周刚,赵琳娜,王学硕,刘娜,刘宗银,曹慧敏,林兰,崔生辉.复方多粘菌素B软膏外用制剂体外抗菌效果评价研究[J].中国药事,2021,35(6):666-672 |
复方多粘菌素B软膏外用制剂体外抗菌效果评价研究 |
Evaluation of in vitro Antibacterial Effect of Compound Polymyxin B Ointment |
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DOI:10.16153/j.1002-7777.2021.06.009 |
中文关键词: 复方多粘菌素B软膏 琼脂稀释法 体外抗菌效果 评价 |
英文关键词: Compound Polymyxin B Ointment agar dilution method in vitro antibacterial effect evaluation |
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中文摘要: |
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。 |
英文摘要: |
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 effectivedata and method reference for the evaluation of in vitro antibacterial effect of compound polymyxin B topical ointment in the future. |
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