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中国农学通报 ›› 2009, Vol. 25 ›› Issue (24): 24-27.

所属专题: 园艺

• 畜牧 动物医学 蚕 蜂 • 上一篇    下一篇

葡萄糖酸钙注射液的细菌内毒素检查

严宏凤,陈 圆,于生兰   

  • 收稿日期:2009-08-19 修回日期:2009-09-29 出版日期:2009-12-20 发布日期:2009-12-20

Bacterial Endotoxin Test for Calcium Gluconate Injection

  • Received:2009-08-19 Revised:2009-09-29 Online:2009-12-20 Published:2009-12-20

摘要:

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。

关键词: 小麦幼苗, 小麦幼苗, 水杨酸, 一氧化氮, 抗氧化防护

Abstract:

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.