摘要
建立两种含水杨酸或苯甲酸制剂(水杨酸滴耳液和复方苯甲酸软膏)的微生物限度检查方法。按《中国药典》2015年版四部规定,以碳酸氢钠溶液为中和剂,采用金黄色葡萄球菌、铜绿假单胞菌、枯草芽孢杆菌、白色念珠菌和黑曲霉5种试验菌株,进行需氧菌、霉菌和酵母菌总数计数方法的适用性试验,并进行控制菌金黄色葡萄球菌和铜绿假单胞菌检查方法的适用性试验。结果水杨酸滴耳液以0.08 mol/L碳酸氢钠溶液中和法试验,复方苯甲酸软膏以1.5 mol/L碳酸氢钠溶液中和法试验,可去除抑菌成分苯甲酸或水杨酸的干扰。该方法简便可行,结果准确可靠,可用于这两种酸性制剂的微生物限度检查。
To establish microbial limit test methods of two salicylic acid or benzoic acid preparations(salicylic acid ear drops and compound ointment of benzoic acid),based on the requirements in Chinese Pharmacopoeia(vol.IV,2015 edition),the methods for counting of total aerobic bacteria,molds and yeasts were verified for suitability with five test bacteria,including of Staphylococcus aureus,Pseudomonas aeruginosa,Bacillus subtilis,Candida albicans and Aspergillus niger,using sodium hydrogen carbonate as a neutralizing agent,the applicability for the control bacteria of Staphylococcus aureus and Pseudomonas aeruginosa were tested.Salicylic acid ear drops were neutralized by 0.08 mol/L sodium bicarbonate solution,and compound benzoic acid ointment was neutralized by 1.5 mol/L sodium bicarbonate solution,which could be removed the interference of benzoic acid or salicylic acid as an antibacterial component.The established method is simple,accurate and reliable,which may be used for the microbial limit test for the two acidic preparations.
作者
李敏
龚亚
曹健
LI Min;GONG Ya;CAO Jian(Department of Pharmacy,No.2 Affiliated Hospital of the Army Medical University,Chongqing 400037,China)
出处
《药物生物技术》
CAS
2022年第1期50-53,共4页
Pharmaceutical Biotechnology
关键词
水杨酸滴耳液
复方苯甲酸软膏
微生物限度检查
碳酸氢钠
中和法
抑菌成份
Compound ointment of benzoic acid
Salicylic acid ear drops
Microbial limit test
Sodium hydrogen carbonate
Neutra-lization method
Antibacterial component
