甲磺酸多拉司琼注射液无菌检查方法学研究  

Studies on Test for Sterilit of Dolasetron Mesylate for Injection

作　　者：郭跃龙[1] 叶东[2] 宋金浩[2] 

机构地区：[1]江苏省省级机关医院,江苏南京210024 [2]江苏奥赛康药业股份有限公司,江苏南京211112

出　　处：《内蒙古中医药》2013年第3期100-101,共2页Inner Mongolia Journal of Traditional Chinese Medicine

摘　　要：目的:建立甲磺酸多拉司琼注射液的无菌检查方法。方法:按2005年版中国药典注射液无菌检查的有关要求,通过薄膜过滤法,比较不同量的冲洗液对检查方法的影响。结果:采用薄膜过滤法,以pH7.0无菌氯化钠-蛋白胨缓冲液作为冲洗液,冲洗量为1000 ml时,试验组生长没有对照组好,冲洗量为2000ml时阳性对照均和试验均生长均良好。结论:方法准确、可靠,能够进行甲磺酸多拉司琼注射液的无菌检查。Objective ：To establish a method for determining sterility test of Dolasetron Mesylate for Injection. Methods ： According to the Chinese pharmaco- poeia（2005 edition）, the sterility test method of injection,that treated with membrane - filter procedure, compare the effect of detection methods by changing the quantity of washing liquid. Results ： Use pH7.0 sterile sodium chloride - peptone buffered solution as the washing liquid, adopt membrane filtration, the flushing volume between 1000 ml, the test group did not grow as good as contrast group. When flushing volume is 3000ml both positive con- trol and test are growing well. Conclutions：The method is accurate, reliable, and can be applied for Test for Sterilit of Dolasetron Mesylate for Injection.

关 键 词：甲磺酸多拉司琼注射液 无菌 薄膜过滤法 方法验证 

分 类 号：R824.1[医药卫生—临床医学]