酒石酸长春瑞滨的细菌内毒素检查方法验证

Verification of the bacterial endotoxin inspection method of vinorelbine tartrate

目的参考USP、EP,探讨并建立酒石酸长春瑞滨的细菌内毒素标准与检查方法(凝胶法)。方法按《中国药典》(2010年版)二部附录ⅪE细菌内毒素检查方法进行。结果经验证,酒石酸长春瑞滨的细菌内毒素限值确定为L<2.0IU/mg(以长春瑞滨计),通过稀释法可消除干扰,无干扰浓度为0.035mg/mL(以长春瑞滨计)。结论可按此标准采用本法对本品进行细菌内毒素检查。

Objective To explore and establish the standard and inspection method （gel） of vinorelbine tartrate’ bacterial endotoxin refer to USP, EP. Methods According to the“Chinese Pharmacopoeia”（2010 Edition） two appendix XIE’bacterial endotoxin inspection method. Results Through verification, the vinorelbine tartrate’ bacterial endotoxin limit values determined L 〈 2.0IU/mg （taken Changchun vinorelbine meter）, and eliminated interference by dilution method, no interference concentration was 0.035mg/mL（taken Changchun vinorelbine meter）. Conclusion We can make the bacterial endotoxin test according to this standard by adopting the method for this product.