【作者】 谷瑞敏；

【导师】 赵康； 孙鹤；

【作者基本信息】 天津大学 ， 药事管理， 2008， 博士

【摘要】 中药指纹图谱法是中药质量评价和质量控制的一个重要环节。在这一环节里,针对中药实际应用所需选择合适的图谱评价方法,并建立与方法相适应的图谱等同系数是实现中药批次间产品质量稳定性判定的关键。建立一个图谱等同系数指标对于实现中药药政管理的科学化和合理化,实现中药产业化发展,确保和监控同一中药不同批次以及仿制与原创中药质量稳定性具有重要的现实意义。目前,相关图谱的相似性评价方法研究众多,但相应用于最终判定图谱等同指标的体系研究尚未见报道。为此,针对这一现象,本文提出了图谱等同系数概念、图谱等同理论和方法,并将理论结合实际,研究了理论与方法在实际应用中的情况。最后通过这些理论研究,建立了适合中药产业化发展所需的同一中药不同批次及其仿制产品质量合格与否的判定理论体系与评价指标,为促进我国中药产业化、现代化和国际化发展提供了一定的技术和理论支持。本文研究的主要内容及取得的主要成果如下:一、对现有存在的主要中药指纹图谱相似性评价方法进行了深入的研究和探讨,挖掘了各方法的共性与个性,及各方法在实际应用中的主要不足,最后结合实际应用指出了现有方法进一步改进的理论依据和基本思路。二、依据现有图谱相似性评价方法基本原理,在以上改进思路的指导下,构建了一个图谱等同系数计算新模型。并应用计算机仿真实验和实例研究数据进行检验,结果表明新模型可弥补现有图谱相似评价方法在实际应用中的局限性。新模型的优势在于其突出了等同系数对中药批次产品间实际质量的波动范围内的敏感性,从而提高了新模型在中药质量控制中的实际应用性。三、在整体理论研究明确的基础上,给出了图谱等同性评价谱峰分析误差权重系数与图谱等同系数临界指标确立的两个基本理论和方法。并结合新模型的实际应用,建立了中药不同批次以及原创药与仿制药产品之间指纹图谱的等同评价管理体系。更多还原

【Abstract】 Chromatographic fingerprint of Traditional Chinese Medicine (TCM) has played an important role in TCM quality control, in which choosing an appropriate evaluation measurement and setting up equivalent coefficient is a key to evaluate stability of TCM. It is essential to establish an equivalent value for the pharmacy administrators to monitor quality consistency of different batches in the development of TCM industry. Currently, there are a variety of similarity evaluation methods for chromatographic fingerprints; however, the research on the system of methods mating their evaluating indicators has not been reported. The dissertation proposed a new concept, established a new model of equivalent coefficient for chromatographic fingerprints, and introduced its application in TCM, then built a reasonable evaluation system and evaluating indicator and applied them in quality control on different batches of TCM, generic and original drugs. The main achievements as followed:Firstly, an improved approach for feasible application was proposed by finding out the commonness and individuality of the methods and their limitations in practical application, and deeply investigation had been done on the existing similarity methods.Secondly, a new model of equivalent coefficient was set up. The experimental and simulated data were used to verify the characteristics and superiority of the model. The results proved that there are many strong points in the model, and its highlight depends on the sensibility towards practical fluctuation scope of the batches. Thus, the new model improved the practical utilization for TCM quality control.Thirdly, two basic theories and methods were raised on the establishment of weight and equivalent coefficient of chromatographic fingerprints. Based on the above, a reasonable system was formed for pharmacy administers to evaluate the equivalency on original and generic, and different batches of TCM.更多还原