摘要
目的:通过建立浊度法测定红霉素效价的方法并验证方法的可行性,进一步比较管碟法、浊度法测定过程中的优缺点,为检验工作者做好抗生素效价测定提供指导。方法:建立浊度法测定红霉素效价的方法,并选取多个厂家、多个红霉素相关品种采用两种方法测定,进一步对两种方法进行比较。结果:浊度法测定,在0.1~1 U/ml内线性良好(r=0.9975);平均回收率为99.63%,RSD为0.3%;精密度RSD为0.6%。多个厂家的红霉素相关品种两法测定结果表明,浊度法测定的精密度、可信限率高。结论:浊度法的精密度高,浊度法可以应用于红霉素及其他红霉素相关品种的效价测定。
Objective:To establish a turbidimetric method for the determination of erythromycin biotiter and verify the feasibility of the method,and to further compare the advantages and disadvantages of the cylinder-plate method and turbidimetric method in the determination of antibiotic titer to guide inspectors.Methods:A turbidimetric method was established to determine the titer of erythromycin,and two methods were used to determine the titer of erythromycin from several manufacturers and erythromycin-related varieties.Results:The linear range was 0.1~1 U/ml by turbidimetric method,and the results showed that the linear range was good(r=0.9975).The average recovery was 99.63%,and RSD was 0.3%.The RSD of the precision test was 0.6%.The precision and confidence limit rate of the turbidimetric method were higher than those of other methods.Conclusion:The turbidimetric method has high precision and can be used to determine the titers of erythromycin and other erythromycin-related varieties.
作者
杨玉玲
吴愫青
Yang Yuling;Wu Suqing(Zhuhai Institute of Food and Drug Control,Guangdong519000)
出处
《天津药学》
2022年第6期21-23,46,共4页
Tianjin Pharmacy
关键词
红霉素
效价测定
浊度法
管碟法
erythromycin
antibiotics titer determination
turbidimetric method
cylinder-plate method
