电感耦合等离子体放射光谱法测定抗癌药物米铂中微量金属杂质及其安全性评价  

Determination of Trace Metal Impurities in Anti-Cancer Drug of Miriplatin by ICP-AES and Its Safety

作　　者：彭娟[1,2] 普绍平 胡劲[2] 邱学翁 栾春芳 缪祥宏 廖云星 Peng Juan Pu Shaoping Hu Jin Qiu Xueweng Luan Chunfang Miao Xianghong Liao Yunxing(I. Guiyan Phamaceuitical Co., Ltd., Kunming, Yunnan, China 650106 Kunming University of Science and Technology, Kunming, Yunnan, China 650093)

机构地区：[1]昆明贵研药业有限公司,云南昆明650106 [2]昆明理工大学,云南昆明650093

出　　处：《中国药业》2017年第13期9-13,共5页China Pharmaceuticals

基　　金：云南省科技型中小企业技术创新资金项目[2014SC016];云南省昆明市科技计划项目[2012-03-01-B-H-04-0006]

摘　　要：目的建立测定抗癌药物米铂中微量金属杂质的电感耦合等离子体放射光谱(ICP-AES)法,为评价米铂的金属残留对人体的影响提供方法。方法试样于600℃灼烧后经HCl-HNO3溶解,用ICP-AES法直接测定抗癌药物米铂中的微量金属杂质。结果对分析方法进行了验证,线性相关系数(r)为0.99 91~1.000 0,方法精密度为1.1%~5.3%,准确度为85.22%~109.60%,均符合药典要求;通过测定,计算出了钯(Pd)、铑(Rh)、铱(Ir)、钌(Ru)、镍(Ni)、铬(Cr)、铜(Cu)、锰(Mn)、铁(Fe)、锌(Zn)的实际日接触量,远小于允许日接触量(PDE)。结论 ICP-AES法简便、快速、准确,米铂中的金属残留物被充分除去,该药进入人体后,金属杂质的微量残留不会影响人体健康,无安全隐患。Objective To establish an ICP-AES method for the determination of the anticancer drug of miriplatin to evaluate the effect of the metal residue on the human body. Methods The samples were ignited in 600 ℃ and then dissolved with HCl-HNO3. Trace impurities in the anticancer drug of Miriplatin were determined by ICP-AES. Results The analytical method of miriplatin was validated. The linear correlation coefficient （ r ） was 0. 9991-1. 0000, the precision was 1. 1% -5. 3% and the accuracy was 85. 22% -109. 60%, which conforms to the requirements of Chinese Pharmacopoeia. By the determination of the metal residues in the samples, the calculated actual daily exposure and concentration of the metal Pd, Rh, Ir, Ru, Ni, Cr, Cu, Mn, Fe and Zn were much less than the permitted daily exposures （ PDE ） . Conclusion The ICP-AES method is simple, rapid and accurate. The metal residues can de adequately removed from the active pharmaceutical ingredients. The micro metal residues will not affect human health and lead to the safety hazard.

关 键 词：电感耦合等离子体放射光谱法 米铂 微量金属杂质 残留量 日接触量 

分 类 号：R927.11[医药卫生—药学] R979.1