中国药师
中國藥師
중국약사
China Pharmacist
2015年
11期
2010-2012
,共3页
何燕%徐晓月%张军霞
何燕%徐曉月%張軍霞
하연%서효월%장군하
布罗佐喷钠%细菌内毒素检查法%鲎试剂%干扰试验
佈囉佐噴鈉%細菌內毒素檢查法%鱟試劑%榦擾試驗
포라좌분납%세균내독소검사법%후시제%간우시험
Brozopine%Bacterial endotoxin test%Tachypleus amebocyte lysate%Interfering factors test
目的：：建立新型原料药布罗佐喷钠的细菌内毒素检查法。方法：根据《中国药典》2010年版二部附录的细菌内毒素检查法和相关标准及指导原则，用2个厂家的鲎试剂对3个批号的供试品进行干扰试验预试验及干扰试验，确定供试品的细菌内毒素检查的适用性及最大不干扰浓度，并对供试品进行细菌内毒素检查。结果：3个批次的布罗佐喷钠在浓度为2.5 mg ·ml-1及其以下浓度时对鲎试剂与内毒素的反应无干扰作用，细菌内毒素检查均符合规定。结论：细菌内毒素检查法可用于布罗佐喷钠的质量控制。
目的：：建立新型原料藥佈囉佐噴鈉的細菌內毒素檢查法。方法：根據《中國藥典》2010年版二部附錄的細菌內毒素檢查法和相關標準及指導原則，用2箇廠傢的鱟試劑對3箇批號的供試品進行榦擾試驗預試驗及榦擾試驗，確定供試品的細菌內毒素檢查的適用性及最大不榦擾濃度，併對供試品進行細菌內毒素檢查。結果：3箇批次的佈囉佐噴鈉在濃度為2.5 mg ·ml-1及其以下濃度時對鱟試劑與內毒素的反應無榦擾作用，細菌內毒素檢查均符閤規定。結論：細菌內毒素檢查法可用于佈囉佐噴鈉的質量控製。
목적：：건립신형원료약포라좌분납적세균내독소검사법。방법：근거《중국약전》2010년판이부부록적세균내독소검사법화상관표준급지도원칙，용2개엄가적후시제대3개비호적공시품진행간우시험예시험급간우시험，학정공시품적세균내독소검사적괄용성급최대불간우농도，병대공시품진행세균내독소검사。결과：3개비차적포라좌분납재농도위2.5 mg ·ml-1급기이하농도시대후시제여내독소적반응무간우작용，세균내독소검사균부합규정。결론：세균내독소검사법가용우포라좌분납적질량공제。
Objective:To establish bacterial endotoxin test for brozopine. Methods: Interference pre-test and interfering factors test were conduced on 3 batches of samples from 2 manufacturers to confirm the applicability of bacterial endotoxin test and the non-in-terfering concentration. The bacterial endotoxin test was carried out based on the method described in the second part of Chinese Phar-macopeia (2010 edition) and relevant standards and guidelines. Results: The three batches of brozopine showed no interference in bacterial endotoxin test at the concentration less than or equal to 2. 5 mg·ml-1 . The bacterial endotoxin test of the three bathes of samples all met the requirements. Conclusion:Bacterial endotoxin test can be used for the quality control of brozopine.
