葡萄糖酸钙注射液的细菌内毒素检查

目的：建立葡萄糖酸钙注射液的细菌内毒素检查方法。方法：根据2005年版《中国兽药典》一部附录细菌内毒素检查法进行试验。结果：当水为溶剂时，供试品对细菌内毒素检查法有干扰作用；改用稀释剂I作为溶剂，干扰预试验和干扰试验表明，供试品在2倍以上稀释浓度时可排除干扰。结论：葡萄糖酸钙注射液按限值L＝2.5Eu/mL进行细菌内毒素检查是可行的，可以用细菌内毒素检查法代替热原法检测葡萄糖酸钙注射液。

Bacterial Endotoxin Test for Calcium Gluconate Injection

OBJECTIVE: To establish a medthod for the bacterial endotoxin test of calcium gluconate injection.METHODS:The bacterial endotoxin test was carried out according to the bacterial endotoxin test in the addenda of China Pharmacopeia 2005 edition（the first part）.RESULTS: Calcium gluconate injectionshowed interference on the bacterial endotoxin test when water taken as solvent.The preliminary interference test and interference test revealed that using thinner I as solvent,the sample injection in over 2-fold dilution had no interference on the bacterial endotoxin test.CONCLUSIONS：It is feasible for bacterial endotoxin test of calcium gluconate injection be conducted in a limit value of 2.5EU/ml.The bacterial endotoxin test can substitute pyrogen test in the detection of calcium gluconate injection.