白色洗剂处方及制备工艺研究

Research on Formulation and Preparation Process of White Lotion

目的:研究白色洗剂的处方和制备工艺。方法:根据该制剂实际存在的性状及临床使用问题,从化学反应原理,调整白色洗剂处方有关组分用量,并以性状、沉降系数和重新分散性为质量评价指标,考察反应液浓度(浓溶液与稀溶液)、反应液温度(25℃和80℃)对白色洗剂质量的影响。结果:新配方可制备性状符合规定、沉降较慢的成品,反应液温度为80℃时优于25℃,所得白色洗剂颜色乳白,颗粒细小均匀,絮凝程度较高,48 h沉降系数为0.623,重新分散次数为2。结论:原料处方量、反应液浓度、反应温度均会对白色洗剂性状及沉降系数产生影响,只有掌握好每一个环节,才能配制出符合质量标准的成品。

Objective: To analyze the formulation and preparation process of white lotion. Methods:The amount of each component of white lotion was adjusted according to the chemical reaction principle.The effects of reaction solution concentration and reaction temperature(25 ℃ and 80 ℃) on the preparation properties, sedimentation rate and re-dispersibility were examined. Results: The finished product with properties in accordance with the provisions and slower sedimentation was prepared by the new formulation.The white lotion prepared by dilute reaction solution at 25 ℃ was uniformly creamy white. Microscopic pictures showed small particles. The 48 h sedimentation coefficient and re-dispersed times were 0.512 and 5,respectively. The white lotion prepared at 80 ℃ was uniformly creamy white, showed small particles and a higher degree of flocculation, better than that prepared at 25 ℃. The 48 h sedimentation coefficient and redispersed times were 0.623 and 2, respectivelyy. Conclusion: The total preparation amount, reaction solution concentration and reaction temperature affect the preparation properties and sedimentation rate of white lotion. Only when every aspect of the preparation is mastered well, the finished product meeting the quality standards can be formulated.