动态比浊法测定注射用穿琥宁细菌内毒素的含量

Determination of Endotoxin in Chuan Hu Ning Iinjection with Kinetic Turbidimetry Limulus Test

目的测定注射用穿琥宁中细菌内毒素含量。方法应用动态比浊法鲎试验,通过对样品中定量添加标准内毒素的干扰预试验,将穿琥宁原液及1∶40,1∶80,1∶120,1∶200等5个浓度的系列稀释液,定量添加标准内毒素,其回收率分别为0%,21.18%,76.69%,101.1%,117.8%;从中筛选出最佳的检测浓度1∶200稀释液,进行3个批号穿琥宁(000408,000409,001023)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110.5%、124.4%、87.98%。结果标准内毒素使用5.00、0.500、0.0500Eu/mL,将穿琥宁进行1∶200稀释,样品中定量添加标准内毒素,回收率均为50%～200%,无干扰作用,可有效地用于日常检查。结论动态比浊法鲎试验可以定量地测定穿琥宁的细菌内毒素含量。

Objective: The dynamic turbidimetry Limulus test was used to assay endotoxin content in Chuan Hu Ning injection. Methods: When the standardized endotoxin added in Chuan Hu Ning injection sample (Lot.No.000409) and in its 40-fold dilution, 80-fold dilution, 120-fold dilution and 200-fold dilution , the recovery was 0 %, 21.18 %, 76.69 %, 101.1 %and 117.8 %and as the standardized endotoxin added in the three batches of 200-fold dilution of Chuan Hu Ning injection (Lot.No.000408?000409?001023), the recovery was 110.5 %, 124.4 %and 87.98 %. Results: As standardized endotoxin concentration being 5.00, 0.500, 0.0500Eu/mL , the 200-fold dilution of Chuan Hu Ning injection is effective to eliminate the interference in the test. Conclusion: The dynamic turbidimetry Limulus test provides a new way for the determination of endotoxin in Chuan Hu Ning injection.