基于创新体外分析技术对雄黄及其制剂中砷形态与体内毒效的相关性研究

项目名称： 基于创新体外分析技术对雄黄及其制剂中砷形态与体内毒效的相关性研究

项目编号： No.81202887

项目类型： 青年科学基金项目

立项/批准年度： 2013

项目学科： 医学八处

项目作者： 李丽敏

作者单位： 上海市食品药品检验所

项目金额： 23万元

中文摘要： 雄黄是一种以含砷化合物为主的应用广泛、疗效独特的常用中药材，目前关于雄黄发挥疗效和毒性作用的物质基础尚不十分明确，迫切需要以合理的分析技术开展针对雄黄中砷体内外形态的研究揭示雄黄及其制剂在体内发挥疗效和毒性作用的物质基础，从而指导药品的质量控制和临床合理用药。 本课题根据雄黄成分进入体内的生物转化规律，运用体外仿生技术模拟体内环境，采用特殊净化手段，以ICP-MS及HPLC-ICP-MS联用分析技术对雄黄及其制剂中砷在各种代谢和分布情况下的存在形态进行全面的分析研究。从而通过以合理可行的体外分析技术阐明砷的形态与雄黄及其制剂体内疗效和毒效之间的密切关系。

中文关键词： 雄黄；体外分析技术；砷形态；毒性和疗效；物质基础

英文摘要： Mineral arsenicals such as Realgar(As4S4 and AsS) has been widely used in traditional Chinese medicines for thousands of years, and claimed to have therapeutic effects. Since Arsenic(As) is highly toxic subatances, its safety is concerned. However the material basis for toxicity and activity of Realgar was not very clearly by far. It is very urgent to find the material basis of Realgar and it's preparations to reveal the relationship of the efficacy and toxicity in vitro and in vivo by a reasonable and feasible analytical technique, which can guide drug quality control and clinical application. Based on the biological transformation of Realgar ingredients in vivo,the project is going to utilize bionic technology in vitro simulating the environment of human body to extract As,and with special technology to purify, use ICP-MS / HPLC-ICP-MS to study the arsenic speciations of Realgar and its preparations in the metabolism and distribution process of body. The aim of our research is to find the relationship between material basis of efficacy and toxic effects of Realgar and its preparations in vivo, and find the proportion of arsenic specition can be liberated into an absorbable form within the body and be detected by rational techniques in vitro.

英文关键词： Realgar；Analytical technique；Arsenic sepcitions；Toxicity and activity；Material basis