CN1537574A

CN1537574A - Granule for treating prostatic gland retention, and its prepn. method

Info

Publication number: CN1537574A
Application number: CNA031182798A
Authority: CN
Inventors: 毛友昌; 毛晓敏
Original assignee: Individual
Current assignee: Individual
Priority date: 2003-04-15
Filing date: 2003-04-15
Publication date: 2004-10-20

Abstract

An improved Chinese medicine in the form of granule for treating prostatic uroschesis is prepared through grinding part of raw materials, decocting part of raw materials for collecting volatile oil or decocting all raw materials, concentrating, drying and adding additive. Its advantages are correct dosage and high curative effect.

Description

'Qianlielongbitong ' granule and preparation method

Technical field

This invention relates to the particulate processing technology technical field of Chinese patent medicine, relates in particular to 'Qianlielongbitong ' granule and preparation method.

Background technology

Granule is the pharmaceutical formulation of using always, according to the relevant drug act of China, change dosage form as a kind of new drug research, the particulate original dosage form of 'Qianlielongbitong ' is the 'Qianlielongbitong ' capsule, 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: ten Herba indigoferae Pseudotinctoriae are all made encapsulated forming behind the decocting dried cream powder in the prescription.This capsule dose is bigger, 4 large capsules, dysphagia, especially to old person, secondly, and this pharmaceutically dosage form is single, far can not satisfy people's medication demand, its quality standard still can further improve simultaneously, and granule is compared with it, also have onset advantage rapidly, 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, guarantee drug effect, benefit the common people.

Summary of the invention

The purpose of this invention is to provide a kind of 'Qianlielongbitong ' granule 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, the particulate preparation method of 'Qianlielongbitong ' comprises the steps:

1.1 the particulate prescription of 'Qianlielongbitong ' is formed

Radix Astragali 1200g Eupolyphaga Seu Steleophaga 400g Fructus Malvae 400g Semen Persicae 480g Ramulus Cinnamomi 400g

Herba Epimedii 600g Radix Bupleuri 240g Poria 1200g Rhizoma Polygoni Cuspidati 600g Fructus Aurantii 400g

Radix Cyathulae 600g

Right amount of auxiliary materials is made 1000 bags altogether.

1.2 the particulate preparation technology of 'Qianlielongbitong '

Technology one, will write out a prescription in ten Herba indigoferae Pseudotinctoriae be up to the standards standby respectively; More than ten simply medical material be ground into coarse powder/make decoction pieces, decoct with water 2-4 time, each 1-4 hour, collecting decoction filtered, it is 1.20-1.40 (60 ℃) thick paste that filtrate is concentrated into relative density, and drying is pulverized, and adds appropriate amount of auxiliary materials, mixing is granulated, drying, granulate, quality inspection, and packing is promptly.

Technology two, will write out a prescription in ten Herba indigoferae Pseudotinctoriae be up to the standards standby respectively; More than ten simply medical material be ground into coarse powder/make decoction pieces, decoct with water 2-4 time, each 1-4 hour, collecting decoction, filter, filtrate is concentrated into the concentrated solution that relative density is 1.05-1.15 (60 ℃), and spray drying is collected dried cream powder, with the appropriate amount of auxiliary materials mixing, granulate, drying, granulate, quality inspection, packing is promptly.

Technology three, will write out a prescription in ten Herba indigoferae Pseudotinctoriae be up to the standards standby respectively; Get Eupolyphaga Seu Steleophaga, Herba Epimedii, Radix Cyathulae, Semen Persicae mixed powder and be broken into fine powder; Seven flavors such as all the other Radixs Astragali are ground into coarse powder/decoction pieces, add water steaming and decocting 2-4 time, and each 1-4 hour, it was standby to collect volatile oil and water boiling liquid; Above-mentioned volatile oil adds an amount of cyclodextrin inclusion compound and becomes the cyclodextrin of volatile oil clathrate or add an amount of dissolve with ethanol that to make the volatile oil alcoholic solution standby; Water boiling liquid filters, filtrate is condensed into the concentrated solution that relative density is 1.05-1.15 (60 ℃), spray drying, and collecting dried cream powder/be condensed into relative density is the thick paste of 1.20-1.40 (60 ℃), add above-mentioned fine powder and appropriate amount of auxiliary materials mixing, granulate, drying adds cyclodextrin of volatile oil clathrate/volatile oil alcoholic solution mixing, packing, quality inspection, packing, promptly.

1.3 by the technology gained is granule

The added adjuvant of 'Qianlielongbitong ' granule can be: 30 POVIDONE K 30 BP/USP ₃₀, any or multiple mixing in the micropowder silica gel, starch, beta-schardinger dextrin-, hydroxyl beta-schardinger dextrin-, dextrin, sucrose, steviosin, Aspartane, magnesium stearate, essence etc. uses.

Being ground into fine powder in the technology was 80-160 purpose fine powder, and the best is broken into 200-300 purpose fine powder for superfine powder.

Be ground into coarse powder/decoction pieces in the technology for being ground into 5-40 purpose coarse powder/decoction pieces, the best was a 10-20 order coarse powder.

In the technology decocting boil/condition of water steaming and decocting is: amount of water is doubly measured for 6-12 for the first time, second and third, doubly measure for 4-10 for four times, decoct 1-4 hour at every turn 2-4 time.The best decocts with water/water steaming and decocting 3 times, and amount of water is 10 times of amounts for the first time, and second and third time is 8 times of amounts, is 3 hours for the first time, and second and third time is 2 hours.

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 ℃).

The relative density that is condensed into concentrated solution in the technology is 1.05-1.15 (60 ℃), and best relative density is 1.08-1.10 (60 ℃).

The spray drying inlet temperature is 100-220 ℃ in the technology, and leaving air temp is 50-150 ℃, and best inlet temperature is 160-180 ℃, and leaving air temp is 80-100 ℃.

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

Cyclodextrin of volatile oil clathrate preparation in the technology: cyclodextrin can adopt a kind of in beta-schardinger dextrin-, the hydroxyl beta-schardinger dextrin-, the ratio of volatile oil and beta-schardinger dextrin-is 1: 5-15 (ml/g), optimal proportion is 1: 8 (ml/g), the ratio of volatile oil and hydroxyl beta-schardinger dextrin-is 1: 2-10 (ml/g), optimal proportion are 1: 5 (ml/g).

The quality control of this product mainly is discriminating, inspection, three aspects of assay, and existing having increased differentiated the thin layer of Radix Bupleuri, Radix Cyathulae, Herba Epimedii; Heavy metal, arsenic salt are carried out limit examine, have heavy metal must not cross 10/1000000ths, arsenic salt must not be crossed 2/1000000ths limit detection, increased on the assay to Radix Bupleuri quantitatively.

This invention its superiority compared with the prior art is: dosage form manufacturing technique more becomes fully rationally, quality standard has had further raising, makes product that the qualitative, quantitative control method of more comprehensive science be arranged, and makes the quality of product that better guarantee arranged.

The specific embodiment

The optimum implementation of this invention is: ten Herba indigoferae Pseudotinctoriae are up to the standards standby respectively in will writing out a prescription; More than ten simply medical material be ground into coarse powder, decoct with water 3 hours for the first time 3 times, second and third time is 2 hours, collecting decoction filters, and filtrate is concentrated into the concentrated solution that relative density is 1.08-1.10 (60 ℃), spray drying, collect dried cream powder,, granulate with the appropriate amount of auxiliary materials mixing, drying, granulate, quality inspection, packing promptly.

Claims

1, a kind of 'Qianlielongbitong ' granule and preparation method is characterized in that:

(1) will write out a prescription in ten Herba indigoferae Pseudotinctoriae be up to the standards standby respectively; The above Radix Astragali, Eupolyphaga Seu Steleophaga, Fructus Malvae, Semen Persicae, Ramulus Cinnamomi, Herba Epimedii, Radix Bupleuri, Poria, Rhizoma Polygoni Cuspidati, Fructus Aurantii, Radix Cyathulae ten medical material simply are ground into coarse powder/make decoction pieces, decoct with water each 1-4 hour 2-4 time, collecting decoction, filter, it is 1.20-1.40 (60 ℃) thick paste that filtrate is concentrated into relative density, drying, pulverize, add appropriate amount of auxiliary materials, mixing is granulated, drying, granulate, quality inspection, packing promptly.

(2) will write out a prescription in ten Herba indigoferae Pseudotinctoriae be up to the standards standby respectively; The above Radix Astragali, Eupolyphaga Seu Steleophaga, Fructus Malvae, Semen Persicae, Ramulus Cinnamomi, Herba Epimedii, Radix Bupleuri, Poria, Rhizoma Polygoni Cuspidati, Fructus Aurantii, Radix Cyathulae ten medical material simply are ground into coarse powder/make decoction pieces, decoct with water 2-4 time, each 1-4 hour, collecting decoction, filter, filtrate is concentrated into the concentrated solution that relative density is 1.05-1.15 (60 ℃), and spray drying is collected dried cream powder, with the appropriate amount of auxiliary materials mixing, granulate, drying, granulate, quality inspection, packing is promptly.

(3) will write out a prescription in ten Herba indigoferae Pseudotinctoriae be up to the standards standby respectively; Get Eupolyphaga Seu Steleophaga, Herba Epimedii, Radix Cyathulae, Semen Persicae mixed powder and be broken into fine powder; All the other Fructus Malvae, Ramulus Cinnamomi, Radix Bupleuri, Poria, Rhizoma Polygoni Cuspidati, Fructus Aurantii, the Radix Astragali seven flavors are ground into coarse powder/decoction pieces, add water steaming and decocting 2-4 time, and each 1-4 hour, it was standby to collect volatile oil and water boiling liquid; Above-mentioned volatile oil adds an amount of cyclodextrin inclusion compound and becomes the cyclodextrin of volatile oil clathrate or add an amount of dissolve with ethanol that to make the volatile oil alcoholic solution standby; Water boiling liquid filters, filtrate is condensed into the concentrated solution that relative density is 1.05-1.15 (60 ℃), spray drying, and collecting dried cream powder/be condensed into relative density is the thick paste of 1.20-1.40 (60 ℃), add above-mentioned fine powder and appropriate amount of auxiliary materials mixing, granulate, drying adds cyclodextrin of volatile oil clathrate/volatile oil alcoholic solution mixing, packing, quality inspection, packing, promptly.

2, 'Qianlielongbitong ' granule according to claim 1 and preparation method is characterized in that: the added adjuvant of 'Qianlielongbitong ' granule can be: 30 POVIDONE K 30 BP/USP ₃₀, any/multiple mixing in the micropowder silica gel, starch, beta-schardinger dextrin-, hydroxyl beta-schardinger dextrin-, dextrin, sucrose, steviosin, Aspartane, magnesium stearate, essence etc. uses.

3, 'Qianlielongbitong ' granule according to claim 1 and preparation method, it is characterized in that: being ground into fine powder in the technology was 80-160 purpose fine powder, the best is broken into 200-300 purpose fine powder for superfine powder, be ground into coarse powder/decoction pieces in the technology for being ground into 5-40 purpose coarse powder/decoction pieces, the best was a 10-20 order coarse powder.

4, 'Qianlielongbitong ' granule according to claim 1 and preparation method is characterized in that: in the technology decocting boil/condition of water steaming and decocting is: amount of water is doubly measured for 6-12 for the first time, second and third, doubly measure for 4-10 for four times, decoct 1-4 hour at every turn 2-4 time.The best decocts with water/water steaming and decocting 3 times, and amount of water is 10 times of amounts for the first time, and second and third time is 8 times of amounts, is 3 hours for the first time, and second and third time is 2 hours.

5, 'Qianlielongbitong ' granule according to claim 1 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 ℃), best relative density is 1.32-1.35 (60 ℃), the relative density that is condensed into concentrated solution in the technology is 1.05-1.15 (60 ℃), and best relative density is 1.08-1.10 (60 ℃).

6, 'Qianlielongbitong ' granule according to claim 1 and preparation method, it is characterized in that: the spray drying inlet temperature is 100-220 ℃ in the technology, leaving air temp is 50-150 ℃, best inlet temperature is 160-180 ℃, leaving air temp is 80-100 ℃, the temperature of particle drying is controlled at 50-80 ℃ in the technology, is preferably 60 ℃.

7, 'Qianlielongbitong ' granule according to claim 1 and preparation method, it is characterized in that: cyclodextrin of volatile oil clathrate preparation in the technology: cyclodextrin can adopt a kind of in beta-schardinger dextrin-, the hydroxyl beta-schardinger dextrin-, the ratio of volatile oil and beta-schardinger dextrin-is 1: 5-15 (ml/g), optimal proportion is 1: 8 (ml/g), the ratio of volatile oil and hydroxyl beta-schardinger dextrin-is 1: 2-10 (ml/g), optimal proportion are 1: 5 (ml/g).

8, 'Qianlielongbitong ' granule according to claim 1 and preparation method is characterized in that: have the thin layer of Radix Bupleuri, Radix Cyathulae, Herba Epimedii to differentiate on the quality inspection standard; Have heavy metal must not cross 10/1000000ths, arsenic salt must not be crossed 2/1000000ths limit detection, and the detection by quantitative of Radix Bupleuri is arranged.