蒸桑寄生和宽筋藤药材质量标准的改进  

Improvement of the quality standard of steamed mulberry parasitic and caulis tinosporae sinensis

作　　者：刘鑫 杨雪 孙晓雪 王昊 马世威 崔方 赵杰 张加余 王志斌 王少平 LIU Xin;YANG Xue;SUN Xiaoxue;WANG Hao;MA Shiwei;CUI Fang;ZHAO Jie;ZHANG Jiayu;WANG Zhibin;WANG Shaoping(School of Pharmacy,Binzhou Medical University,Yantai 264003,Shandong,P.R.China;Beijing Zhongyan Tongrentang Pharmaceutical R&D Co.,Ltd.,Beijing 100075,P.R.China)

机构地区：[1]滨州医学院药学院,山东烟台264003 [2]北京中研同仁堂医药研发有限公司,北京100075

出　　处：《滨州医学院学报》2022年第6期446-453,共8页Journal of Binzhou Medical University

基　　金：泰山学者青年专家项目(tsqn202103110);山东省青创人才引育计划(10073004);山东省中药材及饮片标准研究项目(2020-201);烟台校地融合中药大健康产业化平台(2019XDRHXMPT18)。

摘　　要：目的建立蒸桑寄生和宽筋藤药材的质量标准。方法对来自不同厂家和产地的蒸桑寄生和宽筋藤药材切片及粉末进行显微观察。根据中国药典的要求,采用薄层色谱法对药材进行定性鉴别,并对不同硅胶板、展开剂、点样量、温度、饱和状态对结果的影响进行考察。参照2020年版《中国药典》(四部)通则方法,对水分、总灰分、酸不溶性灰分和浸出物含量等项目进行考察。结果药材外观和显微结构明显,与现有描述一致。在供试品和对照品的薄层色谱法检测中,在相同位置显示出相同颜色斑点且分离度好。在10批药材的检测中,蒸桑寄生水分为2.40%~9.51%,总灰分为3.45%~4.61%,酸不溶性灰分为0.19%~0.45%,乙醇热浸法浸出物含量为5.35%~6.43%;宽筋藤水分为7.28%~9.95%,总灰分为6.97%~7.44%,酸不溶性灰分为0.18%~0.93%,水热浸法浸出物含量为14.11%~19.62%。结论蒸桑寄生水分不得超过12.0%、总灰分不得超过5.0%,酸不溶性灰分不得超过1.0%,乙醇热浸法限度为不得低于5.0%。宽筋藤水分不得超过13.0%,总灰分不得超过10.0%,酸不溶性灰分不得超过5.0%,水热浸法限度为不得低于10.0%。以上标准的制定为丰富该药材质量控制内容和药典修订提出了建议。Objective To establish the quality standards for steamed mulberry parasitic and caulis tinosporae sinensis.Methods The medicinal material slice and powders of ten batches of steamed mulberry parasitic and caulis tinosporae sinensis from different manufacturers and producing areas were observed by microscopic identification method.According to the requirements of Chinese Pharmacopoeia,the thin layer chromatography(TLC)was used for the qualitative identification of these medicinal material,and the effects of different silica gel plates,developing agents,sample size,temperature and saturation on the sample were investigated.The moisture content,total ash,acid-insoluble ash,acid-base property and extract were investigated according to the 2020 edition of Chinese Pharmacopoeia(Ⅳpart)general rule method.Results The appearance and microstructure of medicinal material were obvious and consistent with the existing description.And the same color spots were showed at the same position with good separation in the inspection of TLC of the reference medicinal material and the test medicinal material.In the test results of ten batches of steamed mulberry parasitic,the content of moisture was 2.40%~9.51%,total ash 3.45%~4.61%,acid insoluble ash 0.19%~0.45%,and soluble extract of ethanol hot leaching method 5.35%~6.43%;in caulis tinosporae sinensis,the content of moisture was 7.28%~9.95%,total ash 6.97%~7.44%,acid insoluble ash 0.18%~0.93%,and soluble extract of hydrothermal leaching method 14.11%~19.62%.Conclusion The quality standard of steamed mulberry parasitic for the water content should be below 12.0%,the average content of ash less than 5.0%,acid insoluble ash under 1.0%,and soluble extract of ethanol hot leaching method above 5.0%;the quality standard of caulis tinosporae sinensis should be below 13.0%for the water content,the average content of ash less than 10.0%,acid insoluble ash under 5.0%,and soluble extract of hydrothermal leaching method above 10.0%.The establishment of the above quality standards provides some

关 键 词：蒸桑寄生 宽筋藤 质量标准 显微鉴别 薄层色谱法 水分 总灰分 酸不溶性灰分 浸出物 

分 类 号：R282.5[医药卫生—中药学]