Analysis method for researching fingerprint spectrum of Mailuoning injection based on UPLC-DAD-MS

A fingerprint and analysis method technology, applied in the direction of analysis of materials, material separation, instruments, etc., can solve the problems of low quality control standards and unclear components, and achieve the effect of improving quality control standards and good reproducibility

Active Publication Date: 2020-06-05
JINLING PHARMA
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Problems solved by technology

At present, traditional Chinese medicine injections generally have unclear ingredients, low quality control standards, and great safety problems. Therefore, how to combine and use various advanced tec...

Method used

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  • Analysis method for researching fingerprint spectrum of Mailuoning injection based on UPLC-DAD-MS
  • Analysis method for researching fingerprint spectrum of Mailuoning injection based on UPLC-DAD-MS
  • Analysis method for researching fingerprint spectrum of Mailuoning injection based on UPLC-DAD-MS

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Embodiment 1

[0018] Instruments, Reagents and Samples

[0019] One hundred thousandth electronic balance Mettler AE240; liquid mass spectrometer Agilent 1260UPLC-DAD-6530ESI-QTOF MS; including the following components: G1322A, 1260Degasser; G1312B, 1260Bin Pump; G1367E, 1260HipALS; G1316C, 1290TCC; G4212DAD, 1260 G6530A, 6530Accurate-Mass Q-TOF LC / MS; MassHunter B0.05.0 workstation. Mailuoning Injection, Nanjing Jinling Pharmaceutical Factory of Jinling Pharmaceutical Co., Ltd.; Chlorogenic Acid Standards, China Institute for the Control of Pharmaceutical and Biological Products, batch number 110753-201314 (content is 96.6%); Methanol, Merck (Pesticide Residues) grade); formic acid, American Ruyi ROE (>99%, LCMS grade); deionized purified water (18Ω).

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Abstract

The invention discloses an analysis method for researching a fingerprint spectrum of a Mailuoning injection based on UPLC-DAD-MS. On the basis of research on early-stage chemical components, the UPLC-DAD-MS liquid chromatography-mass spectrometry fingerprint spectrum of the Mailuoning injection is established, and 23 main components including 13 organic acids, 1 coumarin, 2 iridoid, 1 flavone, 1 lignan, 3 saponins and 2 other components can be directly analyzed and identified. According to the method, optimized chromatographic conditions can be rapidly obtained; therefore, the optimal fingerprint spectrum is obtained, reproducibility is good, the relative retention time and the relative peak area variation are both less than 5%; the main chemical component composition of the Mailuoning injection is accurately illustrated, which is of great significance to illustration of the pharmacodynamic material basis of the Mailuoning injection, and lays a foundation for improvement of the qualitycontrol standard of the Mailuoning injection, establishment of a scientific and reasonable quality control method and optimization of a preparation process.

Description

technical field [0001] The invention relates to an analysis method for studying the fingerprint of Mailuoning injection based on UPLC-DAD-MS, which belongs to the field of natural medicinal chemistry. Background technique [0002] Compared with traditional dosage forms such as pills, powders, ointments, and pills, traditional Chinese medicine injections are a unique new type of traditional Chinese medicine dosage form. It is a good option for patients who are not suitable for oral administration or drugs that are not suitable for oral administration. There are more than 100 kinds of traditional Chinese medicine injections in my country, involving hundreds of manufacturers. From 1999 to 2009, the average growth rate of the national Chinese medicine injection market was above 30%, and 300 million patients use traditional Chinese medicine injections every year, with annual sales exceeding 15 billion yuan. However, there are many problems in the production and use of traditiona...

Claims

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Application Information

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IPC IPC(8): G01N30/88G01N30/86
CPCG01N30/88G01N30/8686
Inventor 李剑徐向阳张蕙夏云倪洁张庆晓崔凌云周红燕
Owner JINLING PHARMA
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