复方泰乐菌素颗粒剂的品质控制

Quality Control of Compound Tylosin Granule

对制备出的复方泰乐菌素颗粒剂进行质量控制检测。紫外分光光度法测定复方泰乐菌素颗粒剂中的泰乐菌素和黄芩苷含量。建立复方泰乐菌素颗粒剂的紫外检测方法,泰乐菌素的平均回收率96.90%,日内平均RSD为0.0903%,日间平均RSD为0.1563%,泰乐菌素平均含量为97.0 mg/g;黄芩苷的平均回收率为101.35%,日内平均RSD为0.5553%,日间平均RSD为0.4808%,黄芩苷的平均含量为57.1 mg/g。粒度、干燥后质量损失和溶化性符合要求。经筛选后处方制备的复方泰乐菌素颗粒剂符合品质要求和含量要求,本方法操作简便、结果准确。

To investigate the quality control of compound Tylosin granule,the UV-spectrophotometer was used to survey the contents of Tylosin and baicalin in Compound Tylosin Granule.The UV detection method for Compound Tylosin Granules was established.The average recovery of Tylosin was 96.90%,the RSD within a day was 0.0903% and the assay precision RSD between days was 0.1563%,the average content of Tylosin was 9.70% as well.The average recovery of baicalin was 101.35%,the RSD within a day was 0.5553% and the RSD between days was 0.4808%,the average content of Baicalin was 5.71% as well.Granularity,dry agravity,and nature of dissolve meet the requirements.The grains prepared by the optimum formulation meet the requirements on quality and content,this method was simple and accurate.