CN100415269C

CN100415269C - Method for preparing cow-bezoar snake bile Sichuan fritillary bulb dispersive tablet

Info

Publication number: CN100415269C
Application number: CNB021542007A
Authority: CN
Inventors: 毛友昌
Original assignee: Individual
Current assignee: Individual
Priority date: 2002-12-30
Filing date: 2002-12-30
Publication date: 2008-09-03
Anticipated expiration: 2022-12-30
Also published as: CN1425427A

Abstract

The present invention relates to a method for preparing dispersive tablets with bezoar, snake bile and fritillaria cirrhosa, which is characterized in that fritillaria cirrhosa in the components of the dispersive tablets is prepared with a pulverization /ultramicro-pulverization method and is reserved; snake bile is concentrated into a liquid extract with definite relative density through a film and is reserved / is dried into dry extract powder and is reserved; then the materials reserved, bezoar and supplementary materials are put together according to the prescription requirement of the national pharmacopoeia. Finally the materials are processed through preforming and cover coating, and the complete set of the preparation method is completed. The dispersive tablets are prepared by reforming the existing preparation forms, and have better preservation of active substances in snake bile. On the aspect of quality standards, the detection of heavy metal and arsenic salt is added, and the main medicine of fritillaria cirrhosa is quantified, so the quality control standards of products are greatly improved. Furthermore, the present invention has quick disintegration and good mouth feel, not only is suitable for adults, but also is more suitable for children and old people, is a safe stable effective medicine, and is an ideal product for modern medicine preparation enterprises.

Description

Bezoar-shake bile-fritillary dispersible tablet and preparation method

Technical field

This invention relates to the processing technology technical field of Chinese patent medicine tablet, relates in particular to bezoar-shake bile-fritillary dispersible tablet and preparation method.

Background technology

Tablet is a kind of pharmaceutical formulation commonly used; according to the relevant drug act of China; change dosage form as a kind of new drug research, the existing bezoar-shake bile-fritillary of former dosage form looses, bezoar-shake bile-fritillary capsule and bezoar-shake bile-fritillary oral liquid and all listed Drug Standard of Ministry of Public Health of the Peoples Republic of China or new drug in and become a full member in the standard.The technology features of former powder, two kinds of dosage forms of capsule is that the whole medical materials (three flavors) in the prescription are to form through direct pulverizing packing.Oral liquid is that the prescription Chinese crude drug is formed through fill through suitably extracting the refining correctives that adds.Though powder has clothes backs performance to make fast advantage, its divided dose is inaccurate, takes that to be inconvenient to be the big defective of one; Though capsule has solved the divided dose problem, exist dose big equally, and the capsule prolonged disintegration, influence shortcomings such as drug effect plays a role rapidly.Powder and capsule children taking difficulty, oral liquid has solved the difficulty of children, but oral liquid has lost some composition for solution clears up problems in preparation process, and production cost is higher relatively, carries, transports also difficulty relatively.Simultaneously powder, capsule and oral liquid all exist in the processing technology quality standard controlling index low, detect data and wait the significant drawbacks that influences quality less.All have the significant drawback that influences quality based on powder, capsule and oral liquid, we use the modern pharmaceutical technology this product technology are made significant improvement, form new preparation, guarantee the quality monitoring of product, improve drug effect, benefit the common people.

Summary of the invention

The purpose of this invention is to provide a kind of bezoar-shake bile-fritillary dispersible tablet and preparation method, improve the quality of products and curative effect, increase the stability of product, satisfy needs of medical treatment better.

The objective of the invention is such realization:

Bezoar-shake bile-fritillary dispersible tablet and preparation method comprise the steps:

One, the prescription of bezoar-shake bile-fritillary dispersible tablet is formed

Calculus Bovis 8-16g Fel Serpentis 40-81g Bulbus Fritillariae Cirrhosae 240-500g

Right amount of auxiliary materials is made 1000 altogether.

Its optimum formula is: Calculus Bovis 16g, Fel Serpentis 81g, Bulbus Fritillariae Cirrhosae 484g

Right amount of auxiliary materials is made 1000 altogether.

Two, bezoar-shake bile-fritillary dispersible tablet preparation technology

Technology one is tested three flavor medicine inspections qualified standby; Bulbus Fritillariae Cirrhosae powder is broken into fine powder and becomes fine powder with Fel Serpentis mixing, crushed after being dried, adds Calculus Bovis and right amount of auxiliary materials, and mixing adds right amount of auxiliary materials again and granulates, and drying adds right amount of auxiliary materials, mixing, and tabletting, coating, quality inspection, packing, promptly.

Technology two is tested three flavor medicine inspections qualified standby; Fel Serpentis is concentrated into the Fel Serpentis fluid extract of relative density 1.05-1.15 (50 ℃); Bulbus Fritillariae Cirrhosae powder is broken into fine powder and adds Calculus Bovis and right amount of auxiliary materials mixing, adds above-mentioned Fel Serpentis fluid extract mixing, granulation, and drying adds the right amount of auxiliary materials mixing, tabletting, and coating, quality inspection, packing, promptly.

Technology three is tested three flavor medicine inspections qualified standby; The Fel Serpentis fluid extract that Fel Serpentis is concentrated into relative density 1.03-1.15 (50 ℃) is standby; Dry then and Bulbus Fritillariae Cirrhosae mixed powder is broken into fine powder, adds the Calculus Bovis mixing, adds right amount of auxiliary materials, and mixing adds right amount of auxiliary materials again and granulates, and drying adds the right amount of auxiliary materials mixing, tabletting, and coating, quality inspection, packing, promptly.

Three, be Film coated tablets by technology one, two, three, prepared tablet, its film-coat material all adopts stomach dissolution type film-coat pre-mixing agent (Opadry).

Added adjuvant before granulating in the technology: 5-20% microcrystalline Cellulose, 3-10% low-substituted hydroxypropyl cellulose, 1-5% carboxymethylstach sodium, 1-2% Aspartane, 2-10% polyvinylpolypyrrolidone, optimum amount is: 15% microcrystalline Cellulose, 6% low-substituted hydroxypropyl cellulose, 3% carboxymethylstach sodium, 1.2% Aspartane, 5% polyvinylpolypyrrolidone.The consumption of added adjuvant and concentration during granulation: 2-10% 30 POVIDONE K 30 BP/USP ₃₀, be made into the alcoholic solution of 5-12%.Optimum amount and concentration are: 6% 30 POVIDONE K 30 BP/USP ₃₀, be made into 8% alcoholic solution; Added adjuvant and consumption before the tabletting: 0.5-3% micropowder silica gel, 1-5% carboxymethylstach sodium, 0.1-5% Herba Menthae essence.Optimum amount is: 0.5% micropowder silica gel, 1% carboxymethylstach sodium, 0.3% Herba Menthae essence.

Being ground into fine powder in the technology was that 80-160 purpose fine powder or superfine powder are broken into 200-300 order fine powder.

The Fel Serpentis method for concentration can adopt concentrating under reduced pressure or thin film concentration in the technology.

The relative density of Fel Serpentis fluid extract is 1.05-1.15 (50 ℃) in the technology two, and best relative density is 1.12 (50 ℃).

The relative density of Fel Serpentis fluid extract is 1.03-1.15 (50 ℃) in the technology three, and best relative density is 1.05 (50 ℃).The drying means of Fel Serpentis fluid extract can adopt spray drying or lyophilization.

This invention its superiority compared with the prior art is: reduce dose remaining with under the effective substance prerequisite, stability is much improved, effect duration can reach more than 2 years, quality standard has increased the limit detection of heavy metal, arsenic salt on the original basis, Bulbus Fritillariae Cirrhosae quantitatively, make the quality of product and curative effect that assurance arranged.The product disintegrate is fast, easily absorb, mouthfeel is good, child, old people's taking convenience, thus accomplished safety, stable, effectively.

The specific embodiment

The optimum implementation of this invention is: according to testing three flavor medicine inspections qualified standby; Fel Serpentis is concentrated into the Fel Serpentis fluid extract of relative density 1.05-1.15 (50 ℃); Bulbus Fritillariae Cirrhosae powder is broken into fine powder and adds Calculus Bovis and right amount of auxiliary materials mixing, adds above-mentioned Fel Serpentis fluid extract mixing, granulation, and drying adds the right amount of auxiliary materials mixing, tabletting, and coating, quality inspection, packing, promptly.

Claims

1. the preparation method of bezoar-shake bile-fritillary dispersible tablet, described bezoar-shake bile-fritillary dispersible tablet is prepared by following Chinese medicine raw materials by weight proportion: Calculus Bovis 8-16g, Fel Serpentis 40-81g, Bulbus Fritillariae Cirrhosae 240-500g, and this Chinese medicine raw materials by weight proportion can prepare 1000; It is characterized in that may further comprise the steps:

(1) Bulbus Fritillariae Cirrhosae in the prescription adopts that to be ground into 80-160 purpose fine powder standby;

(2) Fel Serpentis in the prescription adopts thin film concentration to relative density under 50 ℃ condition to be: 1.05-1.15, Fel Serpentis are that to adopt spray drying/lyophilization to make the Fel Serpentis extract powder standby;

(3) Calculus Bovis in the prescription adopts directly in the input Bulbus Fritillariae Cirrhosae fine powder in mixing/Fel Serpentis extract powder mixing in mixing/Fel Serpentis granule;

(4) supplementary product consumption before granulation in the prescription: 5-20% microcrystalline Cellulose, 3-10% low-substituted hydroxypropyl cellulose, 1-5% carboxymethylstach sodium, 1-2% Aspartane, 2-10% polyvinylpolypyrrolidone, adjuvant during granulation and consumption and concentration: 2-10% 30 POVIDONE K 30 BP/USP ₃₀Be made into the alcoholic solution of 5-12%, adjuvant and consumption before the tabletting: 0.5-3% micropowder silica gel, 1-5% carboxymethylstach sodium, 0.1-5% Herba Menthae essence;

(5) coating material of tablet adopts stomach dissolution type film-coat pre-mixing agent;

(6) the standby material of (1), (2), (3), (4), (5) is converted by the prescription consumption of state-promulgated pharmacopoeia requirement feed intake, mixing, granulation, drying, tabletting, bag film-coat, quality inspection, packing make the bezoar-shake bile-fritillary dispersible tablet.

2. it is standby that the Bulbus Fritillariae Cirrhosae during the preparation method of bezoar-shake bile-fritillary dispersible tablet according to claim 1 is characterized in that writing out a prescription is that superfine powder is broken into 200-300 order fine powder.

3. it is that 1.12 Fel Serpentis fluid extract is standby under 50 ℃ condition that Fel Serpentis during the preparation method of bezoar-shake bile-fritillary dispersible tablet according to claim 1 is characterized in that writing out a prescription adopts thin film concentration to relative density.

4. the adjuvant during the preparation method of bezoar-shake bile-fritillary dispersible tablet according to claim 1 is characterized in that writing out a prescription added adjuvant and consumption before granulation are: 15% microcrystalline Cellulose, 6% low-substituted hydroxypropyl cellulose, 3% carboxymethylstach sodium, 1.2% Aspartane, 5% polyvinylpolypyrrolidone.

5. added adjuvant and consumption and concentration were when the preparation method of bezoar-shake bile-fritillary dispersible tablet according to claim 1 is characterized in that granulating: 6% 30 POVIDONE K 30 BP/USP ₃₀Be made into 8% alcoholic solution.

6. the preparation method of bezoar-shake bile-fritillary dispersible tablet according to claim 1 is characterized in that preceding added adjuvant of tabletting and consumption are: 0.5% micropowder silica gel, 1% carboxymethylstach sodium, 0.5% Herba Menthae essence.