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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 and existing problems of gonadotropin for injection in national evaluation test varieties in 2010. Methods: In accordance with the general requirements of the national appraisal sampling plan, using the statutory test method combined with the exploratory research on effectiveness and safety to carry out the sample test, and at the same time carry out the basic research of the hybrid protein and do the quality, risk and standard status of the variety Out of the overall analysis and evaluation. Results: Statutory test showed that 76 batches of samples were in compliance with the passing rate of 100%. Exploratory studies show that the purity of samples produced by different enterprises is quite different. The results of 76 batches of samples are 43.0% (86.4%, most of the samples are only about 50% pure). When moisture is used instead of the original dry weight loss method, The pass rate was 2.6%, and the basic research showed that there were nearly 10 kinds of impurity proteins in the raw materials of vellum.Conclusion: The quality of the products of injection velvet hormone can meet the requirements of the current quality standards; A lot of hidden quality problems, indicating the urgent need to improve and improve the current standard should be added to identify the liquid chromatography, purity, pH, hepatitis B virus antigen and nucleic acid and other inspection items to develop a reasonable purity and specific activity limits; revised loss on drying Moisture; at the same time strengthen the monitoring of the quality of cashmere hormone raw materials, from the source to control the quality of cashmere hormone.