血栓通注射剂质量分析

Quality Analysis for Xueshuantong Injections

目的通过对5个生产企业84批次血栓通注射剂的抽验,评价血栓通注射剂的质量状况和现行质量标准的可行性。方法通过法定标准检验,结合药品安全性、稳定性及有效性等探索性研究,综合评价其质量状况。结果 84批次血栓通注射剂样品按现行法定标准检验,合格率为100%;探索性研究检验合格率仍为100%。结论血栓通注射剂的质量状况较好,现行标准可行。

OBJECTIVE To evaluate the quality of Xueshuantong injections and the feasibility of the current legal quality stand- ards through testing 84 batches of samples from five factories. METHODS The samples were tested according to the legal quality standards, combined with the exploration of the safety, stability and effectiveness of the drug to comprehensively evaluate its quality. RESULTS The qualified rate of the 84 batches of samples of Xueshuantong injections was 100% according to the current legal quality standards ; the qualified rate by exploratory examination was 100%. CONCLUSION The quality status of Xueshuantong injections is good, and the current quality standard is feasible.