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A kind of enteric polymer film and preparation method thereof

An enteric-coated polymer and polymer technology are applied in the direction of pharmaceutical formulations and medical preparations of non-active ingredients, etc., and can solve problems such as the mixed use of vitamin E and acrylic enteric-coated polymers, and the lack of enteric-coated coatings. , to achieve the effect of good plasticizing effect and huge economic and social value

Active Publication Date: 2017-02-15
ZHEJIANG UNIV OF TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

So far, no material has been published: vitamin E is compatible with acrylic polymers, so vitamin E has never been mixed with acrylic enteric polymers
In addition, there is no material disclosed so far: Vitamin E can be prepared using conventional polar solvents as dispersion media, or using conventional coating pans and fluidized beds to prepare coating films containing vitamin E, not to mention the preparation of enteric coatings.

Method used

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  • A kind of enteric polymer film and preparation method thereof
  • A kind of enteric polymer film and preparation method thereof
  • A kind of enteric polymer film and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Example 1: The mixture of vitamin E acetate: vitamin E succinic acid polyethylene glycol 1000=1:1 is used as plasticizer, the total amount of plasticizer is 10% of the polymer content, and the polymer is acrylic resin No. 1 , dissolve in pure water, add lye, mix evenly, and make an aqueous dispersion with a polymer mass fraction of 20%. The pellets were coated at 30-50°C with a fluidized bed bottom spray coating device, and the weight gain of the coating was 15%. The packaged pellets were evaluated for acid resistance according to the Pharmacopoeia method. After 2 hours, the film was complete and the acid resistance was qualified.

Embodiment 2

[0039] Embodiment 2: Take the vitamin E acetate of 15% polymer content as plasticizer, polymer is acrylic resin No. Ⅱ, be dissolved in the ethanol solution of 75%, mix uniformly, be dubbed as polymer mass fraction is 10% Organic coating solution. The coating device is a high-efficiency rotary coating pan, which is coated at 40-50 °C, and the weight gain of the coating is 8%. The packaged tablet was evaluated for acid resistance according to the Pharmacopoeia method. After 2 hours, the film was complete and the acid resistance was qualified.

Embodiment 3

[0040] Embodiment 3: with the vitamin E acetate of 10% polymer content as plasticizer, polymer is acrylic resin No. Ⅱ, is dissolved in 50% acetone solution, mixes evenly, is made into the organic compound that polymer mass fraction is 10%. Coating solution. The coating device is a high-efficiency rotary coating pan, which is coated at 40-50 ° C, and the weight gain of the coating is 9.5%. The packaged tablet was evaluated for acid resistance according to the Pharmacopoeia method. After 2 hours, the film was complete and the acid resistance was qualified.

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Abstract

The invention relates to an enteric polymer coating film and a preparation method thereof. The enteric polymer coating film comprises one or more plasticizers and one or more polymers. The one or more plasticizers are selected from vitamins E, the one or more polymers are selected from acrylic resin I, acrylic resin II and acrylic resin III, the use mass of the one or more plasticizers is 2-15% total mass of the one or more polymers, and the vitamins E are vitamin E and its esters and comprise fat soluble vitamin E and water-soluble vitamin E. The preparation method utilizes the vitamins E as the plasticizers and solves the problem that in existing enteric coating production, less types of plasticizers are used and toxicity is large. The invention discloses a compounding scheme adopting vitamins E as plasticizers and improves enteric coating film-forming properties and ductility.

Description

technical field [0001] The invention relates to an enteric polymer coating film and a preparation method thereof, and belongs to the field of pharmaceutical preparation coating. Background technique [0002] The enteric polymer material has good acid resistance, which can ensure that the enteric coating preparation does not release drugs in the stomach, and releases drugs rapidly in the intestine. However, the plasticity and ductility of enteric polymer materials are poor, and a certain amount of plasticizer needs to be added during coating to improve the film-forming properties of the coating solution and ensure that the coating film has a certain degree of ductility to prevent rupture. Phthalate is currently the most commonly used plasticizer, and it is also a legal plasticizer in the Pharmacopoeia, but it is also an environmental estrogen, which is harmful to human health and causes ecological environment pollution. In addition, its dispersibility in water is not good, a...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/32A61K47/22
Inventor 单伟光屠凌翔杨燕孙支钢唐岚张晨芳
Owner ZHEJIANG UNIV OF TECH