不同厂家复方银翘氨敏胶囊溶出度比较

Dissolution Comparison of Compound Fructus Forsythiae,Paracetamol and Chlorphenamine Maleate Capsules from Different Manufacturers

目的:比较7个厂家复方银翘氨敏胶囊在4种溶出介质中的溶出曲线,以评价其质量。方法:采用篮法、转速100 r·min^(-1)、溶出介质900 ml进行体外溶出试验,分别考察不同厂家复方银翘氨敏胶囊在盐酸溶液、pH 4.5醋酸盐缓冲液、水和pH 6.8磷酸盐缓冲液4种溶出介质中的体外溶出行为,测定溶出曲线并采用相似因子法进行比较分析。结果:7个厂家复方银翘氨敏胶囊在盐酸溶液中30min时累积溶出度均大于70%,在pH 4.5醋酸盐缓冲液、水和pH 6.8磷酸盐缓冲液中溶出结果差;4种溶出介质中的溶出曲线均存在不同程度的批间差异。结论:各厂家复方银翘氨敏胶囊的质量存在差异,在确保产品具有良好溶出的同时应着力提高制剂的稳定性。

Objective： To compare the dissolution of compound fructus forsythiae, paracetamol and chlorphenamine maleate capsules from different manufacturers. Methods： The dissolution test was carried out by a basket method in 900 ml dissolution medium with the rotating speed at 100 r·min-1. The dissolution profiles of compound fructus forsythiae, paracetamol and chlorphenamine maleate capsules from different manufacturers in four dissolution media including hydrochloric acid solution, pH 4.5 acetate buffer solution, water and pH 6.8 phosphate buffer solution were determined, and the dissolution curves were compared by a similar factor method. Results： The cumulative dissolution of compound fructus forsythiae, paracetamol and chlorphenamine maleate capsules from seven manufacturers was all over 70% in 30 min in hydrochloric acid solution, while failed to dissolve well in pH 4.5 acetate buffer solution, water and pH 6.8 phosphate buffer solution. All the dissolution curves in the 4 dissolution media were different among the batches. Conclusion： The quality of compound fructus forsythiae, paracetamol and chlorphenamine maleate capsules from various manufacturers is much different. Promising dissolution should be guaranteed, at the same time, the stability needs to be improved.