注射用乳糖酸阿奇霉素含量测定  

Determination of the Content of Azithyromycin Lactobionate for Injection

作　　者：邹积宏[1] 邹积先[2] 刘红梅[3] 刘长海[3] 杨晶[1] 许莉[1] 李响[1] 

机构地区：[1]黑龙江大学生命科学学院,150080 [2]大庆职工医学院 [3]哈尔滨医科大学药学院

出　　处：《黑龙江医药》2006年第6期436-437,共2页Heilongjiang Medicine journal

摘　　要：目的：比较微生物效价法与高效液相色谱法测定乳糖酸阿奇霉素含量的数据,以确定高效液相色谱法是否可以在工业生产中应用、推广。方法：建立高效液相色谱法测定乳糖酸阿奇霉素注射剂含量的方法学,分别按2000版药典的微生物法及新建立的高效液相色谱法对乳糖酸阿奇霉素粉针剂进行含量测定,用统计学方法比较两种方法测定的结果是否有统计学差异。结果：统计学分析结果表明两种方法测定乳糖酸阿奇霉素粉针剂的含量结果无统计学意义。结论：高效液相色谱法可以应用于乳糖酸阿奇霉素粉针剂的含量测定。Objective：To compare two dates acquired from microbiological Assay method and HPLC method respectively, and to determine if the HPLC method can be used industrialization production. Methods： To establish a HPLC method to determine the content of azithyromycin lactobionate for injection. The microbiological assay and HPLC method were used to determine the content of azithyromyein lactobionate for injection respectively, and the two results were compared by statistics assay method. Results：The statistics analysis results showed that there were no statistics meaning of two methods（ P〈 0.05） . Conclusion： HPLC can be used in determination content of Azithyromycin Lactobionate for Injetion.

关 键 词：乳糖酸阿奇霉素 微生物效价法 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学]