A method for constructing the hplc fingerprint of Shenge Shuxin Prescription
A fingerprint and construction method technology, which is applied in the field of HPLC (high performance liquid chromatography) fingerprint construction of Shenge Shuxin Recipe, can solve problems such as the difficulty in comprehensively controlling the quality of compound prescriptions, drug efficacy, and insufficient quality control methods, and achieve Improve quality control methods, enrich scientific connotations, and controllable content
Active Publication Date: 2016-08-24
LIAONING UNIV OF TRADITIONAL CHINESE MEDICINE
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[0004] The applicant has previously carried out patent protection for the preparation method and preparation of the compound and its effective chemical components (a preparation method and preparation of traditional Chinese medicine for the treatment of coronary heart disease and its effective chemical components, patent number 201110330186.3), due to the compound The quality control method is not perfect, it is difficult to comprehensively control the quality of the compound formula and the curative effect of the drug, and it is somewhat one-sided to use the activity of one of the drugs to explain the quality of Shenge Shuxin Prescription
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[0028] 1. Instruments and reagents.
[0029] 1.1 Instruments: electronic balance (AB135-S, dual range, readability 0.01 / 0.1mg, Mettler-Toledo, Switzerland); high performance liquid chromatography (Agilent 1100, Agilent Technologies Co., Ltd., USA); analytical chromatographic column (Agilent Poroshell 120 SB-C18 (4.6mm×100mm, 2.7m), American Agilent Company); ultrapure water treatment device (Milli-Q, American Millipore Company); ultrasonic cleaner (KQ5200 type, Kunshan Ultrasonic Instrument Co., Ltd.); DAD Detector (G1313A, Agilent, USA).
[0030] 1.2 Test drug: Shenge Shuxin Prescription (provided by Liaoning University of Traditional Chinese Medicine, batch numbers 20120108, 20120124, 20120201, 20120210, 20120225, 20120302, 20120314, 20120401, 20120412, 20120426); acetonitrile (mass spec pure, Fisher company) (18.2MΩ); puerarin (110752-200511, purchased from China National Institute for the Control of Pharmaceutical and Biological Products); daidzein (MUST-11121201, purchas...
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A method for constructing the HPLC fingerprint of Shenge Shuxin Prescription, comprising: preparation of a test product solution, preparation of a reference substance solution, high performance liquid chromatography conditions, and measurement, to obtain the HPLC fingerprint of the Shenge Shuxin Prescription. The HPLC fingerprint of Shenge Shuxin Recipe has detected 17 characteristic peaks in total, among which there are 14 characteristic peaks belonging to Radix Puerariae; there are 3 characteristic peaks belonging to Salvia miltiorrhiza; the present invention adopts HPLC-DAD-TOF / MS series technology , identify each chromatographic peak of the HPLC standard fingerprint of Shenge Shuxin Prescription; at the same time, use the method of one test and multiple evaluations to determine the content of the main active ingredients in Shenge Shuxin Prescription, and formulate content limit standards. Therefore, the construction method of the HPLC fingerprint of Shenge Shuxin Prescription provided by the present invention combines qualitative and quantitative methods to establish a polymorphic fingerprint with clear spectrogram, definite components and controllable content, which more comprehensively reflects Shenge Shuxin Prescription The quality has effectively improved the quality control method of Shenge Shuxin Prescription.
Description
technical field [0001] The invention relates to the technical field of drug analysis, in particular to a method for constructing the HPLC (high performance liquid chromatography) fingerprint of Shenge Shuxin Prescription. Background technique [0002] Traditional Chinese medicine fingerprint is a method widely accepted at home and abroad to comprehensively evaluate the quality mode of traditional Chinese medicine. It is an effective control method for the overall evaluation of the quality of traditional Chinese medicine in complex samples with multidimensional components. The US FDA allows the declaration in the guidelines for botanical pharmaceutical products The author provides the chromatographic fingerprint information of the product, and the German Society of Medicinal Botany, the British Herbal Codex, the Indian Herbal Pharmacopoeia, and the Canadian Association of Medicinal Aromatic Plants also use fingerprints as one of the quality control standards. [0003] Shenge ...
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IPC IPC(8): G01N30/88
Inventor 孟宪生包永睿王帅王玉凤王思思
Owner LIAONING UNIV OF TRADITIONAL CHINESE MEDICINE
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