CN1548087A - Cough treating bolus and its prepn - Google Patents

Abstract

The present invention discloses cough treating 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. and is especially suitable for children, old people and weakling. The medicine has the functions of relieving cough, relieving asthma and eliminating phlegm, and is used in treating cough, asthma, etc. with high curative effect.

Description

Cough treating bolus and preparation method

Technical field

This invention relates to the processing technology technical field of Chinese patent medicine pill, relates in particular to cough 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, 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 cough treating bolus is a KEKE JIAONANG, and has listed Drug Standard of Ministry of Public Health of the Peoples Republic of China (in " Chinese traditional patent formulation preparation " the 17) in.This pharmaceutically dosage form is single, application forms still has only capsule, far can not satisfy people's medication demand, and there is not quantitative target in its quality standard, and ball by comparison, have that drug release rate is fast, bioavailability is high, zest is little, divided dose is accurate, take, easy to carry, especially adapt to old man and child's advantage; We use the modern pharmaceutical technology this product processes are done necessary improvement based on this, form new preparation, thereby and the quality of product carried out overall monitor assurance product quality, 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 cough treating bolus and preparation method thereof, improve the quality of products, satisfy needs of medical treatment better.

The objective of the invention is such realization:

1. cough treating bolus and preparation method comprise the steps:

1.1 the prescription of cough treating bolus is formed

Herba Ephedrae 500～1000g Pericarpium Papaveris 500～1000g Radix Glycyrrhizae 500～1000g

Semen Armeniacae Amarum 500～1000g Semen Raphani 150～3000g Radix Platycodonis 150～300g

Gypsum Fibrosum 150～300g right amount of auxiliary materials is made 1000g altogether.

Its optimum formula is:

Herba Ephedrae 720g Pericarpium Papaveris 720g Radix Glycyrrhizae 720g Semen Armeniacae Amarum 720g

Semen Raphani 225g Radix Platycodonis 225g Gypsum Fibrosum 225g right amount of auxiliary materials is made 1000g altogether.

1.2 cough treating bolus preparation technology

Technology one, the seven flavor medicine material is cleaned respectively, remove impurity, it is standby to be up to the standards; Get Herba Ephedrae and Pericarpium Papaveris and pulverize, sieve, respectively stay fine powder 330g standby, the residue coarse powder decocts 2-3 time with acidic aqueous solution (with about 10% hydrochloric acid solution adjust pH to 5), each 1-3 hour, filters, filtrate is with 10% sodium hydroxide solution adjust pH to 7, and medicinal liquid is standby; Five tastes medical materials such as all the other Radix Glycyrrhizaes are ground into coarse powder/be cut into decoction pieces, decoct with water 2-3 time, each 1-3 hour, filter, filtrate and above-mentioned solution merge, and are condensed into thick paste/concentrate drying and make dried cream powder, add Herba Ephedrae and Pericarpium Papaveris fine powder and appropriate amount of auxiliary materials, mixing, make ball, drying, promptly.

Technology two, the seven flavor medicine material is cleaned respectively, remove impurity, it is standby to be up to the standards; Get Herba Ephedrae and Pericarpium Papaveris and be ground into coarse powder and decoct 2-3 time with acidic aqueous solution (with about 10% hydrochloric acid solution adjust pH to 5), 1-3 hour at every turn, filtration, filtrate is with 10% sodium hydroxide solution adjust pH to 7, and medicinal liquid is standby; Five tastes medical materials such as all the other Radix Glycyrrhizaes are ground into coarse powder/be cut into decoction pieces, decoct with water 2-3 time, and each 1-3 hour, filter, filtrate and the merging of above-mentioned solution are condensed into thick paste or concentrate drying and make dried cream powder, with the appropriate amount of auxiliary materials mixing, make ball, drying, promptly.

1.3 by technology one, two prepared balls is cough treating bolus

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 technology Chinese crude drug is ground into fine powder and was generally 80～160 order fine powders, and being preferably superfine powder, to be broken into 200～300 order fine powders standby.

The condition that the technology Chinese crude drug decocts with water is: decoct 2-3 time, amount of water is that 6-12 doubly measures for the first time, doubly measure for 4-8 for the second time, each decocting time is 1-3 hour, being preferably for the first time, amount of water is 10 times of amounts, be 8 times of amounts for the second time, Herba Ephedrae etc. are best for acidic aqueous solution decocts 2 times, each 2 hours; The bests such as Radix Glycyrrhizae are for decocting with water each 1 hour 2 times.

The relative density of thick paste is 1.08～1.45 (60 ℃) in the technology, and optimal proportion is 1.23 (60 ℃).

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 ℃.

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-, 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.

2. the quality control of this product mainly is: inspection, qualitative, quantitative three aspects.Former dosage form has been carried out the thin layer discriminating to Herba Ephedrae, Radix Glycyrrhizae on differentiating, existing having increased differentiated the thin layer of Pericarpium Papaveris, Radix Platycodonis; Having increased on checking has heavy metal must not cross 10/1000000ths, and arsenic salt must not be crossed 2/1000000ths limit examine; Former dosage form does not have quantitative target on assay, now increases the quantitative check of Herba Ephedrae.

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 tablet disintegration rate is fast, easily absorbs the performance drug effect.

The specific embodiment

The optimum implementation of this invention is that the seven flavor medicine material is cleaned respectively, removes impurity, and it is standby to be up to the standards; Get Herba Ephedrae and Pericarpium Papaveris and be ground into coarse powder and decoct secondary with acidic aqueous solution (with about 10% hydrochloric acid solution adjust pH to 5), each 2 hours, filtration, filtrate is with 10% sodium hydroxide solution adjust pH to 7, and medicinal liquid is standby; All the other Radix Glycyrrhizaes, Semen Armeniacae Amarum, Semen Raphani, Radix Platycodonis, Gypsum Fibrosum five tastes medical material are ground into coarse powder and decoct with water secondary, each 1 hour, filter, filtrate and above-mentioned solution merge, being concentrated into relative density is the concentrated solution of 1.08～1.10 (60 ℃), spray drying is collected dried cream powder, adds appropriate amount of auxiliary materials, mixing, make ball, drying, promptly.

Claims (8)

1, a kind of cough treating bolus and preparation method is characterized in that:

(1) Herba Ephedrae, Pericarpium Papaveris, Radix Glycyrrhizae, Semen Armeniacae Amarum, Semen Raphani, Radix Platycodonis, Gypsum Fibrosum seven flavor medicine material are cleaned respectively, remove impurity, it is standby to be up to the standards; Get Herba Ephedrae and Pericarpium Papaveris and pulverize, sieve, respectively stay fine powder 330g standby, the residue coarse powder decocts 2-3 time with acidic aqueous solution (with about 10% hydrochloric acid solution adjust pH to 5), each 1-3 hour, filters, filtrate is with 10% sodium hydroxide solution adjust pH to 7, and medicinal liquid is standby; All the other Radix Glycyrrhizaes, Semen Armeniacae Amarum, Semen Raphani, Radix Platycodonis, Gypsum Fibrosum five tastes medical material are ground into coarse powder/be cut into decoction pieces, decoct with water 2-3 time, each 1-3 hour, filter, filtrate and solution merge, be condensed into thick paste/concentrate drying and make dried cream powder, add Herba Ephedrae and Pericarpium Papaveris fine powder and appropriate amount of auxiliary materials, mixing is made ball, drying, promptly.

(2) Herba Ephedrae, Pericarpium Papaveris, Radix Glycyrrhizae, Semen Armeniacae Amarum, Semen Raphani, Radix Platycodonis, Gypsum Fibrosum seven flavor medicine material are cleaned respectively, remove impurity, it is standby to be up to the standards; Get Herba Ephedrae and Pericarpium Papaveris and be ground into coarse powder and decoct 2-3 time with acidic aqueous solution (with about 10% hydrochloric acid solution adjust pH to 5), 1-3 hour at every turn, filtration, filtrate is with 10% sodium hydroxide solution adjust pH to 7, and medicinal liquid is standby; Five tastes medical materials such as all the other Radix Glycyrrhizaes, Semen Armeniacae Amarum, Semen Raphani, Radix Platycodonis, Gypsum Fibrosum are ground into coarse powder/be cut into decoction pieces, decoct with water 2-3 time, each 1-3 hour, filter, filtrate and solution merge, and are condensed into thick paste/concentrate drying and make dried cream powder, with the appropriate amount of auxiliary materials mixing, make ball, drying, promptly.

2. cough treating bolus according to claim 1 and preparation method is characterized in that: the technology Chinese crude drug is ground into coarse powder/be cut into decoction pieces and was generally 5～30 order coarse powder/be cut into decoction pieces, and the best was 10 order coarse powder; The technology Chinese crude drug is ground into fine powder and was generally 80～160 order fine powders, and the best is standby for superfine powder is broken into 200～300 order fine powders.

3. cough treating bolus according to claim 1 and preparation method is characterized in that: the condition that the technology Chinese crude drug decocts with water is: decoct 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 amount of water for the first time is 10 times of amounts, is 8 times of amounts for the second time; Herba Ephedraes etc. are best for acidic aqueous solution decocts 2 times, each 2 hours; The bests such as Radix Glycyrrhizae are for decocting with water each 1 hour 2 times.

4. cough treating bolus according to claim 1 and preparation method is characterized in that: the relative density of thick paste is 1.08～1.45 (60 ℃) in the technology, and optimal proportion is 1.23 (60 ℃).

5. cough treating bolus 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 ℃.

6. cough treating bolus 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.

7. cough 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 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.

8. cough treating bolus according to claim 1 and preparation method is characterized in that: the thin layer discriminating has been carried out to Pericarpium Papaveris, Radix Platycodonis in the quality standard aspect, has heavy metal must not cross 10/1000000ths, and arsenic salt must not be crossed 2/1000000ths limit examine; There is Herba Ephedrae to carry out quantitative check.