A quality detection method for traditional Chinese medicine Kuhuang injection

Abstract

The invention discloses a method for testing quality of Chinese medicinal Kuhuang injection. In the method, a high performance liquid chromatography method is used for simultaneously detecting eight flavonoid and anthraquinone active compounds online or simultaneously detecting four alkaloid active compounds online; by virtue of vast of experiments, the best analysis conditions such as mobile phase composition, gradient elution program, flow velocity, detection wavelength and chromatographic column are selected; multiple experiments verify that the method for testing the quality of the Chinese medicinal Kuhuang injection provided by the invention has good stability and repeatability, high analyzing efficiency, separating degree to each analysis component is high, and each compound can be sensitively, accurately, qualitatively and quantitatively detected, thus the quality of the Kuhuang injection can be objectively, comprehensively and accurately evaluated and the method disclosed by the invention has significance for controlling the quality of the Kuhuang injection and guaranteeing clinical effect.

Description

technical field [0001] The invention relates to a quality detection method of a traditional Chinese medicine preparation, in particular to a quality detection method of a traditional Chinese medicine bitter yellow injection. Background technique [0002] Kuhuang injection is a classic traditional Chinese medicine injection with stable and good clinical efficacy. The prescription comes from "Yinchenhao Decoction" (Yinchen, rhubarb, and Shanma) in "Treatise on Febrile Diseases". This prescription has always been recognized as a famous prescription for treating damp-heat jaundice. On the basis of this prescription, Kuhuang injection is composed of 45-120 parts by weight of capillary, 45-120 parts by weight of Bupleurum radix, 15-40 parts by weight of sophora flavescens, 20-50 parts by weight of rhubarb, and 35-100 parts by weight of Daqingye. prepared intravenous solution. The injection was first approved for marketing in 1996, and the implementation standard is the national...

AI Technical Summary

Problems solved by technology

The injection was first approved for marketing in 1996, and the implementation standard is the national drug standard (new drug standardization volume 30). It is an effective treatment for jaundice-type viral infections developed by Changshu Leiyunshang Pharmaceutical Co., Ltd. (formerly the state-owned Changshu Pharmaceutical Factory). Traditional Chinese medicine injections for hepatitis (drug approval number is Z10960004), Kuhuang injections have been sold for more than 20 years, and the clinical effect is obvious, bringing recovery opportunities for patients with liver diseases. Quinone and alkaloid compounds, but the current quality standard detection method for the active ingredients of Kuhuang injection can only detect the active ingredients one by one, the detection work is cumbersome, the detection efficiency is low, and the number of active ingredients detected is limited, which is not good The quality of the reaction preparations, and the competition of similar products in the market is becoming increasingly fierce. Therefore, in order to protect the interests of patients, it is necessary to study and design a method that can simultaneously detect flavonoids and anthraquinones in Kuhuang injection on the basis of existing technologies. The detection method of class and total alkaloid compounds

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