CN1548083A - Cholelithiasis treating bolus and its prepn - Google Patents
Cholelithiasis treating bolus and its prepn Download PDFInfo
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- CN1548083A CN1548083A CNA031244211A CN03124421A CN1548083A CN 1548083 A CN1548083 A CN 1548083A CN A031244211 A CNA031244211 A CN A031244211A CN 03124421 A CN03124421 A CN 03124421A CN 1548083 A CN1548083 A CN 1548083A
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Abstract
The present invention discloses cholelithiasis treating bolus and its preparation. The present invention relates to preparation form innovation on the basis of available capsule, and the medicine has the advantages of fast release speed, high bioavailability, less irritation, etc. The medicine has the functions of clearing away heat, promoting the function of gallbladder, removing blood stasis and removing stone, and is used in treating chronic cholecystitis, gall stone, etc. with high curative effect.
Description
Technical field
This invention relates to the processing technology technical field of Chinese patent medicine pill, relates in particular to cholelithiasis treating Danshitongli ball and preparation method.
Background technology
Pill is a kind of conventional dosage forms, because quick development of modern science and technology, the pharmacy structural establishment 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, advantages such as it has changed people to the traditional prejudice of traditional pill " black, big, thick ", and 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; According to the relevant drug act of China, change dosage form as a kind of new drug research, original dosage form of cholelithiasis treating Danshitongli ball is the cholelithiasis treating Danshitongli 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: three flavors such as Olibanum break into fine powder in the prescription, and ten flavors such as all the other Herba Lysimachiaes decoct with water, and make thick paste, add above-mentioned fine powder, and drying is pulverized, and granulates, and is encapsulated, promptly.This medicine 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 pill compares with it, also has the onset advantage easily of swallowing rapidly, based on this, we use the modern pharmaceutical technology this product technology are done necessary improvement, form new preparation, the control criterion that improves the quality simultaneously guarantees the quality monitoring of product, improve drug effect, benefit 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 cholelithiasis treating Danshitongli ball 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. cholelithiasis treating Danshitongli ball and preparation method comprise the steps:
1.1 the prescription of cholelithiasis treating Danshitongli ball is formed
Herba Lysimachiae 315-630g Herba Artemisiae Scopariae 315-630g Radix Curcumae 126-252g
Pericarpium Citri Reticulatae 210-420g Radix Scutellariae 63-126g Olibanum 49-98g
Sal Nitri 112-224g Alumen 49-98g Radix Et Rhizoma Rhei 63-126g
Rhizoma sparganic 63-126g Fructus Gardeniae 63-126g Radix Glycyrrhizae 35-70g
Myrrha 49-98g right amount of auxiliary materials is made 1000g altogether.
Optimum formula is:
Herba Lysimachiae 540g Herba Artemisiae Scopariae 540g Radix Curcumae 216g Pericarpium Citri Reticulatae 360g Radix Scutellariae 108g
Olibanum 84g Sal Nitri 192g Alumen 84g Radix Et Rhizoma Rhei 108g rhizoma sparganic 108g
Cape jasmine 108g Radix Glycyrrhizae 60g Myrrha 84g right amount of auxiliary materials is made 1000g altogether.
1.2 the preparation technology of cholelithiasis treating Danshitongli ball
Technology one, will write out a prescription in 13 the flavor medicines be up to the standards standby respectively; Olibanum, Myrrha is ground into fine powder, and it is standby that Alumen is ground into fine powder; All the other Herba Lysimachiaes etc. ten flavor is ground into coarse powder/be cut into decoction pieces, decocts with water 2-3 time, decocts collecting decoction 1-3 hour at every turn, filter, filtrate is condensed into thick paste, adds above-mentioned fine powder, mixes vacuum drying thoroughly, be ground into fine powder,, make ball with the appropriate amount of auxiliary materials mixing, drying, promptly.
Technology two, will write out a prescription in 13 the flavor medicines be up to the standards standby respectively; Olibanum, Myrrha is ground into fine powder, and it is standby that Alumen is ground into fine powder; All the other Herba Lysimachiaes etc. ten flavor is ground into coarse powder/be cut into decoction pieces, decocts with water 2-3 time, and each 1-3 hour, collecting decoction, filtration, filtrate is condensed into thick paste or concentrate drying is made dried cream powder, adds above-mentioned fine powder and appropriate amount of auxiliary materials mixing, makes ball, drying, promptly.
1.3 the ball by above-mentioned technology gained is the cholelithiasis treating Danshitongli ball.
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-, 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 optimum grain-diameter is 1.5-4mm.
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.
Be ground into fine powder in the technology and be generally 80-160 purpose fine powder, the best is broken into 200-300 purpose fine powder for superfine powder.
Be ground into coarse powder/be cut into decoction pieces in the technology and be 5-30 purpose coarse powder/be cut into decoction pieces, be preferably and be ground into 10-20 purpose coarse powder.
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 three times, and second and third time is 8 times of amounts, 2 hours for the first time, and 1.5 hours for the second time, 1 hour for the third time.
The relative density that is condensed into thick paste in the technology is 1.15-1.45 (60 ℃), and best relative density is 1.32-1.36 (60 ℃).
In the technology extracting solution filter also can adopt centrifugal, the conventional filtration, ultrafiltration filters after adding clarifier, method such as ultrafiltration again after adding clarifier and filtering.
The extract 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 1.08-1.10 (60 ℃), and inlet temperature is 160-180 ℃, and leaving air temp is 80-100 ℃.
2. quality control standard of the present invention is mainly aspect three of discriminatings, inspection, assay.
The quality standard of this product is further to improve on the capsular basis of original cholelithiasis treating Danshitongli, and former dosage form has the thin layer of Fructus Gardeniae, Pericarpium Citri Reticulatae to differentiate on differentiating, is now kept, and has increased the thin layer of Radix Et Rhizoma Rhei, Radix Scutellariae, Herba Lysimachiae is differentiated; Former dosage form has carried out quantitatively now being kept to Pericarpium Citri Reticulatae on the assay, and increased to Radix Et Rhizoma Rhei 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
The optimum implementation of this invention is to be up to the standards 13 flavor medicines in the prescription standby respectively; Olibanum, Myrrha is ground into fine powder, and it is standby that Alumen is ground into fine powder; Ten flavors such as all the other Herba Lysimachiaes are ground into coarse powder, decoct with water 3 times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, collecting decoction filters, and filtrate is condensed into the concentrated solution that relative density is 1.08-1.10 (60 ℃), spray drying, collect dried cream powder,, make ball with above-mentioned fine powder and appropriate amount of auxiliary materials mixing, drying, promptly.
Claims (10)
1. cholelithiasis treating Danshitongli ball and preparation method is characterized in that:
(1) will write out a prescription in 13 the flavor medicines be up to the standards respectively standby, Olibanum, Myrrha is ground into fine powder, it is standby that Alumen is ground into fine powder, and all the other Herba Lysimachiaes, Herba Artemisiae Scopariae, Radix Curcumae, Pericarpium Citri Reticulatae, Radix Scutellariae, Sal Nitri, Radix Et Rhizoma Rhei, rhizoma sparganic, Fructus Gardeniae, Radix Glycyrrhizae ten flavors are ground into coarse powder/be cut into decoction pieces, decoct with water 2-3 time, the each decoction 1-3 hour, collecting decoction filters, filtrate is condensed into thick paste, adds fine powder, mixes thoroughly, vacuum drying is ground into fine powder, with the appropriate amount of auxiliary materials mixing, make ball, drying, promptly.
(2) will write out a prescription in 13 the flavor medicines be up to the standards respectively standby, Olibanum, Myrrha is ground into fine powder, it is standby that Alumen is ground into fine powder, and all the other Herba Lysimachiaes, Herba Artemisiae Scopariae, Radix Curcumae, Pericarpium Citri Reticulatae, Radix Scutellariae, Sal Nitri, Radix Et Rhizoma Rhei, rhizoma sparganic, Fructus Gardeniae, Radix Glycyrrhizae ten flavors are ground into coarse powder/be cut into decoction pieces, decoct with water 2-3 time, each 1-3 hour, collecting decoction filters, and filtrate is condensed into thick paste/concentrate drying and makes dried cream powder, add fine powder and appropriate amount of auxiliary materials mixing, make ball, drying, promptly.
2. cholelithiasis treating Danshitongli ball according to 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-, microcrystalline Cellulose, hydroxypropyl cellulose, carboxymethylstach sodium, Aspartane, polyvinylpolypyrrolidone, 30 1 kinds/multiple mixing use of 30 POVIDONE K 30 BP/USP.
3. cholelithiasis treating Danshitongli ball according to claim 1 and preparation method is characterized in that: the particle diameter of the ball of gained is 0.5-6mm, and optimum grain-diameter is 1.5-4mm; 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. cholelithiasis treating Danshitongli ball according to claim 1 and preparation method is characterized in that: be ground into fine powder and be generally 80-160 purpose fine powder, the best is broken into 200-300 purpose fine powder for superfine powder.
5. cholelithiasis treating Danshitongli ball according to claim 1 and preparation method is characterized in that: be ground into coarse powder/be cut into decoction pieces and be 5-30 purpose coarse powder/be cut into decoction pieces, and best for being ground into 10-20 purpose coarse powder.
6. cholelithiasis treating Danshitongli ball according to claim 1 and preparation method, it is characterized in that: the condition that decocting boils is: amount of water is that 6-15 doubly measures for the first time, second and third time doubly measured for 4-10, decocts each 1-3 hour 2-3 time, best for decocting three times, amount of water is 10 times of amounts for the first time, and second and third time is 8 times of amounts, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time.
7. cholelithiasis treating Danshitongli ball according to claim 1 and preparation method is characterized in that: the relative density that is condensed into thick paste is 1.15-1.45 (60 ℃), and best relative density is 1.32-1.36 (60 ℃).
8. cholelithiasis treating Danshitongli ball according to claim 1 and preparation method is characterized in that: extracting solution filter also can adopt centrifugal, the conventional filtration, ultrafiltration filters after adding clarifier, the method for ultrafiltration again after adding clarifier and filtering.
9. cholelithiasis treating Danshitongli ball according to claim 1 and preparation method, it is characterized in that: the drying of extract can adopt vacuum drying/employing spray drying, the vacuum drying temperature is controlled at 50-80 ℃, the best is 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 1.08-1.10 (60 ℃), inlet temperature is 160-180 ℃, and leaving air temp is 80-100 ℃.
10. cholelithiasis treating Danshitongli ball according to claim 1 and preparation method is characterized in that: this product quality standard is controlled at the thin layer that Radix Et Rhizoma Rhei, Radix Scutellariae, Herba Lysimachiae are arranged in the discriminating and differentiates; Have heavy metal must not cross 10/1000000ths, arsenic salt must not be crossed 2/1000000ths limit examine; The quantitative of Radix Et Rhizoma Rhei arranged on the assay.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031244211A CN1548083A (en) | 2003-05-24 | 2003-05-24 | Cholelithiasis treating bolus and its prepn |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031244211A CN1548083A (en) | 2003-05-24 | 2003-05-24 | Cholelithiasis treating bolus and its prepn |
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| CN1548083A true CN1548083A (en) | 2004-11-24 |
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| CNA031244211A Pending CN1548083A (en) | 2003-05-24 | 2003-05-24 | Cholelithiasis treating bolus and its prepn |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1323712C (en) * | 2005-08-25 | 2007-07-04 | 咸阳步长医药科技发展有限公司 | Medicine composition for treating cholelithiasis |
-
2003
- 2003-05-24 CN CNA031244211A patent/CN1548083A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1323712C (en) * | 2005-08-25 | 2007-07-04 | 咸阳步长医药科技发展有限公司 | Medicine composition for treating cholelithiasis |
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