浊度法测定地红霉素效价

Content determination of dirithromycin by turbidimetric method

目的:建立浊度法测定地红霉素效价的方法,及效价测定的最佳条件并探讨地红霉素含量测定的最佳方法。方法: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。同时以高效液相色谱法、管碟法对样品及对照品进行测定。结果:地红霉素浊度法抗生素线性浓度范围为1.0～10.0μg·mL^(-1),回归方程为 A=384.448C+588.816,r=0.9998;一剂量、二剂量的平均回收率分别为102.5%(n=5)、101.7%(n=6),口内 RSD 分别为1.45%,0.94%;日间 RSD 分别为1.97%,1.12%。结论:浊度法灵敏,快速,可作为地红霉素效价测定法。

Objective：To establish a turbidimetric method for the content determination of dirithromycin. Method： The test organism was adjusted spore suspension of inoclulated with a 1.5% - 3% （V/V） ratio, at（37 ± 1 ）℃ for 4 - 6 hours. Results. The linear range was 1.0 - 10. 0 μg · mL^- 1. r = 0. 9998 ; The precision （RSD） of the standard curve assay and two - level assay was 1.45% ,0. 94% for intra - day,1.97% and 1.12% for inter - day and the average recoveries were 102.5% （ n = 5 ） and 101.7% （ n = 6 ） respectively. Conclusion： The method ： sensitive, rapid and feasible to determine dirithromycin.