CN1548100A - Yangweishu bolus and its prepn - Google Patents
Yangweishu bolus and its prepn Download PDFInfo
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- CN1548100A CN1548100A CNA031244408A CN03124440A CN1548100A CN 1548100 A CN1548100 A CN 1548100A CN A031244408 A CNA031244408 A CN A031244408A CN 03124440 A CN03124440 A CN 03124440A CN 1548100 A CN1548100 A CN 1548100A
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Abstract
The present invention discloses Yangweishu 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 strengthening body's resistance, nourishing Yin and stomach, regulating middle warmer, etc. and is used in treating chronic gastritis, 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 YANGWEISHU 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, changing dosage form needs as a kind of new drug research, and the original dosage form of YANGWEISHU ball is: yangweishu capsules, and listed Drug Standard of Ministry of Public Health of the Peoples Republic of China (in " Chinese traditional patent formulation preparation " the 13) in.The technology features of former dosage form is that the whole medical materials (ten simply) in the prescription decoct with water, and decocting liquid is condensed into thick paste, adds adjuvant, granulates the drying cartridge capsule.This medicine is the volatile ingredient total loss aborning, and in its quality standard, there is the significant drawbacks that influences quality in the indefiniteness quantitative target.And this pharmaceutically dosage form is single, far can not satisfy people's medication demand.We use the modern pharmaceutical technology this product technology are done necessary improvement based on this, form new preparation, and the quality of product is carried out overall monitor, thereby guarantee that product quality benefits 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 YANGWEISHU ball and preparation method, improve the quality of products, satisfy needs of medical treatment better.
The objective of the invention is such realization:
1. YANGWEISHU ball and preparation method comprise the steps:
1.1 the prescription of YANGWEISHU ball is formed:
Radix Codonopsis 374-744g Pericarpium Citri Reticulatae 314-628g Rhizoma Polygonati (steaming) 374-744g
Rhizoma Dioscoreae 374-744g Rhizoma Zingiberis 152-304g Semen Cuscutae 374-744g
The Rhizoma Atractylodis Macrocephalae (stir-fry) 374-744g Radix Scrophulariae 374-744g Fructus Mume 466-932g
Fructus Crataegi 466-932g Radix Glehniae 374-744g right amount of auxiliary materials is made 1000g altogether.
Its optimum formula is:
Radix Codonopsis 468g Pericarpium Citri Reticulatae 393g Rhizoma Polygonati (steaming) 468g Rhizoma Dioscoreae 468g
The Rhizoma Zingiberis 190g Semen Cuscutae 468g Rhizoma Atractylodis Macrocephalae (stir-fry) 468g Radix Scrophulariae 468g
Fructus Mume 583g Fructus Crataegi 583g Radix Glehniae 468g right amount of auxiliary materials is made 1000g altogether.
1.2 YANGWEISHU ball preparation technology
Technology one, ten Herba indigoferae Pseudotinctoriae are cleaned respectively, remove impurity, it is standby to be up to the standards; Ten Herba indigoferae Pseudotinctoriae decoct with water (Semen Cuscutae is decocted a drug wrapped) 2-3 time in will writing out a prescription, and each 1-3 hour, collecting decoction filtered, and filtrate is condensed into thick paste, adds appropriate amount of auxiliary materials, and mixing is made ball, drying, promptly.
Technology two, ten Herba indigoferae Pseudotinctoriae are cleaned respectively, remove impurity, it is standby to be up to the standards; Ten Herba indigoferae Pseudotinctoriae decoct with water (Semen Cuscutae is decocted a drug wrapped) 2-3 time in will writing out a prescription, and each 1-3 hour, collecting decoction filtered, and the filtrate concentrate drying is made dried cream powder, adds appropriate amount of auxiliary materials, and mixing is made ball, drying, promptly.
Technology three, ten Herba indigoferae Pseudotinctoriae are cleaned respectively, remove impurity, it is standby to be up to the standards; It is standby that the ten flavor medicine mixed powders of except that Semen Cuscutae all the other in the prescription are broken into coarse powder/be cut into decoction pieces, and ten add water steaming and decocting (Semen Cuscutae is decocted a drug wrapped) 2-3 time simply in the prescription, and 1-3 hour at every turn, collection volatile oil was standby; Merge cooking liquor, filter, filtrate is condensed into thick paste/concentrate drying, and to make dried cream powder standby; The volatile oil of collecting is with an amount of anhydrous alcohol solution/become the cyclodextrin of volatile oil clathrate standby with cyclodextrin inclusion compound; Get above-mentioned thick paste/dried cream powder and cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixing, make ball, drying, promptly.Or get above-mentioned thick paste/dried cream powder and add the appropriate amount of auxiliary materials mixing, make ball, drying, spray adds the volatile oil ethanol solution, mixing, coating, promptly.
1.3 by technology one, two, three prepared balls is the YANGWEISHU ball.
The technology Chinese crude drug is ground into coarse powder/be cut into decoction pieces, is generally 5～30 order coarse powder/be cut into decoction pieces, is preferably 10-20 order coarse powder.
The extraction of volatile oil in the technology can be extracted fully or with supercritical process with the way of distillation and be extracted.
Cyclodextrin of volatile oil clathrate preparation in the technology, cyclodextrin can be adopted any in beta-schardinger dextrin-or the HP-; The ratio of volatile oil and beta-schardinger dextrin-is 1: 6-15cm/g, optimal proportion are 1: 10 (ml/g); The ratio of volatile oil and HP-is 1: 3-12cm/g, optimal proportion are 1: 5.5 (ml/g).
In the technology one, three, the relative density of thick paste is 1.20～1.45 (60 ℃), and optimal proportion is 1.28～1.30 (60 ℃).
The technology Chinese crude drug decocts with water/and the condition of steaming and decocting is: decoction/steaming and decocting 2-3 time, amount of water is that 6-12 doubly measures for the first time, and second and third time doubly measured for 4-8, and decocting time is 1-3 hour at every turn; Be preferably: decoction/steaming and decocting 2 times, amount of water is 10 times of amounts for the first time, and the time is 1.5 hours, is 6 times of amounts for the second time, and the time is 1 hour.
The drying of extract 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 spray drying inlet temperature is 100-200 ℃, leaving air temp 50-150 ℃; Best relative density is 1.08-1.10 (60 ℃), and inlet temperature is 160-180 ℃, leaving air temp 80-100 ℃.
Filter in the technology and also can adopt centrifugal not conventional filtration, ultrafiltration filters after adding clarifier, method such as ultrafiltration again after adding clarifier and filtering.
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 sucrose, lactose, starch, beta-schardinger dextrin-, HP-, microcrystalline Cellulose, hydroxypropyl cellulose, carboxymethylstach sodium, Aspartane, polyvinylpolypyrrolidone, 30 POVIDONE K 30 BP/USP 30 etc. in the technology, and a kind of/multiple mixing is used.
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.
2. the quality control of this product mainly is discriminating, inspection, three aspects of assay.
Former dosage form has only two physicochemical identification on differentiating, the existing thin layer that has increased the Rhizoma Atractylodis Macrocephalae, Fructus Crataegi, Pericarpium Citri Reticulatae, Rhizoma Zingiberis, Semen Cuscutae is differentiated; The inspection aspect has increased must not cross 10/1000000ths to heavy metal, and arsenic salt must not be crossed 2/1000000ths limit examine; Carry out quantitatively the naringin in the Pericarpium Citri Reticulatae assay aspect.
This invention its superiority compared with the prior art is: production technology more becomes to improving rationally, quality standard improves greatly, 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 Herba indigoferae Pseudotinctoriae are cleaned respectively, removes impurity, and it is standby to be up to the standards; Except that Semen Cuscutae, it is standby that all the other ten flavor medicine mixed powders are broken into coarse powder in will writing out a prescription, and gets that ten Herba indigoferae Pseudotinctoriae add water steaming and decocting (Semen Cuscutae is decocted a drug wrapped) 2 times in the prescription, and 1.5 hours for the first time, 1 hour for the second time, it was standby to collect volatile oil; Merge secondary boiled liquid, filter, it is the concentrated solution of 1.08～1.10 (60 ℃) that the filtrate thin film concentration becomes relative density, spray drying, and it is standby to collect dried cream powder; The volatile oil of collecting becomes the cyclodextrin of volatile oil clathrate standby with cyclodextrin inclusion compound; Get above-mentioned dried cream powder, cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixing, make ball, drying, promptly.
Claims (10)
1, a kind of YANGWEISHU ball and preparation method is characterized in that:
(1) Radix Codonopsis, Pericarpium Citri Reticulatae, Rhizoma Polygonati, Rhizoma Dioscoreae, Rhizoma Zingiberis, Semen Cuscutae, the Rhizoma Atractylodis Macrocephalae, Radix Scrophulariae, Fructus Mume, Fructus Crataegi, Radix Glehniae ten Herba indigoferae Pseudotinctoriae are cleaned respectively, remove impurity, it is standby to be up to the standards; Ten Herba indigoferae Pseudotinctoriae decoct with water (Semen Cuscutae is decocted a drug wrapped) 2-3 time in will writing out a prescription, and each 1-3 hour, collecting decoction filtered, and filtrate is condensed into thick paste, adds the appropriate amount of auxiliary materials mixing, makes ball, drying, promptly.
(2) Radix Codonopsis, Pericarpium Citri Reticulatae, Rhizoma Polygonati, Rhizoma Dioscoreae, Rhizoma Zingiberis, Semen Cuscutae, the Rhizoma Atractylodis Macrocephalae, Radix Scrophulariae, Fructus Mume, Fructus Crataegi, Radix Glehniae ten Herba indigoferae Pseudotinctoriae are cleaned respectively, remove impurity, it is standby to be up to the standards; Ten Herba indigoferae Pseudotinctoriae decoct with water (Semen Cuscutae is decocted a drug wrapped) 2-3 time in will writing out a prescription, and each 1-3 hour, collecting decoction filtered, and the filtrate concentrate drying is made dried cream powder, adds appropriate amount of auxiliary materials, and mixing is made ball, drying, promptly.
(3) Radix Codonopsis, Pericarpium Citri Reticulatae, Rhizoma Polygonati, Rhizoma Dioscoreae, Rhizoma Zingiberis, Semen Cuscutae, the Rhizoma Atractylodis Macrocephalae, Radix Scrophulariae, Fructus Mume, Fructus Crataegi, Radix Glehniae ten Herba indigoferae Pseudotinctoriae are cleaned respectively, remove impurity, it is standby to be up to the standards; It is standby that the ten flavor medicine mixed powders of except that Semen Cuscutae all the other in the prescription are broken into coarse powder/be cut into decoction pieces, and ten add water steaming and decocting (Semen Cuscutae is decocted a drug wrapped) 2-3 time simply in will write out a prescription, and 1-3 hour at every turn, collection volatile oil was standby; Merge cooking liquor, filter, filtrate is condensed into thick paste/concentrate drying, and to make dried cream powder standby; The volatile oil of collecting becomes volatile oil alcoholic solution/become the cyclodextrin of volatile oil clathrate standby with cyclodextrin inclusion compound with an amount of anhydrous alcohol solution; Get thick paste/dried cream powder and cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixing, make ball, drying, promptly; Or get thick paste/dried cream powder and appropriate amount of auxiliary materials mixing, and make ball, drying, spray adds the volatile oil ethanol solution, mixing, promptly.
2. YANGWEISHU ball according to claim 1 and preparation method is characterized in that: pulverizing medicinal materials becomes coarse powder/be cut into decoction pieces to be generally 5～30 order coarse powder/be cut into decoction pieces, and the best was a 10-20 order coarse powder; The extraction of volatile oil can be extracted with the way of distillation and be equipped with/be extracted with supercritical process.
3. YANGWEISHU ball according to claim 1 and preparation method is characterized in that: cyclodextrin of volatile oil clathrate preparation, cyclodextrin can be adopted any in beta-schardinger dextrin-/hydroxyl beta-schardinger dextrin-; The ratio of volatile oil and beta-schardinger dextrin-is 1: 6-15cm/g, optimal proportion are 1: 10 (ml/g); The ratio of volatile oil and hydroxyl beta-schardinger dextrin-is 1: 3-12cm/g, optimal proportion are 1: 5.5 (ml/g).
4. YANGWEISHU ball according to claim 1 and preparation method is characterized in that: the relative density of thick paste is 1.20～1.45 (60 ℃), and optimal proportion is 1.28～1.30 (60 ℃).
5. YANGWEISHU ball according to claim 1 and preparation method, it is characterized in that: medical material decocts with water/and the condition of steaming and decocting is: decoction/steaming and decocting 2-3 time, amount of water is that 6-12 doubly measures for the first time, and second and third time doubly measured for 4-8, and each decocting time is 1-3 hour; Best is decoction/steaming and decocting 2 times, and amount of water is 10 times of amounts for the first time, and the time is 1.5 hours, is 6 times of amounts for the second time, and the time is 1 hour.
6. YANGWEISHU ball according to claim 1 and preparation method, it is characterized in that: the drying of extract can adopt vacuum drying/employing spray drying, and the vacuum drying temperature is controlled at 50-80 ℃, and the best is 60 ℃, the spray drying inlet temperature is 100-200 ℃, leaving air temp 50-150 ℃; Best relative density is 1.08-1.10 (60 ℃), and inlet temperature is 160-180 ℃, leaving air temp 80-100 ℃.
7. YANGWEISHU ball according to claim 1 and preparation method is characterized in that: filter also can adopt centrifugal, the conventional filtration, ultrafiltration filters after adding clarifier, the method for ultrafiltration again after adding clarifier and filtering.
8. YANGWEISHU 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-, hydroxypropyl, microcrystalline Cellulose, hydroxypropyl cellulose, carboxymethylstach sodium, Aspartane, polyvinylpolypyrrolidone, 30 1 kinds/multiple mixing use of 30 POVIDONE K 30 BP/USP.
9. YANGWEISHU 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.
10. YANGWEISHU ball according to claim 1 and preparation method, it is characterized in that: the thin layer discriminating that the Rhizoma Atractylodis Macrocephalae, Fructus Crataegi, Pericarpium Citri Reticulatae, Rhizoma Zingiberis, Semen Cuscutae are arranged is differentiated in the quality standard control of this product, there is heavy metal must not cross 10/1000000ths in the inspection, arsenic salt must not be crossed 2/1000000ths limit examine, and the quantitative of Pericarpium Citri Reticulatae arranged on the assay.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031244408A CN1548100A (en) | 2003-05-24 | 2003-05-24 | Yangweishu bolus and its prepn |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031244408A CN1548100A (en) | 2003-05-24 | 2003-05-24 | Yangweishu bolus and its prepn |
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| Publication Number | Publication Date |
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| CN1548100A true CN1548100A (en) | 2004-11-24 |
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| Application Number | Title | Priority Date | Filing Date |
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| CNA031244408A Pending CN1548100A (en) | 2003-05-24 | 2003-05-24 | Yangweishu bolus and its prepn |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106552254A (en) * | 2015-09-30 | 2017-04-05 | 上海中医药大学附属曙光医院 | It is a kind of to treat Chinese medicine preparation of chronic obstructive pulmonary disease and preparation method thereof |
-
2003
- 2003-05-24 CN CNA031244408A patent/CN1548100A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106552254A (en) * | 2015-09-30 | 2017-04-05 | 上海中医药大学附属曙光医院 | It is a kind of to treat Chinese medicine preparation of chronic obstructive pulmonary disease and preparation method thereof |
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