中国药业2017，Vol.26Issue(13)：9-13,5.DOI:10.3969/j.issn.1006-4931.2017.13.003
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
摘要
Abstract
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Key words
ICP-AES/miriplatin/trace metal impurities/amount of residue/daily exposures分类
医药卫生引用本文复制引用
彭娟,普绍平,胡劲,邱学翁,栾春芳,缪祥宏,廖云星..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[J].中国药业,2017,26(13):9-13,5.基金项目
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]. （）
