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矿物药青礞石质量控制技术研究

Studies on Quality Control Technology of Mineral Chinese Medicine Chloriti Lapis

【作者】 刘圣金

【导师】 吴德康;

【作者基本信息】 南京中医药大学 , 中药资源与鉴定, 2012, 博士

【摘要】 青礞石为临床常用矿物药,应用历史悠久。目前,青礞石质量标准粗略,市场品种来源混乱。在获得国家“十一五”科技支撑计划项目(2006BAI55B02)“矿物药中金属含量检测技术及中药外源性有害残留物检测技术研究”及江苏省普通高校研究生科研创新计划(CX09B-282Z)“矿物药(青礞石)及其制剂质量控制技术研究”资助下,为更好的控制青礞石药材的质量,本课题对青礞石的基原鉴定、分析技术、炮制工艺等质量控制手段及方法进行研究,以期获得科学、可行的青礞石质量控制技术及质量控制标准。本课题对目前矿物药质量控制现状、质量控制技术手段及青礞石的相关文献进行了系统研究。古代文献重点关注了古代医书、本草等历史著作对青礞石的相关记载,主要研究了矿物基原、临床应用,炮制方法的历史沿革、炮制机理及前人炮制的原始意图。通过现代国内外文献研究,综合评价分析了青礞石的化学成分、炮制工艺、临床应用、药效毒理、质量控制手段等相关领域的研究状况。在此基础上,利用现代仪器设备、统计分析方法等对青礞石的质量控制技术进行了研究。通过研究,主要获得了青礞石质量控制技术及炮制工艺技术参数,并初步建立了青礞石药材质量控制标准。1、质量控制技术:首次建立了青礞石的FTIR指纹图谱;首次建立了XRD Fourier指纹图谱;首次建立了青礞石药材的TA鉴别方法;首次利用ICP-MS技术对青礞石药材进行了25种元素分析,并做了主成分和相关性分析;首次建立了含20种元素的青礞石无机元素的特征指纹图谱;初步建立和完善了青礞石药材质量控制标准。2、炮制技术控制研究:首次对青礞石药材进行了较为系统深入的炮制工艺研究,建立了青礞石的最佳炮制工艺;首次较全面的比较分析了炮制品与生品在红外光谱、XRD图谱、热分析、全元素含量、水溶出率等方面的差异。该课题研究中,偏光显微镜、TA、XRD、FTIR、AFS、ICP-MS、电子探针等现代技术在青礞石质量控制技术中的应用及青礞石的炮制工艺研究思路、主成分分析方法、元素相关性分析方法等具有示范性,对其它矿物药的相关研究具有指导意义。

【Abstract】 Chloriti Lapis used in Chinese medicine for the clinical commonly used mineral medicine,the application history is glorious.At present,the mineral used in Chinese medicine quality specification is sketchy,the market variety origin is chaotic.Access to Projects in the National Science&Technology Pillar Program during the11th Five-Year Plan Period of China.(Grant No.2006BAI55B02) and Program sponsored for scientific innovation research of University postgraduate in Jangsu province,China.(Grant No.CX09B-282Z) funding,to better control the quality of Chloriti Lapis,the subject based origin identification, analysis techniques,processing technology and other means of quality control study,to expect a scientific and feasible quality control techniques and quality control standards.Quality control and control technical means of mineral drugs to the status quo,and the literature about Chloriti Lapis had been systematically studied.The ancient literature focus on the historical writings of ancient medical books, mainly mineral species,clinical application,history of the processing method,processing mechanism and the original intent.Through the modern domestic and foreign literature research,chemical composition,clinical practice,efficacy and toxicology,quality control methods of Chloriti Lapis were summarized.In this foundation,quality control methods of Chloriti Lapis were studied by modern instrumentation equipments and statistical analysis methods.Through research,main access to the quality control technology and parameters of processing of Chloriti Lapis,and quality control standards were further established.For the first time to Chloriti Lapis,FTIR and XRD Fourier fingerprints were established,TA authentication method was established,25kinds of inorganic elements were determined by ICP-MS,the feature recognition chart of20kinds of inorganic elements was established.Carried on systematically preparing processing research and established the best preparing processing method. Comparative analysis of the processed products and raw materials in the FTIR spectrum,the XRD Fourier spectrum,and elements content difference,the difference of the water-soluble out rate.In addition,polarizing microscopes,TA,XRD,FTIR,AFS,ICP-MS,electron microprobe and preparing processing research ideas would guiding significance to the study of the drug for other minerals.

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