摘要
目的研究甘油果糖注射液对细菌内毒素检查试验的干扰情况,建立其细菌内毒素的限量检查方法。方法参照《中国药典》2005年版二部附录细菌内毒素凝胶限量检查法进行实验,以不同生产厂家、不同批号的鲎试剂对多批供试品进行干扰试验研究。结果甘油果糖注射液经4倍稀释后对检测无干扰作用。结论该制剂可用细菌内毒素检查法替代家兔热原检查法控制产品质量,其内毒素限值为每1mL含内毒素量应小于1.2 EU。
OBJECTIVE To study the interference of glycerol and fructose injection in bacterial endotoxin test, and to establish a method of endotoxin limit test for the pr.eparation. METHODS The bacterial endotoxin test is performed according to the bacterial endotoxin determination method in China Pharmacopoeia 2005, using different tachypleus a mebocyte lysate （TAI.） made in more manufacturers. RESULTS In four times diluted concentration, the glycerol and fructose injection did not interfere in the result of the test.CONCLUSION In place of rabbit pyrogen method, the gel-clot test of bacterial endotoxin could be used for control the quality of glycerol and fructose injection, in which the bacterial endotoxin limit should be less than 1.2 EU·mL^-1.
出处
《海峡药学》
2010年第7期93-95,共3页
Strait Pharmaceutical Journal
关键词
甘油果糖注射液
细菌内毒素凝胶限量检查法
干扰试验
Glycerol and fructose injection
Gel-clot test method of bacterial endotoxin
Interference test
