期刊文献+

常规法与细菌集菌法复试无菌检测中可疑阳性样品的结果比较

Results Comparison of Retesting the Doubtful Positive Samples with Conventional Test and Bacteria-collecting Test
下载PDF
导出
摘要 目的:建立鉴定样品灭菌彻底与否的方法,以杜绝药物医疗事故的发生。方法:将常规法检测中的可疑阳性样品(5个品种、20批次),用常规法和细菌集菌法进行复试。结果:常规法复试的阳性率为0;细菌集菌法复试的阳性率为65.0%,其中20%甘露醇注射液为87.5%,5%葡萄糖注射液为66.6%,10%葡萄糖注射液为50.0%。结论:细菌集菌法不受外环境污染,能高效、快速、准确地检验样品的灭菌情况,是药物制剂质量控制的好方法。 Objective: To develop a method for truly identifying whether the sample sterilization is absolute to avoid the medical accidents. Methods: The doubtful positive samples with conventional sterility test were retested with conventional sterility test and bacteria-collecting sterility test,including five breeds and twenty batches. Results: The positive rates were 0 for conventional retesting, 65.0% for bacteria-collecting retesting, 87.5% for 20% mannitol injection, 66.6% for 5% glucose injection, 50.0% for 10% glucose, respectively. Conclusion: The closed bacteria-collecting sterility testing isn't polluted by environment and it can identify sterilization of the sample high efficiently, rapidly and accurately. The test is a good way to control the quality of drug preparation.
出处 《中国药业》 CAS 2005年第9期42-43,共2页 China Pharmaceuticals
关键词 常规法 细菌集菌法 可疑阳性样品 复试 conventional sterility test bacteria-collecting sterility test doubtful positive sample retest
  • 相关文献

相关作者

内容加载中请稍等...

相关机构

内容加载中请稍等...

相关主题

内容加载中请稍等...

浏览历史

内容加载中请稍等...
;
使用帮助 返回顶部