万古霉素不同市售抗生素产品抑菌活性的体外比较研究。

Jorge A Diaz, Edelberto Silva, Maria J Arias, María Garzón
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引用次数: 17

摘要

背景:抗菌药物治疗中最关键的问题之一是抗生素耐药性的增加。以往的研究表明,错误处方、剂量、途径、治疗时间与抗生素耐药性有直接关系。另一个重要问题是处方药质量的不确定性。一些医生认为仿制药不如创新药有效,因此有证据表明所有商业化药物都适合用于治疗是非常重要的。方法:采用微生物测定法建立药价、最低抑菌浓度(mic)、最低杀菌浓度(MBCs)、临界浓度以及万古霉素耐药突变体的产生。结果:建立了万古霉素效价测定方法。所有产品的效价均在90 - 115% (USP要求)之间。产物表现相似,因为mic、MBCs、临界浓度、标准与样品之间的临界浓度比以及自发突变体的产生没有显著差异。结论:所有产品的微生物试验分析表明,商标和仿制药均不存在统计学变异性,抗菌活性的答案也表明它们是药物等效的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Comparative in vitro study of the antimicrobial activities of different commercial antibiotic products of vancomycin.

Comparative in vitro study of the antimicrobial activities of different commercial antibiotic products of vancomycin.

Comparative in vitro study of the antimicrobial activities of different commercial antibiotic products of vancomycin.

Comparative in vitro study of the antimicrobial activities of different commercial antibiotic products of vancomycin.

Background: One of the most critical problems about antimicrobial therapy is the increasing resistance to antibiotics. Previous studies have shown that there is a direct relation between erroneous prescription, dosage, route, duration of the therapy and the antibiotics resistance. Other important point is the uncertainty about the quality of the prescribed medicines. Some physicians believe that generic drugs are not as effective as innovator ones, so it is very important to have evidence that shows that all commercialized drugs are suitable for therapeutic use.

Methods: Microbial assays were used to establish the potency, the Minimal Inhibitory Concentrations (MICs), the Minimal Bactericidal Concentration (MBCs), the critical concentrations, and the production of spontaneous mutants that are resistant to vancomycin.

Results: The microbial assay was validated in order to determine the Vancomycin potency of the tasted samples. All the products showed that have potency values between 90 - 115% (USP requirement). The products behave similarly because the MICs, The MBCs, the critical concentrations, the critical concentrations ratios between standard and samples, and the production of spontaneous mutants don't have significant differences.

Conclusions: All products analyzed by microbiological tests, show that both trademarks and generics do not have statistical variability and the answer of antimicrobial activity Show also that they are pharmaceutical equivalents.

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