摘要
目的:建立复方多粘菌素B软膏外用制剂的抗菌效能评价体系。方法:建立适用于美国临床和实验室标准协会(Clinical and Laboratory Standards Institute,CLSI)制定的琼脂稀释法的复方多粘菌素B软膏外用制剂前处理方法,搭建由11个种属72株细菌构成的评价用菌种库,并对不同厂家生产的复方多粘菌素B软膏外用制剂的抗菌效果进行评价。结果:待评价制剂MIC与相同处方比例的复方多粘菌素B软膏X和Y的MIC间未见显著性差异(P>0.05),极显著高于进口制剂A的MIC(P<0.01),极显著低于进口制剂B的MIC(P<0.01)。结论:本文初步建立了复方多粘菌素B软膏外用制剂体外抗菌效果评价用菌种库和针对性前处理方法,该方法可有效识别不同制剂之间由于抗菌成分配方不同引起的抗菌效果差异,为今后复方多粘菌素B软膏外用制剂体外抗菌效果评价提供了有效的数据和方法参考。
Objective: To establish the antibacterial efficacy evaluation system of compound polymyxin B ointment for external use. Methods: A pre-treatment method for the external preparation for compound polymyxin B ointment was established which was suitable for the agar dilution method formulated by the Clinical and Laboratory Standards Institute(CLSI). A bacterial library consisting of 72 strains of 11 species and genera was established for evaluation. The antibacterial effects of the compound polymyxin B ointment for external use produced by different manufacturers were evaluated. Results: There was no significant difference in MIC between the preparation to be evaluated and the compound polymyxin B ointment with the same prescription ratio X and Y(P>0.05), which was extremely significantly higher than that of the imported ointment A(P<0.01), and significantly lower than the MIC of the imported ointment B(P<0.01). Conclusion: This article preliminarily established a bacteria strain library and targeted pretreatment method of in vitro antibacterial effect evaluation of compound polymyxin B ointment for external use. This method could effectively identify the difference in antibacterial effect between different preparations due to different antibacterial ingredients. It provides effective data and method reference for the evaluation of in vitro antibacterial effect of compound polymyxin B topical ointment in the future.
作者
周刚
赵琳娜
王学硕
刘娜
刘宗银
曹慧敏
林兰
崔生辉
Zhou Gang;Zhao Linna;Wang Xueshuo;Liu Na;Liu Zongyin;Cao Huimin;Lin Lan;Cui Shenghui(Inner Mongolia Institutes for Drug Control,Hohhot 010020,China;National Institutes for Food and Drug Control,Beijing 100050,China;Shandong Ruian Pharmaceutical Company Limited,Jinan 251400,China)
出处
《中国药事》
CAS
2021年第6期666-672,共7页
Chinese Pharmaceutical Affairs
关键词
复方多粘菌素B软膏
琼脂稀释法
体外抗菌效果
评价
Compound Polymyxin B Ointment
agar dilution method
in vitro antibacterial effect
evaluation
