经前方中挥发油提取工艺优化与滴丸制备工艺研究

Optimization of Extraction Technology from Essential Oil in JF and Preparation of Dropping Pill

目的:对经前方中挥发油提取工艺与滴丸制备工艺进行研究,以提高挥发油得率,为后期制作滴丸以及临床研究做准备。方法:分别对经前方中的主要药味当归、川芎、玫瑰花、小茴香、赤芍有效成分进行提取。通过对制剂中的基质配比、滴制温度、冷却剂温度、辅料种类、滴速、滴距等因素进行研究,以重量差异、崩解时限为考察指标采用正交试验筛选,验证最佳制备工艺。结果:实验确定的挥发油最佳提取工艺是:当归、川芎、玫瑰花、小茴香以其10倍量的水,浸泡5 h后加热至微沸提取9 h。最后得出最佳制备条件为药物-基质比(1:4),药液温度为80℃,基质为聚乙二醇6000,冷却剂为液体石蜡,冷却剂温度为4℃,滴距为4 cm,滴速为40滴/min。结论:以其10倍量的水按水蒸气蒸馏法提取挥发油得率有明显提高,依据实验条件所制得的经前方滴丸,符合《中华人民共和国药典》2010版的滴丸制备要求。

Objective： To optimize the extraction technology from essential oil in JF and the preparation of dropping pill, in order to improve the yield of volatile, for the post-production in dropping pill and preparing for the clinical research. Methods ： The volatile oil was extracted from Angelliea sinensis Diels, Ligusticum chuangxiong Hort, Rosa rugosa Thunb, Foeniculum vulgate Mill, Paeonia lactiflora Pall. By inspecting the factors which affect the preparation for dropping pills such as the temperature of drug and refrigerant, dropping speed and space in dropping process, we selected coefficient of weigh variation, dissolution time as inspection factors to further screen the best technology using orthogonal experiment. Results ： The optimum extraction process of volatile oil was that immersed these traditional Chinese medicine in 10 times accounting of water for 5 hours, and then extracted them 9 hours under slightly boiled condition. The optimized preparation technology was as follows： Drugs-matrix ratio was 1 ： 4, liquid temperature was 80 ℃, and the best matrix was PEG6000, the dropping distance was 4 cm, the speed was 40 drops every minute. Conclusion ： It＇s significantly improved of volatile oil yield by steam distillation in 10 times of the amount of water. JF pill obtained based on the experimental conditions meets the preparation requirements of Chinese Pharmacopoeia in 2010.