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用于测定眼用溶液中阿奇霉素的微生物学测定法。

Microbiological assay for the determination of azithromycin in ophthalmic solutions.

作者信息

Salgado Hérida Regina Nunes, Roncari Ana Flávia Ferreira

机构信息

Programa de Pós-graduaçaão em Ciências Farmacêuticas, Departamento de Fármacos e Medicamentos, Faculdade de Ciências Farmacêuticas, UNESP, Rodovia Araraquara-Jaú, km 1, Araraquara- SP-CEP 14801-902, Brazil.

出版信息

Yao Xue Xue Bao. 2005 Jun;40(6):544-9.

Abstract

The validation of a simple, sensitive and specific agar diffusion bioassay, applying cylinder-plate method, for the determination of the antibiotic azithromycin in ophthalmic solutions is described. Using a strain of Bacillus subtilis ATCC 9372 as the test organism, azithromycin at concentrations ranging from 50.0 to 200.0 microg.mL(-1) could be measured in 1.6667 mg.mL(-1) ophthalmic solutions. A prospective validation of the method showed that the method was linear (r = 0. 999 9) and precise (RSD = 0. 70) and accurate (it measured the added quantities). The results obtained by bioassay method could be statistically calculated by linear parallel model and by means of regression analysis and verified using analysis of variance (ANOVA). We conclude that the microbiological assay is satisfactory for quantification of azithromycin in ophthalmic solutions.

摘要

本文描述了一种采用圆筒平板法的简单、灵敏且特异的琼脂扩散生物测定法用于测定眼用溶液中抗生素阿奇霉素的验证过程。使用枯草芽孢杆菌ATCC 9372菌株作为测试菌,可在1.6667 mg.mL(-1)的眼用溶液中测定浓度范围为50.0至200.0 μg.mL(-1)的阿奇霉素。该方法的前瞻性验证表明,该方法具有线性(r = 0.9999)、精密度高(RSD = 0.70)且准确度高(能准确测定添加量)。生物测定法获得的结果可通过线性平行模型进行统计计算,并通过回归分析进行验证,同时使用方差分析(ANOVA)进行核实。我们得出结论,微生物测定法对于眼用溶液中阿奇霉素的定量分析是令人满意的。

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