目的 測(cè)定中/低硼硅玻璃管制注射劑瓶在5種不同提取條件下可提取物成分，評(píng)估其遷移量對(duì)藥品安全性的風(fēng)險(xiǎn)。方法 采用電感耦合等離子體發(fā)射光譜-質(zhì)譜（ICP-MS）法分析測(cè)定萃取液中24種元素含量。結(jié)果 建立24種元素標(biāo)準(zhǔn)曲線，確定檢出限及定量限，完成5種提取溶液中元素測(cè)定并評(píng)價(jià)其安全性。結(jié)論 用于天津天士力之驕藥業(yè)有限公司凍干產(chǎn)品包裝的中/低硼硅玻璃管制注射劑瓶，Li、V、Cr、Fe、Co、Ni、Cu、Zn、As、Cd、Sb、Ba、Hg、Pb 14種元素每天的遷移攝入量均低于人每日允許暴露量（PDE），遷移量不會(huì)給藥品帶來(lái)風(fēng)險(xiǎn)，因而不影響注射劑質(zhì)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.

重大新藥創(chuàng)制國(guó)家科技重大專項(xiàng)（2013ZX09402202）