双嘧达莫凝胶剂的制备与质量控制

目的 制备双嘧迭莫新型凝胶剂,并建立其质量控制方法.方法 以卡波姆-940为基质,以双嘧达莫为主药,以薄荷脑为透皮促进剂.辅以1,3-丙二醇、羟苯乙酯、吐温-80,制成凝胶剂,用紫外分光光度法测定凝胶剂的主药双嘧达莫含量,测定波长为(283±1)nm.结果 双嘧达莫质量浓度在2～12μg/mL范围内与峰面积线性关系良好,回归方程A=0.060 8 C-0.0016(r=1).回收率为99.78%,RSD为0.70%.结论 双嘧达莫凝胶剂制备工艺简单,具有良好黏合性、成膜性和稳定性;质量控制方法 简便且准确,可在临床推广使用.

Preparation and Quality Control of Dipyridamole Gel

Objective To develop the preparation of new-type dipyridamole gel and to establish its quality control method.Methods With carbopol-940 as substrate,dipyridamole as the main drug,menthol as transdermal enhancer,supplemented by 1,3-propylene glycol,hydroxyl ethyl benzene and Tween-80,the gel was prepared.The content of dipyridamole in the gel was determined by ultraviolet spectrophotometry.The detection wavelength was（283±1）nm.Results The peak area with the concentration of dipyridamole was linear within the range of 2-12 μg/mL.The linear regress equation was A=0.060 8C-0.001 6（r=1）.The recovery rate was 99.78%,RSD 0.70%.Conclusion The preparation technology of dipyridamole gel is simple with good adhesivity,membranization and stability.The method of quality control is simple and accurate.Dipyridamole gel can be used for clinical development and application.