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22種無(wú)機(jī)元素的含量測(cè)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，采用電感耦合等離子體質(zhì)譜儀測(cè)定注射用益氣復(fù)脈（凍干）中22種無(wú)機(jī)元素（Li、B、Mg、Al、Si、S、Ti、V、Cr、Fe、Ni、Co、Zn、Ga、As、Sr、Mo、Cd、Sb、Ba、Ce、Pb）的量，并進(jìn)行專(zhuān)屬性、線性關(guān)系、精密度、重復(fù)性、回收率考察；完成6批制劑中22種元素測(cè)定并評(píng)價(jià)其安全性。結(jié)果 建立22種元素標(biāo)準(zhǔn)曲線，確定檢出限及定量限，方法學(xué)驗(yàn)證均符合要求。6批供試品中已檢出元素含量均遠(yuǎn)低于安全限值，對(duì)產(chǎn)品質(zhì)量不會(huì)造成安全風(fēng)險(xiǎn)。結(jié)論 該方法簡(jiǎn)便、快速、準(zhǔn)確，可用于測(cè)定注射用益氣復(fù)脈（凍干）中22種元素的含量，為其質(zhì)量控制、安全性評(píng)價(jià)提供一定參考。

Objective To establish a method for determination of 22 kinds inorganic element in Yiqi Fumai Lyophilized Injection by ICP-MS. Methods The samples with nitric acid system as digestion reagent were eliminated by microwave, determination of 22 kinds inorganic elements (Li, B, Mg, Al, Si, S, Ti, V, Cr, Fe, Ni, Co, Zn, Ga, As, Sr, Mo, Cd, Sb, Ba, Ce, and Pb) content in Yiqi Fumai Lyophilized Injection by ICP-MS. Specificity, linearity, precision, repeatability and recovery were investigated. Results The standard curve of 22 elements was established; Determination of LOD, LOQ; The determination of 22 elements in 6 batches of preparations was completed and their safety was evaluated. The safety of 22 elements in 6 batches of preparations was evaluated. The standard curves of 22 elements were established, and the limits of detection and quantification were determined. The detected element content in 6 batches of tested products were far below the safety limit, which will not cause safety risk to product quality. Conclusion The method is simple, rapid and accurate, which can be used to determine the content of 22 elements in Yiqi Fumai Lyophilized Injection, and providing a reference for its quality control and safety evaluation.

R284.1