Construction method of HPLC specific chromatogram of traditional Chinese medicines treating wind-heat cold
A feature map, a technology for wind-heat and cold, applied in the field of medicine, can solve the problem that the quality of raw medicinal materials, intermediates, and finished products cannot be monitored, there is no detection of multiple main chemical components, and the method is cumbersome. And other issues
Active Publication Date: 2016-06-15
吉林修正药业新药开发有限公司
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Problems solved by technology
[0004] 1. In the methods specified in the Pharmacopoeia, there is no comprehensive and systematic detection of the main chemical components of the multi-flavored medicinal materials
[0005] 2. The current non-quality inspection method cannot monitor the quality of raw materials, intermediates, and finished products
[0006] In summary, in the prior art, a method for treating wind-heat-cold preparation (Patent No. CN104623082A) has defects such as cumbersome methods, inability to quickly and comprehensively detect and identify a kind of wind-heat-cold preparation
Method used
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Embodiment 1
[0032] Example 1: Establishment of a characteristic map method for treating Fengreganmao preparation.
[0033] 1 Instrument: UltiMate3000DGLC high-performance liquid chromatography, ultraviolet DAD detector; MettlerAE240 1 / 100,000 analytical balance (Shanghai Mettler-Toledo Instrument Co., Ltd.); AB204-E electronic balance (Shanghai Mettler-Toledo Instrument Co., Ltd.); Ltd.) etc.
[0034] 2 Reagents and reagents
[0035] 2.1 Reagents: methanol, etc. are analytically pure, phosphoric acid and acetonitrile are chromatographically pure, and water is ultrapure water.
[0036] 2.2 Reagents: chlorogenic acid, forsythiaside A, liquiritin, luteolin, forsythin, baicalin, ammonium glycyrrhizinate (all from China Food and Drug Appraisal Institute), batch number of a preparation for treating wind-heat and cold : 120601, 120602, 120603, 130501, 130502, 130503, 130504, 130505, 141201, 141202, 141203 (from Jilin Xiuxiu Pharmaceutical New Drug Development Co., Ltd.).
[0037] 3 Methods an...
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The invention relates to a construction method of an HPLC specific chromatogram of traditional Chinese medicines treating wind-heat cold. The construction method includes the steps of: preparing a test sample solution, preparing a reference substance solution, specifying chromatographic conditions, precisely sucking 10 [mu]l of the test sample solution and 10 [mu]l of a medicine solution respectively, injecting the solutions into a liquid chromatographic instrument, and performing HPLC test to obtain the HPLC specific chromatogram. Under the same chromatographic conditions, the chemical components in various traditional Chinese medicines can be detected to determine quality consistency of a lot of batches according to the similarity of finger-print spectrum, and furthermore, the method can be used for searching problems in process operations fundamentally. The similarities of the finger-print spectrum and a reference spectrum are both higher than 0.9. The method effectively shows the quality between the batches of a finish product and can be used for comprehensively monitoring product quality, thereby avoiding simplicity and one-sidedness during quality control. The method is convenient, quick, stable and precise and has good repeatability.
Description
technical field [0001] The invention belongs to the field of medicine, and in particular relates to a quality control method of a preparation for treating anemopyretic cold. Background technique [0002] The characteristic map of traditional Chinese medicine can comprehensively and comprehensively reflect the relative relationship of the components contained in it, and better reflect the complexity and correlation of the components of traditional Chinese medicine. It has the characteristics of obvious characteristics, strong specificity, and good reproducibility. Application, as a quality control method of Chinese herbal medicines and their extracts, characteristic maps have become a technique widely accepted at home and abroad to evaluate the quality of Chinese medicines. [0003] Previously, there was no clear detection method for a preparation for treating wind-heat and cold (patent number CN104623082A), but for the medicinal flavors (honeysuckle, forsythia, brocade lante...
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IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/027
Inventor 高嵩白冰郭文英吴萍李桂峰
Owner 吉林修正药业新药开发有限公司