论文部分内容阅读
目的：为２０００年版《中国药典》新增药品替硝唑注射液确定合理的内毒素限值，建立快速准确的细菌内毒素检查法。方法：根据药品、生物制品的细菌内毒素限值 Ｌ＝Ｋ／Ｍ，确定替硝唑注射液的内毒素限值；利用不同厂家生产的鲎试剂与同厂家和不同厂家生产的替硝唑注射液进行干扰试验，以确定供试品的稀释倍数和鲎试剂的灵敏度。结果：替硝唑注射液细菌内毒素限值为０．６２５ＥＵ／ｍＬ，供试品按１：２．５稀释后，选用标定灵敏度为０．２５ＥＵ／ｍＬ的鲎试剂可以检测其细菌内毒素限度。结论：对替硝唑注射液，用细菌内毒素检查法与用热原检查法所得出的结论基本一致，且前者操作简便、灵敏度高、重现性好、实用性强。
OBJECTIVE: To establish a reasonable limit of endotoxin for the new drug tinidazole injection in the 2000 edition of “Chinese Pharmacopoeia” and to establish a rapid and accurate bacterial endotoxin test. Methods: The limit of endotoxin of tinidazole injection was determined according to the bacterial endotoxin limit L = K / M of drugs and biological products. The test of tinidazole injection produced by different manufacturers and tinidazole produced by different manufacturers Liquid interference test to determine the dilution of the test sample and reagent sensitivity. Results: The limit of bacterial endotoxin in tinidazole injection was 0.625EU / mL. After diluting with 1: 2.5, the limit of detection of bacterial endotoxin was . Conclusion: For tinidazole injection, the results of bacterial endotoxin test and pyrogen test are basically the same, and the former is simple, high sensitivity, good reproducibility and practicality.