|
|
Methodology research on microbial limit test of Wuqi Shujin Tongluo Tablets |
CHEN Zhen-yao XIE Kai-biao YAO Wei-sheng |
Department of Pharmacy,Zhaoqing Traditional Chinese Medicine Hospital in Guangdong Province,Zhaoqing 526020,China |
|
|
Abstract ObjectiveTo establish a microbial limit test method of Wuqi Shujin Tongluo tablets.MethodsMethodology research on microbial limit test of Wuqi Shujin Tongluo tablets was conducted according to the"1105,1106,1107"of Chinese Pharmacopoeia 2015 edition with the fourth part.ResultsThe total number of aerobic bacteria could be tested by plate dilution method and membrane filtration method,the total number of fungus and yeasts could be tested by the plate routine method,and the recovery was between 0.5 and 2,Escherichia coli,Salmonella,Bile salt resistant Gram-negative bacteria could be detected through control bacteria by direct inoculation method.ConclusionThe total number of aerobic bacteria can be tested by plate dilution method,the total number of fungus and yeasts can be tested by plate routine method,and the control bacteria can be tested by direct inoculation method,the methods used are feasible,and easier to operate,which are suitable for the microbial limit test of Wuqi Shujin Tongluo tablets.
|
|
|
|
|
[1] |
陈震尧,陈金英,姚伟生,等.乌芪舒筋通络片乌头碱限量检测方法研究[J].中国药房,2015,26(36):5144-5146.
|
[2] |
国家药典委员会.中国药典[M].一部.北京:中国医药科技出版社,2010:附录 79-88.
|
[3] |
国家药典委员会.中国药典[M].四部.北京:中国医药科技出版社,2015:140-151.
|
[4] |
刘广文,苑艳飞.养肝解毒丸微生物限度检查法的验证实验[J].中国医药科学,2016,6(13):54-57.
|
[5] |
文玉辉,韩珍珍.11种医院制剂微生物限度检查方法验证[J].临床医药实践,2015,24(10):763-765.
|
[6] |
柴海毅.浅析微生物计数方法的回收率[J].医药工程设计,2013,34(1):30-31.
|
[7] |
陈志禹,夏佳,席时东.八珍丸的中国药典2015年版微生物学检查结果分析与评价[J].药物分析杂志,2016,36(3):418-425.
|
[8] |
陈志禹,夏佳,席时东.八珍颗粒《中国药典》2015年版微生物限度检查法的建立及检验结果分析[J].中国卫生检验杂志,2015,25(23):4051-4055.
|
[9] |
陈志禹,席时东.中国药典2015年版八珍胶囊和八珍片微生物限度检查与探讨[J].中国现代应用药学,2016,33(5):628-634.
|
[10] |
李趣嫦,江艳芳.《中国药典》2010版与2015版微生物限度检查法对四种药物检测结果的比较[J].中国药品标准,2015,16(2):86-90.
|
[11] |
景荣先,张国林.2015年版《中国药典》微生物限度检查法洁净环境及计数培养基修订分析探讨[J].中国卫生产业,2015,12(5):184-185.
|
[12] |
王洪家.解毒散结颗粒《中国药典》2015年版微生物限度检查方法学验证[J].天津药学,2016,28(4):17-19.
|
[13] |
杨晓莉,李辉,马英英,等.《中国药典》2015年版非无菌产品微生物限度检查:控制菌检查法解读与对策[J].中国药师,2016,19(4):748-752.
|
[14] |
黄英.清热安宫丸等中成药微生物限度检查方法验证[J].中国药业,2013,22(24):38-40.
|
[15] |
刘广桢,张冕,胡文红,等.5种洗剂类医疗机构制剂微生物限度检查方法验证[J].药学研究,2015,34(6):332-334.
|
|
|
|