复方庆大霉素颗粒剂制备与含量测定方法的建立

Preparation and Establishment of Content Determination Method of Compound Gentamicin Granules

选取庆大霉素和黄芩苷,经确定配比后,采用传统手工湿法制备复方庆大霉素颗粒剂,并依据兽药典分别采用旋光法和紫外分光光度法对其中的庆大霉素和黄芩苷进行含量测定。结果表明,庆大霉素在0.5 mg/mL~3.5 mg/mL范围内线性关系良好,平均回收率为98%~99%,RSD小于1%,精密度试验中RSD均小于5%,方法稳定性好,在复方庆大霉素颗粒剂中的平均含量为2.4 mg/mL,为标示量的96%,符合兽药典规定;黄芩苷在1μg/mL~13μg/mL范围内线性关系良好,平均回收率为98%~102%,RSD小于1%,精密度试验中RSD均小于5%,方法稳定性好,在复方庆大霉素颗粒剂中的平均含量为2.43μg/mL,为标示量的97.2%,符合兽药典规定。说明庆大霉素与黄芩苷所制备的复方庆大霉素颗粒剂其含量测定符合兽药典相关规定,在临床上有一定应用价值。

In this experiment,gentamicin and baicalin were selected.After determining the ratio,compound gentamicin granules were prepared by the traditional manual wet method.According to the veterinary pharmacopoeia,the gentamicin and baicalin were determined by optical rotation and ultraviolet spectrophotometry.The results showed that gentamicin had a good linear relationship in the range of 0.5-3.5 mg/mL,with an average recovery rate of 98%to 99%and an RSD of less than 1%.In the precision test,the RSD was less than 5%,and the method had good stability.The average content in compound gentamicin granules was 2.4 mg/mL,which is 96%of the labeled amount;it complies with veterinary pharmacopoeia regulations;baicalin had a good linear relationship in the range of 1 to 13μg/mL,and the average recovery was 98%-102%,RSD was less than 1%,RSD was less than 5%in precision test,the method had good stability,the average content in compound gentamicin granules was 2.4.3μg/mL,which is 97.2%of the labeled amount;it complies with veterinary pharmacopoeia regulation.The results showed that the determination of the compound gentamicin granules prepared by gentamicin and baicalin complies with the relevant regulations of the veterinary pharmacopoeia and has certain clinical application value.