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Quality control method for Chinese medicine preparation

A quality control method and preparation technology, applied in the directions of pharmaceutical formulation, drug combination, drug delivery, etc., can solve the problems of difficult product quality control, lack of component content determination, affecting product production and quality assurance, etc.

Inactive Publication Date: 2006-11-08
GUIZHOU YIBAI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The children's lung-clearing and phlegm-removing preparation of the present invention is a kind developed through reform on the basis of the original dosage form ("Chinese Medicine Prescription" Xiaoer Qingfei-resolving phlegm oral liquid issued by the Ministry), and the existing children's lung-clearing and phlegm-resolving preparation has the quality The control method is backward and the product quality is not easy to control.
It shows that the method of identifying the medicinal materials contained in the preparation is not complete, and it lacks the content of content determination of its ingredients
Therefore, the existing quality control methods cannot effectively control the quality of Xiaoer Qingfei Huatan preparation, which will affect the production and quality assurance of products.

Method used

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  • Quality control method for Chinese medicine preparation
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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0107] The quality control of embodiment 1 children's Qingfei Huatan decoction (ointment)

[0108] The quality control method of the present invention comprises the following steps:

[0109] The observation of traits, the steps are:

[0110] 【Properties】This product is a decoction (ointment), the content is yellow to yellow-brown semi-fluid; sweet, slightly bitter.

[0111] Content identification, the steps are:

[0112] [Identification] (1) Take 10g of this product, add 10ml of water to dissolve, add 0.5ml of concentrated ammonia test solution, add 20ml of ether, shake and extract, separate the ether layer, evaporate to dryness, add 1ml of methanol to the residue to dissolve, and use it as the test sample solution. Take another ephedrine hydrochloride reference substance, add methanol to make a solution containing 0.5mg per 1ml as the reference substance solution. Test according to thin-layer chromatography (Appendix VI B, Chinese Pharmacopoeia, 2005 Edition), draw 10 μl ...

Embodiment 2

[0122] Example 2 Quality Control of Xiaoer Qingfeihuatan Granules

[0123] The quality control method of the present invention comprises the following steps:

[0124] The observation of traits, the steps are:

[0125] 【Properties】This product is a granule, the content is yellow to yellow-brown granules; sweet, slightly bitter.

[0126] Content identification, the steps are:

[0127] [Identification] (1) Take 10g of this product, add 10ml of water to dissolve, add 0.5ml of concentrated ammonia test solution, add 20ml of ether, shake and extract, separate the ether layer, evaporate to dryness, add 1ml of methanol to the residue to dissolve, and use it as the test sample solution. Take another ephedrine hydrochloride reference substance, add methanol to make a solution containing 0.5mg per 1ml as the reference substance solution. Test according to thin-layer chromatography (Appendix VI B, Chinese Pharmacopoeia, 2005 Edition), draw 10 μl of each of the above two solutions, spo...

Embodiment 3

[0139] The quality control of embodiment 3 children Qingfei Huatan syrup

[0140] The quality control method of the present invention comprises the following steps:

[0141] The observation of traits, the steps are:

[0142] 【Properties】This product is a syrup, the content is a yellow-brown transparent liquid; sweet, slightly bitter.

[0143] Content identification, the steps are:

[0144] [Identification] (1) Take 10ml of this product, add 10ml of water to dissolve, add 0.5ml of concentrated ammonia test solution, add 20ml of ether, shake and extract, separate the ether layer, evaporate to dryness, add 1ml of methanol to the residue to dissolve, and use it as the test sample solution. Take another ephedrine hydrochloride reference substance, add methanol to make a solution containing 0.5mg per 1ml as the reference substance solution. Test according to thin-layer chromatography (Appendix VI B, Chinese Pharmacopoeia, 2005 Edition), draw 10 μl of each of the above two soluti...

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Abstract

The present invention relates to quality control method for infantile lung heat eliminating and phlegm removing preparation, which is prepared with eight kinds of Chinese medicinal materials, including ephedra, hogfenel root, skullcap root, etc. The method includes thin-layer chromatography for identification and high efficiency liquid chromatograhy for content measurement. The method has high precision, high sensitivity and high stability to ensure the quality safety, homogeneity, stability, effectiveness and controllability.

Description

Technical field: [0001] The invention relates to a quality control method of traditional Chinese medicine preparations, in particular to a quality control method of children's lung-clearing and phlegm-resolving preparations. Background technique: [0002] The children's lung-clearing and phlegm-resolving preparation is prepared from 90g of ephedra, 225g of Peucedanum, 225g of scutellaria baicalensis, 225g of perilla seeds (stir-fried), 675g of gypsum, 225g of bitter almonds (peeled and fried), 279g of Tinglizi and 225g of Zhuru. The preparation has the effects of clearing away heat and resolving phlegm, relieving cough and relieving asthma. Clinically, it is used for shortness of breath, cough, phlegm and wheeze caused by lung heat and cold in children, and has a good therapeutic effect. The children's lung-clearing and phlegm-resolving preparation already on the market is an oral liquid. [0003] The children's lung-clearing and phlegm-removing preparation of the present ...

Claims

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Application Information

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IPC IPC(8): A61K36/539A61K9/00A61K9/06A61K9/16A61P11/00A61P11/10
Inventor 王泽坤武燕江帆张羽斌
Owner GUIZHOU YIBAI PHARMA CO LTD
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