基于脑卒中治疗作用的清开灵注射液生物活性质控方法的建立

目的 从清开灵注射液的临床应用出发,依据其改善氧化应激在治疗脑卒中过程中发挥的作用,建立基于生物活性的清开灵注射液的质量控制新方法.方法 考察清开灵注射液对超氧阴离子、羟自由基、DPPH自由基的清除以及其总抗氧化能力这4种生物活性指标的作用强度,选择线性关系和灵敏度最佳的生物指标进行方法学考察,并以该法测定3个批次的清...

Establishment of Bioactivity Assay Method for the Quality Control of Qingkailing Injection Based on Its Application in Treating Cerebral Stroke

OBJECTIVE To establish a new bioactivity assay method for the quality control of Qingkailing injection based on its effect of ameliorating oxidative stress in treating cerebral stroke. METHODS Four bioactivity indicators including investigating the activity of Qingkailing injection on scavenging superoxide anion radical, hydroxy radical and DPPH radical along with its total antioxidant capacity were assessed. Among these, the total antioxidant capacity assay with the best linearity and sensitivity was selected for further methodological investigation, and then applied to compare the quality of three batches of Qingkailing injections. RESULTS Total antioxidant capacity assay possessed the best linearity and sensitivity compared with the other 3 methods. Following methodological investigation exhibited that its intra- and inter-day precision, stability were also conformance to requirements. The biological qualities of three batches'' samples, which was represented by the concentration of trolox with equivalent activity, were similar without statistical difference. CONCLUSION The total antioxidant capacity assay is suitable for evaluating the quality of Qingkailing injection in its clinical applications associated with the antioxidant capacity, such as cerebral stroke, etc. This method also serves as a beneficial supplement for the current quality control mode.