CN1548116A - Breast nodule treating bolus and its prepn - Google Patents
Breast nodule treating bolus and its prepn Download PDFInfo
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- CN1548116A CN1548116A CNA031244599A CN03124459A CN1548116A CN 1548116 A CN1548116 A CN 1548116A CN A031244599 A CNA031244599 A CN A031244599A CN 03124459 A CN03124459 A CN 03124459A CN 1548116 A CN1548116 A CN 1548116A
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Abstract
The present invention discloses breast nodule treating bolus of 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 dispersing the stagnated liver energy, alleviating mental depression, promoting blood circulation, clearing away toxic matter, softening the dry feces and dissipating mass, and has obvious curative effect on hyperplasia of mammary glands, mastitis, etc.
Description
Technical field
This invention relates to the processing technology technical field of Chinese patent medicine pill, relates in particular to breast nodule treating bolus 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, it has changed people to the traditional prejudice of traditional pill " black; big; thick ", it is fast that the pill that makes it to produce has drug release rate, the bioavailability height, zest is little, divided dose is accurate, take, advantage such as easy to carry, according to the relevant drug act of China, change dosage form as a kind of new drug research, former dosage form has the nodules of the breast relieving capsule, and listed in National Drug Administration's country's standard for traditional Chinese medicines compilation Chinese patent medicine provincial standard rising national standard part " surgery fascicle ", form by seven flavor Chinese medicines.The technology of former dosage form is: Rhizoma Corydalis is ground into fine powder, Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra alcohol reflux, and extracting solution is condensed into thick paste; Four flavor decoctings such as Pericarpium Trichosanthis are carried, and decocting liquid is condensed into thick paste; Merge thick paste, add above-mentioned fine powder, drying is pulverized encapsulated forming.This capsule dose is big, and ampoule is 5 large capsules, and Ms difficulty swallows, and the quality standard of control product quality is lower, the difficult product quality of control comprehensively, and this pharmaceutically dosage form is single simultaneously.We use the modern pharmaceutical technology this product technology are done necessary the improvement based on this, form new preparation, guarantee 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 breast nodule treating bolus and preparation method, improve the quality of products and curative effect, increase the stability of product, the Ms is more pleased to take to satisfy needs of medical treatment better.
The objective of the invention is such realization:
1. breast nodule treating bolus and preparation method comprise the steps:
1.1 the prescription of breast nodule treating bolus is formed
Pericarpium Trichosanthis 675-1350g Herba Taraxaci 675-1350g Radix Salviae Miltiorrhizae 337.5-675g
Radix Paeoniae Rubra 337.5-675g Rhizoma Bolbostematis 225-450g Radix Bupleuri 225-450g
Rhizoma Corydalis 225-450g right amount of auxiliary materials is made 1000g altogether.
Best prescription is: Pericarpium Trichosanthis 1125g Herba Taraxaci 1125g Radix Salviae Miltiorrhizae 562.5g
Radix Paeoniae Rubra 562.5g Rhizoma Bolbostematis 375g Radix Bupleuri 375g
Rhizoma Corydalis 375g right amount of auxiliary materials is made 1000g altogether.
1.2 the preparation technology of breast nodule treating bolus
Technology one cleans seven flavor medicine respectively, removes impurity, and it is standby to be up to the standards; Getting Rhizoma Corydalis, to be ground into fine powder standby; Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra 60-95% ethanol extraction, extracting solution filters, and filtrate recycling ethanol is condensed into thick paste; All the other 4 flavor mixed powders such as Pericarpium Trichosanthis are broken into coarse powder/be cut into decoction pieces, decoct with water 2-3 time, and each 1-3 hour, collecting decoction filtered, and filtrate is condensed into thick paste, merges above-mentioned thick paste, adding Rhizoma Corydalis fine powder and appropriate amount of auxiliary materials, and mixing is made ball, drying, promptly.
Technology two cleans seven flavor medicine respectively, removes impurity, and it is standby to be up to the standards; Getting Rhizoma Corydalis, to be ground into fine powder standby; Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra 60-95% ethanol extraction, extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of; All the other Pericarpium Trichosanthiss etc. 4 flavor mixed powders are broken into coarse powder/be cut into decoction pieces, decoct with water 1-3 hour at every turn 2-3 time, collecting decoction, filter, filtrate is concentrated in right amount, mixes with above-mentioned concentrated solution, be condensed into thick paste or concentrate drying is made dried cream powder, add Rhizoma Corydalis fine powder and appropriate amount of auxiliary materials, mixing is made ball, drying, promptly.
1.3 by technology one, two prepared balls is breast nodule treating bolus.
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, 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.
Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra are ground into coarse powder/middle powder in the technology, and the best was a powder in the 30-40 purpose.
4 flavor pulverizing medicinal materials such as Pericarpium Trichosanthis become coarse powder/be cut into decoction pieces to be generally 5-30 purpose coarse powder/be cut into decoction pieces in the technology, and the best was a 10-20 order coarse powder.
Rhizoma Corydalis is ground into fine powder and was generally 80-160 purpose fine powder in the technology, and the best is broken into 200-300 order fine powder for superfine powder.
The condition that decocting boils in the technology is: decoct 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 each 1-3 of the time of decoction hour for the 4-10 of dose; The best is: decoct 3 times, amount of water is 10 times of amounts of dose for the first time, and second and third time amount of water is 8 times of amounts of dose, and decocting time is 2 hours for the first time, 1.5 hours for the second time, and 1 hour for the third time.
The condition of ethanol extraction is in the technology: with 60-95% ethanol is solvent, adopts percolation or heating reflux method to extract, and the best is that 95% ethanol is solvent, the 8-10 that adds for the first time amount of alcohol and be dose doubly, the 6-8 that adds for the second time amount of alcohol and be dose doubly, reflux, extract, 2 times, each 2 hours.
The relative density of thick paste is 1.26-1.40 (60 ℃) in the technology, and best relative density is 1.35-1.38 (60 ℃).
Concentrate in the technology and can adopt concentrating under reduced pressure, thin film concentration or vacuum film to concentrate.
Filter in the technology and can also adopt conventional the filtration, centrifugal, ultrafiltration, add filter behind the clarifier, centrifugal, add the method that filters ultrafiltration again behind the clarifier.
Dry vacuum drying or the spray drying of adopting of extract in the technology, the vacuum drying temperature is controlled at 50-90 ℃, 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. the quality control of this product mainly is discriminating, inspection, three aspects of assay.
This product is to increase the Rhizoma Corydalis to prescription, the thin layer discriminating of Radix Bupleuri on the basis of nodules of the breast relieving capsule; Heavy metal, arsenic salt are limited the quantity of, and the regulation heavy metal must not cross 10/1000000ths, arsenic salt must not cross 2/1000000ths; Increase on the assay to Rhizoma Corydalis quantitatively.
This invention its superiority compared with the prior art is: production technology more becomes fully rationally, quality standard improves comprehensively, makes product that the qualitative, quantitative control method of science be arranged, and makes the quality of product that further guarantee arranged.
The specific embodiment
The optimum implementation of this invention is that seven flavor medicine is cleaned respectively, removes impurity, and it is standby to be up to the standards; Getting Rhizoma Corydalis, to be ground into fine powder standby; Powder added 95% alcohol reflux 2 times during Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra mixed powder were broken into, and each 2 hours, merge ethanol extract, filter, filtrate recycling ethanol also is concentrated into the thick paste that relative density is 1.26-1.40 (60 ℃); All the other 4 flavors such as Pericarpium Trichosanthis, mixed powder is broken into coarse powder, decocts 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 concentrated into the thick paste that relative density is 1.36 (60 ℃), merge above-mentioned thick paste, add Rhizoma Corydalis fine powder and appropriate amount of auxiliary materials mixing, make ball, drying, coating, promptly.
Claims (10)
1. breast nodule treating bolus and preparation method is characterized in that:
(1) Pericarpium Trichosanthis, Herba Taraxaci, Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra, Rhizoma Bolbostematis, Radix Bupleuri, Rhizoma Corydalis seven flavor medicine are cleaned respectively, remove impurity, it is standby to be up to the standards; Getting Rhizoma Corydalis, to be ground into fine powder standby; Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra add 60-95% ethanol extraction 2-3 time, and each 1-3 hour, merge ethanol extract, filter, filtrate recycling ethanol is condensed into thick paste; All the other 4 flavor mixed powders such as Pericarpium Trichosanthis are broken into coarse powder/be cut into decoction pieces, decoct with water 2-3 time, and each 1-3 hour, collecting decoction filtered, and filtrate decompression is condensed into thick paste, merges thick paste, adding Rhizoma Corydalis fine powder and appropriate amount of auxiliary materials, and mixing is made ball, drying, promptly.
(2) Pericarpium Trichosanthis, Herba Taraxaci, Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra, Rhizoma Bolbostematis, Radix Bupleuri, Rhizoma Corydalis seven flavor medicine are cleaned respectively, remove impurity, it is standby to be up to the standards; Getting Rhizoma Corydalis, to be ground into fine powder standby; Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra add 60-95% ethanol extraction 2-3 time, and each 1-4 hour, merge ethanol extract, filter, filtrate recycling ethanol also is concentrated into an amount of; All the other Pericarpium Trichosanthiss etc. 4 flavor mixed powders are broken into coarse powder/be cut into decoction pieces, decoct with water 1-3 hour at every turn 2-3 time, collecting decoction, filter, filtrate is concentrated in right amount, mixes with concentrated solution, be condensed into thick paste/concentrate drying and make dried cream powder, add Rhizoma Corydalis fine powder and appropriate amount of auxiliary materials, mixing is made ball, drying, promptly.
2. breast nodule treating bolus 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-, HP-, microcrystalline Cellulose, hydroxypropyl cellulose, carboxymethylstach sodium, Aspartane, polyvinylpolypyrrolidone, 30 1 kinds/multiple mixing use of 30 POVIDONE K 30 BP/USP.
3. breast nodule treating bolus 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. breast nodule treating bolus according to claim 1 and preparation method is characterized in that: Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra are ground into coarse powder/middle powder, and the best was a powder in the 30-40 purpose; Pericarpium Trichosanthis etc. 4 flavor pulverizing medicinal materials become coarse powder/be cut into decoction pieces to be generally 5-30 purpose coarse powder/be cut into decoction pieces, and the best was a 10-20 order coarse powder; Rhizoma Corydalis is ground into fine powder and was generally 80-160 purpose fine powder, and the best is broken into 200-300 order fine powder for superfine powder.
5. breast nodule treating bolus according to claim 1 and preparation method is characterized in that: the condition that decocting boils is: decoct 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 each 1-3 of the time of decoction hour for the 4-10 of dose; The best is: decoct 3 times, amount of water is 10 times of amounts of dose for the first time, and second and third time amount of water is 8 times of amounts of dose, and decocting time is 2 hours for the first time, 1.5 hours for the second time, and 1 hour for the third time.
6. breast nodule treating bolus according to claim 1 and preparation method, it is characterized in that: the condition of ethanol extraction is: with 60-95% ethanol is solvent, adopt percolation/heating reflux method to extract, the best is that 95% ethanol is solvent, the 8-10 that adds for the first time amount of alcohol and be dose doubly, the 6-8 that adds for the second time amount of alcohol and be dose doubly, reflux, extract, 2 times, each 2 hours.
7. breast nodule treating bolus according to claim 1 and preparation method is characterized in that: the relative density of thick paste is 1.26-1.40 (60 ℃), and best relative density is 1.35-1.38 (60 ℃); Concentrate and to adopt concentrating under reduced pressure, thin film concentration/vacuum film to concentrate.
8. breast nodule treating bolus according to claim 1 and preparation method is characterized in that: filter and also can adopt conventional the filtration, centrifugal, ultrafiltration, add filter behind the clarifier, centrifugal, add the method that filters ultrafiltration again behind the clarifier.
9. breast nodule treating bolus according to claim 1 and preparation method, it is characterized in that: the dry vacuum drying/spray drying that adopts of extract, the vacuum drying temperature is controlled at 50-90 ℃, and the best is 60 ℃, and 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 ℃, and leaving air temp is 50-150 ℃, and best relative density is 1.08-1.10 (60 ℃), inlet temperature is 160-180 ℃, and leaving air temp is 80-100 ℃.
10. breast nodule treating bolus according to claim 1 and preparation method, it is characterized in that: have the thin layer of Rhizoma Corydalis, Radix Bupleuri to differentiate on the quality control standard, have that heavy metal must not cross 10/1000000ths, arsenic salt must not be crossed 2/1000000ths limit examine, the detection by quantitative of Rhizoma Corydalis is arranged.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031244599A CN1548116A (en) | 2003-05-24 | 2003-05-24 | Breast nodule treating bolus and its prepn |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031244599A CN1548116A (en) | 2003-05-24 | 2003-05-24 | Breast nodule treating bolus and its prepn |
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| Publication Number | Publication Date |
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| CN1548116A true CN1548116A (en) | 2004-11-24 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA031244599A Pending CN1548116A (en) | 2003-05-24 | 2003-05-24 | Breast nodule treating bolus and its prepn |
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| CN (1) | CN1548116A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2013044570A1 (en) * | 2011-09-30 | 2013-04-04 | 西安千禾药业有限责任公司 | Detection method of medicine for curing mastitis and hyperplasia of mammary glands |
-
2003
- 2003-05-24 CN CNA031244599A patent/CN1548116A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2013044570A1 (en) * | 2011-09-30 | 2013-04-04 | 西安千禾药业有限责任公司 | Detection method of medicine for curing mastitis and hyperplasia of mammary glands |
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