目的 建立注射用益气复脉（冻干）（YQFM）体外抗氧化活性测定方法，并对30批样品体外抗氧化活性进行测定。方法 一定浓度的YQFM溶液与等体积的DPPH溶液混合均匀并放置一定时间后，采用紫外可见分光光度法，测定其吸收值相对于DPPH控制液（由DPPH溶液与等体积溶剂混合）的变化情况（DPPH自由基清除情况），考察波长为517 nm，并进行空白吸收考察、专属性考察、反应平衡时间的确定、DPPH线性考察、YQFM线性考察、精密度试验、重复性试验、耐用性试验等方法学验证；以YQFM随行样品作为对照，以YQFM清除DPPH自由基的半数抑制浓度（IC₅₀）和相对抗氧化强度作为衡量其抗氧化活性的指标。结果 方法学验证结果表明，建立的体外抗氧化研究方法符合要求；30批YQFM样品IC₅₀均值为4.07 mg/mL。结论 建立的方法适用于YQFM体外抗氧化活性测定，YQFM具有较强的抗氧化活性。

Objective To establish a method for the determination of antioxidant activity of Yiqi Fumai Lyophilized Injection (YQFM) in vitro, and determine the antioxidant activity in vitro of 30 batches of samples. Methods After a certain concentration of YQFM solution and equal volume of DPPH solution were evenly mixed and placed for a certain time, the change of absorption value relative to DPPH control solution (mixed by DPPH solution and equal volume solvent) (DPPH free radical scavenging) was determined by UV-VIS spectrophotometry. The wavelength was 517 nm, meanwhile, the blank absorption, specificity, reaction equilibrium time, DPPH linearity, YQFM linearity, precision test, repeatability test and durability test were used to verify the methodology; the IC₅₀ and relative antioxidant strength of YQFM were used as the indexes to measure the antioxidant activity of YQFM. Results The results of methodology validation showed that the established in vitro antioxidant research method met the requirements. The mean IC₅₀ of 30 samples was 4.07 mg/mL, which indicated that YQFM had strong antioxidant activity. Conclusion The method was applicable to the determination of antioxidant activity of YQFM in vitro, YQFM has strong antioxidant activity.

R965

天津市科技计划项目（18YFCZZC00430）