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Quality control method for pile eliminating tablet

A quality control method, a technology for resolving hemorrhoids, applied in the field of quality control of traditional Chinese medicine Huazhi Tablets, can solve problems such as difficult to achieve quality, difficult to control the quality of agents, and incomplete methods

Active Publication Date: 2006-05-17
JIANGXI HUIREN PHARMA CO LTD
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  • Abstract
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AI Technical Summary

Problems solved by technology

Therefore, the quality control method contained in this standard cannot effectively reflect the requirements for quality control of preparations, and cannot effectively ensure the stability of preparations
[0004] For a long time, the quality of traditional Chinese medicine preparations has been difficult to effectively control. Effectively controlling the quality of traditional Chinese medicine products is a major issue. The methods used in the prior art are incomplete, and a few are not targeted. It is difficult to achieve the purpose of real quality control by using these methods
The above Huazhi Tablets are difficult to control the quality of the agent due to the lack of good quality control methods; it has brought difficulties to normal production and operation, and it is difficult to provide good quality control methods for this preparation product by using known technologies. There are technical deficiencies, and new methods are used to control the quality of Huazhi Tablets, especially the use of high-performance liquid chromatography to determine the content of rutin in the drug, which solves the problem of quality control of the preparation

Method used

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Examples

Experimental program
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Effect test

Embodiment 1

[0049] Get the Huazhi tablet sold on the market, after preparing by the preparation method of content determination need testing solution in the present invention, carry out HPLC measurement respectively, record rutin peak area integral value, calculate the content of rutin, result: the content of rutin It is 12.6mg / tablet.

Embodiment 2

[0051] Get 2 parts of commercially available items (A) of Huazhi Tablets, after preparing by the preparation method of need testing solution in the present invention, carry out HPLC measurement respectively, record the rutin peak area integral value, calculate the content of rutin, the result: contain rutin The dosage is 3.29mg / tablet.

Embodiment 3

[0053] Get 2 parts of commercially available items (B) of Huazhi Tablets, after preparing by the preparation method of need testing solution in the present invention, carry out HPLC measurement respectively, record the rutin peak area integral value, calculate the content of rutin, the result: contain rutin The dose is 3.28mg / tablet.

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Abstract

The present invention relates to quality control method of Chinese medicine preparation, and is especially the quality control method for pile eliminating tablet. The quality control method for pile eliminating tablet includes the thin layer chromatographic identification of sophora flower-bud, bitter orange, notoginseng and chemical components in pile eliminating tablet, and the high efficiency liquid phase chromatographic determination of rutin content as the main medicine component.

Description

1. Technical field [0001] The invention relates to a quality control method of traditional Chinese medicine preparations, in particular to a quality control method of traditional Chinese medicine Huazhi Tablets. 2. Background technology [0002] Huazhi tablets, a traditional Chinese medicine preparation, are prepared from Sophora japonica, madder, citrus aurantium, triangular, and Sanqi; they have the functions of clearing away heat, cooling blood, stopping bleeding, promoting qi and dissipating blood stasis, and can be used for internal hemorrhoids, external hemorrhoids, mixed hemorrhoids, and internal and external hemorrhoids for thrombus treatment . The formulation, preparation method and quality standard of the preparation are recorded in Volume 15 of "Ministry of Health Drug Standards of the People's Republic of China Traditional Chinese Medicine Prescription Preparations" (Standard No. WS3-B-2907-98), [0003] The main quality control content of Huazhi Tablets contain...

Claims

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Application Information

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IPC IPC(8): A61K36/902A61P9/14G01N30/02G01N33/15
Inventor 陈年代蔡培烈丁楚良耿炤
Owner JIANGXI HUIREN PHARMA CO LTD
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