注射用盐酸洛拉曲克细菌内毒素的检查研究

Study on Bacterial Endotoxin Test to Nolatrexed Hydrochloride for Injection

目的 建立注射用盐酸洛拉曲克细菌内毒素检查法。方法 采用《中国药典》2 0 0 0年版附录细菌内毒素检查法。结果 注射用盐酸洛拉曲克浓度为 0 .4mg·ml-1,用灵敏度为 0 .2 5Eu·ml-1的鲎试剂检测细菌内毒素无干扰因素的影响。结论 注射用盐酸洛拉曲克可应用鲎试剂进行细菌内毒素检查。

Aim To establish detection method for bacterial endotoxin in nolatrexed hydrochloride for injection.Methods According to the bacterial endotoxin test in Chinese pharmacopoeia 2000 edition.Results It was proved that the maximum noninterference concentration was 0.4mg·ml -1 and the sensitivity of TAL was 0.25Eu·ml -1.Conclusion The results suggest that bacterial endotoxin test is suitable for the detection of endotoxin in nolatrexed hydrochloride for injection.