消旋山莨菪碱凝胶的制备及质量控制

Preparation and Quality Control of Racanisodamine Gel

目的:制备消旋山莨菪碱凝胶并建立其质量控制方法。方法:选择卡波姆-940为基质,月桂氮酮为透皮促进剂,甘油为保湿剂进行制备;采用高效液相色谱法测定其中消旋山莨菪碱的含量。结果:所制备凝胶涂展性好;消旋山莨菪碱检测浓度线性范围为20～80μg.mL-1(r=0.9994),平均回收率为100.2%(RSD=0.62%)。结论:本制剂制备工艺简单,质量可控。

OBJECTIVE： To prepare the racanisodamine gel arid establish a standard for its quality control. METHODS： The racanisodamine gel was prepared with carbomer as base material, Laurocapram as transdermal promoter, and Glucerol as humectant, and with its content determined by HPLC. RESULTS： The racanlsodamine gel prepared in this method was proved to be well- distributed, and its linear range was 20-80μg·mL^-1（r = 0.999 4） and average recovery was 100.2% （RSD =0.62 %）. CONCLUSION. The preparation method is simple and the quality control method is feasible.