目的 建立一種用于測(cè)定注射用益氣復(fù)脈（凍干）中鈉元素含量的方法。方法 采用強(qiáng)陽離子交換色譜柱（SCX），以0.05 mol/L乙酸銨（乙酸調(diào)節(jié)pH至4.8）-乙腈（50：50）為流動(dòng)相，體積流量為1.0 mL/min，柱溫30℃，撞擊器“關(guān)閉”模式，漂移管溫度為90℃，壓縮空氣流量為2.5 L/min，檢測(cè)器的增益值為1。結(jié)果 鈉元素在60～180 μg/mL范圍內(nèi)線性良好（r＝0.999 3）；準(zhǔn)確度試驗(yàn)（n＝9）平均回收率為90.4%，RSD為1.8%；注射用益氣復(fù)脈（凍干）中鈉元素質(zhì)量分?jǐn)?shù)均值為0.48%（0.33%～0.55%）。結(jié)論 所建立的方法簡單可靠，可用于測(cè)定注射用益氣復(fù)脈（凍干）中鈉元素的含量測(cè)定。

Objective To establish an HPLC-ELSD method for the determination of the content of sodium element in Yiqi Fumai Lyophilized Injection. Methods The chromatographic separation was achieved on the strong cation exchange chromatography columns (SCX). The mobile phase was 0.05 mol/L ammonium acetate solution (adjusted pH to 4.8 with acetic acid)-acetonitrile (50:50). The flow rate of the mobile phase was 1.0 mL/min. The column temperature was 30℃. The drift tube temperature was 90℃, the impactor was "OFF", the compressed air flow rate was 2.5 L/min and the gain of the detector was 1. Results Good linearity (r=0.9993)was observed in the standard curves of sodium element in the range of 60-180 μg/mL. The accuracy experiments (n=9), the average recovery of sodium element was 90.4%, RSD was 1.8%. The content of sodium element in Yiqi Fumai Lyophilized Injection was 0.48% (range:0.33%~0.55%). Conclusion The method is simple and accurate, and is applicable for determining the content of sodium element in Yiqi Fumai Lyophilized Injection.

天津市中藥注射劑關(guān)鍵技術(shù)校企協(xié)同創(chuàng)新實(shí)驗(yàn)室建設(shè)（17PTSYJC00090）