药用滑石粉酸中可溶物中杂质元素的分析及探讨  

Analysis and Discussion of Impurity Elements in Acid-soluble Substances in Medical Talc Powder

作　　者：余少文[1] 陈蕾[2] 王学清[3] 陈英[1] Yu Shaowen;Chen Lei;Wang Xueqing;Chen Ying(Guangdong Institute for Drug Control,Guangzhou 510700,China;Chinese Pharmacopoeia Commission,Beijing 100061,China;School of Pharmaceutical Sciences,Peking University,Beijing 100191,China)

机构地区：[1]广东省药品检验所,广州510700 [2]国家药典委员会,北京100061 [3]北京大学药学院,北京100191

出　　处：《中国药事》2020年第7期820-824,共5页Chinese Pharmaceutical Affairs

摘　　要：目的:通过能谱扫描电镜与ICP-AES的联合应用,考察滑石粉酸中可溶物项目控制的必要性与可行性。方法:通过扫描电子显微镜/X-射线能谱仪(SEM/EDS)对滑石粉酸中可溶物的主要金属元素构成进行分析,并采用电感耦合等离子体原子发光光谱法(ICP-AES)定量测定酸中可溶物中的钙、镁、铁等主要金属元素杂质。结果:扫描电子显微镜/X-射线能谱仪(SEM/EDS)发现滑石粉酸中可溶物普遍存在镁元素,但现行各国药典中均未对可能存在的酸溶性镁盐进行控制。增加ICP-AES测定法,对滑石粉酸中可溶的钙、镁、铁进行考察,并经方法学验证,方法可行。结论:(1)不同来源的滑石粉,酸中可溶物的金属元素含量构成比例有所不同,有必要对酸中可溶物进行控制;(2)ICP-AES可对滑石粉酸中可溶物的钙、镁、铁等主要金属元素杂质进行质量控制及评价。Objective:To explore the necessity and feasibility of controlling acid-soluble substances in talc with combined applications of scanning electron microscopy/energy dispersive x-ray spectrometry(SEM/EDS)and ICP-AES.Methods:SEM/EDS was applied to analyze the components of major metal elements in acid-soluble substances in talc.Calcium,magnesium and iron contents were quantified by ICP-AES.Results:Scanning electron microscope/energy dispersive X-ray spectrometer(SEM/EDS)found that magnesium was commonly found in the acid-soluble substances of talc,but the current Pharmacopoeias do not control the magnesium in acid-soluble substances.The ICP-AES method was added to investigate calcium,magnesium and iron in the acid-soluble substance of talc,and the method was verified to be feasible by methodology.Conclusion:(1)The components of metal elements in acid-soluble substances may vary depending on the origin of talc,so it is necessary to control the acid-soluble substances in talc.(2)ICP-AES could be used for the quality control and evaluation of the major metal elements,such as calcium,magnesium and iron,in acid-soluble substances in talc.

关 键 词：滑石粉 酸中可溶物 金属元素杂质 扫描电子显微镜/X-射线能谱仪(能谱扫描电镜) 电感耦合等离子体原子发光光谱法(ICP-AES) 

分 类 号：R917[医药卫生—药物分析学]