Enteric coated type thin membrane coated premixed agent and preparation method thereof

A film coating and premix technology, which is applied in the directions of pill delivery, sugar-coated pills, pharmaceutical formulations, etc., can solve the problems of difficult to evenly distribute the drug surface, poor coating film density, unreasonable mechanical parameters of the coating film, etc. The composition and its ratio are scientific and reasonable, easy to manage according to GMP standards, and the preparation method is simple and controllable.

Inactive Publication Date: 2005-06-22
成都市泰山药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Most of the existing various enteric-coating film coating premixes, due to the unreasonable selection of polymers or unreasonable composition ratios, some of them have too low viscosity after being formulated into coating slurry, resulting in the coating of solid pharmaceutical preparations The adhesion between the coating film of the finished product and the core of the drug is poor, and the surface of the finished product is worn, and the edge of the film is cracked or peeled off; some have too high viscosity, and it is easy to form larger droplets during the coating process, which is difficult to distribute evenly On the surface of the drug, there is a lot of aggregation on the surface of the drug to cause adhesion, and the density of the coating film is also p

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Example 1 Composition and preparation of enteric-coated colorless and transparent film coating premix 1

[0023] composition:

[0024] Hydroxypropyl methylcellulose phthalate: 70Kg; Polyacrylic resin No. II: 5Kg; Polyacrylic resin No. III: 5Kg; Povidone K-30: 8Kg; Polyethylene glycol 6000: 3Kg.

[0025] Preparation:

[0026] Take the various ingredients of the above weight, add them to the double-cone mixer, and start mixing for 1 hour to obtain 70 parts of hydroxypropyl methylcellulose phthalate, 5 parts of polyacrylic resin No. II, polyacrylic resin No. Enteric colorless transparent film coating premix with 5 parts of acrylic resin No. III, 8 parts of povidone K-30 and 3 parts of polyethylene glycol 6000.

Embodiment 2

[0027] Example 2 Composition and preparation of enteric-coated colorless and transparent film coating premix 2

[0028] composition:

[0029] Hydroxypropyl methylcellulose phthalate: 55Kg; Polyacrylic resin No. II: 15Kg; Polyacrylic resin No. III: 10Kg; Povidone K-30: 15Kg; Polyethylene glycol 6000: 7Kg.

[0030] Preparation:

[0031] Take the various ingredients of the above weight, add them to the double cone mixer, start the machine and mix for 10 minutes, and then you can get 55 parts of hydroxypropyl methylcellulose phthalate, 15 parts of polyacrylic resin No. II, polyacrylic resin No. Acrylic resin No. III is 10 parts, povidone K-30 is 15 parts and polyethylene glycol 6000 is 7 parts enteric colorless transparent film coating premix.

Embodiment 3

[0032] Example 3 Composition and preparation of enteric-coated colorless and transparent film coating premix 3

[0033] composition:

[0034] Hydroxypropyl methylcellulose phthalate: 60Kg; Polyacrylic resin No. II: 10Kg; Polyacrylic resin No. III: 15Kg; Povidone K-30: 12Kg; Polyethylene glycol 6000: 10Kg.

[0035] Preparation:

[0036] Take the various ingredients of the above weight, add them to the double cone mixer, start the machine and mix for 20 minutes, and then you can get 60 parts of hydroxypropyl methylcellulose phthalate, 10 parts of polyacrylic resin No. II, poly Acrylic resin No. III is an enteric colorless transparent film coating premix with 15 parts, povidone K-30 12 parts and polyethylene glycol 6000 10 parts.

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PUM

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Abstract

Disclosed is an enteric coated type thin membrane coated premixed agent and preparation method, which comprises intestine dissoluble cellulose derivative, intestine dissoluble acrylic resin derivative, polyethylene glycol 6000. The intestine soluble type thin film coated premix has advantages of low cost, simple process for manufacturing, thus fitting for mass production.

Description

technical field [0001] The invention relates to a film coating premix and a preparation method of the film coating premix. Background technique [0002] Film coating is to uniformly spray a layer of relatively stable polymer coating on the surface of solid pharmaceutical preparations by spraying to form a plastic film layer with a thickness of several microns. [0003] Enteric-coated film coating is suitable for the coating of drugs that do not dissolve in gastric juice but need to be dissolved in intestinal juice. The material must be insoluble or seldom dissolved when it encounters digestive juice such as gastric acid, so as to effectively avoid oral cavity, esophagus, stomach and other parts. Drug release, but does not affect the dissolution and dissolution time of the drug in intestinal juice. Commonly used materials for enteric film coating include enteric acrylic resin derivatives, enteric cellulose derivatives and enteric polyethylene derivatives. [0004] Most of t...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K9/28A61K47/38
Inventor 谢秀琼林志丹李文军
Owner 成都市泰山药业有限公司
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