CN1552373A - Pills for preventing osteoproliferation and preparing method thereof - Google Patents
Pills for preventing osteoproliferation and preparing method thereof Download PDFInfo
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- CN1552373A CN1552373A CNA031245129A CN03124512A CN1552373A CN 1552373 A CN1552373 A CN 1552373A CN A031245129 A CNA031245129 A CN A031245129A CN 03124512 A CN03124512 A CN 03124512A CN 1552373 A CN1552373 A CN 1552373A
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Abstract
A Chinese medicine 'Anti-hyperosteogeny pill' for treating hypertrophic spondylitis, cervical spondylopathy, osteophyte, hyperplastic arthritis, etc is an improvement to existing relative medicine in the form of tablet. 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 KANGGU ZENGSHENG 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, change dosage form as a kind of new drug research, original dosage form of KANGGU ZENGSHENG WAN is: anti-bone regeneration tablet, form by seven flavor Chinese medicines, listed in the 7th of the Drug Standard of Ministry of Public Health of the Peoples Republic of China " Chinese traditional patent formulation preparation ".The technology features of former dosage form is: Caulis Spatholobi (recipe quantity 1/2) is ground into fine powder, and Six-element medicines such as remaining Caulis Spatholobi and all the other Radix Rehmanniae Preparata decoct with water, and are condensed into thick paste, with above-mentioned fine powder, mixing, drying is pulverized, add adjuvant and granulate, tabletting, sugar coating forms.The coated tablet coating is loaded down with trivial details, and disintegrate is slow, and this medicine quality control standard is low, a few indefiniteness quantitative targets, and this pharmaceutically dosage form is single simultaneously, can not satisfy people's medication demand far away.We use the improvement of modern pharmaceutical technology to this product technology necessity based on this, form new preparation, improve simultaneously and improve quality standard, guarantee the quality monitoring of product, improve curative 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 KANGGU ZENGSHENG WAN and preparation method, improve the quality of products and curative effect, satisfy needs of medical treatment better.
The objective of the invention is such realization:
1. KANGGU ZENGSHENG WAN and preparation method comprise the steps:
1.1 the prescription of KANGGU ZENGSHENG WAN is formed
Radix Rehmanniae Preparata 560-700g Herba Pyrolae 360-500g Rhizoma Drynariae (scalding) 360-500g
Caulis Spatholobi 360-500g Herba Cistanches 360-500g Herba Epimedii 360-500g
Semen Raphani (stir-fry) 172-300g right amount of auxiliary materials is made 1000g altogether.
Its optimum formula is:
Radix Rehmanniae Preparata 612g Herba Pyrolae 408g Rhizoma Drynariae (scalding) 408g
Caulis Spatholobi 408g Herba Cistanches 408g Herba Epimedii 408g Semen Raphani (stir-fry) 258g
Right amount of auxiliary materials is made 1000g altogether.
1.2 KANGGU ZENGSHENG WAN preparation technology
Technology one cleans seven flavor medicine respectively, removes impurity, and it is standby to be up to the standards.Caulis Spatholobi (recipe quantity 1/2) is ground into fine powder, and Six-element medicated powder such as remaining Caulis Spatholobi and all the other Radix Rehmanniae Preparata are broken into coarse powder/be cut into decoction pieces to decoct with water 2-3 time, each 1-4 hour, filter, merging filtrate is condensed into thick paste, with above-mentioned fine powder and appropriate amount of auxiliary materials mixing, pill, drying, promptly.
Technology two cleans seven flavor medicine respectively, removes impurity, and it is standby to be up to the standards.Caulis Spatholobi (recipe quantity 1/2) is ground into fine powder, Six-elements such as remaining Caulis Spatholobi and all the other Radix Rehmanniae Preparata are ground into coarse powder/be cut into decoction pieces to decoct with water 2-3 time, each 1-4 hour, filter, merging filtrate, concentrate drying is made dried cream powder, with above-mentioned Caulis Spatholobi fine powder and appropriate amount of auxiliary materials mixing, pill, drying, promptly.
Technology three cleans seven flavor medicine respectively, removes impurity, and it is standby to be up to the standards.Get seven flavors such as Caulis Spatholobi and be ground into coarse powder/be cut into decoction pieces to decoct with water 2-3 time, each 1-4 hour, collecting decoction, filtration, filtrate is condensed into thick paste/concentrate drying and makes dried cream powder, adds the appropriate amount of auxiliary materials mixing, pill, drying, promptly.
1.3 the ball that makes by technology one, two, three is a KANGGU ZENGSHENG WAN.
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, one or more mixing of methylcellulose to 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 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 to be 5-30 purpose coarse powder or to cut decoction pieces, preferably was ground into 10-20 purpose coarse powder.
It was 80-160 purpose fine powder that the technology Chinese crude drug is ground into fine powder, and best superfine powder was broken into 200-300 purpose fine powder.
Technology decocts with water condition: amount of water is doubly measured for the 6-12 of dose for the first time, doubly measures for the 4-10 of dose for the second time; Decoct each 1-4 hour 2-3 time; Best 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, decocts secondary, 3 hours for the first time, and 2 hours for the second time.
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 ℃.
Filter in the technology to adopt and conventionally filter, centrifugal, ultrafiltration, add filtration/centrifugal/methods such as ultrafiltration behind the clarifier.
The relative density of thick paste is 1.10-1.40 (80 ℃) in the technology, and best relative density is 1.20 (80 ℃).
2. this product quality standard mainly contains discriminating, inspection and three aspects of assay.
This product is dosage form technological innovation on the basis of former dosage form tablet, on differentiating, former dosage form has only a microscopical identification, and the existing thin layer that has increased Radix Rehmanniae Preparata, Herba Epimedii is differentiated; Increased 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 assay, the existing content that has increased Herba Epimedii.
This invention its superiority compared with the prior art is: production technology more becomes to improving rationally, and quality standard improves greatly, makes the quality of product and curative effect that guarantee arranged.
The specific embodiment
The optimum implementation of this invention is: seven flavor medicine is cleaned respectively, remove impurity, it is standby to be up to the standards.Get seven flavor medicine such as Caulis Spatholobi and be ground into coarse powder, decoct with water 2 times, 3 hours for the first time, 2 hours for the second time, filter, merging filtrate, being concentrated into relative density is 1.08-1.10 (60 ℃), spray drying is collected dried cream powder, adds appropriate amount of auxiliary materials, mixing, pill, drying, promptly.
Claims (9)
1. KANGGU ZENGSHENG WAN and preparation method is characterized in that:
(1) Radix Rehmanniae Preparata, Herba Pyrolae, Rhizoma Drynariae, Caulis Spatholobi, Herba Cistanches, Herba Epimedii, Semen Raphani seven flavor medicine are cleaned respectively, remove impurity, it is standby to be up to the standards; Caulis Spatholobi (recipe quantity 1/2) is ground into fine powder, and Six-element medicated powder such as remaining Caulis Spatholobi and all the other Radix Rehmanniae Preparata are broken into coarse powder/be cut into decoction pieces to decoct with water 2-3 time, each 1-4 hour, filter, merging filtrate is condensed into thick paste, with fine powder and appropriate amount of auxiliary materials mixing, pill, drying, promptly.
(2) Radix Rehmanniae Preparata, Herba Pyrolae, Rhizoma Drynariae, Caulis Spatholobi, Herba Cistanches, Herba Epimedii, Semen Raphani seven flavor medicine are cleaned respectively, remove impurity, it is standby to be up to the standards; Caulis Spatholobi (recipe quantity 1/2) is ground into fine powder, Six-elements such as remaining Caulis Spatholobi and all the other Radix Rehmanniae Preparata are ground into coarse powder/be cut into decoction pieces to decoct with water 2-3 time, each 1-4 hour, filter, merging filtrate, concentrate drying is made dried cream powder, with Caulis Spatholobi fine powder and appropriate amount of auxiliary materials mixing, pill, drying, promptly.
(3) Radix Rehmanniae Preparata, Herba Pyrolae, Rhizoma Drynariae, Caulis Spatholobi, Herba Cistanches, Herba Epimedii, Semen Raphani seven flavor medicine are cleaned respectively, remove impurity, it is standby to be up to the standards; Get seven flavors such as Caulis Spatholobi and be ground into coarse powder/be cut into decoction pieces to decoct with water 2-3 time, each 1-4 hour, collecting decoction, filtration, filtrate is condensed into thick paste/concentrate drying and makes dried cream powder, adds the appropriate amount of auxiliary materials mixing, pill, drying, promptly.
2. according to described KANGGU ZENGSHENG 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 KANGGU ZENGSHENG WAN 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 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 KANGGU ZENGSHENG WAN of claim 1 and preparation method, it is characterized in that: pulverizing medicinal materials becomes coarse powder/be cut into decoction pieces was 5-30 purpose coarse powder/cut decoction pieces, and the best was ground into 10-20 purpose coarse powder; What pulverizing medicinal materials became fine powder was 80-160 purpose fine powder, and best superfine powder was broken into 200-300 purpose fine powder.
5. according to described KANGGU ZENGSHENG WAN of claim 1 and preparation method, it is characterized in that: the condition of decocting with water is: amount of water is doubly measured for the 6-12 of dose for the first time, doubly measures for the 4-10 of dose for the second time; Decoct each 1-4 hour 2-3 time; Best 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, decocts secondary, 3 hours for the first time, and 2 hours for the second time.
6. according to described KANGGU ZENGSHENG 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 ℃, 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, 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 150-170 ℃, and leaving air temp is 80-100 ℃.
7. according to described KANGGU ZENGSHENG 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.
8. according to described KANGGU ZENGSHENG WAN of claim 1 and preparation method, it is characterized in that: the relative density of thick paste is 1.10-1.40 (80 ℃), and best relative density is 1.20 (80 ℃).
9. according to described KANGGU ZENGSHENG WAN of claim 1 and preparation method, it is characterized in that: the quality standard of this product is controlled at the thin layer that Radix Rehmanniae Preparata, Herba Epimedii 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 Herba Epimedii arranged on assay.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB031245129A CN100522200C (en) | 2003-06-03 | 2003-06-03 | Pills for preventing osteoproliferation and preparing method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB031245129A CN100522200C (en) | 2003-06-03 | 2003-06-03 | Pills for preventing osteoproliferation and preparing method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1552373A true CN1552373A (en) | 2004-12-08 |
| CN100522200C CN100522200C (en) | 2009-08-05 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB031245129A Expired - Fee Related CN100522200C (en) | 2003-06-03 | 2003-06-03 | Pills for preventing osteoproliferation and preparing method thereof |
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| Country | Link |
|---|---|
| CN (1) | CN100522200C (en) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101829224B (en) * | 2009-03-10 | 2012-12-05 | 北京亚东生物制药有限公司 | Traditional Chinese medicine composition preparation and preparation method and quality control method |
| CN104547222A (en) * | 2015-01-04 | 2015-04-29 | 崔红萍 | Traditional Chinese medicine patching agent for treating hyperostosis |
| CN107213407A (en) * | 2017-05-25 | 2017-09-29 | 计怀安 | Strong bone is peaceful |
| CN107551045A (en) * | 2017-07-14 | 2018-01-09 | 大连理工大学 | A kind of preparation method and application of kidney-nourishing tcm drug decoction freeze-dried powder |
-
2003
- 2003-06-03 CN CNB031245129A patent/CN100522200C/en not_active Expired - Fee Related
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101829224B (en) * | 2009-03-10 | 2012-12-05 | 北京亚东生物制药有限公司 | Traditional Chinese medicine composition preparation and preparation method and quality control method |
| CN104547222A (en) * | 2015-01-04 | 2015-04-29 | 崔红萍 | Traditional Chinese medicine patching agent for treating hyperostosis |
| CN107213407A (en) * | 2017-05-25 | 2017-09-29 | 计怀安 | Strong bone is peaceful |
| CN107551045A (en) * | 2017-07-14 | 2018-01-09 | 大连理工大学 | A kind of preparation method and application of kidney-nourishing tcm drug decoction freeze-dried powder |
| CN107551045B (en) * | 2017-07-14 | 2021-01-19 | 大连理工大学 | Preparation method and application of kidney-tonifying traditional Chinese medicine decoction freeze-dried powder |
Also Published As
| Publication number | Publication date |
|---|---|
| CN100522200C (en) | 2009-08-05 |
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Granted publication date: 20090805 Termination date: 20120603 |