The Selection of Bacterial Strain and Inoculum Concentration in Microbial Bioassay for the Development of Cefixime Potency Test in Pharmaceutical Preparations

R. Islamie, Dian Natasya Raharjo, N. Agustiningrum
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Abstract

Cefixime is one the antibiotic that use widely in the clinical setting. Microbiological bioassay is an essential step to ensure the efficacy of the antibiotic. Several factors including bacterial strain, inoculum concentration, and solvent, pH, reference concentration, storage time of antibiotic standard influenced the zone inhibition of the bioassay. This study was aimed to optimize two factors from microorganism aspect for the development antibiotic potency test of cefixime in pharmaceutical preparation. Cylinder cup method was used for this microbiological assay. Our results revealed that Escherichia coli ATCC 10536 with the concentration of 1.0% was the optimum bacterial strains for cefixime reference standard. In conclusion, the optimizing both factors from the test microorganism could be helpful to develop the appropriate method for microbial bioassay of Cefixime in pharmaceutical preparations.
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头孢克肟药物效价试验中微生物测定菌株和接种浓度的选择
头孢克肟是临床上广泛使用的抗生素之一。微生物生物测定是保证抗生素疗效的重要步骤。菌株、接种量、溶剂、pH、标准浓度、抗生素标准品的保存时间等因素影响生物测定的带抑制效果。本研究旨在从微生物方面优化头孢克肟在药物制剂中抗生素效价试验的两个因素。本实验采用柱杯法。结果表明,浓度为1.0%的大肠埃希菌ATCC 10536是制备头孢克肟标准品的最佳菌株。综上所述,从试验微生物角度对这两个因素进行优化,有助于建立头孢克肟在药物制剂中的微生物含量测定方法。
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