Silva Edelberto, Díaz Jorge A, Arias María J, Hernández Angela P, de la Torre Andrés
UNIVERSIDAD NACIONAL DE COLOMBIA, FACULTAD DE CIENCIAS, DEPARTAMENTO DE FARMACIA, Laboratorio de Asesorías e Investigaciones en Microbiología. Postal Code: 472. Ciudad Universitaria. Carrera 30 Calle 45. A.A. 14490, Bogotá D. C., Colombia.
BMC Clin Pharmacol. 2010 Jan 29;10:3. doi: 10.1186/1472-6904-10-3.
The antimicrobial resistance is a global problem, probably due to the indiscriminate and irrational use of antibiotics, prescriptions for incorrect medicines or incorrect determinations of dose, route and/or duration. Another consideration is the uncertainty of patients receiving antibiotics about whether the quality of a generic medicine is equal to, greater than or less than its equivalent brand-name drug. The antibiotics behaviors must be evaluated in vitro and in vivo in order to confirm their suitability for therapeutic use.
The antimicrobial activities of Meropenem and Piperacillin/Tazobactam were studied by microbiological assays to determine their potencies (content), minimal inhibitory concentrations (MICs), critical concentrations and capacity to produce spontaneous drug-resistant mutants.
With respect to potency (content) all the products fulfill USP requirements, so they should all be considered pharmaceutical equivalents. The MIC values of the samples evaluated (trade marks and generics) were the same for each strain tested, indicating that all products behaved similarly. The critical concentration values were very similar for all samples, and the ratios between the critical concentration of the standard and those of each sample were similar to the ratios of their specific antibiotic contents. Overall, therefore, the results showed no significant differences among samples. Finally, the production of spontaneous mutants did not differ significantly among the samples evaluated.
All the samples are pharmaceutical equivalents and the products can be used in antimicrobial therapy.
抗菌药物耐药性是一个全球性问题，这可能归因于抗生素的滥用和不合理使用、开具错误药物的处方或剂量、给药途径和/或疗程的错误判定。另一个需要考虑的因素是，接受抗生素治疗的患者不确定仿制药的质量是否等同于、优于或劣于其等效的品牌药。必须在体外和体内对抗生素的性能进行评估，以确认其是否适合用于治疗。
通过微生物测定法研究了美罗培南和哌拉西林/他唑巴坦的抗菌活性，以确定它们的效价（含量）、最低抑菌浓度（MIC）、临界浓度以及产生自发耐药突变体的能力。
就效价（含量）而言，所有产品均符合美国药典要求，因此它们都应被视为药学等效品。对于所测试的每个菌株，评估的样品（商标药和仿制药）的MIC值相同，这表明所有产品的表现相似。所有样品的临界浓度值非常相似，标准品的临界浓度与每个样品的临界浓度之比与其特定抗生素含量之比相似。因此，总体而言，结果表明样品之间没有显著差异。最后，在所评估的样品中，自发突变体的产生没有显著差异。
所有样品均为药学等效品，这些产品可用于抗菌治疗。
