目的 建立一測多評法（QAMS）測定注射用益氣復(fù)脈（凍干）（YQFM）中4種糖類成分含量的分析方法，并探討在蒸發(fā)光散射檢測器（ELSD）上建立QAMS分析法的可行性。方法 采用HPLC-ELSD技術(shù)，以果糖對照品為內(nèi)參物，建立其與葡萄糖、蔗糖、麥芽糖的相對校正因子（f），通過f計算YQFM中3種糖類成分；并在25批YQFM中進行驗證，同時將該方法與外標(biāo)兩點法測定的結(jié)果進行對比分析，以驗證QAMS法的適用性、可行性和重復(fù)性。結(jié)果 在一定的線性范圍內(nèi)，YQFM中4種糖類成分間的相對校正因子分別為：f_葡/果＝0.743，f_蔗/果＝0.823，f_麥/果＝0.695。QAMS法的計算結(jié)果與外標(biāo)兩點法的實測值之間存在顯著性差異，其相對偏差遠遠大于5%。結(jié)論 HPLC-ELSD外標(biāo)法能夠準(zhǔn)確地測定YQFM中4種糖類成分的含量，而在ELSD檢測器上建立的QAMS法準(zhǔn)確度不如外標(biāo)法，其原理與適用范圍需要更進一步的探究。

Objective To establish a quantitative analysis of multi-components with a single-marker (QAMS) method for the determination of four components in Yiqi Fumai Lyophilized Injection (YQFM) and the feasibility of establishing QAMS methods on ELSD was further explored. Methods Fructose was used as the internal reference substance. The relative correlation factors (f) of glucose, sucrose and maltose were calculated and established. The results were compared with those obtained by the external standard method in 25 batches of YQFM. Results Within the linear ranges, the f values of glucose, sucrose and maltose to fructose were 0.743, 0.823, 0.695. The two methods show the significant difference in assay results. Conclusion HPLC-ELSD can precisely determine contents of four carbohydrates in YQFM; meanwhile, the accuracy of QAMS method built on ELSD was inferior to that of external standard method, and the working principle of ELSD and feasible concentration range remain to be further studied.

“重大新藥創(chuàng)制”科技重大專項（No.2013ZX09402202）