目的 采用電感耦合等離子體-質(zhì)譜（ICP-MS）法建立注射用益氣復(fù)脈（凍干）中硫元素的含量測定方法。方法 以微波消解法處理樣品，硝酸為消解試劑，樣品經(jīng)微波消解后，以鍺（Ge）元素為內(nèi)標(biāo)元素，采用ICP-MS法測定藥液中硫元素的量。結(jié)果 硫元素質(zhì)量濃度在1～15 μg/mL內(nèi)線性關(guān)系良好（r=0.999 0）；準(zhǔn)確度試驗（n=6）平均回收率為95.4%，RSD值為5.9%；結(jié)論 該方法簡便、快速、準(zhǔn)確，可用于測定注射用益氣復(fù)脈（凍干）中硫元素的含量，為其質(zhì)量控制、安全性評價提供一定參考。

Objective To establish a method for determination of sulfur content in Yiqi Fumai Lyophilized Injection by ICP-MS. Methods The samples of Yiqi Fumai Lyophilized Injection with nitric acid system as digestion reagent were eliminated by microwave, the sulfur content of which were determined by ICP-MS using the Ge element as the internal standard. Result Good linearity (r=0.999 0) was observed in the standard curves of sulfur element in the range of 1~15 μg/mL; The average recovery and RSD value of sulfur element in the accuracy experiments (n=6) were 95.4% and 5.9%, respectively. Conclusion The method is simple, rapid and accurate, which can be used to determine the content of sulfur in Yiqi Fumai Lyophilized Injection, and provide the reference for its quality control and safety evaluation.

天津市中藥注射劑關(guān)鍵技術(shù)校企協(xié)同創(chuàng)新實驗室建設(shè)項目（17PTSYJC00090）；天津市中藥注射劑新技術(shù)企業(yè)重點實驗室