CAJ | 학술논문

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Ⅺ E 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。
목적：삼고 USP、EP，탐토병건립주석산장춘서빈적세균내독소표준여검사방법（응효법）。방법안《중국약전》（2010년판）이부부록Ⅺ E 세균내독소검사방법진행。결과경험증，주석산장춘서빈적세균내독소한치학정위 L ＜2.0IU/mg（이장춘서빈계），통과희석법가소제간우，무간우농도위0.035mg/mL（이장춘서빈계）。결론가안차표준채용본법대본품진행세균내독소검사。
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.