目的 測定氯化丁基膠塞在5種不同提取條件下可提取無機(jī)元素成分，評估其遷移量對藥品安全的影響，以降低干粉針的包材風(fēng)險。方法 氯化丁基膠塞分別在5種溶劑（水、15%乙醇、0.9%氯化鈉、pH 3.5磷酸緩沖液、pH 8.0磷酸緩沖液）中提取后，采用電感耦合等離子體發(fā)射光譜-質(zhì)譜法（ICP-MS）分別測定5種提取溶液中鎂（Mg）、鋁（Al）、硅（Si）、硫（S）、鈣（Ca）、鈦（Ti）、鐵（Fe）、鋅（Zn）、砷（As）、鎘（Cd）、銻（Sb）11種元素的量。結(jié)果 建立了11種元素的標(biāo)準(zhǔn)曲線，各元素的線性關(guān)系均良好（R>0.99），檢測了5種提取溶液的各元素檢出限和定量限，均滿足檢測要求，5種提取溶液中11種元素測定結(jié)果均低于限度值。結(jié)論 用于天津天士力之驕藥業(yè)有限公司凍干產(chǎn)品包裝用的氯化丁基膠塞，F(xiàn)e、Zn、As、Cd、Sb 5種元素遷移量均低于每日允許暴露量（PDE），另外6種無PDE報道的元素，評估結(jié)果顯示遷移量不會給藥品帶來安全風(fēng)險。

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.

R286.2;TQ460.4

天津市科技計劃項目（18YFCZZC00430）；天津市中藥注射劑安全性評價企業(yè)重點(diǎn)實驗室