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Quality control method for Desheng preparation

A quality control method and preparation technology, which can be used in testing pharmaceutical preparations, measuring devices, pharmaceutical formulations, etc., and can solve problems such as inability to effectively control the quality of preparations, affecting product production and ensuring quality.

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

AI Technical Summary

Problems solved by technology

Therefore, the existing quality control methods cannot effectively control the quality of Desheng preparations, which will affect the production and quality assurance of products.

Method used

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  • Quality control method for Desheng preparation

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0131] The quality control of embodiment 1 Desheng granules

[0132] The quality control method of the present invention comprises the following steps:

[0133] The observation of traits, the steps are:

[0134] 【Properties】This product is yellow to yellow-brown granules; sweet in taste.

[0135] Content identification, the steps are:

[0136] [Identification] (1) Take 5g of this product, add 30ml of ethanol, ultrasonic for 30 minutes, let cool, filter, and concentrate the filtrate to about 5ml, add it to an activated carbon-alumina column (activated carbon 0.5g; neutral alumina 100-120 Mesh, 2g, inner diameter 10mm), elute with 30ml of ethanol, collect the eluent, evaporate to dryness, add 0.5ml of ethanol to dissolve the residue, and use it as the test solution. Take another stachydrine hydrochloride reference substance, add ethanol to form a solution containing 5mg per 1ml, as the reference substance solution. According to the test of thin-layer chromatography (Appendix...

Embodiment 2

[0148] Embodiment 2 gets raw granule

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Abstract

The present invention relates to quality control method for Desheng preparation. The quality control method includes identification through thin layer chromatography process and content measurement through spectrophotometric process. The quality control method is precise, sensitive and stable, and can ensure the quality of product.

Description

Technical field: [0001] The invention relates to a quality control method for traditional Chinese medicine preparations, in particular to a quality control method for Desheng granule preparations. Background technique: [0002] The original dosage form of Desheng Granules is Desheng Tablets, which is listed in the "Ministry of Health Drug Standards Traditional Chinese Medicine Prescriptions Volume III". Nourishing blood, regulating qi and removing blood stasis. For irregular menstruation, abdominal pain during menstruation, blood stasis and Qi stagnation, abdominal mass in the abdomen. [0003] The existing Desheng preparation has the disadvantages that the quality control method is backward and the product quality is not easy to control. In the existing quality control methods, there is no identification of its ingredients, or content determination of its ingredients. Therefore, the existing quality control methods cannot effectively control the quality of Desheng prepar...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/71A61K9/16A61P15/00G01N30/02G01N30/90G01N33/15
Inventor 周美娟耿炤
Owner JIANGXI HUIREN PHARMA CO LTD
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