电感耦合等离子体发射光谱-质谱法测定硼硅玻璃管制注射剂瓶中的金属元素  

Evaluation of the safety of metallic elements in borosilicate glass controlled injection bottle by ICP-MS

作　　者：鞠爱春 潘超 李海燕 岳洪水 

机构地区：[1]天津天士力之骄药业有限公司,天津300400

出　　处：《药物评价研究》2017年第11期1569-1575,共7页Drug Evaluation Research

基　　金："重大新药创制"国家科技重大专项(2013ZX09402202)

摘　　要：目的测定中/低硼硅玻璃管制注射剂瓶在5种不同提取条件下可提取物成分,评估其迁移量对药品安全性的风险。方法采用电感耦合等离子体发射光谱-质谱(ICP-MS)法分析测定萃取液中24种元素含量。结果建立24种元素标准曲线,确定检出限及定量限,完成5种提取溶液中元素测定并评价其安全性。结论用于天津天士力之骄药业有限公司冻干产品包装的中/低硼硅玻璃管制注射剂瓶,Li、V、Cr、Fe、Co、Ni、Cu、Zn、As、Cd、Sb、Ba、Hg、Pb 14种元素每天的迁移摄入量均低于人每日允许暴露量(PDE),迁移量不会给药品带来风险,因而不影响注射剂质量。Objective Determination of extractable components in medium/low borosilicate glass controlled injection bottles under 5 different extraction conditions, assess the risk of drug safety by the amount of migration. Methods Determination of 24 elements in extraction solution by ICP-MS. Result Establish the standard curves of 24 elements, and the detection limit and quantitative limit were determined. The determination of the elements in the 5 extraction solutions was completed and their safety was evaluated. Conclusion Medium/low borosilicate glass injection bottle for packing freeze-dried products of Tianjin Tasly Pride Pharmaceutical Co., Ltd., the daily intake of Li、V、Cr、Fe、Co、Ni、Cu、Zn、As、Cd、Sb、Ba、Hg、Pb was lower than permitted daily exposure, the amount of migration does not pose a risk to drugs, therefore, the injection quality is not affected.

关 键 词：中/低硼硅玻璃管制注射剂瓶 电感耦合等离子体发射光谱-质谱 金属元素 注射剂安全性 

分 类 号：R965.2[医药卫生—药理学]