Method for establishing fingerprint spectrum of Xuepin tablets and fingerprint spectrum of Xuepin tablets
A technique for fingerprinting and establishing methods, which is applied in the field of quality control of traditional Chinese medicine preparations, can solve problems such as complex components of Xueping Tablets, and achieve long-term stability, good reproducibility, and accurate and reliable control.
Active Publication Date: 2022-06-03
JIANGXI POZIN PHARMA
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[0004]
The composition of the blood flat film is complex, and contains some components that are not suitable for detection by ultraviolet detectors, such as no ultraviolet absorption or only ultraviolet terminal absorption.
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[0036] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Generally, the nomenclature used in the present invention and the following experimental methods are well known or commonly used in the art. In order to make the technical problems, technical solutions and beneficial effects solved by the present invention clearer, the present invention will be further described below with reference to specific embodiments.
[0037] 1. Instrument: Shimadzu LC20A-ELSD liquid chromatograph; Waters 2695-2996-ELSD liquid chromatograph; KQ-250DB CNC ultrasonic cleaning; Mili-Q ultrapure water instrument.
[0038]2. Reagents and reagents: Xueping tablets batch numbers are 150902, 160301, 170301, 171101, 181001, 190903, 190904, 191101, 191201, 191202, 191203, 191204, 191205; methanol, chromatographic grade; methanol, analytical grade; formic acid , analytical...
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The invention relates to the field of traditional Chinese medicine analysis, in particular to a method for establishing a fingerprint spectrum of Xuepin tablets and the fingerprint spectrum of the Xuepin tablets. The method comprises the following steps: preparing a test sample; preparing a reference substance solution; injecting into a liquid chromatograph combined with an ultraviolet detector and an evaporative light-scattering detector, and recording a chromatogram; and importing the obtained chromatogram into a traditional Chinese medicine fingerprint similarity evaluation system for similarity evaluation. A fingerprint spectrum is established by combining a liquid chromatography with an ultraviolet detector and an evaporative light scattering detector, so that the defect that a traditional detector cannot detect macromolecular components without ultraviolet absorption or ultraviolet terminal absorption is overcome, multiple components of the Xuepin tablets are analyzed on the whole, 23 common peaks are calibrated, and the detection accuracy is high. Wherein 10 compounds are verified by reference substances, reaction information is relatively complete, similarity evaluation is carried out on the established Xuepin tablet fingerprint spectrum and a corresponding reference spectrum, the similarity is larger than 0.9, specific components of all medicinal materials in a Xuepin tablet prescription can be effectively represented, the quality of the medicinal materials can be effectively represented, and comprehensive monitoring of the product quality is facilitated. The method has the advantages of convenience, rapidness, stability, high precision, good reproducibility and the like, and the quality of the Xuepin tablets can be evaluated more comprehensively, objectively and scientifically, so that the effectiveness of the Xuepin tablets in treatment is guaranteed.
Description
technical field [0001] The invention relates to a quality control method for traditional Chinese medicine preparations, in particular to a method for constructing the fingerprint of Xueping tablet preparations by high performance liquid chromatography and the obtained fingerprint. 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 is considered to be an effective means of quality control of traditional Chinese medicine. Traditional Chinese medicine fingerprints can scientifically reflect the types of chemical substances in related prescription drugs in traditional Chinese medicine preparations. The establishment of TCM fingerprints will comprehensively reflect the types and quantities of chemical components contained in TCM and its preparations, and further describe and evaluate the quality of drugs as a whole. [0003] Xueping Tablet is a...
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IPC IPC(8): G01N30/86G01N30/06
CPCG01N30/8686G01N30/06Y02A50/30
Inventor 周朝忠吴志平罗祎明王翠龙军康兴东郭邦亮旷春兰何慧莹夏淑英康爱华肖绍川
Owner JIANGXI POZIN PHARMA