葛根素注射液细菌内毒素定量法(动态比浊法)

Application of the kinetic turbidimetric limulus test to Pue rarin injection

目的：应用动态比浊法鲎试验定量测定葛根素注射液的细菌 内毒素。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，将葛根素原液及1∶40，1∶80，1∶120，1∶200稀释液等5个浓度系列，定量添加标 准内毒素，其回收率分别为41.71%，60.02%，85.15%，85.49%，98.30% ；从中筛选出最佳的检测浓度1∶200稀释液，进行3个批号葛根素(0007211，0011241，00 12061)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112.0%，107.4% ，123.5%。结果：标准内毒素使用5.00，0.500，0.0500 Eu·ml-1 ，将葛根素进行1∶200稀释，样品中定量添加标准内毒素，回收率均在50%～200%，无干扰 作用，可用于有效的日常检查。结论：动态比浊法鲎试验可以高效地测定葛根素的细菌内毒素。

OBJECTIVE The kinetic turbidimetric limulus test was used in the endotoxin assay of Puer arin injection. METHODS The validation test was fulfiled,when the amount of end otoxin spiked in Puerarin injection sample (Lot.No.0011241) and its 40-fold dilution,80-fold dilution,120-fold dilution,200-fold dilution were recovered in 41.71%，60.02%，85.15%，85.49，98.30%.With th e amount of endotoxin spiked in a 200-fold dilution toPuerarin injec tion (Lot.No.000 7211,0011241,0012061) were recovered in 112.0%，107.4%，123.5%．RESULTS With st andard endotoxin working curve is 5.00，0. 500，0.0500 Eu·ml-１，the 200-fold dilution to Puerarin injecti on is effective to eliminate the interference in Limulus test. CONCLUSIONS The kinetict turbidimetric Linulus test provide a n ew way to the detection in Puerarin injection.