虎贞痛风胶囊中重金属含量的测定  

Determination of heavy metal content in Huzhen Gout Capsule

作　　者：利奕成[1] 罗勇[1] 杨珂[1] 钱垂文[1] 黄立[1] 林潮平[2] 王一飞[1] 

机构地区：[1]暨南大学生物医药研究开发基地,广州510632 [2]暨南大学实验技术中心

出　　处：《中国卫生检验杂志》2009年第7期1507-1508,共2页Chinese Journal of Health Laboratory Technology

基　　金：广州市科技型中小企业创新基金项目(2008V41C201)

摘　　要：目的:了解国家六类新药虎贞痛风胶囊重金属含量,建立质控体系,为临床中的安全用药提供科学依据。方法:采用湿法消化法对样品进行前处理,使用ICP-AES进行重金属检测分析。结果:测出虎贞痛风胶囊中含有微量的重金属成分,结果分别是:镉(Cd)≤0.02 mg/kg,铜(Cu)≤4.2 mg/kg,铬(Cr)≤0.16 mg/kg;锌(Zn)≤1.6 mg/kg;铅(Pb)≤0.6 mg/kg。砷(As)未检出。结论:虎贞痛风胶囊含有微量重金属成分,但其含量远低于国家相关标准。对该中药制剂建立可行的重金属检测体系,是完成其安全、有效、稳定、可控目标的一个部分,也为虎贞痛风胶囊符合国际化公认标准奠定基础。Objective：To determine the heavy metal content of the National Grade VI New Medicine ＂ Huzhen gout capsule＂ for the establishment of a quality control system and provision of scientific base for safe medication and its future internationalization. Methods： Pre - treatment of sampling by wet digestion method and heavy metal analysis by ICP - AES. Results： There are minute quantity of heavy metal in the Huzhen gout capsule with the following result： Cd ≤0. 02 mg/kg, Cu ≤4. 2 mg/kg, Cr ≤ 0. 16 mg/kg, Zn≤1. 6 mg/kg, Pb≤0.6 mg/kg and no As was found. Condusion：Huzhen gout capsule contains minute quantity of heavy metal. However, the content is far lower than the relevant national standard. To establish a feasible heavy metal determination system is part of the work to build a safe, effective, stable and controllable object and will establish a foundation for it to get international recognition.

关 键 词：虎贞痛风胶囊 重金属 含量测定 ICP-AES 

分 类 号：O657.31[理学—分析化学]