CAJ | 학술논문

目的：建立氟维司群原料药的细菌内毒素检查方法。方法以DMSO溶解氟维司群，再用细菌内毒素检查用水稀释，按《中国药典》2010年版（二部）附录Ⅺ E细菌内毒素检查法进行干扰试验；同时对DMSO溶解氟维司群的步骤进行细菌内毒素回收率试验。结果氟维司群的最大不干扰浓度为0.25 mg·mL-1，DMSO溶解液细菌内毒素回收率在100％~150％之间。结论氟维司群原料药可采用细菌内毒素检查法控制其质量。
목적：건립불유사군원료약적세균내독소검사방법。방법이DMSO용해불유사군，재용세균내독소검사용수희석，안《중국약전》2010년판（이부）부록Ⅺ E세균내독소검사법진행간우시험；동시대DMSO용해불유사군적보취진행세균내독소회수솔시험。결과불유사군적최대불간우농도위0.25 mg·mL-1，DMSO용해액세균내독소회수솔재100％~150％지간。결론불유사군원료약가채용세균내독소검사법공제기질량。
Objective To establish the bacterial endotoxins determination method for fulvestrant. Methods DMSO were added to dissolve fulvestrant,then dilute the solution with pyrogen-free water. The interference test was conducted ac-cording to the appendix Ⅺ E of Chinese Pharmacopoeia 2010 Vol.Ⅱ,the endotoxins recovery test of DMSO solution was conduct. Results Maximum nondisturb concentration of fulvestrant for bacterial endotoxins test was 0. 25 mg·mL-1 ,the endotoxins recovery of DMSO solution was 100% ~150%. Conclusion The established method of endotoxins test was fea-sible for fulvestrant.