Method for determining contents of six components of mango cough-relieving tablet by HPLC QAMS (quantitative analysis of multi-components by single-marker) method

Abstract

The invention discloses a method for determining the contents of six components in a mango cough-relieving tablet by HPLC and QSMA methods. The HPLC method with a Phenomenex Gemini C18 column (4.6mm*250 mm, 5 mu m) as the chromatographic column, the acetonitrile (B)-0.1% phosphoric acid aqueous solution (A) as the mobile phase, with gradient elution, and at the flow rate of 1.0 mL / min, the detection wavelength of 258nm, and the column temperature of 30 DEG C is adopted. According to the QSMA method, gallic acid is used as an internal reference substance, relative correction factors (RCF) of protocatechuic acid, mangiferin, homomangiferin, hyperoside and isoquercitrin are established, the contents of the same are calculated via the RCFs, amd determining values are compared with determiningresults via an external standard method for analysis. The determining result of the QSMA method has no significant difference (P is greater than 0.05) from that of the external standard method, the RCFs are high in repeatability, the HPLC and QSMA methods can be used to determine contents of the six components in the mango cough-relieving tablet, and the method of the invention is accurate, reliable, highly repeatable and can be used for quality control of the mango cough-relieving tablet.

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 contents of six components in Mango Cough Tablets by HPLC. Background technique [0002] Mango cough tablet is a Chinese and Western medicine compound preparation made from dried mango leaf extract, sodium houttuyniatin, and chlorpheniramine maleate. It has the effects of clearing the lungs and reducing phlegm, relieving cough and asthma, and is clinically used to treat cough , 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 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. Althoug...

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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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