Objective To discuss the control strategy of elemental impurities in Chinese materia medica by taking the research of elemental impurities in the whole industrial chain of R&D and production of Citrus aurantium total flavonoid tablets as an example.Methods 7 elemental impurities in Citrus aurantium total flavonoid tablets were determined by inductively coupled plasma mass spectrometry(ICP-MS).After risk assessment,heavy metals in intermediates and decoction pieces were determined by heavy metal inspection method in Pharmacopoeia of the People's Republic of China.Results The specificity,quantitative limit,linearity,precision,and accuracy,etc.of ICP-MS method all met the verification requirements.The residual amount of impurities in four batches of finished products was all less than 30%of the limit.The results of heavy metals in four batches of Fructus Aurantii Immaturus extracts were all less than 10×10-6 mg/kg.The results of heavy metals in three batches of Fructus Aurantii Immaturus decoction pieces were all less than 30×10-6 mg/kg.Conclusion A set of elemental impurities control strategies suitable for the whole industrial chain of R&D and production in Chinese materia medica is established.
关键词
中药/元素杂质/控制策略/枳实总黄酮片/电感耦合等离子体质谱
Key words
Chinese materia medica/Elemental impurities/Control strategy/Citrus aurantium total flavonoid tablets/Inductively coupled plasma mass spectrometry
维普
万方数据