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Chinese medical extractum dropping pill with food grade matrix and preparation method thereof

A food-grade, matrix technology, used in pharmaceutical formulations, pill delivery, medical preparations with non-active ingredients, etc., can solve the problems of excessive softening of the matrix, delamination, and uneven active ingredients in dropping pills, achieving qualified hardness, No toxic side effects, good mutual solubility effect

Inactive Publication Date: 2012-05-09
SHANGHAI INST OF TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Polyethylene glycol matrix has the advantages of low melting point, good pilling property, and fast disintegration speed, but there are still many insurmountable disadvantages at the same time, including: it can be complexed with some drugs such as benzoic acid, salicylic acid, tannic acid, etc. combined, resulting in excessive softening of the matrix; after melting and mixing with some traditional Chinese medicine extracts, stratification is easy to occur after standing, resulting in uneven active ingredients in dripping pills and unstable product quality; in addition, in chemically synthesized polyethylene glycol products Impurities ethylene glycol and diethylene glycol often remain, and their metabolites have certain nephrotoxicity

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Alcohol / water extract of salvia miltiorrhiza 10g, raffinose 30g.

[0027] Add the base raffinose to the salvia miltiorrhiza extract, stir and melt in a water bath at 85°C, and leave it to stand for no stratification, then drop it into the simethicone cooling liquid at 15°C at a rate of 20 drops / min at a temperature of 85°C, and wait for After forming and drying, it is tested according to the disintegration time limit inspection method of the Chinese Pharmacopoeia 2000 edition. The results show that the disintegration speed is fast, and it can pass through the sieve in an average of 2.51 minutes without a baffle.

Embodiment 2

[0029] Rhubarb water extract 10g, raffinose 10g, polyethylene glycol 5g.

[0030] Add the mixture matrix to the rhubarb extract, stir and melt in a water bath at 85°C, and leave it to stand without stratification, drop it into the simethicone cooling liquid at 15°C at a rate of 30 drops / min under heat preservation at 85°C, and wait until it is formed and dried Afterwards, it was tested according to the disintegration time limit inspection method of the Chinese Pharmacopoeia 2000 edition, and the results showed that the disintegration speed was fast, and it could pass through the sieve in an average of 3.32 minutes without a baffle.

Embodiment 3

[0032] Salvia miltiorrhiza water extract 7g, raffinose 3g, xylitol 28g, sucrose ester 2g.

[0033] Add the mixture matrix to the Danshen extract, stir and melt in a water bath at 95°C, no stratification after standing, drop into the simethicone cooling liquid at 15°C at a speed of 30 drops / min under heat preservation at 95°C, and wait for forming and drying Afterwards, it was tested according to the disintegration time limit inspection method of the Chinese Pharmacopoeia 2000 edition, and the results showed that the disintegration speed was fast, and it could pass through the sieve in an average of 3.67 minutes without a baffle.

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Abstract

The invention relates to a Chinese medical extractum dropping pill with food grade matrix and a preparation method thereof. The Chinese medical extractum dropping pill with food grade matrix comprises food grade matrix auxiliary material and Chinese medical extractum which are at proportion of 0.5-10:1 by weight. The preparation method includes the steps of material fusing, dropping preparation of the dropping pill, and drying of the dropping pill, wherein in the preparation process of the dropping pill, the fusing temperature of the matrix and the dropping preparation temperature are 65-100 DEG C, the cooling liquid used in the dropping preparation process of the dropping pill is simethicone or liquid paraffins, and the cooling temperature is 0-30 DEG C. The invention uses the food gradeauxiliary material to replace the chemical materials of polyethylene glycol and the like, which are always widely used, so the Chinese medical dropping pill prepared through the method is safe to take, has no toxic and side effects and is easier to be dissolved with drugs, cheap and easy to get. The dropping pill product produced through the method has qualified shape, is quick in disintegration speed and accords with the pharmacopoeia requirement of China.

Description

technical field [0001] The invention relates to a safe and non-toxic food-grade matrix Chinese medicinal extract dripping pill and a preparation method thereof. Background technique [0002] As a new type of preparation, dripping pills are not only widely used in pharmaceutical preparations, but also can be used to produce various new health foods and common foods. The emergence of solid dispersion technology, coating technology, inclusion technology, emulsification technology, and nanotechnology has promoted the continuous development and improvement of drop pill technology, but the research on the matrix excipients of drop pills has been stagnant. The current dropping pill matrix mainly adopts polyether products, and polyethylene glycol is the most widely used. Polyethylene glycol matrix has the advantages of low melting point, good pilling property, and fast disintegration speed, but there are still many insurmountable shortcomings at the same time, including: it can be ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K47/26A61K47/36A61K47/34A61K36/00A61K47/10
Inventor 鲁彦郭建宇
Owner SHANGHAI INST OF TECH
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