紫杉醇注射液细菌内毒素检查法研究

Study on Bacterial Endotoxins Test for Paclitaxel Injection

目的:在现行的国家标准的基础上对紫杉醇注射液细菌内毒素检查法进行再研究。方法:按中国药典2000年版二部,确定合理的紫杉醇注射液内毒素限值,并研究紫杉醇注射液对细菌内毒素与鲎试剂反应的干扰情况,以确定其最大不干扰试验浓度。结果:根据临床实际应用情况,将紫杉醇注射液的内毒素限值定为0.4EU/mg,使用本品现有的国家标准所确定的内毒素限值不变;同时对四川太极制药有限公司生产的三批紫杉醇注射液研究证明,本品稀释至0.075mg/ml浓度(对应使用λ=0.03EU/ml的鲎试剂)时对两个不同厂家生产的鲎试剂的干扰试验符合要求。结论:紫杉醇注射液细菌内毒素检查法还需要另用不同药厂生产的样品及不同鲎试剂厂生产的鲎试剂作进一步研究,考察干扰试验结果的重现性。

Objective ：On the basis of the national standard ,we have studied on bacterial endotoxins test for Paclitaxel Injection. Methods：The limit of bacterial endotoxins in this product was defined according to ChP2000. We have studied the interference to bacterial endotoxins test by Paclitaxel Injection in order to confirm the maximum noninterference concentration. Results： The most suitable limit of bacterial endotoxins in Paclitaxel Injection was 0.4EU·mg^-1. It was proved that the maximum noninterference concentration was 0. 075mg·ml^-1 by three batches of products of Taiji Pharmaceutical Ltd. Conclusion：The standard for the bacterial endotoxins test of Paclitaxel Injection had better use other manufacturer＇s products to study again.