摘要
目的:建立决明子等7种中药配方颗粒微生物限度检查方法适用性。方法:参照《中华人民共和国药典》2020年版四部“通则1105、1106、1107”进行方法适用性试验。结果:采用平皿倾注法(稀释法),需氧菌计数中合欢花(合欢花)、槐花(槐花)配方颗粒(1∶50,1 mL/皿),合欢皮、槐角、皂角刺、胡芦巴配方颗粒(1∶20,1 mL/皿);霉菌和酵母菌计数中合欢花(合欢花)配方颗粒(1∶20,1 mL/皿)、合欢皮配方颗粒(1∶50,1 m L/皿)均消除抑菌性。控制菌检查采用平皿倾注法(常规法)。结论:本方法可为决明子等7种中药配方颗粒质量控制提供参考。
Objective:Applicability of establishing microbial limit testing methods for 7 traditional Chinese medicine formula granules,including cassia seed.Method:Conduct method suitability tests according to the"General Principles 1105,1106,1107"in Part IV of the 2020 edition of the Pharmacopoeia of the People's Republic of China.Result:Using the plate pouring method(dilution method),the aerobic bacterial count showed that Albizia flower(Albizia flower),Sophora flower(Sophora flower)(1:50,1 mL/dish),as well as Albizia bark,Sophora fruit,Spina gleditsiae,and Fenugreek(1:20,1 mL/dish);In the counting of mouldi and yeast,the antibacterial properties of the formulation particles of Albizia flower(1:20,1 mL/dish)and the acacia skin formulation particles(1:50,1 mL/dish)are eliminated.The control bacteria test is conducted using the plate pouring method(conventional method).Conclusion:This method can provide reference for quality control of seven traditional Chinese medicine formula granules,including Cassia seed.
作者
刘琪雯
王春林
田霞
秦德松
陈琤
LIU Qiwen;WANG Chunin;TIAN Xia;QIN Desong;CHEN Cheng(Chongqing Qianjiang Institute for Food and Drug Control Qianjiang,Chongqing 409000,China)
关键词
中药配方颗粒
微生物限度
适用性验证
traditional chinese medicine formula granules
microbial limit
applicability verification
作者简介
刘琪雯,女,1990年出生,工程师,学士,研究方向为药品和化妆品质量检测。;通信作者:陈琤,女,1980年出生,副主任药师,学士,研究方向为药品和化妆品质量检测与管理,462436881@qq.com,19102372755。
