[关键词]
[摘要]
目的 测定氯化丁基胶塞在5种不同提取条件下可提取无机元素成分,评估其迁移量对药品安全的影响,以降低干粉针的包材风险。方法 氯化丁基胶塞分别在5种溶剂(水、15%乙醇、0.9%氯化钠、pH 3.5磷酸缓冲液、pH 8.0磷酸缓冲液)中提取后,采用电感耦合等离子体发射光谱-质谱法(ICP-MS)分别测定5种提取溶液中镁(Mg)、铝(Al)、硅(Si)、硫(S)、钙(Ca)、钛(Ti)、铁(Fe)、锌(Zn)、砷(As)、镉(Cd)、锑(Sb)11种元素的量。结果 建立了11种元素的标准曲线,各元素的线性关系均良好(R>0.99),检测了5种提取溶液的各元素检出限和定量限,均满足检测要求,5种提取溶液中11种元素测定结果均低于限度值。结论 用于天津天士力之骄药业有限公司冻干产品包装用的氯化丁基胶塞,Fe、Zn、As、Cd、Sb 5种元素迁移量均低于每日允许暴露量(PDE),另外6种无PDE报道的元素,评估结果显示迁移量不会给药品带来安全风险。
[Key word]
[Abstract]
Objective To determine the extractable inorganic elements of chloridized butyl rubber stopper under five different extraction conditions and to evaluate the risk of drug safety by the amount of migration. Methods The extraction solution of chloridized butyl rubber stopper in water, 15% ethanol, 0.9% sodium chloride, pH 3.5 phosphate buffer solution, pH 8.0 phosphate buffer solution, respectively, inductively coupled plasma emission spectrometry-mass spectrometry (ICP-MS) was used to detect the assay of Mg, Al, Si, S, Ca, Ti, Fe, Zn, As, Cd, Sb. Results Establish the standard curves of 11 elements, the linear of each element was good (R>0.99), the detection limit and quantitative limit of each element in five extraction solutions met the detected requirement, the result of 11 elements in five extraction solutions was less than limited value. Conclusion Chloridized butyl rubber stopper for packing freeze -dried product of Tianjin Tasly Pride Pharmaceutical Co.,Ltd., the amountof migration of Mg, Fe, Zn, As, Cd and Sb was lower than permitted daily exposure (PDE), the other six elements without PDE report, through evaluation, the amount of migration does not pose a risk to drugs.
[中图分类号]
R286.2;TQ460.4
[基金项目]
天津市科技计划项目(18YFCZZC00430);天津市中药注射剂安全性评价企业重点实验室