【作者】 韩智峰；

【导师】 邹华彬；

【作者基本信息】 山东大学 ， 分析化学， 2008， 硕士

【摘要】 中药是中华医学的重要组成部分,可大致分为中药材、中药注射剂和复方(包括中成药)三大类。组分极其复杂和“多靶点”作用是其主要特点。中药的品质优劣直接决定药效,这对于中医药作用机理研究和临床疗效意义重大,故其质量评价和控制一直受到医药工作者重视。中药质量评价不能简单应用西药质量评价的模式。中药成分复杂,不同于西药,若像评价西药那样,只对主要成分进行含量测定,得到的结论往往不能客观准确,同时这也背离了中医理论整体用药和“多靶点”作用的思想;若对所有成分进行分离鉴别,难度很大,不符合简便、快速、准确的现实要求。中药指纹图谱是近几十年来兴起的国际公认的用于评价中药质量的技术手段。尤其近几年,其出色的中药鉴别及质量评价能力在研究实践中得到充分的证明。它立足于中药成分,却又不拘束于以往中药成分分析检测的常规思路,而是借助于各种分析测试手段收集中药成分的相关数据信息,再利用数学和统计学的方法对数据进行提取加工,最后得出鉴定结论。其结果准确、客观,操作简便、迅速。中药指纹图谱主要在中药材、中药注射剂质量评价方面进行了大量研究,积累了丰富的经验。中药复方是由几种甚至数十种中药材组成,成分远较单一中药材、中药注射剂复杂,目前关于中药复方鉴别和质量评价研究的报道较少。本研究旨在以三种组成非常相近的中成药——桂附地黄丸、金匮肾气丸和杞菊地黄丸为代表,用中药指纹图谱的两种主要测试手段:红外光谱(IR)和高效液相色谱(HPLC)采集信息,利用共有峰率和变异峰率双指标序列分析进行数据处理,结合数理统计方法,对中药复方进行初步鉴别和质量评价研究。在IR指纹图谱研究中,作者对三种地黄丸的原药粉末(代表整体,即全成分)和系统溶剂提取物(氯仿、无水乙醇和水提取物,即三个不同极性成分区间,分别代表三个组成部分,三者之和视为近全成分)分别测试采集数据和进行数据分析,对原药粉末和提取物的结果进行了比较分析,比较它们之间结论的异同,并考察了不同灵敏度对实验结果的影响。在HPLC指纹图谱研究中,作者对三种地黄丸的系统溶剂乙醇提取物进行了测试和数据处理,得出结论,最后与IR指纹图谱的结论进行比较。地黄丸原药粉末的IR指纹图谱质量评价结果显示,桂附地黄丸和金匮肾气丸之间差异显著,不同品种的地黄丸能够明确区分开。同种地黄丸药品的各样品相似程度很高。杞菊地黄丸与知柏地黄丸之间具有一定的相似性,不同厂家的杞菊地黄丸样品质量具有明显的差异。氯仿提取物、无水乙醇提取物、水提取物的IR指纹图谱质量评价结果不仅明确区分不同品种的地黄丸药品,而且对地黄丸样品的厂家和批次给出客观的鉴别结论。比较原药粉末和三种提取物的鉴别结果,后者能够获取更多的有效信息,能够精细描述不同厂家和批次产品间的差异,鉴别能力更强。地黄丸无水乙醇提取物HPLC指纹图谱的质量评价结果显示,同一厂家尤其同一批次的地黄丸产品之间相似性很高,这与事实相符。中药指纹图谱分析的发展趋势是强调药品鉴别的科学性、严谨性和精细化,即以数值形式全面反映药品相似程度的大小。而本研究所采用的鉴别方法符合中药指纹图谱的发展要求,所有结论均反映了双指标序列分析在评价复方中药质量方面的准确性和可靠性。更多还原

【Abstract】 Traditional Chinese Patent Medicine plays an important role in Chinese medicine. It includes herbal medicine, traditional Chinese medicine injections and traditional Chinese medicine formula. Its characteristics are complexity in composition and "multiple target action". Since the quality of Traditional Chinese Medicine determines the efficiency which is important to both operation mechanism research and clinical effect, Chinese physicians always pay great attention to the estimation and quality control of Traditional Chinese Medicine.The quality estimation of Traditional Chinese Medicine is different from that of western medicines. If only the major components’ content in Traditional Chinese Medicine are measured just done as in western medicines. It cannot reflect the quality of Traditional Chinese Medicine exactly and disobeys the theory of Traditional Chinese Medicine and the "multiple target effect". In the same way, it is too difficult to separate all the hundreds, even thousands of components and to analyze their contents quantitatively, which also collides with the estimation’s desire to be exact, more simple and convenient.Traditional Chinese Medicine fingerprint spectra technique is one approbatory way to estimate quality of Traditional Chinese Medicine in recent years, and is popular with all the world now. Not limited in the quality estimation of western medicine, many kind imaginabale experiments are used to collect information on chemical ingredients in Traditional Chinese Medicine. With the help of mathematics and statistics the data are dealt with and right conclusions are achieved finally .The operation is simple and convenient, too. For the moment fingerprint spectra technique is mostly applied to the quality estimation of both herbal medicine, traditional Chinese medicine injections and extracts from herbal medicines. Nowadays, however, fingerprint spectra technique is not applyied to the quality estimation of formula frequently, that is because much more complex characteristics are in formula than that in herbal medicines and traditional Chinese medicine injections.My study aims at applying IR and HPLC fingerprint technique, which is two major means used in fingerprint technique, to collect relevant information from three similar Dihuang Pills (Guifu Dihuang Pill, Jinkui Dihuang Pill and Qiju Dihuang Pill), and dual-index sequence analysis (two indexes: common peak ratio and variant peak ratio) are carried out based on the measured data. The quality estimation of three similar Dihuang Pills (Guifu Dihuang Pill, Jinkui Dihuang Pill and Qiju Dihuang Pill) then are performed.In the study of IR fingerprint spectra: the IR spectra of both original powder (standing for the whole components) and three kinds of extracts with chloroform, ethanol and water (standing for three different part of polar composition, and all of them can nearly be considered as the whole components) of every Dihuang Pill were collected and processed. The estimating conclusions are made respectively, and the results were compared with each other. The effects of different degree of measuring sensitivity on the conclusions are also analyzed. In the study of HPLC fingerprint spectra, the HPLC fingerprint spectra of ethanolic extracts of every Dihuang Pill were determined and analyzed in detail. The results are compared with that of IR fingerprint spectra.The estimating conclusions of IR fingerprint spectra of Dihuang Pills show that the same kind of Dihuang Pill are highly similar, howover, different kinds of Dihuang Pill are distinct obviously. The estimating conclusions of IR fingerprint spectra of all the three extracts of Dihuang Pill can not only achieve the purpose to tell Dihuang Pills apart but also to identify and differentiate their manufacturers and batches. Comparing the estimating conclusion of original powder’s IR fingerprint spectra with that of extracts, the latter can provide more detail information and its capability of judgment is even more useful. The estimating conclusions of HPLC fingerprint spectra of ethanolic extracts indicate that Dihuang Pills coming from the same company and batch are extraordinarily alike, especially, which accords with the truth.The results offered by our work show that the Dual index sequence analytical method combining with statistics is more effect on identifying and evaluating formula-the extremely complex Traditional Chinese medicines.更多还原