电感耦合等离子体-质谱法测定注射用益气复脉（冻干）中的22种无机元素

目的 采用电感耦合等离子体-质谱（ICP-MS）法建立注射用益气复脉（冻干）中22种无机元素的含量测定方法。方法 以微波消解法处理样品，硝酸为消解试剂，样品经微波消解后，采用电感耦合等离子体质谱仪测定注射用益气复脉（冻干）中22种无机元素（Li、B、Mg、Al、Si、S、Ti、V、Cr、Fe、Ni、Co、Zn、Ga、As、Sr、Mo、Cd、Sb、Ba、Ce、Pb）的量，并进行专属性、线性关系、精密度、重复性、回收率考察；完成6批制剂中22种元素测定并评价其安全性。结果 建立22种元素标准曲线，确定检出限及定量限，方法学验证均符合要求。6批供试品中已检出元素含量均远低于安全限值，对产品质量不会造成安全风险。结论 该方法简便、快速、准确，可用于测定注射用益气复脉（冻干）中22种元素的含量，为其质量控制、安全性评价提供一定参考。

Determination of 22 kinds inorganic elements in Yiqi Fumai Lyophilized Injection by ICP-MS

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.