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Slow-release film-coated premixed agent and preparation method thereof

A technology of film coating and premix, applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, etc., can solve the problems of complex operation methods, changing the speed of drug release, and the impossibility of film coating, etc., and the method is simple Convenience, controllability, and efficiency-enhancing effects

Active Publication Date: 2014-07-23
BEIJING YINGMAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In order to solve the problem that the above-mentioned film coating cannot change the drug release rate through the composition ratio, and control the release rate of various drugs by changing the film thickness, pore size and curvature Technical problem, the present invention discloses a film-coated premix that can meet the specific release rate requirements of various drugs only by changing the amount of ingredients, and also discloses the preparation method of this film-coated premix

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  • Slow-release film-coated premixed agent and preparation method thereof
  • Slow-release film-coated premixed agent and preparation method thereof

Examples

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Comparison scheme
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Embodiment 1

[0017] Embodiment 1: A kind of sustained-release film coating premix of the present invention comprises 80 parts of film-forming materials, 5 parts of talcum powder, 5 parts of glyceryl triacetate, and mass concentration is 5 parts of 99% ethanol, and the balance is purified Water, the above-mentioned ingredients are all in parts by mass, wherein the film-forming material includes cellulose derivatives and polyvinyl acetate, and the mass ratio of the two components in the film-forming material is 1 to 10:1, and different proportions can make The drug release rate is different. Various types of drugs can be selected according to the specific release rate required by themselves. According to the mass ratio between cellulose derivatives and ethyl acetate, talcum powder is used as an anti-adhesive agent in the premix , Glyceryl triacetate is used as a plasticizer.

[0018] The cellulose derivatives in the above-mentioned film-forming materials include esters of cellulose ethers. ...

Embodiment 2

[0022] Embodiment two: the formula of the sustained-release type film coating premix of the present invention comprises 55 parts of film-forming materials, 15 parts of talcum powder, 20 parts of glyceryl triacetate, and mass concentration is 6 parts of 99% ethanol, and the balance is For purified water, the above-mentioned ingredients are in parts by mass, wherein the film-forming material includes cellulose derivatives and polyvinyl acetate, and the mass ratio of the two components in the film-forming material is 1-10:1.

[0023] The cellulose derivatives in the above-mentioned film-forming materials include cellulose esters.

[0024] The above-mentioned cellulose esters commonly include any one or a mixture of any two or more of cellulose acetate, cellulose acetate butyrate, and cellulose acetate. The preparation method is the same as in Example 1.

[0025] Such as figure 1As shown, the drug release rate is controlled by changing the thickness of the film coating. Taking p...

Embodiment 3

[0027] Embodiment 3: The sustained-release film coating premix of the present invention includes 60 parts of film-forming materials, 20 parts of talcum powder, 6 parts of glyceryl triacetate, 10 parts of ethanol with a mass concentration of 99%, and the balance is purified water , the above-mentioned ingredients are all in parts by mass, wherein the film-forming material includes cellulose derivatives and polyvinyl acetate, and the mass ratio of the two components in the film-forming material is 1 to 10:1. Different proportions can make the drug The release speed is different, and the mass ratio between the cellulose derivative and polyvinyl acetate can be selected according to the specific release speed required by various kinds of drugs.

[0028] The cellulose derivatives in the film-forming material include cellulose ethers.

[0029] The above-mentioned cellulose ethers include any one or any two or any two of methyl cellulose, carboxymethyl cellulose, ethyl cellulose, hydr...

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Abstract

The invention discloses a slow-release film-coated premixed agent comprising the components in parts by mass: 55-85 parts of film-forming material, 5-20 parts of talcum powder, 5-20 parts of glycerol triacetate and 5-15 parts of ethanol with the mass concentration of 99%, wherein the film-forming material comprises a cellulose derivative and polyvinyl acetate in the mass ratio of (1-10):1. A preparation method of the premixed agent comprises the steps of (1) smashing the film-forming material at low temperature, mixing with the components by the mass part and the balance of purified water at normal temperature and stirring for 1h; (2) drying the mixture obtained in the step (1) at the temperature of 35-45 DEG C for 5h and carrying out sampling inspection; and (3) sieving the dried mixture obtained in the step (2) by using a 30-50-mesh sieve, and uniformly mixing for 60 minutes to obtain the premixed agent. The slow-release film-coated premixed agent disclosed by the invention has the advantage that the drug can be controlled to be regularly released through changing the mass ratio in the film-forming material; and the preparation method has the advantages that the polymer smashing efficiency can be increased and premixed agent grain and powder with proper granularity can be directly obtained.

Description

technical field [0001] The invention relates to the technical field of drug coating formulation and technology, in particular to a slow-release film coating premix and a preparation method thereof. Background technique [0002] Drug coating technology is one of the oldest and most commonly used methods in the production of pharmaceutical preparations. However, it has long been considered that coating is a technology rather than a science. Film coating technology was invented in 1930 and applied to the pharmaceutical industry in the 1950s. People have a new understanding of coating. With the development of polymer science, polymer materials with various properties have been introduced continuously. In this field, film coating technology has gradually matured and applied in the production of preparations. The promotion and application of film coating technology in my country started relatively late. In the 1980s, some large pharmaceutical companies in my country began to intr...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/38A61K47/32
Inventor 陈佩英
Owner BEIJING YINGMAO PHARMA