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Enteric drug film coating premixture 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 very high technical requirements, uncertain reaction degree, and large restrictions, and achieve the reduction of active ingredients , improved food safety, good effect of chips

Active Publication Date: 2015-03-25
BEIJING YINGMAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Most of the existing drug film coating premixes are mainly chemical reagents. With the rapid development of science and technology, the safety of drug consumption has been paid more and more attention. Therefore, it is necessary to develop new safe ingredients as film coatings. Coating premixes, some edible polymer materials, such as polysaccharides, cellulose derivatives, etc., are constantly being introduced into this field, but there are generally two ways to obtain polymer materials: 1. Through complex chemical synthesis reactions to obtain Polymer materials with specific chemical properties. This method has the characteristics of high yield, sufficient source of raw materials, uncertain degree of reaction, and chemical residues. To apply such polymer materials to pharmaceutical excipients requires very high technological requirements.
2. Extract and refine materials to obtain polymer materials with certain chemical properties. This method has the characteristics of stable product performance and safety, but is limited by raw materials.
In addition, the vast majority of polymer synthetic materials are water-insoluble, which limits the use of film coating premixes made of polymer synthetic materials to exclude water when coating the solvent selected, and in actual production It is necessary to find a suitable method to apply this polymer synthetic material well in the field of film coating technology

Method used

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  • Enteric drug film coating premixture and preparation method thereof
  • Enteric drug film coating premixture and preparation method thereof
  • Enteric drug film coating premixture and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0019] Embodiment one: the enteric-coated drug film coating premix of the present invention, its composition comprises 40 parts of alginate, 20 parts of talcum powder, 20 parts of triethyl citrate, 5 parts of ethanol whose mass concentration is 99%, above-mentioned The parts are the parts by mass of each component in the premix.

[0020] The method for preparing the above drug film coating premix comprises the following steps, (1) mixing 40 parts of alginate, 20 parts of talcum powder, 20 parts of triethyl citrate, and 5 parts of ethanol with a mass concentration of 99%. Stirring, the above-mentioned parts all represent the mass parts of each component in the coating premix;

[0021] (2) Dry the mixture in the previous step. When the mass percentage of water in the mixture is ≤8%, it is qualified and enters the next step;

[0022] (3) Grind the dried mixture in step (2) until it can pass through a 50-mesh sieve. After sieving, mix it uniformly for 60 minutes to obtain a premi...

Embodiment 2

[0028] Embodiment two: a kind of drug film coating premix developed by the present invention, the premix includes 60 parts of alginate, 40 parts of talcum powder, 30 parts of triethyl citrate, 10 parts of 99% mass concentration For ethanol, the above-mentioned parts are the parts by mass of each component in the premix.

[0029] The premix also includes 10 parts by mass of silica gel, and the particle size of the silica gel is at least 320 mesh.

[0030] The method for preparing the above drug film coating premix comprises the following steps: (1) 60 parts of alginate, 40 parts of talcum powder, 30 parts of triethyl citrate, 10 parts of ethanol with a mass concentration of 99%, 10 parts The silica gel is mixed and stirred, and the above-mentioned parts represent the mass parts of each component in the coating premix;

[0031] (2) Dry the mixture in the previous step. When the mass percentage of water in the mixture is ≤8%, it is qualified and enters the next step;

[0032] (...

Embodiment 3

[0037] Embodiment 3: A kind of pharmaceutical film coating premix developed by the present invention comprises 50 parts of alginate, 30 parts of talcum powder, 25 parts of triethyl citrate, 8 parts of ethanol with a mass concentration of 99%, 5 parts of Titanium dioxide, the above-mentioned parts are the parts by mass of each component in the premix.

[0038] The premix also includes 20 parts by mass of silica gel, and the particle size of the silica gel is at least 320 mesh.

[0039] The method for preparing the above drug film coating premix comprises the following steps: (1) 60 parts of alginate, 40 parts of talcum powder, 30 parts of triethyl citrate, 10 parts of ethanol with a mass concentration of 99%, 20 parts of The silica gel is mixed and stirred, and the above-mentioned parts represent the mass parts of each component in the coating premix;

[0040] (2) Dry the mixture in the previous step. When the mass percentage of water in the mixture is ≤8%, it is qualified and...

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Abstract

The invention discloses an enteric drug film coating premixture which comprises the following components in parts by mass: 40-60 parts of algin, 20-40 parts of talcum powder, 20-30 parts of triethyl citrate and 5-10 parts of 99 wt% ethanol. The invention also discloses a method for preparing the premixture, which comprises the following steps: (1) mixing and stirring the raw materials; (2) drying the mixture, and sending the acceptable mixture to the next step when the water content in the mixture is less than or equal to 8 wt%; and (3) grinding the dried mixture in the step (2) until the mixture can pass through a 50-mesh sieve, screening, and uniformly mixing for 60 minutes to obtain the premixture. By replacing the original high molecular synthetic material with the pure plant extracted material, the edible safety of the drug coating is obviously enhanced.

Description

technical field [0001] The invention belongs to the technical field of preparation of finished medicines, in particular to an enteric-coated drug film coating premix and a preparation method thereof. Background technique [0002] Most of the existing drug film coating premixes are mainly chemical reagents. With the rapid development of science and technology, the safety of drug consumption has been paid more and more attention. Therefore, it is necessary to develop new safe ingredients as film coatings. Coating premixes, some edible polymer materials, such as polysaccharides, cellulose derivatives, etc., are constantly being introduced into this field, but there are generally two ways to obtain polymer materials: 1. Through complex chemical synthesis reactions to obtain Polymer materials with specific chemical properties. This method has the characteristics of high yield, sufficient source of raw materials, uncertain degree of reaction, and chemical residues. To apply such p...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/30A61K47/14
Inventor 陈佩英
Owner BEIJING YINGMAO PHARMA
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