[关键词]
[摘要]
目的 建立注射用丹参多酚酸(SAFI)体外抗氧化活性测定方法,并对29批样品体进行测定。方法 一定浓度的SAFI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,测定其吸光度(A)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、重复性试验等方法学验证,以VC作为阳性对照,以SAFI清除DPPH自由基的半抑制浓度(IC50)和相对抗氧化活性作为衡量其抗氧化活性指标。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;29批样品IC50均值为25.26 μg/mL,相对于Vc抗氧化活性为61.8%。结论 SAFI具有较强的抗氧化活性,所建方法适用于SAFI体外抗氧化活性测定,为多维度评价中药注射剂质量提出新思路。
[Key word]
[Abstract]
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.
[中图分类号]
R965
[基金项目]
天津市科技重大专项与工程(18ZXXYSY00120)