Diaz Jorge A, Silva Edelberto, Arias Maria J, Garzón María
Universidad Nacional de Colombia, Facultad de Ciencias, Departamento de Farmacia, Laboratorio de Asesorías e Investigaciones en Microbiología, 472. Ciudad Universitaria. Carrera 30 Calle 45. A.A.14490. Bogotá D. C. Colombia.
Vitalis Pharmaceutical, Proyectos Especiales, Carrera 7 No 156-80. Oficina No 1104. Bogotá D. C. Colombia.
BMC Clin Pharmacol. 2011 Jul 21;11:9. doi: 10.1186/1472-6904-11-9.
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.
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.
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.
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.
抗菌治疗最关键的问题之一是对抗生素的耐药性不断增加。先前的研究表明，错误的处方、剂量、给药途径、治疗持续时间与抗生素耐药性之间存在直接关系。另一个重要问题是所开药物质量的不确定性。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治疗用途非常重要。
采用微生物测定法来确定效力、最低抑菌浓度（MICs）、最低杀菌浓度（MBCs）、临界浓度以及对万古霉素耐药的自发突变体的产生情况。
对微生物测定法进行了验证，以确定受试样品的万古霉素效力。所有产品的效力值均在90 - 115%之间（符合美国药典要求）。这些产品表现相似，因为MICs、MBCs、临界浓度、标准品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。
通过微生物测试分析的所有产品表明，品牌药和仿制药均无统计学差异，抗菌活性结果也表明它们是药学等效物。
