目的 优选稳定的盐酸苯海拉明软胶囊处方。方法 首先检索国外同品种的有关资料,通过组合胶囊壳配方与内容物配方制备样品,进行初步稳定性考察评价,并对优化处方进行验证。结果 按照A4处方制备的样品质量稳定。结论 组合处方A4最佳。
Objective To select the best steady recipe of Diphenhydramine Hydrochloride Soft Capsules. Methods The relevant information of the same production abroad was firstly searched and the samples were prepared by combining the recipes of soft capsules shell and content matter, and their stability was evaluated by preliminary stabilization test, then the stabilization of the samples prepared by the optimize recipe was validated. Results The quality of the samples prepared by combination recipe A4 was kept stability in period of validity. Conclusion Combination recipe A4 was the best recipe.