CN1552376A - Light relaxing pills and their preparation - Google Patents
Light relaxing pills and their preparation Download PDFInfo
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- CN1552376A CN1552376A CNA03124517XA CN03124517A CN1552376A CN 1552376 A CN1552376 A CN 1552376A CN A03124517X A CNA03124517X A CN A03124517XA CN 03124517 A CN03124517 A CN 03124517A CN 1552376 A CN1552376 A CN 1552376A
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Abstract
A Chinese medicine 'Qingshu pill' for treating constipation 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 light relaxing pill 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, change dosage form as a kind of new drug research, the light relaxation grain of former dosage form has been listed country of National Drug Administration standard for traditional Chinese medicines compilation terrestrial reference in and has been risen in the GB tentative standard.The technology features of this dosage form is that five kinds of Chinese medicine decocts with water in the prescription, is condensed into clear paste, with adjuvant grain mixing, granulate, and drying, promptly.This granule supplementary product consumption is bigger, and its quality standard still can further improve.Based on this, we use the modern pharmaceutical technology this product technology are necessarily improved, and 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 light relaxing pill and preparation method, improve the quality and the curative effect of product, enrich medicine variety, satisfy better and guarantee people medication demand.
The object of the present invention is achieved like this:
1. light relaxing pill and preparation method comprise the steps:
1.1 the prescription of light relaxing pill is formed
Radix Polygoni Multiflori 1900-3800g Herba Cistanches 1580-3160g Radix Astragali 2400-4800
Fructus Cannabis 1000-2000g Fructus Aurantii Immaturus 790-1590g right amount of auxiliary materials is made 1000g
Its optimum formula is:
Radix Polygoni Multiflori 2360-2835g Herba Cistanches 2000-2400g Radix Astragali 3000-3600
Fructus Cannabis 1380-1650g Fructus Aurantii Immaturus 985-1200 right amount of auxiliary materials is made 1000g altogether
1.2 light relaxing pill preparation technology
Technology one, will write out a prescription in five kinds of Chinese medicine be up to the standards standby; Get five tastes medical material and be ground into coarse powder/be cut into decoction pieces to decoct with water 2-3 time, each 1-3 hour, collecting decoction filtered, and filtrate is condensed into thick paste/concentrate drying and makes dried cream powder, with appropriate amount of auxiliary materials mixing, pill, drying, promptly.
Technology two, will write out a prescription in five kinds of Chinese medicine be up to the standards standby respectively; The prescription Chinese crude drug is ground into coarse powder/be cut into decoction pieces, and with 40-95% ethanol extraction 2-3 time, merge extractive liquid, filters, and recovery ethanol is concentrated into standby in right amount; Medicinal residues decoct with water 1-3 time, and collecting decoction filters, and filtrate is concentrated in right amount, merge with above-mentioned alcohol extract, are condensed into thick paste/concentrate drying and make dried cream powder, add the appropriate amount of auxiliary materials mixing, pill, and drying, promptly.
1.3 the ball that makes by technology one, two is a light relaxing 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, 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-, 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 condition that decocting boils in the technology is: soaked earlier before the decoction 0.5-1 hour, and decocted 2-3 time, amount of water is doubly measured for the 6-12 of dose for the first time, and second and third time doubly measured for the 4-10 of dose, and decocting time is 1-3 hour.The best is: decoct 2 times, 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, and 1.5 hours for the second time.
Adopt the ethanol extraction of 40-95% can adopt percolation or heating reflux method in the technology, the best is 70% ethanol percolate extraction.
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, be preferably 10-30 purpose coarse powder.
The drying of thick paste/concentrated solution 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 ℃), and inlet temperature is 100-200 ℃, leaving air temp 50-150 ℃; The best relative density of concentrated solution is 1.08-1.10 (55-60 a ℃), and inlet temperature is 160-180 ℃, leaving air temp 80-100 ℃.
The relative density of concentrated solution is 1.05-1.15 (55-60 a ℃) in the technology, and best relative density is 1.08-1.10 (55-60 a ℃).
The relative density of thick paste is 1.15-1.45 (55-60 a ℃) in the technology, and best relative density is 1.36-1.38 (55-60 a ℃).
Filter in the technology to adopt and conventionally filter, centrifugal, ultrafiltration, add filtration/centrifugal/methods such as ultrafiltration behind the clarifier.
2. the quality standard among the present invention is controlled at discriminating, inspection and three aspects of assay.
This product is further to improve on the basis of original light relaxation grain, has the thin layer of Herba Cistanches, Radix Polygoni Multiflori, the Radix Astragali, Fructus Aurantii Immaturus, Fructus Cannabis to differentiate on differentiating; Former dosage form does not have the limit examine of arsenic salt, heavy metal on checking, has now increased heavy metal limit and must not cross 10/1000000ths, and arsenic salt must not cross 2/1000000ths; Former dosage form has carried out quantitatively now being kept to Radix Polygoni Multiflori on the assay, and increased to the Radix Astragali quantitatively.
This invention is dosage form technological innovation on the basis of existing tablet, produces easylier, and technology is more reasonable, and quality standard has new raising again, to improving the quality of products significant meaning is arranged, and has enriched medicine variety, and is satisfied and ensured people's medication demand.
The specific embodiment
The optimum implementation of this invention is: five kinds of Chinese medicine is up to the standards standby respectively in will writing out a prescription; The prescription Chinese crude drug is ground into coarse powder, is that solvent carries out the percolation extraction with 70% ethanol, and extracting solution is concentrated into standby in right amount after reclaiming ethanol; Medicinal residues decoct with water 2 times, and 2 hours for the first time, 1.5 hours for the second time, collecting decoction filtered, filtrate is concentrated in right amount, merges with above-mentioned alcohol extract, is concentrated into relative density 1.08-1.10 (55-60 ℃), and spray drying is made dried cream powder, add the appropriate amount of auxiliary materials mixing, pill, drying, promptly.
Claims (10)
1. light relaxing pill and preparation method is characterized in that:
(1) will write out a prescription Radix Polygoni Multiflori, Herba Cistanches, the Radix Astragali, Fructus Cannabis, Fructus Aurantii Immaturus five kinds of Chinese medicine is up to the standards standby; Get five tastes medical material and be ground into coarse powder/be cut into decoction pieces to decoct with water 2-3 time, each 1-3 hour, collecting decoction filtered, and filtrate is condensed into thick paste/concentrate drying and makes dried cream powder, with appropriate amount of auxiliary materials mixing, pill, drying, promptly.
(2) will write out a prescription Radix Polygoni Multiflori, Herba Cistanches, the Radix Astragali, Fructus Cannabis, Fructus Aurantii Immaturus five kinds of Chinese medicine is up to the standards standby respectively; The prescription Chinese crude drug is ground into coarse powder/be cut into decoction pieces, and with 40-95% ethanol extraction 2-3 time, merge extractive liquid, filters, and recovery ethanol is concentrated into standby in right amount; Medicinal residues decoct with water 1-3 time, and collecting decoction filters, and filtrate is concentrated in right amount, merge with alcohol extract, are condensed into thick paste/concentrate drying and make dried cream powder, add the appropriate amount of auxiliary materials mixing, pill, and drying, promptly.
2. according to described light relaxing 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 light relaxing pill of claim 1 and preparation method, it is characterized in that: used adjuvant can be sucrose, lactose, starch, beta-schardinger dextrin-, 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 light relaxing 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 light relaxing pill of claim 1 and preparation method, it is characterized in that: the condition that decocting boils is: soaked earlier before the decoction 0.5-1 hour, and decocted 2-3 time, amount of water is doubly measured for the 6-12 of dose for the first time, second and third time doubly measured for the 4-10 of dose, and decocting time is 1-3 hour; The best is: decoct 2 times, 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, and 1.5 hours for the second time.
6. according to described light relaxing pill of claim 1 and preparation method, it is characterized in that: adopt the ethanol extraction of 40-95% can adopt percolation/heating reflux method, the best is 70% ethanol percolate extraction.
7. according to described light relaxing pill of claim 1 and preparation method, it is characterized in that: what be ground into coarse powder/be cut into decoction pieces was generally 5-40 purpose coarse powder/be cut into decoction pieces, and the best was a 10-30 purpose coarse powder.
8. according to described light relaxing pill of claim 1 and preparation method, it is characterized in that: the relative density of concentrated solution is 1.05-1.15 (55-60 a ℃), best relative density is 1.08-1.10 (55-60 a ℃), the relative density of thick paste is 1.15-1.45 (55-60 a ℃), best relative density is 1.36-1.38 (55-60 a ℃), the drying of thick paste/concentrated solution can adopt vacuum drying/employing spray drying, the vacuum drying temperature is controlled at 50-80 ℃, the best is 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 (55-60 a ℃), and inlet temperature is 160-180 ℃, leaving air temp 80-100 ℃.
9. according to described light relaxing 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 light relaxing 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 Herba Cistanches, Radix Polygoni Multiflori, the Radix Astragali, Fructus Aurantii Immaturus, Fructus Cannabis 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 the Radix Astragali arranged on the assay.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA03124517XA CN1552376A (en) | 2003-06-03 | 2003-06-03 | Light relaxing pills and their preparation |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA03124517XA CN1552376A (en) | 2003-06-03 | 2003-06-03 | Light relaxing pills and their preparation |
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| Publication Number | Publication Date |
|---|---|
| CN1552376A true CN1552376A (en) | 2004-12-08 |
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| CNA03124517XA Pending CN1552376A (en) | 2003-06-03 | 2003-06-03 | Light relaxing pills and their preparation |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101199638B (en) * | 2007-12-14 | 2010-09-08 | 马应龙药业集团股份有限公司 | Granules for treating enteric canal constipation disease and preparing method thereof |
-
2003
- 2003-06-03 CN CNA03124517XA patent/CN1552376A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101199638B (en) * | 2007-12-14 | 2010-09-08 | 马应龙药业集团股份有限公司 | Granules for treating enteric canal constipation disease and preparing method thereof |
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