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Establishment method of traditional Chinese medicine composite fingerprint

A technique for fingerprinting and establishing methods, which is applied in the field of quality control of traditional Chinese medicine compositions, can solve problems such as the inability to quantitatively analyze product components, the inability to guarantee the quality stability of medicinal materials, and the batch-to-batch quality uniformity of products to achieve good precision and quality. The effect of more standard and comprehensive quality standard

Active Publication Date: 2015-12-23
SICHUAN LVYE BAO GUANG PHARMA IND
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In this standard, the qualitative identification method of thin-layer chromatography is mainly used to control the quality of preparations, and the quantitative analysis of product components cannot be carried out, so the stability of the quality of medicinal materials and the quality uniformity between batches of products cannot be guaranteed.

Method used

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  • Establishment method of traditional Chinese medicine composite fingerprint
  • Establishment method of traditional Chinese medicine composite fingerprint
  • Establishment method of traditional Chinese medicine composite fingerprint

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] Example 1: Quality Control Method for Weilikang Granules Based on Fingerprint

[0054] Instruments: Agilent1260 high performance liquid chromatography, AX205 one hundred thousandth balance, Milli-Q ultrapure water preparation instrument.

[0055] Test drugs: paeoniflorin reference substance (lot number: MUST-12113099), naringin reference substance (lot number: 110722-201312), rutin reference substance (lot number: 100080-200707), emodin-8-O-β-D Glucopyranoside (batch number: W14-7-0): the above reference substances were purchased from China Institute for the Control of Pharmaceutical and Biological Products; glycyrrhizic acid (batch number: 20121098) reference substance, rosmarinic acid (batch number: 20140722) reference substance, salvianol Acid B reference substance (batch number: 20121033): purchased from Tianjin Yifang Technology Co., Ltd., methanol, formic acid (chromatographically pure), Weilikang granules (batch number 1304011, purchased from Sichuan Luye Baoguan...

Embodiment 2

[0067] Example 2: Establishment of fingerprints of Weilikang Granules

[0068] A total of 10 batches of Weilikang granules (1304011, 1304021, 1304031, 1304041, 1304051, 1304061, 1303151, 1303161, 1303171, 1303181) were determined by the method described in Example 1.

[0069] The fingerprints of 10 batches of Weilikang granules are as follows: Figure 4 shown.

[0070] Through the comparison of the HPLC spectra of 10 batches of Weilikang granules, the similarity evaluation was carried out: the "Chinese Medicine Chromatographic Fingerprint Similarity Evaluation System 2004A Edition" was adopted by the National Pharmacopoeia Commission. Calculate the similarity of 10 batches of Weilikang granules, and the similarity between the 10 batches of Weilikang granules and the standard fingerprint (the common pattern S0 generated by 10 batches of Weilikang granules) is greater than 0.99. For specific results, see Table 8 shows.

[0071] Table 8 Similarity Comparison Results of Weilika...

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Abstract

The invention provides an establishment method of a traditional Chinese medicine composite fingerprint, and particularly relates to an establishment method of a Weilikang granule fingerprint. Pure water is added to Weilikang granules, so as to dissolve, and paeoniflorin, naringin, rutin, salvianolic acid B, rosmarinic acid, emodin-8-O-beta-D glucopyranoside and glycyrrhizic acid are used as reference substances, so as to establish the fingerprint by referring to high-performance liquid chromatography. The method is more comprehensive and objective than the current quality standard, and the current quality standard is increased and improved, and more information is provided for the internal quality control of the Weilikang granules.

Description

technical field [0001] The invention relates to a quality control method of a traditional Chinese medicine composition, in particular to a method for constructing fingerprints of Weilikang granule preparations by using high performance liquid chromatography and the fingerprints thereof. Background technique [0002] The quality control of traditional Chinese medicine is an important part of the modernization of traditional Chinese medicine, and the fingerprint technology of traditional Chinese medicine is considered to be an effective means of research on the quality control of traditional Chinese medicine. Traditional Chinese medicine fingerprint refers to the use of modern analysis technology to graphically characterize and describe the chemical information of traditional Chinese medicine. Traditional Chinese medicine fingerprints can more comprehensively reflect the types and quantities of chemical substances in traditional Chinese medicine, and can be used to improve the...

Claims

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Application Information

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IPC IPC(8): G01N30/88G01N30/06
Inventor 龚德泉孙丽芳肖若兰孟莹欧定莲罗涛
Owner SICHUAN LVYE BAO GUANG PHARMA IND
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