疏血通注射液评价性抽验结果与质量分析

目的:了解疏血通注射液的质量现状及存在问题。方法:采用法定检验方法结合探索性研究检验31批样品,统计分析检验结果,对疏血通注射液的质量现状进行评价。结果:法定检验显示全检合格率为96.8%;探索性研究显示6项非标检验使质量风险指数提高了13.6%。结论:地龙药材的生物胺与重金属铅的测定结果均明显高于水蛭药材,应注意监管;活性测定结果与含量测定结果无明显相关性,质量标准应增加活性测定项。

Sampling Results and Quality Analysis of Shuxuetong Injection

Objective:To evaluate the quality status of shuxuetong injection and exsisting problems.Methods:Use statutory testing methods and combine with the exploratory research to examine samples,evaluate the quality status of shuxuetong injection by statistical analysis of the results.Results:Statutory testing result have shown that the pass rate is 96.8%,6 exploratory studies increased the risk index by 13.6%.Conclusion:More biogenic amine(BA)and Pb was determined in pheretima than hirudo;The correlativity of antithrombin activity and the content test in shuxuetong injection was indistinctively.