芎归双层片制备工艺的研究

Study on the Preparation Technology of Xionggui Double-layer Tablets

目的:比较芎归双层片有效成分的4种提取方法及芎归双层片的制备。方法:采用乙醇脱脂后水煎醇沉法;不去脂直接水煎醇沉法;乙醇渗漉法;乙醇回流法提取芎归双层片浸膏的有效成分阿魏酸,用HPLC法测定双层片中阿魏酸的含量,用干法制粒压制双层片。结果:乙醇回流法提取的干膏达30.86%,阿魏酸在5.0～85.0μg范围内呈线性关系(r=0.999 9)平均回收率98.50%,RSD为0.38%。结论:用乙醇回流法提取双层片的干膏回收率高,制备工艺简单,双层片质量可控,达到设计要求。

Objective： To compare four extraction methods for the active ingredient and prepare Xionggui double-layer tablets. Method ： Ferulie acid determined by HPLC as the active ingredient of Xionggui double-layer tablets was extracted by water-extraction and alcohol-precipitation after ethanol degreasing,water-extraction and alcohol-precipitation without ethanol degreasing,ethanol percolation and alcohol refluxing, respectively. Xionggui double-layer tablets were prepared by dry granulation method. Result： The extraction ratio of alcohol refluxing method was 30. 86%. The linear range of ferulie acid was 5.0-85.0 μg（r =0. 999 9） ,and the recovery was 98.50% with RSD of 0. 38%. Conclusion： The alcohol reifuxing extraction is effective and simple, and the preparation technique of Xionggui double-layer tablets is scientific and controllable.