制艾软膏的制备工艺研究

Study on Preparation Technology of Zhiai Ointment

目的:研究制艾软膏的制备工艺。方法:以加水量、提取时间、醇沉浓度为考察因素,以阿魏酸含量和干膏率的综合评分为评价指标,采用正交试验优选提取工艺;采用单因素试验考察软膏基质、乳化温度、水相基质与药物流浸膏比例,筛选成型工艺。结果:优选的提取工艺为采用水蒸气蒸馏法提取艾叶、细辛和桂枝中的挥发油,其余药材用水提取2次,分别加水10、8倍量,提取2、1.5h,再用50%乙醇沉淀24h。成型工艺为取药物流浸膏15g,制备O/W型软膏;水相为甘油5g、蒸馏水30ml,油相为白凡士林25g、羊毛脂12.5g、液体石蜡12.5g,乳化剂为十二烷基硫酸钠2g,透皮促进剂为氮酮2g。药物流浸膏、乳化剂加入水相,透皮促进剂加入油相,两相分别置80℃水浴中熔融,将水相缓缓加入油相中,边加边搅拌,膏体凝固前加入挥发油,搅拌至混合均匀,冷却至室温。结论:所选提取工艺和成型工艺合理、可行,制得的制剂稳定性好。

OBJECTIVE： To study the preparation technology of Zhiai ointment. METHODS： The orthogonal test was used to optimize the extraction technology with the amount of water, extraction time and alcohol precipitation concentration as factors using the comprehensive score of ferulaic acid content and dry extract yield. The forming process was investigated by screening ointment matrix, emulsification temperature and ratio of water phase matrix tofluid extract with single-factor test. RESULTS： The optimal condition of extraction was as follows： the volatile oils were extracted from Artemisia argyi, Asari Radix et Rhizoma and Cinnamomum cassia by steam distillation method; other medicinal materials were extracted with 10 and 8 times of water for 2 times, lasting for 2 and 1.5 h, and the concentration of alcohol precipitation was 50% for 24 h. The forming process technology of O/W ointment was as follows： raw materials fluid extract 15 g; glycerol 5 g and distilled water of 30 ml as water phase; white vaseline 25 g, lanolin of 12.5 g, liquid paraffin of 12.5 g as oil phase; sodium dodecyl sulphate 2 g as emulsifier; azone 2 g as penetration enhancer. Medicine fluid extract and emulsifier were added into water phase, and penetration enhancer also added into oil phase. Through the emulsion process, the water phase and oil phase were melted in the water bath at 80 ℃ ; water phase were slowly added into the oil phase and stirred; volatile oils were added into mixture before paste solidified, stirred thoroughly and cooled to room temperature. CONCLUSION： Optimized extraction technology and forming technology is reasonable and feasible, and Zhiai ointment is stable.