药物制剂中阿奇霉素的微生物学测定法。
Microbiological assay for azithromycin in pharmaceutical formulations.
作者信息
Breier A R, Garcia C V, Oppe T P, Steppe M, Schapoval E E S
机构信息
Departamento de Produção e Controle de Qualidade de Medicamentos, Universidade Federal do Rio Grande do Sul, Faculdade de Farmácia, Av. Ipiranga, 2752, -RS 90610-000, Porto Alegre, Brazil.
出版信息
J Pharm Biomed Anal. 2002 Jul 31;29(5):957-61. doi: 10.1016/s0731-7085(02)00213-3.
The validation of a microbiological assay, applying the cylinder-plate method, for the determination of the antibiotic azithromycin is described. Using a strain of Micrococcus luteus ATCC 9341 as the test organism, azithromycin at concentrations ranging from 0.1 to 0.4 microgml(-1) could be measured in capsules and suspensions. A prospective validation of the method showed that it was linear (r=0.998), precise (RSD=1.40-capsules; RSD=1.19-powder for suspension and RSD=1.73-oral suspension) and accurate (it measured the added quantities). We conclude that the microbiological assay is satisfactory for quantitation of in vitro antibacterial activity of azithromycin.
本文描述了采用杯碟法对测定抗生素阿奇霉素的微生物学方法进行验证的过程。使用藤黄微球菌ATCC 9341菌株作为测试菌，可测定胶囊剂和混悬剂中浓度范围为0.1至0.4 μg/ml的阿奇霉素。该方法的前瞻性验证表明，其具有线性（r = 0.998）、精密度良好（胶囊剂的相对标准偏差为1.40；混悬剂用粉末的相对标准偏差为1.19；口服混悬剂的相对标准偏差为1.73）且准确度高（能准确测定添加量）。我们得出结论，该微生物学方法可用于阿奇霉素体外抗菌活性的定量测定，结果令人满意。
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