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Calculus eliminating tablet fingerprint establishing method

A technique of fingerprinting and establishing methods, which is applied in the field of drug testing, can solve the problems of ineffective control of the quality of finished medicines, only properties, inspection items, and backward quality standards of Jieshitong Tablets, so as to achieve a stable baseline, ensure effectiveness, and separate good effect

Active Publication Date: 2016-07-06
GUANGXI WUZHOU PHARMA GRP
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  • Abstract
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  • Claims
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AI Technical Summary

Problems solved by technology

[0005] The present invention aims at the problem that the quality standard of the current Jieshitong tablet is relatively backward, only the properties and inspection items are available, and the quality of the finished medicine cannot be effectively controlled, and provides a method for establishing the fingerprint of the Jieshitong tablet. Through the establishment of the fingerprint of the Jieshitong tablet, And the standard fingerprint of Jieshitong tablets obtained by this method can effectively control the quality of Jieshitong tablets and make up for the deficiencies of existing quality control technologies, thereby ensuring the effectiveness, safety and stability of Jieshitong tablets

Method used

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Examples

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Effect test

Embodiment 1

[0050] Example 1: Establishment experiment of the HPLC characteristic spectrum of Jieshitong Tablets

[0051] 1. Instruments, reagents and test samples

[0052] Instrument: high performance liquid chromatography: waterse2695 pump, UV2998 detector

[0053] Electronic balance: CP214 Ohaus instrument

[0054] Reference substance: Schaftoside (manufactured by Sichuan Weikeqi Biotechnology Co., Ltd., HPLC greater than 98), batch number: 121015

[0055] Sample: Jieshitong tablets (provided by Guangxi Wuzhou Pharmaceutical (Group) Co., Ltd.), batch numbers are: 140603, 140204, 140605, 140703, 140704, 140705, 140706, 140707, 140802, 140803, 140805

[0056] 2. Chromatographic conditions

[0057] Use octadecylsilane bonded silica gel as filler; use acetonitrile as mobile phase A; use 0.2% phosphoric acid aqueous solution as mobile phase B; use methanol as mobile phase C, the temperature is room temperature, and the flow rate is 1.0ml / min, as follows The program carries out gradient ...

Embodiment 2

[0070] Example 2: Establishment of the HPLC characteristic spectrum of Jieshitong Tablets

[0071] Kishitong tablets were provided by Guangxi Wuzhou Pharmaceutical (Group) Co., Ltd.

[0072] Determine according to high performance liquid chromatography ("Chinese Pharmacopoeia" 2010 edition an appendix VID):

[0073] Use octadecylsilane bonded silica gel as filler; use acetonitrile as mobile phase A; use 0.2% phosphoric acid aqueous solution as mobile phase B; use methanol as mobile phase C, the temperature is room temperature, and the flow rate is 1.0ml / min, as follows The program carries out gradient elution; the detection wavelength is 272nm; the number of theoretical plates should not be less than 3000 in terms of schiaftoside;

[0074] 0-10min, mobile phase A is 10%, mobile phase B is 85%; mobile phase C is 5%;

[0075] 10~20min, mobile phase A is 10%; mobile phase B is 85%→82%; mobile phase C is 5%→8%;

[0076] 20~30min, mobile phase A is 10%→12%; mobile phase B is 82%...

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Abstract

The invention provides a calculus eliminating tablet fingerprint establishing method. The method comprises the following steps: preparing a reference substance, preparing a test sample, and using high performance liquid chromatography (HPLC) to obtain the fingerprint of a calculus eliminating tablet; wherein in the chromatography and system applicability tests, octadecyl silane bonded silica gel is taken as the filling agent, acetonitrile is taken as the mobile phase (A), a phosphoric acid water solution (0.2%) is taken as the mobile phase (B), methanol is taken as the mobile phase (C), the detection wavelength is 272, and the theoretical plate number calculated by schaftoside is not less than 3000.

Description

technical field [0001] The invention relates to the technical field of drug detection, in particular to a method for establishing a fingerprint of a stone tablet. Background technique [0002] The control of compound prescriptions of traditional Chinese medicine is one of the key issues restricting the modernization of traditional Chinese medicine. The theory of traditional Chinese medicine emphasizes the overall effect of traditional Chinese medicine and attaches great importance to the synergistic effect on drug efficacy. Using one or two active ingredients in traditional Chinese medicine as qualitative and quantitative indicators is far from being able to effectively control and evaluate the quality of Chinese medicine, and it is even more difficult to reflect its safety and effectiveness. sex. Traditional Chinese medicine compound is a compound preparation that combines two or more traditional Chinese medicines for disease treatment, and its quality control is more diff...

Claims

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Application Information

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IPC IPC(8): G01N30/88G01N30/06
CPCG01N30/06G01N30/88
Inventor 刘冠萍招丽君朱小凤陈露林广莲
Owner GUANGXI WUZHOU PHARMA GRP
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