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Film-coating premixing auxiliary material and preparation method thereof

A technology of premixed excipients and film coating, which is applied in pharmaceutical formulations, drug delivery, etc., can solve problems such as increased costs and environmental protection, and achieve the effects of improving moisture resistance, strong flexibility, and overcoming internal stress

Active Publication Date: 2010-04-07
浙江瓯伦包衣技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although its moisture resistance and crack resistance are slightly better, the film coating agent is alcohol-soluble, which is not environmentally friendly and increases the cost

Method used

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  • Film-coating premixing auxiliary material and preparation method thereof
  • Film-coating premixing auxiliary material and preparation method thereof
  • Film-coating premixing auxiliary material and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] 1. Proportion:

[0029] Hydroxypropyl methylcellulose 20wt%, polyvinylpyrrolidone vinyl acetate copolymer (6:4) 15wt%, polyvinyl alcohol polyethylene glycol copolymer 15wt%, methacrylic acid-ethyl acrylate copolymer (1: 1) 5wt%, polyethylene glycol 400012wt%, talcum powder 15wt%, titanium dioxide 18wt%.

[0030] 2. Preparation method:

[0031] (1) Premixing: Add the above materials to a multi-directional motion mixer and mix for 10 minutes;

[0032] (2) fine mixing: the material mixed through step (1) is added to the grinding mixer, and mixed for 5 minutes;

[0033] (3) Final mixing: Add the material mixed in step (2) into a multi-directional motion mixer and mix for 22 minutes to obtain a film coating premixed auxiliary material that is finally mixed uniformly.

Embodiment 2

[0035] 1. Proportion:

[0036] Hydroxypropyl methylcellulose 35wt%, polyvinylpyrrolidone vinyl acetate copolymer (6:4) 10wt%, polyvinyl alcohol polyethylene glycol copolymer 3wt%, methacrylic acid-ethyl acrylate copolymer (1: 1) 10wt%, polyethylene glycol 600010wt%, talcum powder 12wt%, titanium dioxide 15.8wt%, fruit green aluminum lake 4.2wt%.

[0037] 2. Preparation method:

[0038] (1) Premixing: Add the above materials to a multi-directional motion mixer and mix for 30 minutes;

[0039] (2) fine mixing: the material mixed through step (1) is added to the grinding mixer, and mixed for 7 minutes;

[0040] (3) Final mixing: Add the material mixed in step (2) into a multi-directional motion mixer and mix for 15 minutes to obtain a film coating premixed auxiliary material that is finally mixed uniformly.

Embodiment 3

[0042] 1. Proportion:

[0043] Hydroxypropyl methylcellulose 50wt%, polyvinylpyrrolidone vinyl acetate copolymer (6:4) 7wt%, polyvinyl alcohol polyethylene glycol copolymer 8wt%, methacrylic acid-ethyl acrylate copolymer (1: 1) 2wt%, polyethylene glycol 40008wt%, talcum powder 9wt%, brown iron oxide 16wt%.

[0044] 2. Preparation method:

[0045] (1) Premixing: Add the above materials to a multi-directional motion mixer and mix for 15 minutes;

[0046] (2) Fine mixing: add the mixed material in step (1) to the grinding mixer, and mix for 1 minute;

[0047] (3) Final mixing: Add the material mixed in step (2) into a multi-directional motion mixer and mix for 20 minutes to obtain a film coating premixed auxiliary material that is finally mixed uniformly.

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Abstract

The invention relates to a film-coating premixing auxiliary material which mainly comprises hydroxypropyl methylcellulose, polyvinylpyrrolidone-vinyl acetate copolymer (6:4), polyvinyl alcohol-polyethylene glycol copolymer, methacrylic acid-ethyl acrylate copolymer (1:1), polyethylene glycol, talcum powder and a colorant. The film-coating premixing auxiliary material has the advantages of favorable dampproof and anti-cracking properties, can disintegrate at a suitable time and uses water as dissolvent.

Description

technical field [0001] The invention relates to a film-coating premixed auxiliary material and a preparation method thereof, more specifically, to an aqueous gastric-soluble film-coated premixed auxiliary material and a preparation method thereof. Background technique [0002] On the surface of oral solid preparations such as tablets, evenly spray a layer of relatively stable polymer coating material by spraying to form a plastic film layer with a thickness of several microns to tens of microns, so as to achieve a certain expected effect. The process is called film coating. The material used for film coating can be a single polymer or an aqueous dispersion of some polymers, but most of them are premixed auxiliary materials for film coating produced by professional manufacturers. Film-coating premixed excipients are a new form of pharmaceutical excipients that are pre-mixed uniformly by a variety of single excipients according to a certain formula ratio and a certain product...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08L1/28C08L33/02C08L87/00A61K9/32
Inventor 邱湘龙黄建国王小伦
Owner 浙江瓯伦包衣技术有限公司
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