注射用绒促性素质量分析

目的: 评价2010年度国家评价性抽验品种注射用绒促性素的质量现状及存在问题。 方法: 按照国家评价性抽验计划总体要求,采用法定检验方法结合有效性与安全性方面的探索性研究进行样品检验,同时进行杂蛋白的基础性研究,对该品种的质量、风险及标准状况做出总体分析及评价。 结果: 法定检验显示76批样品均符合规定,合格率100%。探索性研究显示不同企业生产的样品中纯度差异较大,76批样品的结果为43.0%~86.4%,大部分样品的纯度仅有50%左右;采用水分替代原干燥失重方法,则样品的不合格率为2.6%;基础性研究显示绒促性素原料中有近10种杂蛋白。 结论: 注射用绒促性素的产品质量均能符合现行质量标准的要求;而通过探索性研究也发现了不少隐藏的质量问题,显示现行标准急需完善和提高,应增订液相色谱鉴别、纯度、酸碱度、乙肝病毒抗原和核酸等检查项目,制订合理的纯度和比活限值;修订干燥失重为水分;同时加强对绒促性素原料质量的监管,从源头上控制绒促性素的质量。

Objective: To evaluate the quality status of chorionic gonadotrophin for injection belonging to the testing varieties of national assessment in 2010 and find exsisting problems. Methods: According to the general requirements of national assessment programs,use statutory testing methods and combine with the exploratory research on the effectiveness and safety to test sample and study on the protein impurities.Meanwhile,analyze and evaluate the quality,risk and standard status of the variety. Results: The results from statutory testing showed that 76 batches of samples all were qualified and the pass rate was 100%.However,the exploratory studies showed that there were significant difference in sample purity among difference enterprises.The purity of 76 batches was 43.0%-86.4% and mostly was about 50%.In addition,the failure rate was 2.6% when the method of loss on drying was replaced by that of water determination.The results of basic study showed that there were about 10 kinds of protein impurities in the raw material of chorionic gonadotrophin. Conclusions: The product quality of chorionic gonadotrophin for injection all can meet the current standards.However,the exploratory studies also found many hidden quality problems and displayed that the present standard urgently need to be improved and enhanced.some test items such as liquid chromatography identification,purity,acidity and alkaline,hepatitis B virus antigen and nucleic acid determination need to be added,reasonable limits for purity and specific activity should be instituted and the method of the loss on drying should be amended to water determination.Meanwhile,quality supervision of the raw material should be strengthed and the quality of chorionic gonadotrophin should be controled from source.

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