水敷散、硝矾散微生物限度方法学验证  

Methodological Verification of Microbial Limit of Shuifu Powder and Xiaofan Powder

作　　者：刘德军[1] 贺玲 慕杨娜[3] 郭媛 LIU Dejun;HE Ling;MU Yangna;GUO Yuan(The Third Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,Shenyang 110003,Liaoning,China;Shenyang Hongqi Pharmaceutical Co.,Ltd.,Shenyang 110179,Liaoning,China;The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,Shenyang 110034,Liaoning,China)

机构地区：[1]辽宁中医药大学附属第三医院,辽宁沈阳110003 [2]沈阳红旗制药有限公司,辽宁沈阳110179 [3]辽宁中医药大学附属第二医院,辽宁沈阳110034

出　　处：《实用中医内科杂志》2024年第5期36-38,I0009,共4页Journal of Practical Traditional Chinese Internal Medicine

基　　金：国家中医药管理局科研基金项目(T20194828003)。

摘　　要：目的 建立并验证水敷散、硝矾散微生物限度的检验方法。方法 按照《中华人民共和国药典》(四部)“非无菌产品微生物限度检查”对水敷散和硝矾散进行微生物限度检验方法验证。结果 水敷散和硝矾散需氧菌总数、霉菌与酵母菌总数、控制菌采用无菌滤纸过滤后再薄膜过滤方法检查,其实验组菌落数减去供试品对照组菌落数的值与菌液对照组菌落数的比值均在0.5~2的范围内。结论 两种制剂均可采用无菌滤纸过滤后薄膜过滤的方法进行微生物限度检查。Objective To establish and verify the microbial limit test method of Shuifu powder and Xiaofan powder.Methods According to the fourth part of Pharmacopoeia of the people's Republic of China(2020 Edition)"Microbial limit test for nonaseptic products",the test methods of Shuifu powder and Xiaofan powder were verified.Results The total number of aerobic bacteria,mold and yeast,and control bacteria in Shuifu powder and nifeng powder were filtered by sterile filter paper and then examined by membrane filtration.The ratio of the number of colonies in the test group minus the number of colonies in the control group and the number of colonies in the control group were all within the range of 0.5-2.Conclusion Both of the two preparations can be tested by membrane filtration after filtration with sterile filter paper.The data are accurate and the method is feasible.

关 键 词：水敷散 硝矾散 微生物方法学验证 过滤后薄膜过滤 

分 类 号：R289[医药卫生—方剂学]