关于完善《中国药典》2010年版炒槐花质量标准的研究

Study on Improvement of the Quality Standard for Flos Sophorae Tostus in Chinese Pharmacopoeia(2010)

目的:建立炒槐花中总黄酮、芦丁、槲皮素含量限度要求,为完善2010年版药典中该饮片的质量标准提供实验数据。方法:采用紫外-可见分光光度法测定总黄酮含量。采用HPLC测定芦丁和槲皮素的含量,均以十八烷基硅烷键合硅胶为填充剂;芦丁的流动相为甲醇-1%冰醋酸溶液(32∶68);槲皮素的流动相为甲醇-水-冰醋酸(44∶56∶0.4);检测波长均为257 nm。结果:炒槐花(花)中总黄酮、芦丁、槲皮素含量均不得低于8%,6%,0.35%;炒槐花(花蕾)中总黄酮、芦丁、槲皮素含量均不得低于20%,16%,0.3%。结论:本文方法简便易行、重复性好、结果准确,所制定炒槐花的质量标准提高了该饮片的质控水平,为其临床应用的安全性和有效性提供了实验数据。

Objective：To improve the quality standard of Flos Sophorae Tostus in Chinese Pharmacopoeia（2010）,according to the limitation of the content of total flavonoids,rutin,quercetin in the processed pieces.Method： The content of total flavonoids was determined by UV-Vis Spectrophotometry.The content of rutin and quercetin were determined by HPLC.Octadecylsilane bonded silica gel was used as filling material.Mobile phase for rutin consisted of methanol-1% glacial acetic acid（32∶68）.Mobile phase for quercetin was methanol-water-glacial acetic acid（44∶56∶0.4）.The detection wavelengths were all at 257 nm.Result： The content of total flavonoids,rutin,quercetin was no lower than 8%,6%,0.35% in flower and no lower than 20%,16%,0.3% in flower buds.Conclusion： These methods are simple,accurate and with good reproducibility.The established quality standards improve the quality control and provide experimental datas for safety and efficacy of clinical application of Flos Sophorae Tostus.