赤丹丸微生物限度检查方法适用性研究  

Validation on Microbial Limit Test Method of ChiDan Pills

作　　者：刘佳[1] 杨跃辉[1] LIU Jia;YANG Yue-hui(Department of Pharmacy,Shengjing Hospital of China Medical University,Shenyang 110004,China)

机构地区：[1]中国医科大学附属盛京医院药学部,辽宁沈阳110004

出　　处：《海峡药学》2024年第7期44-47,共4页Strait Pharmaceutical Journal

摘　　要：目的建立医院制剂赤丹丸的微生物限度检查方法。方法根据四部通则1105-1107,2020年版《中国药典》的规定,采用常规法和稀释法计算赤丹丸中各个菌株的回收比,并对控制菌进行检查。结果赤丹丸有较强的抑菌性,当采用1∶100稀释法时,各试验菌株的回收比均在0.5~2范围内,常规法检出相应的控制菌。结论赤丹丸采用1∶100稀释法用于需氧菌总数、霉菌及酵母菌总数的计数,常规法用于控制菌的检查。OBJECTIVE To establish a method for microbiological limit test of ChiDan pills.METHODS According to the general rules 1105-1107 of the fourth part of Chinese Pharmacopoeia in 2020,the recovery ratio of each strain in ChiDan pills was calculated by conventional method and dilution method,and the control bacteria were checked.RESULTS ChiDan Pills had strong bacteriostasis.When 1∶100 dilution method was used,the recovery ratio of each test strain was in the range of 0.5-2,and the corresponding control bacteria were detected by conventional method.CONCLUSION The 1∶100 dilution method was used to count the total number of aerobic bacteria,mold and yeast in ChiDan pills,and the conventional method was used to check the control bacteria.

关 键 词：赤丹丸 微生物限度检查 方法适用性研究 

分 类 号：R927[医药卫生—药学]