呋布西林钠及其制剂的含量测定及抗菌活性考察

Content Determination and Antimicrobial Activity of Furbenicillin Sodium

目的：采用容量法、HPLC法对呋布西林钠及其制剂的含量进行测定，并采用浊度法对其抗菌活性进行考察。方法：抗生素微生物检定方法中的浊度法，以金黄色葡萄球菌为实验菌，加菌量为1．5％～3％（V／V），（37±1）℃培养4—6h测定。高效液相色谱法采用C18柱；以磷酸盐缓冲液（0．1mol·L^-1磷酸二氢钾溶液，用磷酸调pH3．5）：乙腈（75：25）为流动相；流速1．0g·L^-1；检测渡长为225nm。同时以容量法对样品进行测定。结果：采用容量法测得的含量比较接近，但采用HPLC法测得含量和抗菌活性均存在很大差异。结论：HPLC法方法简便、准确、灵敏度高，并与浊度法测得效价基本一致。HPLC法与浊度法均可作为评价呋布西林钠及其制剂抗菌活性的方法。为生产厂家改进生产工艺和提高产品质量提供了科学依据。

Objective： To determine the content by volumetric method, HPLC and assay of antimicrobial activity by a turbidimetric method for the content determination of furbenicillin sodium. Method：The test organism was Staphylococcus anreus. Adjusted spore suspension of Staphylococcus aureus inoclulated with a 1.5%-3% （V/V）ratio, at（ 37 ± 1 ）℃ for 4-6 hours. HPLC C18 column was used. The mobile phase was phosphate buffer （0. 1 mol · L^- 1 potassium dihydrogen phosphate solution, pH adjusted to 3.5 by phosphoric acid） ：acetonitrile （75： 25） o The flow rate is 1. 0 mL · min^ -1. The wavelength of UV detector was 225 nm. And determination the content by volumetric method. Results： The content results of samples were closed by Volumetric method but HPLC and the antimi- erobial activity results of them were very different. Conclusion： HPLC was convenient and accurate . The Turbidimetric method was sensitive, rapid and feasible to appraise furbenicillin sodium.