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Sustained-release film coating premix and preparation method thereof

A film-coating, sustained-release technology, applied in sugar-coated pills, pill delivery, pharmaceutical formulations, etc., can solve the problems of low barrier ability, softening, affecting drug storage and use, etc., to improve moisture-proof performance, improve color and luster. The effect of uniformity

Active Publication Date: 2022-05-20
BEIJING YINGMAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] When the sustained-release film coating is used in the preparation of traditional Chinese medicine ingredients, due to the strong hygroscopicity of the traditional Chinese medicine ingredients, and the resistance to water penetration after the ethyl cellulose film is formed is not high, it is easy to cause the overall hygroscopicity and softening of the medicine, affecting Storage and Administration of Medications

Method used

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  • Sustained-release film coating premix and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] Sustained-release film coating premix prepared by the following method:

[0053] S1. Add 1000g of ethyl cellulose, 500g of black fungus polysaccharide with a polysaccharide content of 50%, 35g of sodium caseinate and 3000g of water into the reaction kettle, heat and stir at 80°C for 4h, filter to obtain a solid, and put the solid in an oven at 50°C Drying for 1 h in the middle to obtain modified ethyl cellulose;

[0054] S2. 650g modified ethyl cellulose, 160g talcum powder, 30g dibutyl sebacate, 80g polyethylene glycol 6000 and 50g mass concentration obtained by S1 step are 95% ethanol at 18 ℃ and uniformly mixed into stirring Mixed solution, stirring the mixed solution for 1 hour, and then drying at 45°C for 4 hours to obtain the primary mixture;

[0055] S3. Add 30g of titanium dioxide and 20g of allure red aluminum lake to the initial mixture obtained in the S2 step, continue mixing for 1h at 18°C, then add to the grinder and grind for 4h, and then sieve the ground...

Embodiment 2

[0057] Sustained-release film coating premix prepared by the following method:

[0058] S1. Add 1000g ethyl cellulose, 500g black fungus polysaccharide with a polysaccharide content of 50%, 60g sodium caseinate and 4000g water into the reaction kettle, heat and stir at 90°C for 4h, filter to obtain a solid, and put the solid in an oven at 50°C Drying for 1 h in the middle to obtain modified ethyl cellulose;

[0059] S2. 750g modified ethyl cellulose, 80g magnesium stearate, 70g triethyl citrate, 100g polyethylene glycol 6000 and 80g mass concentration obtained by S1 step are mixed evenly at 24°C with 95% ethanol to form Stir the mixed solution, stir the mixed solution for 2 hours, and then dry at 35° C. for 6 hours to obtain the primary mixture;

[0060] S3. Add 30g titanium dioxide and 20g allure red aluminum lake to the primary mixture obtained in the S2 step, continue to mix at 24°C for 1h, then add to the grinder and grind for 4h, and then sieve the ground mixture with a ...

Embodiment 3

[0062] Sustained-release film coating premix prepared by the following method:

[0063] S1. Add 1000g of ethyl cellulose, 500g of black fungus polysaccharide with a polysaccharide content of 50%, 20g of sodium caseinate and 3000g of water into the reaction kettle, heat and stir at 85°C for 3h, filter to obtain a solid, and put the solid in an oven at 50°C Dry for 1h to obtain modified ethyl cellulose;

[0064] S2. 720g modified ethyl cellulose, 100g talcum powder, 60g dibutyl sebacate, 60g polyethylene glycol 6000 and 100g mass concentration obtained by S1 step are 95% ethanol at 30 ℃ and uniformly mixed into stirring Mixed solution, stirring the mixed solution for 1 hour, and then drying at 40°C for 5 hours to obtain the primary mixture;

[0065] S3. Add 20g of titanium dioxide and 10g of Allura red aluminum lake to the initial mixture obtained in step S2, continue to mix at 30°C for 0.5h, then add it to a grinder and grind for 5h, and then sieve the ground mixture to a sieve....

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Abstract

The application relates to the field of pharmaceutical coating preparation, and specifically discloses a slow-release film coating premix and a preparation method thereof. Sustained-release film coating premix, made of raw materials containing the following parts by weight: modified ethyl cellulose, lubricant, plasticizer, porogen, filler, colorant and solvent; modified ethyl cellulose Cellulose is prepared from ethyl cellulose, black fungus polysaccharide, sodium caseinate and water; the preparation method is: add ethyl cellulose, black fungus polysaccharide and sodium caseinate to water, heat and stir, and filter to obtain a solid. drying to obtain modified ethyl cellulose; uniformly mixing the modified ethyl cellulose, lubricant, plasticizer, porogen and solvent, and then drying to obtain a primary mixture; Add a covering agent and a coloring agent, continue to mix, grind, and finally mix again to obtain a sustained-release film coating premix. The slow-release film coating premix of the present application has the advantage of improving the moisture-proof performance of the slow-release film coating.

Description

technical field [0001] The present application relates to the field of drug coating preparation, more specifically, it relates to a slow-release film coating premix and a preparation method thereof. Background technique [0002] Sustained-release preparations refer to preparations that slowly release drugs in water or in some special media. They can be applied to various routes of administration and made into various pharmaceutical dosage forms. With the accuracy and precision of people's drug effects With the improvement of requirements, sustained-release preparations have become a research hotspot in recent years. Sustained-release preparations have the advantages of reducing the number of doses, facilitating long-term medication for patients, allowing the drug to be slowly absorbed at an appropriate rate, and reducing the toxic and side effects of the drug. [0003] In sustained-release preparations, the sustained-release film coating is the main sustained-release functio...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/38A61K47/36A61K9/36
CPCA61K47/38A61K47/36A61K9/2866
Inventor 陈佩英
Owner BEIJING YINGMAO PHARMA