硫酸庆大霉素缓释片含量测定方法探讨

Optimization of Determination Method of Gentamycin Sulfate Sustained-release Tablets

目的:筛选硫酸庆大霉素缓释片含量测定中的样品处理方法。方法:针对缓释片制备工艺特性,对以4种方法处理同一样品后的含量测定结果进行比较,方法1采用《中国药典》方法,方法2、方法3增加不同溶解时间,方法4在方法3的基础上进行了研磨处理。结果:与标示值比较,4种方法测定值接近度为方法4>方法3>方法2>方法1,其中方法1、方法4的平均回收率分别为91.1%(RSD=1.46%)、99.8%(RSD=0.74%)。结论:方法4中的样品处理方法较好,更适合该缓释片的含量测定。

OBJECTIVE： To optimize the sample treatment method in the content determination of gentamycin sulfate sustained - release tablets. METHODS： In the light of the characteristics of the preparation technology of sustained - release tablets, the contents of the same sample treated by 4 methods were compared. Method 1 was a method adopted from Chinese Pharmacopeia ; The solution time was increased differently in method 2 and method 3, and method 4 was similar to method 3, but in which additional grinding treatment was performed. RESULTS： Compared with marked value, the approaching degree by method 4 was the highest, followed by method 3, method 2 and method 1, respectively. The average recovery rates for method 1 and method 4 were 91.1% （RSD = 1.46% ） and 99.8% （RSD = 0.74% ）, respectively. CONCLUSION： Method 4 is the optimal one for sample treatment and it is suitable for the determination of the content of this preparation.