大豆异黄酮苷元滴丸的制备和含量测定

Preparation and determination of soybean isoflavone aglycones dripping pills

目的：研究大豆异黄酮苷元滴丸的处方、制备工艺和含量测定方法。方法：用单因素实验法确定制备工艺中的各种条件；用正交设计法优选处方组成；用HPLC法测定异黄酮苷元的含量。结果：最佳工艺条件为：冷凝剂二甲基硅油温度10℃，药液温度80℃，滴距6cm，滴速15滴／min。染料木素在3．6～36μg·mL^-1（r=0．9992）范围内，与色谱峰面积呈良好的线性关系。染料木素、黄豆苷元和黄豆黄素的含量分别为13．32％、6．00％和0．89％。结论：本制备工艺稳定性好、成型率高，建立的含量测定方法可控性强、专属性高。

Objective： To study the preparation technique and determination of soybean isoflavone aglycones（SIFA） dripping pills. Methods： Based on the result of single factor experiments, the formu- lation were optimized by orthogonal design and the content of SIFA was determined with HPLC. Resuits： The optimum dripping condition was as follows： the condensing agent was dimethyl silicone oil at the temperature of 10℃, the temperature of drug liquor was 80℃, dripping distance was 6 cm, and dripping speed was 15 drops per minute. There was a good linear relationship between genistein and peak area within the concentration range of 3.6 - 36 μg·mL^-4 （ r = 0. 999 2）. The content of genistein, daidzein and glycitein were 13.32% , 6.00% and 0.89%. Conclusion： The preparation method is stable with good product rate; the determination method is feasible and specific.