摘要
目的 :建立磷酸川芎嗪氯化钠注射液中细菌内毒素含量测定方法。方法 :将磷酸川芎嗪氯化钠注射液稀释 16倍 ,采用动态比浊法 ,通过干扰试验和验证试验 ,测定磷酸川芎嗪氯化钠注射液中细菌内毒素含量。结果 :样品稀释 16倍可以有效地消除其对鲎试验的干扰 ,检测平均回收率 92 .80 %～ 10 9.92 %。结论 :动态比浊法鲎试验可以高效地测定磷酸川芎嗪氯化钠注射液中的细菌内毒素含量。
Objective:To set up a method for the determination of the content of bacterial endotoxin in saline injection of ligustrazine phosphate. Methods:A 16 fold dilution of the saline injection of ligustrazine phosphate was prepared. The content of bacterial endotoxin in saline injection of ligustrazine phosphate was determined with kinetic turbidimetry after interference test and verification test had been completed. Results:The 16 fold dilution of the saline injection of ligustrazine phosphate was shown to be effective in eliminating the interference with the limulus test. The average rate of recovery was with the range of 92.80%～109.92%。 Conclusion:The kinetic turbidimetric limulus test was shown to be highly effective for the quantitative determination of bacterial endotoxin in saline injection of ligustrazine phosphate.
出处
《医药导报》
CAS
2003年第12期883-886,共4页
Herald of Medicine
关键词
川芎嗪
磷酸
细菌内毒素
动态比浊法
Ligustrazine phosphate
Bacterial endotoxin
Kinetic turbidimetry
