硅油乳膏制备过程中的条件控制及稳定性考察

Condition Control in the Preparation Process of Silicone Oil Cream and Its Stability

目的:探讨硅油乳膏制剂工艺中条件控制方法,考察所制乳膏的性状和稳定性。方法:通过适当减少处方中油相成分用量,增加乳化剂成分用量,采用拟均匀试验法,以乳膏稠度、细腻度、光泽度作为考察指标,确定优化处方,并控制乳化温度为95℃左右,制备硅油乳膏。结果:按优化处方及条件控制所得乳膏性状和稳定性良好,其pH值为5.5-7.0,卫生学检查符合药典规定。结论:按本文处方及条件控制所得乳膏性状和稳定性符合临床应用要求。

Objective: To discuss the condition control method for the preparation craft of silicone oil cream and to investigate its traits and stability. Methods: By appropriate reduction of oil phase ingredients and the increase of emulsifying agents to optimize the composition of the cream made, a silicone oil cream was prepared at emulsifying temperature of about 95℃. Results: The cream prepared by above method had good traits and higher stability, with pH 5.5-7.0, which agreed with the hygienic requirement in Chinese pharmacopeia. Conclusion: The traits and stability of the cream prepared in the above manner meet with the requirements of the clinical application.