大豆异黄酮滴丸的制备工艺及质量标准

Preparation and quality control of soybean isoflavone dropping pills

目的：确立大豆异黄酮滴丸的最佳成型工艺和研究建立大豆异黄酮滴丸剂质量标准。方法：采用均匀设计法和单因素比较的方法,对提取物与基质的用量,药料温度,滴距等进行优选。采用薄层色谱法对大豆异黄酮提取物及滴丸中的大豆异黄酮进行定性研究。以UV法在262 nm测定原料及滴丸中大豆异黄酮含量。结果：根据实验所确定的工艺,制备的3批样品,符合《中国药典》2005年版关于滴丸的规定。大豆异黄酮可以用薄层色谱鉴别;大豆异黄酮在0.407-4.072μg.mL^-1线性关系良好,r=0.9998;高、中、低浓度加样回收率分别为96.54%,97.27%,97.21%,RSD分别为1.3%,0.71%,0.78%（n=3）。结论：优选的制备工艺方法简便可行,所建立的质量标准能检测和评价滴丸及原料中大豆异黄酮含量,且方法简便、快速、准确、稳定可靠。

Objective： To establish the optimized preparation procedure and study the method to determine the content for soybean isoflavone （SIF） Dropping Pills. Method： The preparation conditions, such as the proportion between SIF and PEGs, the temperature of mixture of SIF and PEGs, dropping distance, etc. , were studied with Uniform Design and One-way ANOVA. SIF was identified by TLC and the content of SIF was determined by UV spectrometry at 262 nm detection wavelength. Result： Three batches of the prepared products meet the standards of the Chinese pharmacopoeia on dropping pills. SIF can be identified by TLC. Using UV spectrometry, the linear range of SIF was 0. 407 2 to 4. 072 g· mL^-1 and the correlation coefficient was 0. 999 8. In high, middle and low concentration, average recovery were 96. 54%, 97.27% and 97. 21%, respectively （RSD were 1.3%, 0. 78% and 0. 71% ）. Conclusion ： The preparation procedure is feasible, simple and suitable, the method established in this paper can be adopted for the quality control of SIF dropping pills, and the determination method is simple, relatively fast and accurate.