Lourenço Felipe Rebello, Kaneko Telma Mary, Pinto Terezinha de Jesus Andreoli
University of São Paulo, Faculty of Pharmaceutical Science, Department of Pharmacy, Ave. Prof. Lineu Prestes, 580-Block 13, 05508-900, São Paulo, Brazil.
J AOAC Int. 2007 Jul-Aug;90(4):1107-10.
The agar diffusion method, widely used in antibiotic dosage, relates the diameter of the inhibition zone to the dose of the substance assayed. An experimental plan is proposed that may provide better results and an indication of the assay validity. The symmetric or balanced assays (2 x 2) as well as those with interpolation in standard curve (5 x 1) are the main designs used in the dosage of antibiotics. This study proposes an alternative experimental design for erythromycin microbiological assay with the evaluation of the validation parameters of the method referring to linearity, precision, and accuracy. The design proposed (3 x 1) uses 3 doses of standard and 1 dose of sample applied in a unique plate, aggregating the characteristics of the 2 x 2 and 5 x 1 assays. The method was validated for erythromycin microbiological assay through agar diffusion, revealing its adequacy to linearity, precision, and accuracy standards. Likewise, the statistical methods used demonstrated their accordance with the method concerning the parameters evaluated. The 3 x 1 design proved to be adequate for the dosage of erythromycin and thus a good alternative for erythromycin assay.
琼脂扩散法在抗生素剂量测定中广泛应用,它将抑菌圈直径与被测物质的剂量相关联。本文提出了一种实验方案,该方案可能会提供更好的结果并能表明测定的有效性。对称或平衡测定法(2×2)以及标准曲线内插法(5×1)是抗生素剂量测定中主要使用的设计方法。本研究提出了一种用于红霉素微生物测定的替代实验设计,并评估了该方法在线性、精密度和准确度方面的验证参数。所提出的设计(3×1)在单个平板中使用3个标准剂量和1个样品剂量,综合了2×2和5×1测定法的特点。通过琼脂扩散法对红霉素微生物测定方法进行了验证,结果表明该方法符合线性、精密度和准确度标准。同样,所使用的统计方法也证明在评估参数方面与该方法相符。3×1设计被证明适用于红霉素的剂量测定,因此是红霉素测定的一个很好的替代方法。