摘要
目的评价国产注射用头孢唑林钠近3年来质量状况和存在问题。方法采用法定检验方法对2009年和2011年的抽样样品进行检验并进行部分留样的稳定性考察,将检验结果进行统计分析。结果在2009年的评价性抽验中,注射用头孢唑林钠合格率偏低,主要不合格项目为溶液的澄清度,质量状况总体评价为一般。在2011年的评价抽验中,该品种的合格率上升至97.8%,不合格项目依然为溶液的澄清度。结论国产注射用头孢唑林钠的质量有明显改善。同时稳定性考察的结果表明:丁基胶塞中释放的物质和样品的相互作用是一个长期过程,采用覆膜胶塞确实能很好地解决头孢唑林钠的澄清度问题。
Objective To evaluate the quality status of domestic cefazolin sodium for injection and existing problems. Methods According to the general requirements of national assessment programs in 2009 and 2011, use statutory testing methods and combine with the exploratory research to evaluate the quality of domestic cefazolin sodium for injection by statistical analysis of the results. Results The qualified rate is not high enough in 2009, clarity of solution was the main cause of failure. The qualified rate is 97.8% in 2011, the cause of failure was also the clarity of solution. Conclusions Through the evaluative testing, the quality status of domestic cefazolin sodium for injection has significantly improved. The results of the stability testing in samples show that the influence of medicines by some harmful substances in the rubber stopper is a lengthy process, using coated rubber stopper is able to prevent the substance that have an impact on the clarity of solution migration into the sample.
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
2013年第5期344-347,共4页
Chinese Journal of Antibiotics
关键词
注射用头孢唑林钠
抽验
质量评价
Cefazolin sodium for injection
Evaluative testing
Quality evaluation
