摘要
目的:建立注射用丹酚酸A及丹酚酸A中11种元素杂质的含量测定方法并进行方法学验证。方法:样品经微波消解后,采用电感耦合等离子体质谱法(ICP-MS)进行测定,以Sc、Ge、In、Te、Bi为内标,对Li、V、Fe、Co、Ni、Cu、As、Cd、Sb、Hg、Pb元素进行含量测定。结果:11种元素的标准曲线线性关系均良好(r均大于0.990),方法检测限为0.0004~0.0198 mg·kg^(-1),注射用丹酚酸A平均回收率为99.7%~104.5%(n=9),丹酚酸A平均回收率为96.5%~106.2%(n=9)。结论:本测定方法专属性强、准确度高、重复性好、灵敏度高,可用于注射用丹酚酸A产品的质量控制,同时为其他中药注射剂中此11种元素杂质的测定提供参考。
Objective:To establish and validate a method for testing the elemental impurities of salvianolic acid A for injection and salvianolic acid A.Methods:The samples were determined by inductively coupled plasma mass spectrometry(ICP-MS)after microwave digestion.Sc,Ge,In,Te and Bi were used as the internal standards and the contents of Li,V,Fe,Co,Ni,Cu,As,Cd,Sb,Hg and Pb were determined.Results:The linear coefficients(r)of the 11 elements showed good linear relationships(r>0.990).The detection limit ranges were from 0.0004 to 0.0198 mg·kg^(-1).The average recoveries of salvianolic acid A for injection were within the range of 96.5%-106.2%(n=9).The average recoveries of salvianolic acid A were within the range of 99.7%-104.5%(n=9).Conclusion:This method is specific,accurate,reproducible and sensitive,which can be used for the quality control of elemental impurities in salvianolic acid A for injection and provides reference for the further research of other injections.
作者
刘芳芳
王章伟
方礼
刘艳红
邓双炳
余水平
刘地发
Liu Fangfang;Wang Zhangwei;Fang Li;Liu Yanhong;Deng Shuangbing;Yu Shuiping;Liu Difa(State Key I>abo-ratory of Innovative Natural Medicine and TCM Injections,Jiangxi Ganzhou 341000,China;Jiangxi Qingfeng Pharmaceutical Co.Ltd.;School of Pharmacy,Nanjing University of Chinese Medicine;Jinan University Guangdong Guangzhou)
出处
《中国药师》
CAS
2022年第1期162-166,共5页
China Pharmacist
基金
国家十三五“重大新药创制”科技重大专项(编号:2017ZX09301039)
江西省重点研发计划项目(编号:20203BBG73065)。
