注射用川芎素细菌内毒素定量法的研究

Application of kinetic turbidimetric limulus test to Sodium Ferulate for injection

目的 :应用动态浊度法定量测定注射用川芎素中的细菌内毒素。方法 :应用动态浊度法 ,通过对样品中定量添加标准内毒素的干扰预试验 ,将川芎素原液及 1∶10 ,1∶2 0 ,1∶4 0 ,1∶6 0 ,1∶80稀释液 6个浓度系列 ,定量添加标准内毒素 ,其回收率分别为 0 .2 0 % ,74 .70 % ,87.93% ,87.0 9% ,98.5 5 % ,119.2 % ;从中筛选出最佳的检测浓度 1∶6 0稀释液 ,进行 3个批号川芎素 (2 0 0 0 0 30 8 2 0 0 0 0 70 4 2 0 0 0 0 315 )正式干扰试验 ,样品中定量添加标准内毒素 ,其回收率分别为 12 0 .4 % ,98.5 5 % ,85 .4 0 %。结果 :标准内毒素使用 5 .0 0 ,0 .5 0 0 ,0 .0 5 0 0Eu/mL ,将川芎素进行 1∶6 0稀释 ,样品中定量添加标准内毒素 ,回收率均为 5 0 %～ 2 0 0 % ,无干扰作用 ,可用于有效的日常检查。结论

Objective: The kinetic turbidimetric limulus test was used in the endotoxin assay of Sodium Ferulate for injection. Methods: The preliminary validation test was fulfilled, when the standard endotoxin spiked in Sodium Ferulate for injection sample (Lot. No. 20000704) and its 10 fold dilution、 20 fold dilution、 40 fold dilution、 60 dilution、 80 fold dilution. The recoveries were 0.20%, 74.70%, 87.93%, 87.09%, 98.55%, 119.2% respectively. The optimum detection concentration found was 60 fold dilution. During the formal interference tests of 3 batches of Sodium Ferulate for injection (Lot. No. 20000308 20000704 20000315), the recoveries were 120.4%,98.55% and 85.40% respectively. Results: 5.00,0.500,0.0500 Eu/mL of standard endotoxin were used. The standard endotoxin was quantitatively added into the 60 fold dilution of Sodium Ferulate for injection. The recoveries were all 50%～200% and no interference action was found.Conclusion: The kinetict turbidimetric limulus test provided a new way to the detection of endotoxin in Sodium Ferulate for injection.