CN1548118A - Breast nodule eliminating bolus and its prepn - Google Patents
Breast nodule eliminating bolus and its prepn Download PDFInfo
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- CN1548118A CN1548118A CNA031244610A CN03124461A CN1548118A CN 1548118 A CN1548118 A CN 1548118A CN A031244610 A CNA031244610 A CN A031244610A CN 03124461 A CN03124461 A CN 03124461A CN 1548118 A CN1548118 A CN 1548118A
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Abstract
The present invention discloses breast nodule eliminating 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, regulating vital energy, softening the dry feces, dissipating mass, removing blood stasis and relieving pain, and has obvious curative effect on vital energy stagnation and blood stasis caused hyperplasia of mammary gland lobules, etc.
Description
Technical field
This invention relates to the processing technology technical field of Chinese patent medicine pill, relates in particular to disappear nodules of the breast 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, 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, the existing nodules of the breast capsule that disappears of former dosage form, 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 ten flavor medicines.The technology of former dosage form is: ground spices such as Radix Notoginseng are broken into fine powder, and the five tastes such as all the other Caulis Kadsurae Longipedunculatae are made the decocting thick paste, mixing then, and drying and crushing encapsulating capsule forms.Volatile ingredient has more easily loss in the capsule technology, and dose is big, and ampoule is 4 large capsules, and Ms difficulty swallows, and the quality standard of control product quality is too low, uncontrollable product quality.Based on this, we use the modern pharmaceutical technology this product technology are done necessary the improvement, form new preparation, and improve its quality standard, 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 nodules of the breast ball and preparation method of disappearing, 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. nodules of the breast ball and the preparation method of disappearing comprises the steps:
The prescription of nodules of the breast ball is formed 1.1 disappear
Radix Notoginseng 112.5-225g Rhizoma Cyperi 112.5-225g Radix et Rhizoma Dysosmatis 67.5-135g
Armadillidium 45-90g Formica fusca 45-90g Caulis Kadsurae Longipedunculatae 900-1800g
Fevervine 900-1800g Rhizoma Fagopyri Dibotryis 900-1800g Radix Campylotropis Hirtella (Herba Myrsines Africanae) 900-1800g
Radix Bupleuri 600-1200g right amount of auxiliary materials is made 1000g altogether.
Optimum formula is: Radix Notoginseng 187.5g Rhizoma Cyperi 187.5g Radix et Rhizoma Dysosmatis 112.5g
Armadillidium 75g Formica fusca 75g Caulis Kadsurae Longipedunculatae 1500g
Fevervine 1500g Rhizoma Fagopyri Dibotryis 1500g Radix Campylotropis Hirtella (Herba Myrsines Africanae) 1500g
Radix Bupleuri 1000g right amount of auxiliary materials is made 1000g altogether.
The nodules of the breast ball preparation technology 1.2 disappear
Technology one cleans ten flavor medicines respectively, removes impurity, and it is standby to be up to the standards; Get Radix Notoginseng, Rhizoma Cyperi, Radix et Rhizoma Dysosmatis, Armadillidium, Formica fusca and be ground into fine powder, mixing, it is standby to sterilize; Ground spices such as all the other Caulis Kadsurae Longipedunculatae 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/concentrate drying and makes dried cream powder, with above-mentioned powder and appropriate amount of auxiliary materials mixing, makes ball, drying, promptly.
Technology two cleans ten flavor medicines respectively, removes impurity, and it is standby to be up to the standards; Get Radix Notoginseng, Rhizoma Cyperi, Radix et Rhizoma Dysosmatis, Armadillidium, Formica fusca and be ground into fine powder, mixing, it is standby to sterilize; Ground spices such as all the other Caulis Kadsurae Longipedunculatae are broken into coarse powder/be cut into decoction pieces, add water steaming and decocting 2-3 time, and each 1-3 hour, it was standby to collect volatile oil and water boiling liquid; Volatile oil adds an amount of cyclodextrin inclusion compound and becomes cyclodextrin of volatile oil clathrate/standby with an amount of anhydrous alcohol solution; Water boiling liquid merges, and filters, and filtrate is condensed into thick paste or concentrate drying is made dried cream powder, adds above-mentioned fine powder, cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixing, makes ball, drying, promptly.Or above-mentioned thick paste/dried cream powder, appropriate amount of auxiliary materials mixing, make ball, drying, spray adds the volatile oil solution mixing, promptly.
1.3 be the nodules of the breast ball that disappears by technology one, two prepared balls.
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.
The technology Chinese crude drug is ground into fine powder and was generally 80-160 purpose fine powder, is preferably superfine powder and is broken into 200-300 order fine powder.
The technology Chinese crude drug is ground into coarse powder/be cut into decoction pieces and was generally 5-30 purpose coarse powder/be cut into decoction pieces, is preferably 10-20 order coarse powder.
In the technology decocting boil/condition of water steaming and decocting is: decoction/steaming and decocting 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 each 1-3 of time hour for the 4-10 of dose; The best is: decoction/steaming and decocting 3 times, amount of water are 10 times of amounts of dose for the first time, and second and third time is 8 times of amounts of dose, and the time is 2 hours for the first time, are 1.5 hours for the second time, are 1 hour for the third time.
The relative density that is condensed into thick paste in the technology is 1.18-1.40 (50 ℃), and best relative density is 1.28-1.35 (50 ℃).
The extract drying can adopt vacuum drying or 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 ℃.
Cyclodextrin of volatile oil clathrate preparation in the technology: cyclodextrin can adopt a kind of in beta-schardinger dextrin-, the HP-, the ratio of volatile oil and beta-schardinger dextrin-is 1: 5-15 (ml/g), optimal proportion is 1: 9 (ml/g), the ratio of volatile oil and HP-is 1: 2-10 (ml/g), optimal proportion are 1: 6 (ml/g).
Filter in the technology 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.
2. the quality control of this product mainly is discriminating, inspection, three aspects of assay.
This product increases on the basis of former dosage form to be differentiated the thin layer of Radix Bupleuri, Rhizoma Cyperi, Radix et Rhizoma Dysosmatis in the prescription; To heavy metal must not cross 10/1000000ths, arsenic salt must not cross 2/1000000ths and carry out limit examine; On the assay Radix Notoginseng has been carried out 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 guarantee arranged.
The specific embodiment
The optimum implementation of this invention is that ten flavor medicines are cleaned respectively, removes impurity, and it is standby to be up to the standards; Get Radix Notoginseng, Rhizoma Cyperi, Radix et Rhizoma Dysosmatis, Armadillidium, Formica fusca and be ground into fine powder, mixing, it is standby to sterilize; Ground spices such as all the other Caulis Kadsurae Longipedunculatae are broken into coarse powder, add the water steaming and decocting 3 times, and 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, it was standby to collect volatile oil and water boiling liquid; Volatile oil adds an amount of beta-cyclodextrin inclusion compound and becomes the cyclodextrin of volatile oil clathrate standby; Water boiling liquid merges, and filters, and it is 1.08-1.10 (60 ℃) that filtrate is concentrated into relative density, and spray drying is collected dried cream powder, adds above-mentioned fine powder, volatile oil clathrate compound and appropriate amount of auxiliary materials mixing, makes ball, drying, and coating, promptly.
Claims (10)
1. disappear nodules of the breast ball and preparation method is characterized in that:
(1) Radix Notoginseng, Rhizoma Cyperi, Radix et Rhizoma Dysosmatis, Armadillidium, Formica fusca, Caulis Kadsurae Longipedunculatae, fevervine, Rhizoma Fagopyri Dibotryis, Radix Campylotropis Hirtella (Herba Myrsines Africanae), Radix Bupleuri ten flavor medicines are cleaned respectively, remove impurity, it is standby to be up to the standards; Get Radix Notoginseng, Rhizoma Cyperi, Radix et Rhizoma Dysosmatis, Armadillidium, Formica fusca and be ground into fine powder, mixing, it is standby to sterilize; Ground spices such as all the other Caulis Kadsurae Longipedunculatae 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/concentrate drying and makes dried cream powder, with powder and appropriate amount of auxiliary materials mixing, makes ball, drying, promptly.
(2) Radix Notoginseng, Rhizoma Cyperi, Radix et Rhizoma Dysosmatis, Armadillidium, Formica fusca, Caulis Kadsurae Longipedunculatae, fevervine, Rhizoma Fagopyri Dibotryis, Radix Campylotropis Hirtella (Herba Myrsines Africanae), Radix Bupleuri ten flavor medicines are cleaned respectively, remove impurity, it is standby to be up to the standards; Get Radix Notoginseng, Rhizoma Cyperi, Radix et Rhizoma Dysosmatis, Armadillidium, Formica fusca and be ground into fine powder, mixing, it is standby to sterilize; Ground spices such as all the other Caulis Kadsurae Longipedunculatae are broken into coarse powder/be cut into decoction pieces, add water steaming and decocting 2-3 time, and each 1-3 hour, it was standby to collect volatile oil and water boiling liquid; Volatile oil adds an amount of cyclodextrin inclusion compound and becomes cyclodextrin of volatile oil clathrate/standby with an amount of anhydrous alcohol solution; Water boiling liquid merges, and filters, and filtrate is condensed into thick paste/concentrate drying and makes dried cream powder, adds fine powder, cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixing, makes ball, drying, promptly; Or thick paste/dried cream powder and appropriate amount of auxiliary materials mixing, make ball, drying, spray adds the volatile oil solution mixing, promptly.
2. nodules of the breast ball and the preparation method of disappearing according to claim 1, 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. nodules of the breast ball and the preparation method of disappearing according to claim 1 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. nodules of the breast ball and the preparation method of disappearing according to claim 1 is characterized in that: pulverizing medicinal materials becomes fine powder to be generally 80-160 purpose fine powder, and the best is broken into 200-300 order fine powder for superfine powder; Pulverizing medicinal materials becomes 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.
5. nodules of the breast ball and the preparation method of disappearing according to claim 1, it is characterized in that: decocting boils/and the condition of water steaming and decocting is: decoction/steaming and decocting 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 time hour for the 4-10 of dose; The best is: decoction/steaming and decocting 3 times, amount of water are 10 times of amounts of dose for the first time, and second and third time is 8 times of amounts of dose, and the time is 2 hours for the first time, are 1.5 hours for the second time, are 1 hour for the third time.
6. nodules of the breast ball and the preparation method of disappearing according to claim 1 is characterized in that: the relative density that is condensed into thick paste is 1.18-1.40 (50 ℃), and best relative density is 1.28-1.35 (50 ℃).
7. nodules of the breast ball and the preparation method of disappearing according to claim 1, it is characterized in that: the extract drying 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 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 ℃.
8. nodules of the breast ball and the preparation method of disappearing according to claim 1, it is characterized in that: cyclodextrin of volatile oil clathrate preparation: cyclodextrin can adopt a kind of in beta-schardinger dextrin-, the HP-, the ratio of volatile oil and beta-schardinger dextrin-is 1: 5-15 (ml/g), optimal proportion is 1: 9 (ml/g), the ratio of volatile oil and HP-is 1: 2-10 (ml/g), optimal proportion are 1: 6 (ml/g).
9. nodules of the breast ball and the preparation method of disappearing according to claim 1 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.
10. nodules of the breast ball and the preparation method of disappearing according to claim 1 is characterized in that: the quality standard control of this product has the thin layer of Radix Bupleuri, Rhizoma Cyperi, Radix et Rhizoma Dysosmatis to differentiate; Have in the inspection that heavy metal must not cross 10/1000000ths, arsenic salt must not be crossed 2/1000000ths limit examine; The quantitative of Radix Notoginseng arranged on the assay.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031244610A CN1548118A (en) | 2003-05-24 | 2003-05-24 | Breast nodule eliminating bolus and its prepn |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031244610A CN1548118A (en) | 2003-05-24 | 2003-05-24 | Breast nodule eliminating bolus and its prepn |
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| Publication Number | Publication Date |
|---|---|
| CN1548118A true CN1548118A (en) | 2004-11-24 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA031244610A Pending CN1548118A (en) | 2003-05-24 | 2003-05-24 | Breast nodule eliminating bolus and its prepn |
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| CN (1) | CN1548118A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109528901A (en) * | 2019-01-23 | 2019-03-29 | 四川维奥制药有限公司 | Red gold disappears the preparation process of sheeting |
-
2003
- 2003-05-24 CN CNA031244610A patent/CN1548118A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109528901A (en) * | 2019-01-23 | 2019-03-29 | 四川维奥制药有限公司 | Red gold disappears the preparation process of sheeting |
| CN109528901B (en) * | 2019-01-23 | 2021-06-18 | 四川维奥制药有限公司 | Preparation process of Hongjin Xiaojie tablet |
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| WD01 | Invention patent application deemed withdrawn after publication |