创新药枳实总黄酮片的元素杂质研究及控制策略  

Research on the element impurities of the innovative Citrus aurantium total flavonoid tablets and its control strategy

作　　者：邓双炳 王章伟 刘芳芳 刘地发 钟仁清 陈文北 DENG Shuangbing;WANG Zhangwei;LIU Fangfang;LIU Difa;ZHONG Renqing;CHEN Wenbei(Jiangxi Qingfeng Pharmaceutical Industry Co.,Ltd.,Jiangxi,Ganzhou 341000,China)

机构地区：[1]南京中医药大学药学院,江苏南京210023 [2]江西青峰药业有限公司,江西赣州341000

出　　处：《中国医药科学》2024年第11期46-50,共5页China Medicine And Pharmacy

基　　金：江西省重点研发计划项目(20212BBG73038,20212BBG73025);江西省科技创新平台组建项目(20194AFD45002);江西省重大科技成果熟化与工程化研究项目(20232AEI92004)。

摘　　要：目的以枳实总黄酮片研发、生产全产业链的元素杂质研究为例,论述中药元素杂质控制策略。方法采用电感耦合等离子体质谱(ICP-MS)法测定枳实总黄酮片的7个元素杂质,经风险评估后,采用《中华人民共和国药典》的重金属检查法测定中间体、饮片的重金属。结果ICP-MS法的专属性、定量限、线性、精密度、准确度等均符合验证要求。测得四批成品的各元素杂质残留量均小于限度的30%;四批枳实提取物的重金属结果均小于10×10^(-6) mg/kg;三批枳实饮片的重金属结果均小于30×10^(-6) mg/kg。结论建立了一套适合中药研发、生产全产业链的元素杂质控制策略。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 

分 类 号：R284.1[医药卫生—中药学]