A method for determining fingerprints of traditional Chinese medicine preparations for treating coronary heart disease

A technology of traditional Chinese medicine preparations and fingerprints, applied in the field of medicine, can solve the problems of insufficient internal quality of traditional Chinese medicine preparations, and achieve the effects of improving neurological function defects, good reproducibility and reliable methods

Active Publication Date: 2015-08-05
SHANXI BUCHANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

We first applied for the patent of publication number CN1686294A for this Chinese medicine preparation, which discloses the prescription and preparation method of its Chinese medicine preparation for the treatment of coronary heart disease. The quality standard of the preparation only controls the content of salvianolic acid B and tanshinone IIA, which is obviously not enough to control the internal quality of traditional Chinese medicine preparations

Method used

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  • A method for determining fingerprints of traditional Chinese medicine preparations for treating coronary heart disease
  • A method for determining fingerprints of traditional Chinese medicine preparations for treating coronary heart disease
  • A method for determining fingerprints of traditional Chinese medicine preparations for treating coronary heart disease

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Embodiment 1: the establishment of Chinese medicine preparation fingerprint spectrum assay method of the present invention

[0034] 1.1 Instruments and reagents

[0035] Agilent1260 (quaternary pump G1311B; autosampler G1329B; column thermostat G1316A; diode array detector G4212B; LAB open chromatography data workstation); electronic analytical balance (model BP211D, d=0.01mg, German Sartorius Balance Co., Ltd. ); Ultrasonic Cleaner (Model: KQ-250DE, Kunshan Ultrasonic Instrument Co., Ltd.); Agilent ZORBAX Extend-C 18 Chromatography column (250mm×4.6mm, 5μm).

[0036] 1.2 Reagent

[0037] 10 batches of Chinese medicine preparations of the present invention are produced by Shaanxi Buchang Pharmaceutical Co., Ltd., and the sample numbers of 10 batches are respectively Y 1 , Y 2 , Y 3 , Y 4 , Y 5 , Y 6 , Y 7 , Y 8 , Y 9 , Y 10 , National Pharmaceutical Standard Z20020055, which is a capsule. Methanol was chromatographically pure (Fisher Reagent Company, USA), ...

Embodiment 2

[0070] Embodiment 2 The establishment of the fingerprint of the Chinese medicine preparation of the present invention

[0071] 2.1 Preparation of the test solution

[0072] Take about 1 g of the contents of 10 different batches of traditional Chinese medicine preparations, accurately weigh them, put them in a 100 mL conical flask with a stopper, add 10 mL of 70% methanol, weigh, ultrasonically (100W, 45kHz) for 30 minutes, let cool, and make up with 70% methanol Lose the lost weight, shake well, filter through a 0.45μm microporous membrane, and take the subsequent filtrate.

[0073] 2.2 Chromatographic conditions:

[0074] Chromatographic column: Agilent ZORBAX Extend-C18 column (250mm×4.6mm, 5μm); column temperature: 35°C, flow rate: 1.0mL min -1 , with methanol as the mobile phase A and 0.4% phosphoric acid aqueous solution as the mobile phase B, perform gradient elution according to the volume concentration preparation ratio in Table 5.

[0075] Table 5 Mobile phase gradie...

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Abstract

The invention relates to a method for determining fingerprint spectrum of traditional Chinese medicine for treating coronary heart disease. The method comprises the following steps: preparing a test solution, preparing a reference solution, and carrying out gradient elution under the chromatographic conditions that an Agilent ZORBAX Extend C18 chromatographic column is used as a filling agent, a mobile phase A is methanol and a mobile phase B is 0.4% phosphoric acid water solution; determining under conditions that the flow velocity is at 1.0ml / min, the column temperature is at 35 DEG C and the detection wavelength is 230-240nm, thus obtaining the fingerprint spectrum of traditional Chinese medicine. The method has the characteristics of being simple and convenient, good in reproducibility, more in characteristic peaks, accurate and reliable, and the like, and the quality of the traditional Chinese medicine preparation can be controlled effectively by the established fingerprint spectrum.

Description

technical field [0001] The invention relates to a method for determining fingerprints of traditional Chinese medicine preparations for treating coronary heart disease, in particular to a high-performance liquid chromatography fingerprint method for determining effective components in traditional Chinese medicine preparations, and belongs to the technical field of medicine. Background technique [0002] Traditional Chinese medicine has a long history in my country. As the material carrier of traditional Chinese medicine for disease prevention and treatment, its inherent quality is directly related to clinical efficacy and safety. Therefore, establishing a quality control system for TCM preparations that can be accepted by the international pharmaceutical industry is one of the key issues in the development of TCM. The quality control of traditional Chinese medicine is an important part of the modernization of traditional Chinese medicine, and fingerprint technology is conside...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/86
Inventor 赵超刘峰李晔杨东华龙凯华马久太孙雯黄壮壮吴云生千珂张建
Owner SHANXI BUCHANG PHARMA CO LTD
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