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。 The inductively coupled plasma-atomic emission spectrometry (ICP-OES) method was used to determine the migration of zinc and titanium in the pharmaceutical synthetic polyisoprene washers in three different pH extraction media. The linearity of zinc was between 0.2 ~ 5.0mg / L and the content of titanium was between 0.02 ~ 0.5mg / L. The recovery of zinc was between 85% and 103% in pH3.5 and 8.0 buffer and water for injection. RSD Less than 5.0%. The test batch of 3 batches was extracted with 3 kinds of extraction media at a ratio of 6cm2: 1ml at 121 ° C for 1h, and no titanium was detected in the extract, but the zinc elements all migrated.