目的 建立注射用丹參多酚酸（SAFI）體外抗氧化活性測定方法，并對29批樣品體進行測定。方法 一定濃度的SAFI溶液與等體積的DPPH溶液混合均勻并放置一定時間后，采用紫外可見分光光度法，測定其吸光度（A）值相對于DPPH控制液（由DPPH溶液與等體積溶劑混合）的變化情況（DPPH自由基清除情況），考察波長為517 nm，并進行空白吸收考察、專屬性考察、反應平衡時間的確定、DPPH線性考察、YQFM線性考察、精密度試驗、重復性試驗等方法學驗證，以V_C作為陽性對照，以SAFI清除DPPH自由基的半抑制濃度（IC₅₀）和相對抗氧化活性作為衡量其抗氧化活性指標。結(jié)果 方法學驗證結(jié)果表明，建立的體外抗氧化研究方法符合要求；29批樣品IC₅₀均值為25.26 μg/mL，相對于Vc抗氧化活性為61.8%。結(jié)論 SAFI具有較強的抗氧化活性，所建方法適用于SAFI體外抗氧化活性測定，為多維度評價中藥注射劑質(zhì)量提出新思路。

Objective To establish a method for the determination of antioxidant activity of Salvianolic Acids for Injection(SAFI) in vitro, and determine the antioxidant activity in vitro of 29 batches of samples. Methods After a certain concentration of SAFI 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; UV-VIS spectrophotometry was used to measure the antioxidant activity of SAFI. The measurement was the IC₅₀ and relative antioxidant activity, which cleared DPPH free radicals by Salvianolic Acids for Injection. Results The results of methodology validation showed that the established in vitro antioxidant research method met the requirements; The mean IC₅₀ of 29 samples was 25.26 μg/mL and the mean relative antioxidant activity was 61.8%. Conclusion SAFI had strong antioxidant capacity. The method was applicable to the determination of antioxidant activity of SAFI in vitro. To put forward new ideas for multidimensional evaluation the quality of traditional Chinese medicine injection.

R965

天津市科技重大專項與工程（18ZXXYSY00120）