CN1537590A

CN1537590A - Xiaoke capsule for relieving cough, and its prepn. method

Info

Publication number: CN1537590A
Application number: CNA031183158A
Authority: CN
Inventors: 毛友昌; 毛晓敏
Original assignee: Individual
Current assignee: Individual
Priority date: 2003-04-20
Filing date: 2003-04-20
Publication date: 2004-10-20

Abstract

An improved Chinese medicine 'Xiaoke capsules' for treating the cough, asthma and expectoration caused by acute or chronic branchitis. Its advantages are high curative effect, high safety and high adaptability to diabetics.

Description

Disappear and cough capsule and preparation method

Technical field

This invention relates to the processing technology technical field of Chinese medicine capsule, and relating in particular to disappears coughs capsule and preparation method.

Background technology

Capsule is the pharmaceutical formulation of using always, according to the relevant drug act of China, changes dosage form as a kind of new drug research, disappears that to cough capsular original dosage form be cough relieving granule, has listed in national Bureau of Drugs Supervision's country's standard for traditional Chinese medicines compilation (terrestrial reference rises the GB tentative standard).The technology characteristics of former dosage form is: the Six-element medicine is except that Mentholum in the prescription, and the five tastes such as all the other Folium Eriobotryaes add auxiliary materials and mixing after decocting with water and being condensed into thick paste, granulates, and drying sprays into the Mentholum alcoholic solution, the mixing packing, promptly.This granule sugar content is up to 95%, the patient who is unsuitable for suffering from diabetes takes, and this pharmaceutically dosage form is single, application forms still has only granule, far can not satisfy people's medication demand, its quality standard still can further improve simultaneously, and capsule is saved adjuvant by comparison more in addition, reduce the advantage of dose, based on this, we use the modern pharmaceutical technology this product technology are done necessary improvement, form new preparation, the control criterion that improves the quality simultaneously guarantees the quality monitoring of product, benefits the common people.

Summary of the invention

The purpose of this invention is to provide a kind of disappearing and cough capsule and preparation method, improve the quality of products and curative effect, increase the stability of product, enrich medicine variety, to satisfy and to ensure people's medication demand better.

1, disappears and cough capsular preparation method and comprise the steps:

Coughing capsular prescription 1.1 disappear forms

Folium Eriobotryae 110-650g Pericarpium Papaveris 80-500g Radix Stemonae 30-200g

Herba Ephedrae 30-200g Radix Platycodonis 20-150g Mentholum 0.3-2.0g

Right amount of auxiliary materials is made 1000 altogether

Optimum formula is:

Folium Eriobotryae 275g Pericarpium Papaveris 200g Radix Stemonae 75g Herba Ephedrae 75g

Radix Platycodonis 50g Mentholum 0.75g right amount of auxiliary materials is made 1000 altogether

Cough capsular preparation technology 1.2 disappear

Technology one, will write out a prescription in the Six-element medicine be up to the standards standby respectively; Except that Mentholum, five tastes medical materials such as all the other Folium Eriobotryaes are ground into coarse powder/make decoction pieces, decoct with water 2-3 time, each 1-3 hour, collecting decoction filtered, filtrate is concentrated into the thick paste that relative density is 1.20-1.40 (60 ℃), adds the right amount of auxiliary materials mixing, makes granule, drying in addition with a little anhydrous alcohol solution of Mentholum, sprays in the granule, mixing, encapsulated, quality inspection, promptly.

Technology two, will write out a prescription in the Six-element medicine be up to the standards standby respectively; Ground spices such as Folium Eriobotryae are broken into coarse powder/make decoction pieces, decoct with water 2-3 time, each 1-3 hour, merge decoction liquor and filter, the filtrate concentrate drying is made dried cream powder, with the appropriate amount of auxiliary materials mixing, granulate, drying is in addition with a little anhydrous alcohol solution of Mentholum, spray in the granule, mixing, encapsulated, quality inspection, packing, promptly.

1.3 by the technology gained is capsule

Added adjuvant can be in the technology: any or multiple mixing in 30 POVIDONE K 30 BP/USP 30, micropowder silica gel, starch, dextrin, the magnesium stearate etc. is used.

Be ground into coarse powder/make decoction pieces in the technology, be preferably 10-20 order coarse powder for being ground into 5-40 purpose coarse powder/decoction pieces.

The condition that decocting boils in the technology is: decoct 2-3 time, each 1-3 hour, amount of water was that 6-12 doubly measures for the first time, and second and third time doubly measured for 4-10, and best each 2 hours, amount of water was 10 times of amounts for the first time in order to decoct 2 times, and be 8 times of amounts the second time.

The relative density that is condensed into thick paste in the technology is 1.20-1.40 (60 ℃), and best relative density is 1.32-1.35 (60 ℃).

Drying can adopt drying under reduced pressure or spray drying, drying under reduced pressure, and temperature is controlled at 50-90 ℃, preferably is controlled at 70 ℃.Spray drying is, extracting solution is concentrated into the concentrated solution that relative density is 1.05-1.15 (60 ℃), best relative density is 1.08-1.10 (60 ℃), spray drying, inlet temperature is 100～200 ℃, leaving air temp is 50～150 ℃, and best inlet temperature is 150-170 ℃, and leaving air temp is 80-100 ℃.

The temperature of particle drying is controlled at 50-90 ℃ in the technology, is preferably 60-80 ℃.

Concentrate in the technology and can adopt concentrating under reduced pressure or thin film concentration.

Extracting solution filters and also can adopt centrifugation method in the technology.

2, disappear among the present invention and cough capsular quality control standard and on the basis of original cough relieving granule, further improve, on differentiating, increased the thin layer of Folium Eriobotryae has been differentiated, former dosage form does not have the limit examine of arsenic salt, heavy metal on checking, now increased heavy metal limit and must not cross 10/1000000ths, arsenic salt must not cross 2/1000000ths; On the assay Pericarpium Papaveris is limited the quantity of, and increased to Herba Ephedrae quantitatively.

This invention is dosage form technological innovation on existing particulate basis, a large amount of sucrose have been saved, reduced dose, and quality standard has new raising again, significant meaning is arranged improving the quality of products, enrich medicine variety, made people especially suffer from more pleased the taking of patient of diabetes, satisfied and ensured people's medication demand.

The specific embodiment

The optimum implementation of this invention is: the Six-element medicine is up to the standards standby respectively in will writing out a prescription; Ground spices such as Folium Eriobotryae are broken into coarse powder, decoct with water 2 times, each 2 hours, merge decoction liquor and filter, filtrate is condensed into the concentrated solution that relative density is 1.08-1.10, spray drying, collect dried cream powder,, granulate with the appropriate amount of auxiliary materials mixing, drying in addition with a little anhydrous alcohol solution of Mentholum, sprays in the granule, mixing, encapsulated, quality inspection, packing, promptly.

Claims

1, a kind of disappearing coughed capsule and preparation method, it is characterized in that:

(1) will write out a prescription in the Six-element medicine be up to the standards standby respectively; Except that Mentholum, Folium Eriobotryae, Pericarpium Papaveris, the Radix Stemonae, Herba Ephedrae, Radix Platycodonis five tastes medical material are ground into coarse powder/make decoction pieces, decoct with water 2-3 time, each 1-3 hour, collecting decoction filtered, filtrate is concentrated into the thick paste that relative density is 1.20-1.40 (60 ℃), adds the right amount of auxiliary materials mixing, makes granule, drying in addition with a little anhydrous alcohol solution of Mentholum, sprays in the granule, mixing, encapsulated, quality inspection, promptly.

(2) will write out a prescription in the Six-element medicine be up to the standards standby respectively; Folium Eriobotryae, Pericarpium Papaveris, the Radix Stemonae, Herba Ephedrae, Radix Platycodonis ground spice are broken into coarse powder/make decoction pieces, decoct with water 2-3 time, each 1-3 hour, merge decoction liquor and filter, the filtrate concentrate drying is made dried cream powder, with the appropriate amount of auxiliary materials mixing, granulate, drying is in addition with a little anhydrous alcohol solution of Mentholum, spray in the granule, mixing, encapsulated, quality inspection, packing, promptly.

2, according to claim 1 disappearing coughed capsule and preparation method, it is characterized in that: be ground into coarse powder/make decoction pieces for being ground into 5-40 purpose coarse powder/decoction pieces in the technology, be preferably 10-20 order coarse powder.

3, according to claim 1 disappearing coughed capsule and preparation method, it is characterized in that: the condition that decocting boils in the technology is: decoct 2-3 time, each 1-3 hour, amount of water is that 6-12 doubly measures for the first time, second and third time doubly measured for 4-10, and be best for decocting each 2 hours 2 times, amount of water is 10 times of amounts for the first time, is 8 times of amounts for the second time.

4, according to claim 1 disappearing coughed capsule and preparation method, it is characterized in that: the relative density that is condensed into thick paste in the technology is 1.20-1.40 (60 ℃), and best relative density is 1.32-1.35 (60 ℃).

5, according to claim 1 disappearing coughed capsule and preparation method, it is characterized in that: drying can adopt drying under reduced pressure/spray drying, drying under reduced pressure, and temperature is controlled at 50-90 ℃, preferably is controlled at 70 ℃.Spray drying is, extracting solution is concentrated into the concentrated solution that relative density is 1.05-1.15 (60 ℃), best relative density is 1.08-1.10 (60 ℃), spray drying, inlet temperature is 100～200 ℃, leaving air temp is 50～150 ℃, and best inlet temperature is 150-170 ℃, and leaving air temp is 80-100 ℃.

6, according to claim 1 disappearing coughed capsule and preparation method, it is characterized in that: the temperature of particle drying is controlled at 50-90 ℃ in the technology, is preferably 60-80 ℃.

7, according to claim 1 disappearing coughed capsule and preparation method, it is characterized in that: added adjuvant can be in the technology: 30 POVIDONE K 30 BP/USP ₃₀, any/multiple mixing in the micropowder silica gel, starch, dextrin, magnesium stearate etc. uses.

8, according to claim 1 disappearing coughed capsule and preparation method, it is characterized in that: have the thin layer of Folium Eriobotryae to differentiate that have heavy metal limit must not cross 10/1000000ths, arsenic salt must not be crossed 2/1000000ths limit detection on quality inspection standard; On the assay Pericarpium Papaveris is limited the quantity of, and to the quantitative assay of Herba Ephedrae.