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A kind of preparation method of premixed auxiliary material

A technology of premixing excipients and suspensions, which is applied in the field of biomedicine to achieve the effects of high yield, shortened production cycle, and increased yield

Active Publication Date: 2018-01-05
HUNAN ER KANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Another object of the present invention is to provide a premixed auxiliary material, which is applied to starch soft capsules and starch empty capsules, which overcomes the cumbersome procedures of selecting the types of auxiliary materials, dosage ratios, etc. one by one in the preparation of existing capsules, Save production cost and time, suitable for large-scale industrial production

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Add 60 parts of hydroxypropyl starch, 15 parts of corn starch, and 0.5 parts of microcrystalline cellulose into deionized water, stir at 25°C for 0.5 hours and keep warm for 0.5 hours to obtain a suspension of premixed auxiliary materials; then premixed auxiliary materials Put the suspension into freeze-drying, the freezing temperature is -60°C, and the absolute pressure is 4Pa, and the premixed auxiliary material can be obtained after freeze-drying.

Embodiment 2

[0023] Add 70 parts of hydroxypropyl starch, 20 parts of corn starch, and 1 part of microcrystalline cellulose into deionized water, stir at 25°C for 1 hour and keep it warm for 1 hour to obtain a suspension of premixed auxiliary materials; then premixed auxiliary materials The suspension is put into freeze-drying, the freezing temperature is -40°C, and the absolute pressure is 6Pa, and the premixed auxiliary material can be obtained after freeze-drying.

Embodiment 3

[0025] Add 80 parts of hydroxypropyl starch, 30 parts of corn starch, and 2 parts of microcrystalline cellulose into deionized water, stir at 25°C for 2 hours and keep warm for 2 hours to obtain a suspension of premixed auxiliary materials; then premixed auxiliary materials The suspension is put into freeze-drying, the freezing temperature is -30°C, and the absolute pressure is 8Pa, and the premixed auxiliary material can be obtained after freeze-drying.

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PUM

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Abstract

The invention discloses a preparation method of a premixed auxiliary material, comprising the following steps: (1) preparing a premixed auxiliary material suspension: adding hydroxypropyl starch, starch, microcrystalline cellulose, and a colorant to deionized water, and Stir at 25°C for 0.5-3 hours to obtain a suspension of the premixed excipients; (2) put the suspension prepared in step (1) into a freeze dryer, and freeze-dry to obtain the premixed excipients. The advantages of the present invention are that the operation steps are simple, convenient and controllable, the shelf life is long, the color and smell of its auxiliary materials can be well maintained by the freeze-drying method, and the tissue is porous and fragile, the rehydration ability is good, and the loss of production is small. At the same time, it was found that this method optimized the indicators of disintegration performance, water retention performance and formability. In addition, the premixed auxiliary material can be prepared into soft and hard capsules after adding an appropriate amount of deionized water to form a glue solution, the production cycle is greatly shortened, the production process is simple, the product quality is improved, and the yield is greatly increased.

Description

technical field [0001] The invention relates to a preparation method of a premixed auxiliary material, which belongs to the field of biomedicine. Background technique [0002] Premixed auxiliary materials are pre-mixed with various single auxiliary materials in a certain proportion and with a certain production process to become a new auxiliary material with specific functions and uniform appearance. Moreover, depending on the production process, most of the premixed excipients only undergo changes in physical form without chemical reactions. Each of the single excipients maintains the original chemical properties, so its toxic side effects and safety are all important. Nothing has changed. Among them, the common production processes of premixed excipients include simple mixing, co-drying, spray drying or co-precipitation. In recent years, premixed excipients have been widely used, mainly in film coating preparations. A complete film coating material mainly includes polyme...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/36A61K9/48A61K47/38
Inventor 帅放文王向峰章家伟
Owner HUNAN ER KANG PHARMA