基于光谱法的六味地黄系列制剂质量再评价研究

Study on Quality Reevaluation of Liuwei Dihuang Series Preparations Based on Spectroscopy

以丸剂(大蜜丸、浓缩丸)、胶囊剂(胶囊、软胶囊)、颗粒剂和口服液为研究对象,建立紫外、红外及近红外光谱评价方法,采用数据处理软件“IBM SPSS statistics”,对六味地黄系列制剂进行质量再评价研究,为其质量标准提升提供参考.实验结果显示,六味地黄系列制剂的光谱图存在一定差异,其整体光谱相似度在0.309~0.985之间,P值在0.000~0.143之间,表明六味地黄系列制剂物质基础存在一定差异,且药效物质基础可能不同.

Taking the pills(big honey pills,concentrated pills),capsules(capsules,softcapsules),granules and oral fluids as the study objects,the paper aims to establish a unified evaluation method of ultraviolet,infrared and near-infrared spectroscopy to reevaluate of the quality of the Liuwei Dihuang series preparations and to perfect its quality standards.The data processing software“IBM SPSS statistics”is used.The results show that there are some differences in the spectral and chromatography of the Liuwei Dihuang series preparations.The overall spectral similarity is between 0.309 and 0.985,and P is between 0.000 and 0.143.It can be concluded that there are differences in the material basis of the Liuwei Dihuang series preparations,and the functional treatment may be different.