus Piperis Longi, the Radix Aucklandiae, Pericarpium Granati, Fructus Crataegi, Radix Inulae, Rhododendron, Fructus Chaenomelis eight flavor medicines be up to the standards standby respectively; Getting Mirabilitum crystallina, to be ground into fine powder standby; Fructus Piperis Longi, the Radix Aucklandiae, Radix Inulae, Rhododendron are ground into coarse powder/be cut into decoction pieces, extract volatile oil, and volatile oil is with cyclodextrin inclusion compound/standby with an amount of anhydrous alcohol solution; Coarse powder/decoction pieces of medicinal residues and Pericarpium Granati, Fructus Chaenomelis, Fructus Crataegi etc. decocts with water 2-3 time, and collecting decoction filters, filtrate is condensed into thick paste/concentrate drying and makes dried cream powder, with Mirabilitum crystallina fine powder, cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixing, makes micropill, drying, promptly; Or thick paste/dried cream powder, Mirabilitum crystallina fine powder and appropriate amount of auxiliary materials mixing, make micropill, drying, spray adds the volatile oil ethanol solution, promptly.
(4) will write out a prescription in Calcitum rubrum, Fructus Piperis Longi, the Radix Aucklandiae, Pericarpium Granati, Fructus Crataegi, Radix Inulae, Rhododendron, Fructus Chaenomelis eight flavor medicines be up to the standards standby respectively; Getting Mirabilitum crystallina, to be ground into fine powder standby; All the other seven flavors decoct with water, and extract volatile oil, gained volatile oil cyclodextrin inclusion compound/standby with an amount of ethanol solution dissolving; Decocting liquid merges, and filters, and filtrate is condensed into thick paste/concentrate drying and makes dried cream powder, with Mirabilitum crystallina fine powder, cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixing, makes micropill, drying, promptly; Or thick paste/dried cream powder, Mirabilitum crystallina fine powder and appropriate amount of auxiliary materials mixing, make micropill, drying, spray adds the volatile oil ethanol solution, promptly.
2. according to precious micropill of the described snow mountain stomach of claim 1 and preparation method, it is characterized in that: the micropill 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 precious micropill of the described snow mountain stomach 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 precious micropill of the described snow mountain stomach of claim 1 and preparation method, it is characterized in that: the particle diameter of the micropill of gained is 0.5-6mm, and the best is 1-4mm; The micropill of gained can directly use/pack in the capsulae vacuus and use.
5. according to precious micropill of the described snow mountain stomach of claim 1 and preparation method, it is characterized in that: what pulverizing medicinal materials became fine powder was generally 80-160 purpose fine powder, and the best is that superfine powder is broken into 200-300 purpose fine powder; What pulverizing medicinal materials became coarse powder/be cut into decoction pieces was generally 5-40 purpose coarse powder/be cut into decoction pieces, and the best was a 10-20 purpose coarse powder.
6. according to precious micropill of the described snow mountain stomach of claim 1 and preparation method, it is characterized in that: decocting boils/and the condition of steaming and decocting is: decoction/steaming and decocting 2-3 time, for the first time amount of water is that the 6-15 of dose doubly measures, second and third time doubly measured for the 4-10 of dose, and decoction/digestion time is 1-4 hour, and the best is: decoction/steaming and decocting 2 times, amount of water is 10 times of amounts of dose for the first time, be 8 times of amounts of dose for the second time, 2 hours for the first time time, 1 hour for the second time.
7. according to precious micropill of the described snow mountain stomach of claim 1 and preparation method, it is characterized in that: the micropill drying can adopt vacuum drying, fluid bed drying, lyophilization; The extract drying can adopt vacuum drying/spray drying; The vacuum drying temperature is controlled at 50-90 ℃, and the best is 60-70 ℃; Spray drying is 1.05-1.15 (55-60 a ℃) for extracting solution is condensed into relative density, and spray drying, inlet temperature are 100-200 ℃, and leaving air temp is 50-150 ℃; Best relative density is 1.08-1.10 (55-60 a ℃), and inlet temperature is 160-180 ℃, and leaving air temp is 80-100 ℃; The relative density of thick paste is 1.15-1.45 (55-60 a ℃), and best relative density is 1.30-1.34 (55-60 a ℃).
8. according to precious micropill of the described snow mountain stomach of claim 1 and preparation method, it is characterized in that: filtration can adopt and conventionally filter, centrifugal, ultrafiltration, add the method for filtration/centrifugal/ultrafiltration behind the clarifier.
9. according to precious micropill of the described snow mountain stomach of claim 1 and preparation method, it is characterized in that: cyclodextrin of volatile oil clathrate preparation: cyclodextrin can adopt any in beta-schardinger dextrin-, the HP-, the ratio of volatile oil and beta-schardinger dextrin-is 1: 6-16 (ml/g), optimal proportion is 1: 9.5 (ml/g), the ratio of volatile oil and HP-is 1: 3-12 (ml/g), optimal proportion are 1: 6 (ml/g).
10. according to precious micropill of the described snow mountain stomach of claim 1 and preparation method, it is characterized in that: quality standard control of the present invention has the thin layer of Fructus Crataegi, the Radix Aucklandiae to differentiate; The quantitative of Fructus Crataegi arranged on assay.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031245234A CN1552382A (en) | 2003-06-03 | 2003-06-03 | Snow mountain stomach nourishing micro-pills and their preparation |
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| Application Number | Priority Date | Filing Date | Title |
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| CNA031245234A CN1552382A (en) | 2003-06-03 | 2003-06-03 | Snow mountain stomach nourishing micro-pills and their preparation |
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| CN1552382A true CN1552382A (en) | 2004-12-08 |
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| CNA031245234A Pending CN1552382A (en) | 2003-06-03 | 2003-06-03 | Snow mountain stomach nourishing micro-pills and their preparation |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7514106B2 (en) * | 2006-03-30 | 2009-04-07 | Yangsen Biotechnology Co., Ltd. | Compositions and methods for uterine relaxing |
| CN102426213A (en) * | 2011-11-08 | 2012-04-25 | 山东阿如拉药物研究开发有限公司 | Method for controlling quality of Xueshan Weibao wan |
| CN102688307A (en) * | 2012-06-14 | 2012-09-26 | 山东阿如拉药物研究开发有限公司 | Chinese medicine composition Xueshan Weibao chewable tablet and preparation method thereof |
-
2003
- 2003-06-03 CN CNA031245234A patent/CN1552382A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7514106B2 (en) * | 2006-03-30 | 2009-04-07 | Yangsen Biotechnology Co., Ltd. | Compositions and methods for uterine relaxing |
| CN102426213A (en) * | 2011-11-08 | 2012-04-25 | 山东阿如拉药物研究开发有限公司 | Method for controlling quality of Xueshan Weibao wan |
| CN102426213B (en) * | 2011-11-08 | 2014-01-08 | 山东阿如拉药物研究开发有限公司 | Method for controlling quality of Xueshan Weibao wan |
| CN102688307A (en) * | 2012-06-14 | 2012-09-26 | 山东阿如拉药物研究开发有限公司 | Chinese medicine composition Xueshan Weibao chewable tablet and preparation method thereof |
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