牛白藤饮片质量标准研究  

Study on quality standard of Hedyotis hedyotidea Chinese Herbal Pieces

作　　者：吉林芳 杨德泉 佘永红 丁野 JI Linfang;YANG Dequan;SHE Yonghong;DING Ye(Department of Traditional Chinese Medicine,Xiangxi Tujia and Miao Autonomous Prefecture of Food and Drug Inspection Office,Hu′nan Province,Jishou416000,China;Institute of Standards,Hu′nan Institute of Drug Inspection and Testing,Hu′nan Province,Changsha410001,China)

机构地区：[1]湖南省湘西土家族苗族自治州食品药品检验所中药室,湖南吉首416000 [2]湖南省药品检验检测研究院标准研究所,湖南长沙410001

出　　处：《中国当代医药》2022年第11期4-6,F0003,共4页China Modern Medicine

基　　金：湖南省自然科学基金项目(2021JJ80030)。

摘　　要：目的制定牛白藤饮片的质量标准。方法牛白藤为茜草科植物牛白藤Hedyotis hedyotidea(DC.)Meer.的干燥藤茎,12批饮片样品来源于湖南省内4家中药饮片公司。完善薄层色谱(TLC)鉴别牛白藤饮片方法。新增水分、总灰分检查项目,按《中国药典》2020年版水分测定法第二法、灰分测定法测定样品的总灰分量,按水分的平均值、总灰分的平均值的120%计算水分、总灰分的控制限度;按浸出物测定法测定水溶性浸出物的含量,按浸出物平均值的80%计算浸出物的控制限度。结果完善后薄层色谱方法检验效率更高。12批牛白藤样品水分平均值为12.67%,建议水分限度定为“不得过15.0%”;总灰分平均值为8.71%,建议总灰分限度定为“不得过11.0%”;浸出物测定样品的水溶性浸出物平均值为16.04%,建议浸出物限度定为“不得少于13.0%”。结论新增了水分、总灰分检查项目;薄层色谱鉴别提高了检验效率;浸出物测定更符合临床应用实际。为牛白藤饮片质量标准完善提供了依据。Objective Develop quality standards for Hedyotis hedyotidea Chinese Herbal Pieces.Methods Hedyotis hedyotidea is a rubiaceae plant Hedyotis hedyotidea(DC.).Dried vine stem,Twelve batches of Chinese Herbal Pieces samples came from four traditional Chinese medicine decoction pieces companies in Hu′nan Province.To improve of thin layer chromatography(TLC)method for identification of Hedyotitis Hedyotidea.Add water content,total ash check items,according to the 2020 edition of Chinese Pharmacopoeia,the second method of moisture determination,determination of total ash content of samples by ash determination method,Average moisture,120%of the mean of total ash,control limit of moisture and total ash.Determine the content of water-soluble extract according to the extract determination method,the control limit of the extract was calculated by 80%of the average value of the extract.Results The improved TLC method was more efficient.The average water content of 12 batches of Hedyotis Hedyotidea samples was 12.67%,the recommended moisture limit was"not to exceed 15.0%";the mean value of total ash was8.71%,it was recommended that the total ash limit be set at"not more than 11.0%";the mean value of water-soluble extract was 16.04%,it was recommended that the extract limit be set at"not less than 13.0%".Conclusion The water and total ash examination items were added,the TLC improved the examination efficiency,and the determination of the extract was more suitable to the clinical practice.It provides the basis for Hedyotis Hedyotidea Chinese Herbal Pieces quality standard improvement.

关 键 词：牛白藤 饮片 薄层色谱 水分 总灰分 浸出物 质量标准 

分 类 号：R282[医药卫生—中药学]