Traditional Chinese medicine prescription granule preparation by melted extrusion method

A traditional Chinese medicine formula granule, melt extrusion technology, applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problems of complex process route, unstable quality, short production cycle, etc. , to achieve the effect of simple and easy process, reduced drying process and adjustable extrusion force

Inactive Publication Date: 2010-03-17
JIANGYIN TIANJIANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] (1) For the traditional Chinese medicine extract powder with strong hygroscopicity, wet granulation technology is used to prepare granules. The granules are prone to sticking, strip-shaped soft materials, sticking nets, etc., and the produced granules are too hard and poor in solubility, resulting in unstable quality;
[0006] (2) Drug powders containing moisture-sensitive ingredients are prone to degradation when exposed to water, and are not suitable for wet granulation;
[0007] (3) The process route is complicated, the energy consumption is high, and water or other organic solvents are often added in the granulation process, which requires heating and drying, and the production cycle is long
The dry granulation process has a short production cycle and high production efficiency. For traditional Chinese medicine varieties with poor viscosity of extract powder, including fatty oil, fruit seeds and rhizomes with high starch content, and some flowers, grasses and skins, etc. In the process of dry granulation, the granules have a low molding rate at one time, and need to be repeatedly extruded under high pressure, so the production efficiency is very low, and the color of the drug or the active ingredient changes due to repeated extrusion, and the solubility becomes poor.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Take 1000g of pinellia extract powder, add 200g of polyethylene glycol 6000 (particle size is 60 mesh), after fully mixing, place in an electric oven at 100°C, heat for 30 minutes, place in an extrusion granulator, pass 25 Mesh sieve, extrusion granulation, and then pass through a 20 mesh sieve for granulation, that is, the Chinese medicine formula granules of Pinellia pinellia are obtained. The granules have good fluidity, solubility and moisture resistance.

Embodiment 2

[0033] Take Phellodendron Phellodendri extract powder 1000g, add 150g glycerol monostearate (particle size is 80 mesh), after fully mixing, place in 80 ℃ electric oven, heat for 10 minutes, take out and pour into extrusion granulator, stir , cooled, passed through a 25-mesh sieve for granulation, and made Phellodendron traditional Chinese medicine formula granules, which have good fluidity, solubility and moisture resistance.

Embodiment 3

[0035] Take 1000g of peach kernel extract powder, add 300g of beeswax (particle size is 100 mesh), mix thoroughly, place in a tank mixer with heating layer, heat for 120 minutes, spray a small amount of absolute ethanol into the mixture Solution, and then the mixture is placed in an extrusion granulator with a screen of 25 mesh, extruded and granulated, cooled, passed through a 20-mesh screen for granulation, and the granules of the Chinese medicine formula are obtained, and the granules have good fluidity. , Solubility and moisture resistance.

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PUM

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Abstract

The invention relates to a melted extrusion method for preparing traditional Chinese medicine prescription granules, comprising the following steps: using an auxiliary material with a low melting point as a binding agent and evenly mixing with traditional Chinese medicine extract powder according to a certain ratio; placing the mixture in an extrusion pelletiser to prepare into granules in the extrusion process; straightening granules after cooling to obtain the traditional Chinese medicine prescription granules, wherein 40-70 DEG C is preferably used as the melting point or melting range of the low melting point auxiliary material; and the dosage ratio of the auxiliary material accounts for 10-40% of the total weight of the auxiliary material to the traditional Chinese medicine extract powder. The invention has higher molding efficiency, avoids the phenomena such as change of medicine tincture and active ingredients caused by repeated extrusion, weakened dissolubility and the like, thus especially being suitable for traditional Chinese medicine extract powder with poor viscosity and varieties such as fruit and seeds containing high fatty oil and starch, roots and tubers, parts offlowers and plants, leather and the like. The granules prepared by the invention have fine mobility, compressibility and dissolubility, and the granules prepared by using hydrophobic auxiliary materials have lower hygroscopicity.

Description

(1) Technical field [0001] The invention relates to a method for preparing traditional Chinese medicine formula granules, in particular to a melt extrusion method for preparing traditional Chinese medicine formula granules. It is suitable for traditional Chinese medicine varieties with poor viscosity of extract powder, including fatty oil, fruit seeds and rhizomes with high starch content, and some flowers, grasses and bark, etc. It belongs to the technical field of traditional Chinese medicine oral preparations. (2) Background technology [0002] Traditional Chinese medicine formula granules are traditional Chinese medicine granules made from traditional Chinese medicine decoction pieces by extraction, decompression concentration, drying and other methods. It can not only be used by clinicians to formulate prescriptions flexibly, but also can be used as raw materials for the production of traditional Chinese medicine preparations such as Chinese patent medicines. [0003]...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/00A61K9/16A61K47/34A61K47/44A61K47/10A61K47/14
Inventor 陈盛君周嘉琳王玉玺过科家王元清
Owner JIANGYIN TIANJIANG PHARMA
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