大黄中药材及其醇、水提取物中大黄素成分分析标准物质研究  

Research on certified reference material of emodin in rhubarb and its alcohol extract,water extract

作　　者：杨世颖 刘淑聪 杜冠华 马林 陈若芸 秦海林 吕扬 

机构地区：[1]中国医学科学院药物研究所药物晶型研究中心晶型药物研究北京市重点实验室,北京100050 [2]中国医学科学院药物研究所国家药物筛选中心药物靶点研究与新药筛选北京市重点实验室,北京100050

出　　处：《中国中药杂志》2016年第3期456-462,共7页China Journal of Chinese Materia Medica

基　　金：科技部科技基础性工作专项(2007FY130100)

摘　　要：采用"单一化学成分→复杂成分体系"的量值传递技术路线,完成了大黄、大黄95%乙醇提取物、大黄水提取物中大黄素成分分析系列标准物质的研制。使用大黄素国家一级纯度标准物质进行量值传递,利用高效液相色谱协作标定法,确定了不同基质中大黄素成分的标准值;建立不确定度评估数学模型并计算各不确定度分量,最终获得不确定度值。完成大黄、大黄95%乙醇提取物、大黄水提取物中大黄素成分分析标准物质,其大黄素成分分别为0.40%±0.03%,1.15%±0.18%,0.16%±0.08%(k=2,P=0.95)。建立的量值传递技术路线成功解决了中药复杂体系中化学成分量值溯源的技术难题,研制的标准物质属国家级计量有证标准物质,为大黄中药材及其提取物中大黄素的定量质量控制提供了准确可靠的标准物质、物质标准、标准方法。The certified reference materials（ CRMs） of emodin in rhubarb and its alcohol extract,water extract were developed by using quantity transfer technology from single chemical composition to the complex systems. The CRM of emodin was used for quantity transfer,and high performance liquid chromatography（ HPLC） method was used to determine the contents of emodin in different matrix composition. By establishing mathematical model and calculating the parts of uncertainty,the uncertainty values were finally gotten.CRMs of emodin in rhubarb,alcohol extract and water extract were accomplished. The content values of emodin were 0. 40% ±0. 03%,1. 15% ± 0. 18%,0. 16% ± 0. 08%（ k = 2,P = 0. 95）,respectively. The established method for quantity transfer has successfully solved the technical problems that the value of active ingredient of traditional Chinese medicine can＇ t be traced to SI units.The series of CRMs are assigned as grade primary reference materials,which are useful for quality control of the emodin content,also provide the accurate and reliable CRM,materials standard and standard methods.

关 键 词：大黄 大黄95%乙醇提取物 大黄水提取物 大黄素 标准物质 不确定度 

分 类 号：R284[医药卫生—中药学]