CN1548025A - Lemaiwan pill and its prepn - Google Patents
Lemaiwan pill and its prepn Download PDFInfo
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- CN1548025A CN1548025A CNA031244521A CN03124452A CN1548025A CN 1548025 A CN1548025 A CN 1548025A CN A031244521 A CNA031244521 A CN A031244521A CN 03124452 A CN03124452 A CN 03124452A CN 1548025 A CN1548025 A CN 1548025A
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Abstract
The present invention discloses Lemaiwan pill and its preparation process, and relates to the improvement in preparation form of available granule. The present invention has the advantages of improved maintenance in active components, fast medicine releasing speed, high bioavailability, less irritation, accurate dosage, etc. The medicine has the functions of activating vital energy, promoting blood circulation and dispersing blood clots; is used for headache, dizziness, coronary heart disease, etc. and has obvious curative effect.
Description
Technical field
This invention relates to the processing technology technical field of Chinese patent medicine pill, relates in particular to Lemaiwan pill 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 Lemaiwan pill is: LEMAI KELI, and listed in the Pharmacopoeia of People's Republic of China (2000 editions an one), the technology of former dosage form filters for seven flavors in the prescription decoct with water decocting liquid, concentrates, drying, granulation forms.This granule adopts extraction process by water, and volatility becomes easily loss, and some effective ingredient are difficult to propose.This granule supplementary product consumption is big, and its quality standard can further improve simultaneously.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, thereby and the quality of product is carried out overall monitor 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 Lemaiwan pill and preparation method, improve the quality of products, satisfy needs of medical treatment better.
The objective of the invention is such realization:
1. Lemaiwan pill and preparation method comprise the steps:
1.1 the prescription of Lemaiwan pill is formed:
Radix Salviae Miltiorrhizae 998-3493g Rhizoma Chuanxiong 499-1747g Radix Paeoniae Rubra 499-1747g Flos Carthami 499-1747g
Rhizoma Cyperi 249-875g Radix Aucklandiae 249-875g Fructus Crataegi 124-437g
Right amount of auxiliary materials is made 1000g altogether.
Its optimum formula is:
Radix Salviae Miltiorrhizae 1247-1996g Rhizoma Chuanxiong 623-998g Radix Paeoniae Rubra 623-998g Flos Carthami 623-998g
Rhizoma Cyperi 311-499g Radix Aucklandiae 311-499g Fructus Crataegi 156-250g
Right amount of auxiliary materials is made 1000g altogether.
1.2 Lemaiwan pill preparation technology
Technology one, seven flavor medicine is cleaned respectively, remove impurity, it is standby to be up to the standards; Get in the prescription seven flavors and be ground into coarse powder/be cut into decoction pieces, decoct with water 2-4 time, collecting decoction, filtration, filtrate is condensed into thick paste or concentrate drying is made dried cream powder, with appropriate amount of auxiliary materials mixing, pill, drying, promptly.
Technology two, seven flavor medicine is cleaned respectively, remove impurity, it is standby to be up to the standards; Get in the prescription seven flavors and be ground into coarse powder/be cut into decoction pieces, add water steaming and decocting 2-4 time, it is standby to collect volatile oil and water boiling liquid, volatile oil suitable cyclodextrin enclose or standby with an amount of anhydrous alcohol solution, water boiling liquid merges, filter, filtrate is condensed into thick paste/concentrate drying, and to make dried cream powder standby, above-mentioned thick paste/dried cream powder and cyclodextrin of volatile oil clathrate, and appropriate amount of auxiliary materials mixing, pill, drying, promptly.Or above-mentioned thick paste/dried cream powder and appropriate amount of auxiliary materials mixing, pill, drying, spray adds above-mentioned volatile oil solution, promptly.
Technology three, seven flavor medicine is cleaned respectively, remove impurity, it is standby to be up to the standards; Get in the prescription seven flavors and be ground into coarse powder/be cut into decoction pieces, with the ethanol extraction of 40-95%, extracting solution filters, and reclaims ethanol, is condensed into thick paste/concentrate drying and makes dried cream powder, with appropriate amount of auxiliary materials mixing, pill, drying, promptly.
Technology four, seven flavor medicine is cleaned respectively, remove impurity, it is standby to be up to the standards; Get in the prescription seven flavors and be ground into coarse powder/be cut into decoction pieces, with the ethanol extraction of 40-95%, extracting solution filters, and reclaims ethanol, and is standby; Medicinal residues decoct with water extraction, and decocting liquid filters, and merge with said extracted liquid, are condensed into thick paste/concentrate drying and make dried cream powder, with appropriate amount of auxiliary materials mixing, pill, drying, promptly.
1.3 by technology one, two, three, four prepared balls is Lemaiwan pill.
The technology Chinese crude drug is ground into coarse powder and was generally 5～40 order coarse powder, is preferably 10-20 order coarse powder.
The technology Chinese crude drug decocts with water/and the condition of steaming and decocting is decoction/steaming and decocting 2-4 time, amount of water is that 6-12 doubly measures for the first time, second and third time doubly measured for 4-8, each decocting time is 0.5-3 hour, technology one, two, three is preferably decoction/steaming and decocting 3 times, amount of water is 10 times of amounts for the first time, and second and third time is 8 times of amounts, each 1 hour.Technology four is preferably and decocts 2 times, and amount of water is 10 times of amounts for the first time, second, inferior be 8 times of amounts, each 1 hour.
The relative density of thick paste is 1.08～1.45 (60 ℃) in the technology, and optimal proportion is 1.30-1.35 (60 ℃).
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.
Alcohol extraction process can adopt heating reflux method or percolation etc. for being solvent with the ethanol of 40-95% in the technology, and technology three is best for being solvent with 60-70% ethanol, heating and refluxing extraction 2 times, each 2 hours.Technology four is best for being solvent with 90-95% ethanol, heating and refluxing extraction 2 times, each 1 hour.
The ball drying can adopt vacuum drying, fluid bed drying, lyophilization etc. in the technology.
Filter in the technology and can adopt conventional the filtration, centrifugal, ultrafiltration, add filter behind the clarifier, centrifugal, add the method that filters ultrafiltration again behind the clarifier.
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 ℃.
2. this product quality control mainly is discriminating, inspection, three aspects of assay.Former dosage form has the thin layer of Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong, the Radix Aucklandiae to differentiate on differentiating, is now kept, and increases the thin layer discriminating of Flos Carthami, Radix Paeoniae Rubra; Must not cross 10/1000000ths to heavy metal on checking, arsenic salt must not be crossed 2/1000000ths limit examine; On assay, increased to Radix Salviae Miltiorrhizae quantitatively.
This invention its superiority compared with the prior art is: production technology more becomes fully 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
Embodiment 1: technology one, seven flavor medicine is cleaned respectively, remove impurity, it is standby to be up to the standards; Get in the prescription seven flavors and be ground into coarse powder, decoct with water 3 times, each 1 hour, collecting decoction filtered, and filtrate is concentrated into relative density 1.08-1.10, and spray drying is made dried cream powder, with appropriate amount of auxiliary materials mixing, pill, drying, coating, promptly.
Technology two, seven flavor medicine is cleaned respectively, remove impurity, it is standby to be up to the standards; Get in the prescription seven flavors and be ground into coarse powder, add the water steaming and decocting 3 times, each 1 hour, it is standby to collect volatile oil and water boiling liquid, and volatile oil is standby with being suitable for beta-cyclodextrin inclusion compound, and water boiling liquid merges, filter, filtrate is concentrated into relative density 1.08-1.10, and it is standby that spray drying is made dried cream powder, above-mentioned dried cream powder and cyclodextrin of volatile oil clathrate, and the appropriate amount of auxiliary materials mixing, pill, drying, coating, promptly.
Technology three, seven flavor medicine is cleaned respectively, remove impurity, it is standby to be up to the standards; Get in the prescription seven flavors and be ground into coarse powder, the alcohol reflux with 70% 2 times, each 2 hours, extracting solution filtered, recovery ethanol, concentrate drying is made dried cream powder, with appropriate amount of auxiliary materials mixing, pill, drying, coating, promptly.
Technology four, seven flavor medicine is cleaned respectively, remove impurity, it is standby to be up to the standards; Get in the prescription seven flavors and be ground into coarse powder, the alcohol reflux with 95% 2 times, each 1 hour, extracting solution filtered, and recovery ethanol is standby; Medicinal residues decoct with water and extract 2 times, and each 1 hour, decocting liquid filtered, and merge with said extracted liquid, and concentrate drying is made dried cream powder, with appropriate amount of auxiliary materials mixing, pill, drying, coating, promptly.
Claims (8)
1, a kind of Lemaiwan pill and preparation method is characterized in that:
(1) Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong, Radix Paeoniae Rubra, Flos Carthami, Rhizoma Cyperi, the Radix Aucklandiae, Fructus Crataegi seven flavor medicine are cleaned respectively, remove impurity, it is standby to be up to the standards; Get in the prescription seven flavors and be ground into coarse powder/be cut into decoction pieces, decoct with water 2-4 time, collecting decoction, filtration, filtrate is condensed into thick paste/concentrate drying and makes dried cream powder, with appropriate amount of auxiliary materials mixing, pill, drying, promptly.
(2) Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong, Radix Paeoniae Rubra, Flos Carthami, Rhizoma Cyperi, the Radix Aucklandiae, Fructus Crataegi seven flavor medicine are cleaned respectively, remove impurity, it is standby to be up to the standards; Get in the prescription seven flavors and be ground into coarse powder/be cut into decoction pieces, add water steaming and decocting 2-4 time, it is standby to collect volatile oil and water boiling liquid, volatile oil suitable cyclodextrin enclose/standby with an amount of anhydrous alcohol solution, water boiling liquid merges, filter, filtrate is condensed into thick paste/concentrate drying, and to make dried cream powder standby, thick paste/dried cream powder and cyclodextrin of volatile oil clathrate, and appropriate amount of auxiliary materials mixing, pill, drying, promptly; Or thick paste/dried cream powder and appropriate amount of auxiliary materials mixing, pill, drying, spray adds volatile oil solution, promptly.
(3) Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong, Radix Paeoniae Rubra, Flos Carthami, Rhizoma Cyperi, the Radix Aucklandiae, Fructus Crataegi seven flavor medicine are cleaned respectively, remove impurity, it is standby to be up to the standards; Get in the prescription seven flavors and be ground into coarse powder/be cut into decoction pieces, with the ethanol extraction of 40-95%, extracting solution filters, and reclaims ethanol, is condensed into thick paste/concentrate drying and makes dried cream powder, with appropriate amount of auxiliary materials mixing, pill, drying, promptly.
(4) Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong, Radix Paeoniae Rubra, Flos Carthami, Rhizoma Cyperi, the Radix Aucklandiae, Fructus Crataegi seven flavor medicine are cleaned respectively, remove impurity, it is standby to be up to the standards; Get in the prescription seven flavors and be ground into coarse powder/be cut into decoction pieces, with the ethanol extraction of 40-95%, extracting solution filters, and reclaims ethanol, and is standby; Medicinal residues decoct with water extraction, and decocting liquid filters, and merge with extracting solution, are condensed into thick paste/concentrate drying and make dried cream powder, with appropriate amount of auxiliary materials mixing, pill, drying, promptly.
2. Lemaiwan pill according to claim 1 and preparation method is characterized in that: the technology Chinese crude drug is ground into coarse powder and was generally 5～40 order coarse powder, and the best was a 10-20 order coarse powder; The technology Chinese crude drug decocts with water/and the condition of steaming and decocting is decoction/steaming and decocting 2-4 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 0.5-3 hour, technology one, two, three the bests are decoction/steaming and decocting 3 times, amount of water is 10 times of amounts for the first time, and second and third time is 8 times of amounts, each 1 hour, technology four is preferably and decocts 2 times, for the first time amount of water is 10 times of amounts, second, inferior be 8 times of amounts, each 1 hour.
3. Lemaiwan pill according to claim 1 and preparation method is characterized in that: in the technology, the relative density of thick paste is 1.08～1.45 (60 ℃), and optimal proportion is 1.30-1.35 (60 ℃); Filter in the technology and can adopt conventional the filtration, centrifugal, ultrafiltration, add filter behind the clarifier, centrifugal, add the method that filters ultrafiltration again behind the clarifier.
4. Lemaiwan pill according to claim 1 and preparation method, it is characterized in that: 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-, microcrystalline Cellulose, hydroxypropyl cellulose, carboxymethylstach sodium, Aspartane, polyvinylpolypyrrolidone, 30 1 kinds/multiple mixing use of 30 POVIDONE K 30 BP/USP in the technology.
5. Lemaiwan pill according to claim 1 and preparation method is characterized in that: the particle diameter of the ball of gained is 0.5-6mm in the technology, and optimum grain-diameter is 1.5-4mm; The ball drying can adopt vacuum drying, fluid bed drying, lyophilization in the technology; The ball of gained can directly use/pack in the capsulae vacuus and use in the technology.
6. Lemaiwan pill according to claim 1 and preparation method, it is characterized in that: alcohol extraction process is a solvent for the ethanol with 40-95% in the technology three, four, can adopt heating reflux method/percolation etc., technology three is best for being solvent with 60-70% ethanol, heating and refluxing extraction 2 times, each 2 hours, technology four was best for being solvent with 90-95% ethanol, heating and refluxing extraction 2 times, each 1 hour.
7. Lemaiwan pill according to claim 1 and preparation method, it is characterized in that: the drying of extract can adopt vacuum drying/employing spray drying in the technology, 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 ℃.
8. Lemaiwan pill according to claim 1 and preparation method is characterized in that: the thin layer discriminating has been carried out to Flos Carthami, Radix Paeoniae Rubra in the quality standard aspect; Must not cross 10/1000000ths to heavy metal, arsenic salt must not be crossed 2/1000000ths limit examine; Radix Salviae Miltiorrhizae has been carried out quantitatively.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031244521A CN1548025A (en) | 2003-05-24 | 2003-05-24 | Lemaiwan pill and its prepn |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031244521A CN1548025A (en) | 2003-05-24 | 2003-05-24 | Lemaiwan pill and its prepn |
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| Publication Number | Publication Date |
|---|---|
| CN1548025A true CN1548025A (en) | 2004-11-24 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA031244521A Pending CN1548025A (en) | 2003-05-24 | 2003-05-24 | Lemaiwan pill and its prepn |
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| CN (1) | CN1548025A (en) |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102885889A (en) * | 2012-11-05 | 2013-01-23 | 太极集团重庆中药二厂有限公司 | Method for producing expelling extract |
| CN102895645A (en) * | 2012-11-05 | 2013-01-30 | 太极集团重庆中药二厂有限公司 | Method for preparing stomach pills of aucklandia and amomum fruit |
| CN102908600A (en) * | 2012-11-05 | 2013-02-06 | 太极集团重庆中药二厂有限公司 | Preparation method for ease pills |
| CN102908601A (en) * | 2012-11-05 | 2013-02-06 | 太极集团重庆中药二厂有限公司 | Preparation method of huoxiang zhengqi pills |
| CN111467429A (en) * | 2020-05-12 | 2020-07-31 | 徐文争 | Pulse-invigorating pill and preparation method thereof |
-
2003
- 2003-05-24 CN CNA031244521A patent/CN1548025A/en active Pending
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102885889A (en) * | 2012-11-05 | 2013-01-23 | 太极集团重庆中药二厂有限公司 | Method for producing expelling extract |
| CN102895645A (en) * | 2012-11-05 | 2013-01-30 | 太极集团重庆中药二厂有限公司 | Method for preparing stomach pills of aucklandia and amomum fruit |
| CN102908600A (en) * | 2012-11-05 | 2013-02-06 | 太极集团重庆中药二厂有限公司 | Preparation method for ease pills |
| CN102908601A (en) * | 2012-11-05 | 2013-02-06 | 太极集团重庆中药二厂有限公司 | Preparation method of huoxiang zhengqi pills |
| CN102895645B (en) * | 2012-11-05 | 2014-06-25 | 太极集团重庆中药二厂有限公司 | Method for preparing stomach pills of aucklandia and amomum fruit |
| CN102908600B (en) * | 2012-11-05 | 2014-06-25 | 太极集团重庆中药二厂有限公司 | Preparation method for ease pills |
| CN102908601B (en) * | 2012-11-05 | 2014-07-16 | 太极集团重庆中药二厂有限公司 | Preparation method of huoxiang zhengqi pills |
| CN102885889B (en) * | 2012-11-05 | 2014-07-30 | 太极集团重庆中药二厂有限公司 | Method for producing expelling extract |
| CN111467429A (en) * | 2020-05-12 | 2020-07-31 | 徐文争 | Pulse-invigorating pill and preparation method thereof |
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