CN1548104A - Compound cordate bouttuynia bolus and its prepn - Google Patents
Compound cordate bouttuynia bolus and its prepn Download PDFInfo
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- CN1548104A CN1548104A CNA031244459A CN03124445A CN1548104A CN 1548104 A CN1548104 A CN 1548104A CN A031244459 A CNA031244459 A CN A031244459A CN 03124445 A CN03124445 A CN 03124445A CN 1548104 A CN1548104 A CN 1548104A
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Abstract
The present invention discloses complex cordate houttuynia bolus and its preparation. The present invention relates to preparation form innovation on the basis of available tablet, and the medicine has the advantages of fast release speed, high bioavailability, less irritation, etc. The medicine has the functions of clearing away heat and toxic material, and is used in treating wind and cold caused throat pain, acute pharyngitis and tonsillitis 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 compound houttuynin 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 compound houttuynin ball is: FUFANG YUXINGCAO PIAN, listed in the Pharmacopoeia of People's Republic of China (2000 editions an one).The technology of former dosage form is beaten fine powder for Fructus Forsythiae, Flos Lonicerae and part Herba Houttuyniae in the prescription, and remaining Herba Houttuyniae and Radix Scutellariae etc. decoct with water, and decocting liquid is condensed into thick paste, and with above-mentioned fine powder mixing, drying is pulverized, granulate, and tabletting, sugar coating forms.This tablets amount is big, dysphagia, and volatile ingredient easily loses aborning, and the coated tablet coating is loaded down with trivial details, and disintegrate is slow, and its quality standard is low simultaneously, no quantitative target.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 compound houttuynin ball and preparation method, improve the quality of products, satisfy needs of medical treatment better.
The objective of the invention is such realization:
1. compound houttuynin ball and preparation method comprise the steps:
1.1 the prescription of compound houttuynin ball is formed:
Herba Houttuyniae 583-4081g Radix Scutellariae 150-1050g Radix Isatidis 150-1050g
Flos Lonicerae 58-406g Fructus Forsythiae 58-406g
Right amount of auxiliary materials is made 1000g altogether
Its optimum formula is:
Herba Houttuyniae 1166-1749g Radix Scutellariae 300-450g Radix Isatidis 300-450g
Flos Lonicerae 116-174g Fructus Forsythiae 116-174g
Right amount of auxiliary materials is made 1000g altogether
1.2 compound houttuynin ball preparation technology
Technology one, five medicines are cleaned respectively, remove impurity, it is standby to be up to the standards; Get Herba Houttuyniae (about recipe quantity 1/3), Fructus Forsythiae, Flos Lonicerae powder and be broken into fine powder, remaining Herba Houttuyniae and Radix Scutellariae, Radix Isatidis decoct with water 2-3 time, collecting decoction, filter, filtrate is condensed into thick paste/concentrate drying and makes dried cream powder, with above-mentioned fine powder and appropriate amount of auxiliary materials, mixing, make ball, drying, promptly.
Technology two, five medicines are cleaned respectively, remove impurity, it is standby to be up to the standards; Get Herba Houttuyniae, Fructus Forsythiae, Flos Lonicerae and extract volatile oil, volatile oil is with an amount of cyclodextrin inclusion compound/standby with an amount of anhydrous alcohol solution; Medicinal residues and Radix Scutellariae, Radix Isatidis decoct with water 2-3 time, and collecting decoction filters, and filtrate is condensed into thick paste/concentrate drying and makes dried cream powder, with above-mentioned cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixing, makes ball, drying, promptly.Or above-mentioned thick paste/dried cream powder and appropriate amount of auxiliary materials mixing, make ball, drying, spray adds above-mentioned volatile oil solution, promptly.
Technology three, five kinds of Chinese medicine is cleaned respectively, remove impurity, it is standby to be up to the standards; Five kinds of Chinese medicine adds water steaming and decocting 2-3 time in the prescription, and it is standby to collect volatile oil and water boiling liquid; Above-mentioned volatile oil is with an amount of Cyclodextrin enclose/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, with above-mentioned cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixing, makes ball, drying, promptly.Or above-mentioned thick paste/dried cream powder and appropriate amount of auxiliary materials mixing, make ball, drying, spray adds above-mentioned volatile oil solution, promptly.
1.3 by technology one, two, three prepared balls is the compound houttuynin ball.
It was 80-160 purpose fine powder that the technology Chinese crude drug is ground into fine powder, and the best is standby for superfine powder is broken into 200-300 purpose fine 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, 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, second and third time doubly measured for 4-8,1-3 hour at every turn; Be preferably: decoction/steaming and decocting 2 times, amount of water is 10 times of amounts for the first time, is 8 times of amounts for the second time, is 2 hours at every turn.
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 conventional the filtration, centrifugal, ultrafiltration, add filter behind the clarifier, centrifugal, the method for 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 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, optimum grain-diameter 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 Fructus Forsythiae, two thin layers of Flos Lonicerae to differentiate on differentiating, the existing thin layer that has increased Radix Scutellariae, Herba Houttuyniae, Radix Isatidis 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; The former dosage form in assay aspect does not have quantitative target, now Radix Scutellariae has been carried out quantitatively.
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
Embodiment 1: five medicines are cleaned respectively, remove impurity, it is standby to be up to the standards; Get Herba Houttuyniae (about recipe quantity 1/3), Fructus Forsythiae, Flos Lonicerae powder and be broken into fine powder, remaining Herba Houttuyniae and Radix Scutellariae, Radix Isatidis decoct with water 2 times, and each 2 hours, collecting decoction, filter, filtrate is condensed into thick paste, with above-mentioned fine powder and appropriate amount of auxiliary materials mixing, makes ball, drying, coating, promptly.
Embodiment 2: five medicines are cleaned respectively, remove impurity, it is standby to be up to the standards; Get Herba Houttuyniae, Fructus Forsythiae, Flos Lonicerae extraction volatile oil, volatile oil is standby with an amount of beta-cyclodextrin inclusion compound; Medicinal residues and Radix Scutellariae, Radix Isatidis decoct with water 2 times, and each 2 hours, collecting decoction filtered, filtrate is concentrated into relative density 1.08-1.10, and spray drying is made dried cream powder, with above-mentioned cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixing, makes ball, drying, coating, promptly.
Embodiment 3: five kinds of Chinese medicine is cleaned respectively, remove impurity, it is standby to be up to the standards; Five kinds of Chinese medicine adds the water steaming and decocting 2 times in the prescription, and each 2 hours, it was standby to collect volatile oil and water boiling liquid; Above-mentioned volatile oil is standby with an amount of β-Cyclodextrin enclose; Water boiling liquid merges, and filters, and filtrate is concentrated into relative density 1.08-1.10, and spray drying is made dried cream powder, with above-mentioned cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixing, makes ball, drying, and coating, promptly.
Claims (10)
1, a kind of compound houttuynin ball and preparation method is characterized in that:
(1) Herba Houttuyniae, Radix Scutellariae, Radix Isatidis, Flos Lonicerae, Fructus Forsythiae five medicines are cleaned respectively, remove impurity, it is standby to be up to the standards; Get Herba Houttuyniae (about recipe quantity 1/3), Fructus Forsythiae, Flos Lonicerae powder and be broken into fine powder, remaining Herba Houttuyniae and Radix Scutellariae, Radix Isatidis decoct with water 2-3 time, and collecting decoction filters, filtrate is condensed into thick paste/concentrate drying and makes dried cream powder, with fine powder and appropriate amount of auxiliary materials, mixing, make ball, drying, promptly.
(2) Herba Houttuyniae, Radix Scutellariae, Radix Isatidis, Flos Lonicerae, Fructus Forsythiae five medicines are cleaned respectively, remove impurity, it is standby to be up to the standards; Get Herba Houttuyniae, Fructus Forsythiae, Flos Lonicerae and extract volatile oil, volatile oil is with an amount of cyclodextrin inclusion compound/standby with an amount of anhydrous alcohol solution; Medicinal residues and Radix Scutellariae, Radix Isatidis decoct with water 2-3 time, and collecting decoction filters, and filtrate is condensed into thick paste/concentrate drying and makes dried cream powder, with cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixing, makes ball, drying, promptly; Thick paste/dried cream powder and appropriate amount of auxiliary materials mixing are made ball, drying, and spray adds volatile oil solution, promptly.
(3) Herba Houttuyniae, Radix Scutellariae, Radix Isatidis, Flos Lonicerae, Fructus Forsythiae five kinds of Chinese medicine are cleaned respectively, remove impurity, it is standby to be up to the standards; Five kinds of Chinese medicine adds water steaming and decocting 2-3 time in the prescription, and it is standby to collect volatile oil and water boiling liquid; Volatile oil is with an amount of Cyclodextrin enclose/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, with cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixing, makes ball, drying, promptly; Thick paste/dried cream powder and appropriate amount of auxiliary materials mixing are made ball, drying, and spray adds that spray adds volatile oil solution, promptly.
2. compound houttuynin ball according to claim 1 and preparation method is characterized in that: pulverizing medicinal materials becomes fine powder to be generally 80-160 order fine powder, and the best is standby for superfine powder is broken into 200-300 purpose fine powder.
3. compound houttuynin ball according to claim 1 and preparation method is characterized in that: the extraction of volatile oil, and can extract with the way of distillation and be equipped with/extract with supercritical process; Cyclodextrin of volatile oil clathrate preparation, cyclodextrin can be adopted any in beta-schardinger dextrin-/hydroxypropyl; 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 hydroxypropyl is 1: 3-12cm/g, optimal proportion are 1: 5.5 (ml/g).
4. compound houttuynin 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. compound houttuynin ball according to claim 1 and preparation method is characterized in that: and 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, second and third time doubly measured for 4-8,1-3 hour at every turn; The best is: decoction/steaming and decocting 2 times, and amount of water is 10 times of amounts for the first time, is 8 times of amounts for the second time, the time is 1 hour.
6. compound houttuynin 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. compound houttuynin ball 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, the method for ultrafiltration again after adding clarifier and filtering.
8. compound houttuynin 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. compound houttuynin ball according to claim 1 and preparation method is characterized in that: the particle diameter of the ball of gained is 0.5-6mm, optimum grain-diameter 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. compound houttuynin ball according to claim 1 and preparation method, it is characterized in that: the thin layer discriminating that Fructus Forsythiae, Flos Lonicerae, Radix Scutellariae, Herba Houttuyniae, Radix Isatidis 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 Radix Scutellariae arranged on the assay.
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Cited By (8)
Publication number | Priority date | Publication date | Assignee | Title |
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CN1883560B (en) * | 2006-05-30 | 2010-05-12 | 薛洪发 | A compound Chinese medicinal preparation containing Chinese globeflower and method for preparing same |
CN102018810A (en) * | 2010-12-09 | 2011-04-20 | 浙江惠松制药有限公司 | Preparation method of compound Houttuynia cordata mixture |
CN101040951B (en) * | 2007-04-29 | 2011-11-02 | 江西天施康中药股份有限公司 | Method of controlling the quality of Ynxingchao dropping pills compound |
CN101040950B (en) * | 2007-04-29 | 2012-02-22 | 江西天施康中药股份有限公司 | Method of preparing compound Houttuynia cordata dropping pills |
CN101683182B (en) * | 2008-09-27 | 2012-07-04 | 湖北中烟工业有限责任公司 | Heartleaf houttuynia herb and radix isatidis compound extract and application thereof as additive of tobacco product |
CN103494928A (en) * | 2013-09-29 | 2014-01-08 | 江西天施康中药股份有限公司 | Preparation method for compound houttuynia cordata preparation |
CN105878525A (en) * | 2014-12-15 | 2016-08-24 | 沈阳伟嘉牧业技术有限公司 | Method for preparing houttuynia cordata lyophilized superfine powder granules |
CN110954645A (en) * | 2019-09-09 | 2020-04-03 | 山东琪康生物技术有限公司 | Detection method of high-quality Sihuang dysentery stopping granules |
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2003
- 2003-05-24 CN CNA031244459A patent/CN1548104A/en active Pending
Cited By (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1883560B (en) * | 2006-05-30 | 2010-05-12 | 薛洪发 | A compound Chinese medicinal preparation containing Chinese globeflower and method for preparing same |
CN101040951B (en) * | 2007-04-29 | 2011-11-02 | 江西天施康中药股份有限公司 | Method of controlling the quality of Ynxingchao dropping pills compound |
CN101040950B (en) * | 2007-04-29 | 2012-02-22 | 江西天施康中药股份有限公司 | Method of preparing compound Houttuynia cordata dropping pills |
CN101683182B (en) * | 2008-09-27 | 2012-07-04 | 湖北中烟工业有限责任公司 | Heartleaf houttuynia herb and radix isatidis compound extract and application thereof as additive of tobacco product |
CN102018810A (en) * | 2010-12-09 | 2011-04-20 | 浙江惠松制药有限公司 | Preparation method of compound Houttuynia cordata mixture |
CN102018810B (en) * | 2010-12-09 | 2012-01-11 | 浙江惠松制药有限公司 | Preparation method of compound Houttuynia cordata mixture |
CN103494928A (en) * | 2013-09-29 | 2014-01-08 | 江西天施康中药股份有限公司 | Preparation method for compound houttuynia cordata preparation |
CN105878525A (en) * | 2014-12-15 | 2016-08-24 | 沈阳伟嘉牧业技术有限公司 | Method for preparing houttuynia cordata lyophilized superfine powder granules |
CN110954645A (en) * | 2019-09-09 | 2020-04-03 | 山东琪康生物技术有限公司 | Detection method of high-quality Sihuang dysentery stopping granules |
CN110954645B (en) * | 2019-09-09 | 2020-09-29 | 山东琪康生物技术有限公司 | Detection method of high-quality Sihuang dysentery stopping granules |
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