Qualitative and quantitative analysis of pyrrolizidine alkaloids for the entire process quality control fromSenecio scandenstoSenecio scandens-containing preparations by high performance liquid chromatography-tandem mass spectrometry

摘要

Senecio scandensas a commonly used traditional Chinese medicine that is used alone or in combination with other herbs in preparations such as QianBai BiYan tablets has attracted much attention because of its hepatotoxic pyrrolizidine alkaloids. Nowadays, most studies for pyrrolizidine alkaloids are only performed on herbs or a preparation, however, production of preparations is a dynamic process, control of toxic impurities for raw materials, or finished products cannot monitor the production process dynamically. Thus, in this study, qualitative and quantitative analysis of pyrrolizidine alkaloids for the entire process quality control fromS. scandensto its preparations was carried out with HPLC-MS/MS for the first time, which was more comprehensive and dynamic than the previous single-layer analysis. First, the species of pyrrolizidine alkaloids inS. scandenswere analyzed, and the characteristic fragmentation rules of pyrrolizidine alkaloids containing common parent nucleus were found, which can be used to identify these components rapidly in the future. Then, a quantitative method forS. scandensto QianBai BiYan tablets and other nineS. scandens-containing preparations was established, and after the medication safety speculation, all of them met the relevant safety requirements. After that, in order to ensure the stability and controllable of drug quality, the limit of pyrrolizidine alkaloids in preparations was determined according to the safe dosage that is stipulated to be the same as raw materials. Finally, the factors causing the content change of pyrrolizidine alkaloids inS. scandensfrom different source were studies, which can provide theoretical basis for selecting suitable raw materials for production.