摘要:
目的 优化维生素E乳膏制剂工艺,提高该制剂质量水平.方法 以主药维生素E检出率和制剂稳定性作为考察指标,用正交试验法对维生素E乳膏工艺条件进行优选.结果 影响维生素E乳膏质量的主次因素为:A>D>C>B(A为加入主药时基质温度,B为乳化剂用量,C为搅拌方式,D为乳化时间),综合分析确立制备工艺条件为A3B2C3D2,即乳化剂用量为2.5%,在基质温度下降至55℃时加入主药维生素E,以高剪切乳化(4000r/min)方式搅拌,恒温乳化30min;结论 优选得到的工艺条件稳定可行.
Abstract:
Objective To choose the best preparing technology of vitaminE cream, improve its quality ;Methods The vitamin E's recall rate and preparation stability was the evaluating index. Orthogonal design method was used. Results The factors influenting extraction efficiency as follows were: A >D>C>B(A: the temperature when added vinaminE, B: the amount of emulsifier' percent, C: the way of mixing, D: the time of emulsifying), We got a result that the optimized technology was A3B2C3D2 by experimentation,namely the amount of emulsifier' percent was 2.5%, the temperature was 55℃,the way of mixing was high-speed cutting, emulsifying for 30min at 55℃. Conclusion The optimal technology is stable and high efficient.
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