CN1537585A

CN1537585A - Granule for cleaning stone and its prepn. method

Info

Publication number: CN1537585A
Application number: CNA031183107A
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 'Jieshiqing granule' for treating cholecystitis and cholelithiasis and its preparing process are disclosed. Its advantages are high curative effect and high safety.

Description

Clear granule of calculus and preparation method

Technical field

The present invention relates to the particulate processing technology technical field of Chinese patent medicine, relate in particular to clear granule of calculus 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 clear particulate original dosage form of calculus is the calculus clearing capsule, has listed in National Drug Administration's country's standard for traditional Chinese medicines compilation (Chinese patent medicine provincial standard rising national standard part liver and gall fascicle).Former dose technology is: it is standby that three flavor medicines are respectively got 10% pulverizing in the prescription; Remaining decocts with water, and is condensed into thick paste and adds above-mentioned fine powder, and drying is pulverized, and is encapsulated, promptly.This capsule dose is big, and dysphagia is especially to old person, and this pharmaceutically dosage form is single, and simultaneously, its quality standard still can further improve, and granule is compared with it, also has onset advantage rapidly, based on this, we use the modern pharmaceutical technology this product forms are done necessary improvement, form new preparation, the control criterion that improves the quality simultaneously guarantees the quality monitoring of product, improve drug effect, benefit the common people.

Summary of the invention

The purpose of this invention is to provide clear granule of calculus and preparation method, improve the quality of products and curative effect, make that the patient is more pleased to take, to satisfy medical demand better.

1, the clear particulate preparation method of calculus comprises the steps:

1.1 the clear particulate prescription of calculus is formed

Calculus grass 5400～25000g Herba Centipedae 300～1400g Rhizoma Corydalis 300～1400g

Right amount of auxiliary materials is made 1000 bags altogether.

Optimum formula is:

Calculus grass 10800～16200g Herba Centipedae 600～900g Rhizoma Corydalis 600～900g

Right amount of auxiliary materials is made 1000 bags altogether.

1.2 the clear particulate preparation technology of calculus

Technology one, will write out a prescription in three the flavor be up to the standards respectively standby; Three flavors are respectively got 10% of recipe quantity and are ground into fine powder in the prescription, and three flavors such as residue calculus grass are ground into coarse powder/decoction pieces, decoct with water 2-3 time, each 1-3 hour, collecting decoction filtered, filtrate is condensed into thick paste, adds above-mentioned fine powder, mixing, drying is ground into fine powder, adds the appropriate amount of auxiliary materials mixing, granulate drying, granulate, packing, promptly.

Technology two, will write out a prescription in three the flavor be up to the standards respectively standby; Three flavors are respectively got 10% of recipe quantity and are ground into fine powder in the prescription, and three flavors such as residue calculus grass are ground into coarse powder/decoction pieces, decoct with water collecting decoction 2-3 time, filter, the filtrate concentrate drying is made dried cream powder, adds above-mentioned fine powder and appropriate amount of auxiliary materials mixing, granulates, drying, granulate, packing, promptly.

Technology three, will write out a prescription in three the flavor be up to the standards respectively standby; Three flavors such as calculus grass are ground into coarse powder/decoction pieces in the prescription, decoct with water 2-3 time, and collecting decoction filters, and the filtrate concentrate drying is made dried cream powder, with the appropriate amount of auxiliary materials mixing, and granulation, drying, granulate, packing, promptly.

1.3 by the technology gained is granule

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

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

Being ground into coarse powder/decoction pieces in the technology was 5-40 purpose coarse powder/decoction pieces, was preferably to be ground into 10-20 purpose coarse powder.

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

The relative density that is condensed into thick paste in the technology is 1.15-1.40 (80 ℃), and best relative density is 1.30-1.32 (80 ℃).

Drying can adopt drying under reduced pressure or spray drying in the technology.The drying under reduced pressure temperature is controlled at 50-90 ℃, and the best is 60 ℃.Spray drying is for to be condensed into the concentrated solution that relative density is 1.05-1.15 (60 ℃) with extracting solution, and spray drying, inlet temperature are 100-200 ℃, leaving air temp is 50-150 ℃, best relative density is 1.08-1.10 (60 ℃), and inlet temperature is 160 ℃, and leaving air temp is 100 ℃.Particle drying adopts drying under reduced pressure.

2, clear granular mass control mainly is discriminating, inspection, three aspects of assay to calculus in the present invention, former dosage form has been carried out the thin layer discriminating to calculus grass, Herba Centipedae on differentiating, now kept, and increased the thin layer of Rhizoma Corydalis has been differentiated, on checking, increased the limit examine of heavy metal, arsenic salt, the regulation heavy metal limit must not cross 10/1000000ths, and arsenic salt must not limit the quantity of 2/1000000ths; Former dosage form has carried out quantitatively now being kept to Rhizoma Corydalis on assay.

This invention is dosage form technological innovation on the basis of existing capsule, and quality standard has new raising again, is of great importance to improving the quality of products, and has enriched medicine variety, satisfies and ensured people's medication demand.

The specific embodiment

Optimum implementation of the present invention is: 13 flavors are up to the standards standby respectively in will writing out a prescription; Three flavors such as calculus grass are ground into coarse powder in the prescription, decoct with water 3 times, and each 2 hours, collecting decoction filtered, filtrate is concentrated into relative density 1.08-1.10 (60 ℃), and spray drying is made dried cream powder, with the appropriate amount of auxiliary materials mixing, granulates, drying, granulate, packing, promptly.

Claims

1, clear granule of a kind of calculus and preparation method is characterized in that:

(1) will write out a prescription in three the flavor be up to the standards respectively standby; Calculus grass, Herba Centipedae, Rhizoma Corydalis three flavors are respectively got 10% of recipe quantity and are ground into fine powder in the prescription, and surplus is ground into coarse powder/decoction pieces, decocts with water 2-3 time, each 1-3 hour, collecting decoction filtered, filtrate is condensed into thick paste, adds above-mentioned fine powder, mixing, drying is ground into fine powder, adds the appropriate amount of auxiliary materials mixing, granulate drying, granulate, packing, promptly.

(2) will write out a prescription in three the flavor be up to the standards respectively standby; Calculus grass, Herba Centipedae, Rhizoma Corydalis three flavors are respectively got 10% of recipe quantity and are ground into fine powder in the prescription, surplus is ground into coarse powder/decoction pieces, decocts with water collecting decoction 2-3 time, filter, the filtrate concentrate drying is made dried cream powder, adds above-mentioned fine powder and appropriate amount of auxiliary materials mixing, granulates, dry, granulate, packing, promptly.

(3) will write out a prescription in three the flavor be up to the standards respectively standby; Calculus grass, Herba Centipedae, Rhizoma Corydalis three flavors are ground into coarse powder/decoction pieces in the prescription, decoct with water 2-3 time, and collecting decoction filters, and the filtrate concentrate drying is made dried cream powder, with the appropriate amount of auxiliary materials mixing, granulate, and drying, granulate, packing, promptly.

2, clear granule of calculus according to claim 1 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, sucrose, steviosin, Aspartane, magnesium stearate, essence etc. uses.

3, clear granule of calculus according to claim 1 and preparation method is characterized in that: be ground into fine powder in the technology and be generally 80-160 purpose fine powder, the best is broken into 200-300 purpose fine powder for superfine powder.Being ground into coarse powder/decoction pieces in the technology was 5-40 purpose coarse powder/decoction pieces, was preferably to be ground into 10-20 purpose coarse powder.

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

5, clear granule of calculus according to claim 1 and preparation method is characterized in that: the relative density that is condensed into thick paste in the technology is 1.15-1.40 (80 ℃), and best relative density is 1.30-1.32 (80 ℃).

6, clear granule of calculus according to claim 1 and preparation method, it is characterized in that: drying can adopt drying under reduced pressure/spray drying in the technology.The drying under reduced pressure temperature is controlled at 50-90 ℃, and the best is 60 ℃.Spray drying is for to be condensed into the concentrated solution that relative density is 1.05-1.15 (60 ℃) with extracting solution, and spray drying, inlet temperature are 100-200 ℃, leaving air temp is 50-150 ℃, best relative density is 1.08-1.10 (60 ℃), and inlet temperature is 160 ℃, and leaving air temp is 100 ℃.Particle drying adopts drying under reduced pressure.

7, clear granule of calculus according to claim 1 and preparation method, it is characterized in that: on quality inspection standard, have the thin layer of Rhizoma Corydalis to differentiate that the limit examine of heavy metal, arsenic salt is arranged, the regulation heavy metal limit must not cross 10/1000000ths, and arsenic salt must not limit the quantity of 2/1000000ths.