摘要
本文参考美国药典ⅩⅩⅢ（１９９５）规定，结合我国国情，将２０％、２５％、５０％葡萄糖注射液的细菌内毒素限值（Ｌ）初定为５ＥＵ／ｍｌ。用不同灵敏度、不同批号的鲎试剂，在严格标准操作的条件下，对３种不同规格浓度的葡萄糖注射液按有效浓度范围稀释后，进行干扰试验考察。２０％、２５％葡萄糖注射液经２倍稀释，５０％葡萄糖注射液经４倍稀释即对细菌内毒素检查法无干扰作用。对１５７批３种不同规格的葡萄糖注射液进行了热原检查及细菌内毒素检查的对比试验，两法符合率为１００％。
The limits of 20%、25% and 50% of glucose injection is supposed to be 5. 0EU/ml according to the condition of China and USP Ⅹ Ⅹ Ⅲ. The inhibition or enhancement test is carried out on these three strength of glucose injection with 3 strength of tachypleus amebocyte lysate (TAL), the result shows that the concentration of 10% and 12. 5 % of glucose has no inhibition or enhancement acting. The comparison test between bacterial endotoxins test and pyrogen test is carried out for 157 lots of these 3 strength of glucose injection and the coincidental rate is 100 % .
出处
《药物分析杂志》
CAS
CSCD
北大核心
1996年第5期305-308,共4页
Chinese Journal of Pharmaceutical Analysis
关键词
干扰试验
细菌内毒素
葡萄糖注射液
检测
interfering test, bacterial endotoxins test, valid concentration, limit
