甲庆栓微生物限度检查的方法学验证  

The Validation of Microbial Limit Determination Method for Jiaqing Suppository

作　　者：冯川[1] 时健[1] 姜清华[2] 段旭[2] 菅凌燕[2] 

机构地区：[1]沈阳药科大学高职院,沈阳110026 [2]中国医科大学附属盛京医院药剂科,沈阳110004

出　　处：《黑龙江医药》2009年第2期136-137,共2页Heilongjiang Medicine journal

摘　　要：目的:确认甲庆栓的检验条件和方法,保证微生物限度检查方法的科学性和检验结果准确性。方法:采用中国药典2005年版二部附录微生物限度检查法项下方法的验证。结果:确定了甲庆栓微生物限度检查的操作方法。结论:为甲庆栓的微生物限度检查提供了依据,对药品的生产及检验部门有实用的价值。Objective： To confirm the check condition and method of Jiaqing Suppository and ensure the science of method and creditability of check result for microbial limit determination. Methods： To use the method validation under the item of microbial limit determination in the appendix of 2005 ＂China Pharmacopoeia＂（Ⅱ）. Result： Confirm the manipulation method of microbial limit determination for Jiaqing Suppository. Conclusion： Provide the basis of microbial limit determination for Jiaqing Suppository and it has the use value to pharmaceutical production and inspection department

关 键 词：甲庆栓 微生物限度 验证 

分 类 号：R927.2[医药卫生—药学]