摘要
目的建立槐枝药材及饮片的质量标准。方法建立槐枝药材及饮片的性状、显微和薄层色谱鉴别方法;并分别对10批槐枝药材和10批槐枝饮片的水分、总灰分、水溶性浸出物进行测定;采用高效液相色谱法(HPLC)对槐枝药材及饮片中的指标性成分芦丁进行含量测定。结果槐枝药材及饮片的显微特征明显,薄层色谱斑点清晰,分离效果好,在与芦丁对照品相应的位置上,显相同的荧光斑点;拟定了槐枝药材及饮片的水分、总灰分、水溶性浸出物限量分别为12.0%、10.0%、8.0%;芦丁在50.7~760.6 ng范围内线性关系良好(r=0.9998),平均回收率为103.6%,相对标准偏差(RSD)为1.7%(n=6)。结论所建标准可用于槐枝药材及饮片的质量评价。
Objective To establish the quality standard of Sophora japonica medicinal materials and decoction pieces.Methods To establish the traits,microscopic and TLC identification methods of Sophora japonica medicinal materials and decoction pieces;The moisture,total ash and water-soluble extracts of 10 batches of Sophora japonica medicinal materials and 10 batches of Sophora japonica decoction pieces were measured respectively;The content of rutin,an index component in Sophora japonica medicinal materials and decoction pieces,was determined by HPLC.Results The microscopic characteristics of Sophora japonica medicinal materials and decoction pieces are obvious;The TLC spots are clear and the separation effect is good,and the same fluorescent spots are displayed at the corresponding positions of the rutin reference substance;The limits of moisture,total ash and water-soluble extracts of Sophora japonica medicinal materials and decoction pieces were drawn up to be 12.0%,10.0% and 8.0%,resepectively;The linear relationship of rutin is good in the range of 50.7~760.6 ng(r=0.999 8),the average recovery was 103.6%,and the RSD was 1.7%(n=6).Conclusion The established standard can be used for the quality evaluation of Sophora japonica medicinal materials and decoction pieces.
作者
李敏
刘洋
郑鹏
于姗姗
王亮
张秋红
LI Min;LIU Yang;ZHENG Peng;Yu Shan-Shan;WANG Liang;ZHANG Qiu-Hong(Jinan Supervision and Inspection Center for Food and Drug Control,Jinan 250102,China;Chinese Medicine and Clinical Pharmacy Research Cente,Shandong Provincial Maternal and Child Health Care Hospital,Jinan 250014,China)
出处
《中国药物经济学》
2022年第6期101-105,109,共6页
China Journal of Pharmaceutical Economics
基金
山东省重大科技创新工程项目(2017CXGC1308)
山东省药品监督管理局山东省中药材及饮片标准研究(2020-138、2020-139)。
关键词
槐枝药材
槐枝饮片
显微鉴别
薄层色谱鉴别
高效液相色谱法
芦丁
质量标准
Sophora japonica medicinal materials
Sophora japonica decoction pieces
Microscopic
TLC
HPLC
Rutin
Quality standard