药用聚异戊二烯垫片中锌、钛元素的提取、迁移和测定

Extraction, Migration and Determination of Zn and Ti Migration in the Polyisoprene Liners for Pharmaceutical Use

采用电感离子耦合等离子体发射光谱（ICP-OES）法,建立了测定药用合成聚异戊二烯垫片中锌、钛元素在3种不同pH值提取介质中迁移量的方法。锌元素在0.2~5.0mg/L、钛元素在0.02~0.5mg/L范围内线性关系良好,在pH3.5和8.0缓冲液及注射用水中的回收率均介于85%~103%,RSD小于5.0%。受试3批垫片用3种提取介质以6cm2∶1ml的比例在121℃提取1h,提取液中均未检出钛元素,但锌元素均发生迁移。

A inductively coupled plasma optical emission spectrometry（ICP-OES） method was established for the determination of zinc（Zn） and titanium（Ti） migrated from the synthetic polyisoprene liners for pharmaceutical use to three extraction media with different p H values. The calibration curves were linear in 0.2—5.0 mg/L for Zn and 0.02—0.5 mg/L for Ti. Their recoveries were between 85%—103% wiht RSDs lower than 5.0% in three extraction media（p H 3.5 and 8.0 buffers as well as water for injection）. When three batches of liners were extracted with above media at 121 ℃ for 1 h in a ratio of liner to extractant of 6 cm2∶1 ml, Ti was no detected but the migration of Zn occurred in all three extractants.