摘要
目的建立跌打止痛凝胶的微生物限度检查方法。方法依据《中华人民共和国药典》2020年版四部通则1105、1106采用平皿法进行跌打止痛凝胶的微生物限度检查验证。结果取稀释级(1∶10)供试品采用加中和剂(稀释剂含5%聚山梨酯80)的平皿法进行检查,各试验菌回收率都在0.5~2.0范围内,说明本品加中和剂后消除防腐剂对羟基苯甲酸乙酯的干扰,其需氧菌总数、霉菌及酵母菌计数都可采用平皿法进行检查,而控制菌(金黄色葡萄球菌和铜绿假单胞菌)采用加中和剂的常规法亦可检出试验菌。结论可采用加中和剂的平皿法和常规法进行跌打止痛凝胶的微生物限度检查。
Objective To establish a method for the microbial limit test of Dieda Zhitong Gel.Methods The microbial limit test of Dieda Zhitong Gel was validated by plate method in accordance with the general rules 1105 and 1106 of the fourth part of the Chinese Pharmacopoeia(2020 Edition).Results Take the test sample of dilution grade(1∶10)and use the plate method with neutralizer(the diluent contains 5%polysorbate 80)for inspection.The recovery rate of all test bacteria is within the range of 0.5-2.0,which means that the interference of preservatives on ethyl hydroxybenzoate can be eliminated after adding neutralizer.The total number of aerobic bacteria,mold and yeast count can be checked using the plate method,The control bacteria(Staphylococcus aureus and Pseudomonas aeruginosa)can also be detected by routine method of adding neutralizer.Conclusion The microbial limit test of Dieda Zhitong Gel can be carried out by the plate method with neutralizer and the conventional method.
作者
李铭
温子帅
李峰
黄荻舒
曾建滨
韩传宝
刘建航
LI Ming;WEN Zishuai;LI Feng;HUANG Dishu;ZENG Jianbin;HAN Chuanbao;LIU Jianhang(Biological Laboratory,Beihai Food and Drug Inspection Institute,Guangxi Zhuang Autonomous Region,Beihai 536000,China;Department of Pharmacy,Beihai Hospital of Traditional Chinese Medicine,Guangxi Zhuang Autonomous Region,Beihai 536000,China;Department of Science and Education,Beihai Hospital of Traditional Chinese Medicine,Guangxi Zhuang Autonomous Region,Beihai 536000,China;Beihai Hospital of Traditional Chinese Medicine,Guangxi Zhuang Autonomous Region,Beihai 536000,China)
出处
《中国当代医药》
CAS
2023年第16期44-48,共5页
China Modern Medicine
基金
广西壮族自治区中医药管理局中药壮瑶药医院制剂质量提升项目(GZZJ202019)。
关键词
跌打止痛凝胶
微生物限度检查
平皿法
验证
Dieda Zhitong Gel
Microbial limit test
Conventional method
Validation
