摘要
目的通过注射用尿激酶的全国抽验[1],全面了解国内注射用尿激酶的质量状况及安全隐患。方法采用《中国药典》标准[2]进行质量分析,同时用酶联免疫吸附法(ELISA)和荧光定量法(PCR)检测病毒[3]进行安全性评价。结果在全国共抽取58批样品,涉及9个生产企业,按《中国药典》2005年版检验,合格率为87.9%。不合格批次共7批,涉及2个生产企业,不合格项目为[效价]、[无菌]、[干燥失重],安全性评价合格率为100%。结论现行药典标准能较好地控制产品质量,安全性评价能较好的监控产品的安全性。
Objective Through a national testing to understand the quality and safety of Urokinase for Injection. Methods A method for the quality analysis of Urokinase for Injection was from Chp. The ELISA and quantitative-PCR methods were used for the safety evaluation. Results In the 58 samples from 9 manufacturing enterprises,the pass rate was 87.9%. It included 7 batches and 2 manufacturing enterprises. The failed projects were titer,sterile and moisture. The pass rate of safety evaluation was 100%. Conclusion The current standard to control the quality and the safety evaluation to monitor the safety of Urokinase for Injection were effective.
出处
《中国药事》
CAS
2010年第9期903-905,共3页
Chinese Pharmaceutical Affairs
关键词
注射用尿激酶
抽验
质量分析
病毒检测
安全评价
Urokinase for Injection
testing
quality analysis
virus detection
safety assessment
