佛甲草的质量标准研究

目的:制定佛甲草饮片质量标准。方法:采用显微鉴别、薄层色谱法对佛甲草饮片进行鉴别,按2015年版《中国药典》(四部)通则进行水分、总灰分、酸不溶性灰分和浸出物的测定,采用高效液相色谱法测定其槲皮素、山柰素和异鼠李素的含量。结果:样品的显微特征明显,薄层色谱鉴别斑点清晰,专属性强;7批样品水分含量为8.04%~9.73%,总灰分含量为15.07%~20.53%,酸不溶性灰分5.12%~8.99%,水溶性浸出物含量为25.42%~40.12%;槲皮素、山奈素和异鼠李素3个成分的线性关系良好,精密度、稳定性和重复性的RSD均低于2.0%,加样回收率分别为98.33%、 98.92%和97.96%, RSD均小于2.0%(n=6);3种成分的线性关系均良好(r≥0.9990)结论:方法准确稳定,可用于佛甲草的质量控制。初步拟定佛甲草水分不得过11.0%,酸不溶性灰分不得过9.0%,浸出物不得少于24.0%,槲皮素含量不得少于0.025%。

Study on the Quality Standard of Sedilinearis Herba

Objective To establish the quality standard of Sedilinearis Herba.Methods Microscopic identification,thin layer chromatography(TLC)were carried out,According to the corresponding methods in 2015 edition of Chinese Pharmacopoeia(PartⅣ),the contents of moisture,total ash and doluble extractive from 7 batches of Sedilinearis Herba were determined.The contents of quercetin,kaempferol and isorhamnetin were determined by high performance liquid chromatography(HPLC).Results The microseopic characteristics of Sedilinearis Herba were described in detail.TLC spots were clear and the specificity was strong.The contents of moisture,total ash,acid insoluble ash,and soluble extract from samples were 8.04%~9.73%,15.07%~20.53%,5.12%~8.99%,25.42%~40.12%,respectively.The linear relationships of quercitrin,kaempferol and isorhamnetin were all good.,and the RSDs were all less than 2.0%.The recovery rates of the 3 components were 98.33%,98.92%and 97.96%,and the RSDs were all less than 2.0%(n=6);the linear ralationships of the 3 components were all good(r≥0.9990).Conclusions This method is accurate and stable,which can be used for the quality control of Sedilinearis Herba.It is preliminarily proposed that moisture and acid insoluble ash content should not exceed 11.0% and 9.0%,and extract and quercetin content should not be less than 24.0% and0.025% respectively.