广东药学院学报
廣東藥學院學報
엄동약학원학보
ACADEMIC JOURNAL OF GUANGDONG COLLEGE OF PHARMACY
2014年
4期
459-462
,共4页
注射用维生素C%细菌内毒素%动态浊度法鲎试验%干扰试验
註射用維生素C%細菌內毒素%動態濁度法鱟試驗%榦擾試驗
주사용유생소C%세균내독소%동태탁도법후시험%간우시험
vitamin C for injection%bacterial endotoxins%kinetic turbidimetric limulus test%interference test
目的：建立定量检测注射用维生素C中细菌内毒素的方法。方法采用动态浊度法鲎试验对样品中的细菌内毒素进行检测,并与凝胶法测定结果相比较。结果注射用维生素C在稀释至8 mg·mL-1时对细菌内毒素检查有明显的干扰作用,而在4 mg · mL-1或以下质量浓度时则无干扰作用；所测样品中细菌内毒素含量均低于0.02 EU·mg-1,与凝胶法测定结果一致。结论动态浊度法鲎试验可应用于定量检测注射用维生素C中的细菌内毒素。
目的：建立定量檢測註射用維生素C中細菌內毒素的方法。方法採用動態濁度法鱟試驗對樣品中的細菌內毒素進行檢測,併與凝膠法測定結果相比較。結果註射用維生素C在稀釋至8 mg·mL-1時對細菌內毒素檢查有明顯的榦擾作用,而在4 mg · mL-1或以下質量濃度時則無榦擾作用；所測樣品中細菌內毒素含量均低于0.02 EU·mg-1,與凝膠法測定結果一緻。結論動態濁度法鱟試驗可應用于定量檢測註射用維生素C中的細菌內毒素。
목적：건립정량검측주사용유생소C중세균내독소적방법。방법채용동태탁도법후시험대양품중적세균내독소진행검측,병여응효법측정결과상비교。결과주사용유생소C재희석지8 mg·mL-1시대세균내독소검사유명현적간우작용,이재4 mg · mL-1혹이하질량농도시칙무간우작용；소측양품중세균내독소함량균저우0.02 EU·mg-1,여응효법측정결과일치。결론동태탁도법후시험가응용우정량검측주사용유생소C중적세균내독소。
Objective To establish a method for quantitative determination of bacterial endotoxins in vitamin C for injection. Methods Kinetic turbidimetric limulus test was applied to detect the bacterial endotoxins in vitamin C for injection quantitatively, and the result was compared with that of gel-clot method. Results Vitamin C for injection obviously interfered with the test for bacterial endotoxins when diluted to the concentration of 8 mg·mL-1,but not at 4 mg·mL-1 or below;the content of bacterial endotoxins in all samples tested were less than 0.02 EU·mg -1 ,which were in accordance with the result of gel-clot method. Conclusion Kinetic turbidimetric limulus test could be applied to determine bacterial endotoxins in vitamin C for injection.
