微生物浊度法测定红霉素及其制剂的效价

Determination of potency in erythromycin and its tablets by turbidimetric method of microbial assays

目的:建立红霉素及制剂的微生物效价浊度法。方法:以金黄色葡萄球菌为试验菌,采用微生物效价浊度仪测定红霉素的效价,并与《中国药典》2005年版二部收载的管碟法测定结果进行比较。结果:红霉素原料效价平均测定值为887单位/mg,RSD为0.4%(n=6),可信限率为1.7%～2.3%。两法比较,浊度法与管碟法测定结果基本一致。结论:浊度法可用于测定红霉素效价,与管碟法比较,该方法灵敏,试验时间缩短,操作简化,可信限率优于管碟法。

Objective：To establish a turbidimetric method for the determination of potency in erythromycin and its tablets. Methods： With Staphylococcus aureus as the test organism, antibiotics turbidimetry instrument was used to determine the potency, and the result with that determined by agar diffusion method was also compared. Results： The average potency in erythromycin was 887 u/mg,with RSD 0. 4% （n = 6）, and the fiducial limits was 1.7% -2. 3%. The results obtained by turbidimetric method and by agar diffusion method were nearly equivalent. Conclusion： Turbidimetric method is sensitive, rapid, simple for the determination of potency in erythromycin and its tablets, with and the fiducial limits superior to that of agar diffusion method.