金银花提取物的质量分析方法评价

目的:探索金银花提取物质量控制的专属性方法,为相关制剂的质量控制提供参考。方法:采用HPLC,流动相乙腈(A)-0.4%磷酸水溶液(B)梯度洗脱(0~15 min,5%~20%A;15~30 min,20%~30%A;30~40 min,30%A),检测波长327 nm。比较金银花提取物与山银花、杜仲叶原药材及其提取物中绿原酸含量和特征图谱,分析银黄制剂中金银花提取物的质量。结果:原药材、提取物中均是山银花所含的绿原酸含量最高,质量分数分别为3.56%~5.09%,4.62%~6.12%;金银花提取物与杜仲叶提取物无明显差异,绿原酸质量分数约4%;金银花、山银花、杜仲叶提取物酸化后绿原酸含量均提高,分别为6.90%,7.35%,6.47%。山银花、杜仲叶提取物及其酸化提取物的特征谱图与金银花提取物标准图谱相同,部分银黄制剂中检测出了杜仲叶的主要成分京尼平苷酸和山银花的主要成分灰毡毛忍冬皂苷乙。结论:金银花提取物中可能存在添加山银花和杜仲叶的情况,需加强质量控制,为金银花提取物质量标准的提高及检测方法的选择提供了重要依据。

Evaluation of Quality Analysis Method of Lonicerae Japonicae Flos Extract

Objective: To explore the exclusive methods for quality control of Lonicerae Japonicae Flos extract.Method: HPLC was employed with mobile phase of acetonitrile-0.4% phosphoric acid solution for gradient elution and detection wavelength at 327 nm.The quality of Lonicerae Japonicae Flos extract in Yinhuang preparations was analyzed, the content of chlorogenic acid and specific chromatogram of Lonicerae Japonicae Flos extract were compared with the extract and original medical herb of Lonicerae Flos and Eucommiae Folium.Result: The highest contents of chlorogenic acid in the original medical herbs and its extracts were Lonicerae Flos, mass fractions were 3.56%-5.09% and 4.62%-6.12%;there was no difference between Lonicerae Japonicae Flos extract and Eucommiae Folium extract, the content of chlorogenic acid was about 4%.After acidification, the contents of chlorogenic acid in Lonicerae Japonicae Flos extract, Lonicerae Flos extract and Eucommiae Folium extract were all increased.Specific chromatogram of extract and acid extract of Lonicerae Flos and Eucommiae Folium were the same as the standard chromatogram of Lonicerae Japonicae Flos extract.Some of Yinhuang preparations had been checked geniposidic acid from Eucommiae Folium and macranthoidin B from Lonicerae Flos.Conclusion: Lonicerae Japonicae Flos extract may be added to Lonicerae Flos and Eucommiae Folium, its quality control should be strengthened.