Objective To prepare isophenylcyclopentylamine hydrochloride capsules and evaluate its quality. Methods The suitable excipients were selected by the drug-excipient compatibility test,and after the formulation and preparation process design and screening,the micromeritic property and hygroscopicity of contents of capsules as well as the basic performance and stability of is-ophenylcyclopentylamine hydrochloride capsules were evaluate. Results The selected formulation was composed of isophenylcyclo-pentylamine hydrochloride 10 mg,anhydrous dibasic calcium phosphate 128.7 mg,mannitol 128.7 mg and aerosil 2.7 mg.The angle of repose of intermediate powders was(30.71±1.09)°,aerated and packed bulk densities were(0.76±0.01)and(0.90±0.02)g/ml re-spectively,Hausner value was 1.19±0.01,Carr′s index was(15.86±1.05)%,indicating good flowability and filling property as well as relatively low humidity.The contents,uniformity of contents and dissolution of capsules fulfilled the requirements.The quality of ca-pusles kept well in the 6-month accelerated and long-term stability test.Conclusion The formulation is simple and reasonable,and the preparation process showed a good reproducibility,which might be suitable for industrialization.%目的 制备盐酸异苯环戊胺胶囊并对其质量进行考察.方法 通过相容性实验选择适宜的辅料,设计筛选处方和制备工艺,评价内容物的粉体学特性、吸湿性和制剂的基本性能及稳定性.结果 制备的处方为:盐酸异苯环戊胺10 mg、无水磷酸氢钙128.7 mg、甘露醇128.7 mg、微粉硅胶2.7 mg.中间体粉末的休止角(30.71±1.09)°、松密度(0.76±0.01)g/ml、轻敲密度(0.90±0.02)g/ml、Hausner比值1.19±0.01、Carr指数(15.86±1.05)%,流动性和填充性良好,吸湿率低.含量、含量均匀度和溶出度均符合要求,6个月加速和长期稳定性实验中制剂质量保持稳定.结论 处方简单、合理,制备工艺重现性良好,适于工业化生产.
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