CAJ | 학술논문

目的：建立注射用埃索美拉唑钠无菌和细菌内毒素的检查法。方法采用中国药典2010年版二部附录无菌和细菌内毒素检查法。结果样品管无菌生长，6株阳性对照菌生长良好。注射用埃索美拉唑钠稀释至浓度为1.0 mg/mL时对细菌内毒素检查法无干扰作用。结论采用薄膜过滤法进行注射用埃索美拉唑钠的无菌检查，使用细菌内毒素检查法检查注射用埃索美拉唑钠中的细菌内毒素是可行的。
목적：건립주사용애색미랍서납무균화세균내독소적검사법。방법채용중국약전2010년판이부부록무균화세균내독소검사법。결과양품관무균생장，6주양성대조균생장량호。주사용애색미랍서납희석지농도위1.0 mg/mL시대세균내독소검사법무간우작용。결론채용박막과려법진행주사용애색미랍서납적무균검사，사용세균내독소검사법검사주사용애색미랍서납중적세균내독소시가행적。
Objective To establish bacterial endotoxin test and sterility test for esomeprazole sodium for injection. Methods According to the method of determination of bacterial endotoxin and sterility approved by Chinese Pharmacopoeia 2010 edition. Results All of six strains positive control tubes reveal growth of micro-organism and the substance control gives no evidence of growth.The interference on the determination of bacterial endotoxin can be excluded when esomeprazole sodium for injection was diluted 1.0mg/mL. Conclusion It is feasible to detect the bacterial endotoxin and microbial contamination of esomeprazole sodium for injection by the method of determination of bacterial endotoxin and membrane filtration,respectively.