A method for determining the content of 6 components in Mango Zhike Tablets by one test and multiple evaluations by hplc method

Abstract

The invention discloses an HPLC method for determining the content of 6 components of Mango Zhike Tablets by one measurement and multiple evaluations. The invention adopts the HPLC method, and the chromatographic column is a Phenomenex Gemini C18 column (4.6 mm×250 mm, 5 μm); the mobile phase is acetonitrile ( B)-0.1% phosphoric acid aqueous solution (A); gradient elution; flow rate 1.0mL / min; detection wavelength: 258nm, column temperature 30°C; one-measurement-multiple-evaluation method takes gallic acid as the internal reference, and establishes protocatechuic acid, protocatechuic acid, The relative correction factor (RCF) of mangiferin, homomangiferin, hypericin and isoquercitrin is calculated by RCF, and its measured value is compared and analyzed with the measured result of external standard method. There is no significant difference between the measurement results of the test-multi-assessment method and the external standard method (P>0.05), and the relative correction factors have good repeatability. The high-performance liquid chromatography content determination and one-test-multi-assessment method established in the present invention can be used for Mango Zhike Tablets The content determination of the six components in the method is accurate and reliable, and the repeatability is good, which can be used for the quality control of mango cough tablets.

Description

technical field [0001] The invention relates to the technical field of component detection of compound preparations of Chinese patent medicines, in particular to a method for determining the content of 6 components of Mango Zhike Tablets by one measurement and multiple evaluations by HPLC. Background technique [0002] Mango cough-relieving tablet is a compound preparation of traditional Chinese and Western medicine made of dried mango leaf extract, sodium houttuyniacin, and chlorpheniramine maleate. , asthma, phlegm embolism. Mango cough tablets have been widely used for a long time and have shown good clinical efficacy. The current quality standard is carried out with reference to the National Drug Standard (2014) National Standard No. 0154 issued by the State Food and Drug Administration. This standard has only simple physical and chemical identification methods, and obviously cannot effectively control the quality of the preparation. Although there have been some liter...

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Problems solved by technology

The current quality standard is based on the National Drug Standard (2014) GBZ-0154 issued by the State Food and Drug Administration. This standard only has a simple physical and chemical identification method, which obviously cannot effectively control the quality of the preparation.

Although there have been some literature reports on the separate determination of mangiferin, sodium houttuyfonate and chlorpheniramine maleate in Mango Zhike Tablets by HPLC over the past ten years, the compound preparations of Chinese patent medicines have complex components, and single components can be quantified It is difficult to fully control its quality and consistency of curative effect, and the determination of multi-index components has become the development trend of related quality evaluation; modern pharmacological studies have shown that flavonoids and phenolic acids contained in mango leaves have obvious anti-asthma, cough-relieving, Anti-phlegm, immune, anti-tumor and other active effects are the efficacy-related components of this preparation; The content determination method of multiple components of hyperoside and isoquercitrin, and on this basis, aiming at the problems of high price and high detection cost of some reference substances such as mangiferin and high mangiferin in this preparation, research and establishment The one-test and multiple-evaluation method for these 6 components

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