中药分析新思路及其质量控制

随着国家对中药现代化的重视,为了更好地诠释中药药性的本质,研究者从不同角度对中药进行研究。分析化学、药学、生物学等多学科的多种不同的技术在这里融合,一些新的思路和方法正在不断涌现,中药的分析与质量控制正沿着综合且全面的方向在不断地发展和前进。该文对当前中药分析新思路及其质量控制进行了简要评述,在此基础上,对中药质量控制的色谱指纹图谱进行了分类说明与研究,表明采用现代分析手段,可以实现对中药质量的有效控制。     

中药质量评价关键问题与分析方法探讨

该文针对我国目前中药质量评价体系现状,总结了中药质量评价的关键科学问题,并围绕“发现”与“控制”有效成分的中药质量评价方法进行探讨。笔者结合多年中药质量分析研究工作经验,分析了中药“谱-效”关系研究、全时段等基线多波长融合指纹图谱、生物活性测定法3种质量评价与检测方法的研究内容、手段、适用范围等,为丰富、完善中药质量控制方法和中药质量标准体系的提升提供了借鉴。     

引言

中药在中国有着几千年的临床使用经验。随着民众对药品有效性和安全性认识的加深,中药质量受到越来越多的重视,中药质量控制也随之成为保障中药产业发展的重要因素之一和中药现代化研究的重要内容之一。由于中药的复杂性、多样性和物质基础研究的局限性,中药质量控制技术的发展成为中药质量控制的关键。随着中药物质基础、药理活性研究的深入和现代分离分析技术对复杂体系分析能力的提高,中药质量控制水平有了明显的提高;在认识到中药药效是多靶点、多成分的协同作用特点后,多指标成分定量成为中药含量测定的发展趋势。近年来,着重于从整体上进行质量控制的指纹图谱技术得到了广泛的关注和应用,并已被国外认可,成为建立国际性中药质量标准的技术纽带。各种色谱、光谱技术在指纹图谱中的运用及利用现代分离和检测技术获取海量数据,使人们对于中药的认识达到了一个新的高度。海量数据的化学计量学分析更成为鉴别中药真伪、优劣的科学依据。
中药质量控制是一个不断认识和深入的过程,新问题、新理念和新技术的层出不穷为我们提出了一个又一个的新课题。随着研究的深入,各方面的研究成果将为中药质量控制提供更为丰富的科学依据,中药质量控制技术也必然随着中药整体研究水平的提高而发展,并为中药的现代化和国际化做出巨大贡献。由于色谱技术在中药质量控制中发挥了巨大作用,本刊特别邀请了部分具有突出贡献的色谱专家、学者撰写了相关学术论文,在本期编辑出版了“中药质量控制”专栏。希望通过这些专栏文章所介绍的工作及思想,广集思路,不断创新,为进一步提高中药质量控制的研究水平作出贡献。     

中药现代化研究与化学计量学

本文对近年来发展的中药指纹图谱技术及相应的化学计量学方法进行了讨论．在中药质量控制中,这些方法被广泛地应用于中药成品或半成品专属性和稳定性的确定．实质上,中药指纹图谱技术是一种探索中药复杂性的高通量整体性分析方法,所以,对其进行更深入的定性定量分析将对进一步全面控制中药质量和探明中药作用机理打下良好的化学基础．结合系统生物学与生物信息学方法,似有可能探明中药的作用机理,进而更全面地对中药质量进行控制．     

现代仪器分析技术在中药炮制机理研究中的应用

现代分析技术以仪器分析为主,大量先进的现代仪器分析技术已经较广泛地应用于中药炮制机理研究领域,对阐明中药炮制的机理,提高中药饮片的质量控制水平起了很大的推动作用.本文对多种现代仪器分析技术进行介绍,并对其在中药炮制机理研究中的应用现状作一综述.     

色谱指纹图谱与中药质量控制

本文综述了近年来色谱指纹图谱研究中多种色谱技术、相关化学计量学方法的发展及其在中药质量控制中的应用,并对中药质量稳定性和有效性的全面评价方法和可行性进行了初步探讨。提出以色谱指纹图谱为核心,依托现代色谱技术、化学计量学和系统生物学方法,建立中药化学成分信息与药效(毒性)信息相关关系的中药质量控制研究策略,深层次揭示中药的内在作用机理,期望真正实现中药质量的可控、安全和有效。     

电化学分析方法在中药质量控制中的研究进展

中药质量控制是保证中药现代化、产业化以及国际化的核心问题。与其它分析方法相比,电化学分析法具有灵敏度高、检测速度快和成本低等优点,是中药质量控制的重要手段,具有广阔的发展前景。本文综述了近年来电化学方法在中药质量控制方面的研究进展,介绍了电化学指纹图谱技术在中药鉴别方面的研究概况,着重归纳了电化学技术在分析中药有效成分和有害物质中的应用,包括黄酮类、生物碱类、醌类、苷类、重金属和农药残留等,并展望了电化学方法在中药质量控制领域的发展前景。     

高效液相色谱指纹图谱在地黄研究中的应用(Ⅰ)

长期以来,中药有效成分的提取分离和质量控制一直是中药产业中特有和尚未很好解决的问题.随着天然产物化学和现代仪器分析技术等相关学科的迅速发展,国内外在植物药及其制剂质量控制研究方面的重点均已转向利用各种仪器进行品质评价方面.中药来源于自然,其化学成分的多样性和复杂性是中药发挥其疗效的物质基础,同时也是质量评价与控制的重点与难点.中药的化学成分复杂,所体现的是综合效应和整体疗效.然而多年以来在中药的研究靠中,采取了与化学药品相同的研究思路,结果将药材及制剂内部各成分的综合作用和相互关系彼此孤立.在中药材及复方制剂质量标准的研究制定中,也往往是采用各种分析检测手段测定其中某种有效成分,并以其含量多少来判断比较某种药材的质量.这种质量控制模式很难做到全面衡量中药及其制剂的质量、疗效和稳定性.单一成分含量达标并不能说明该中药材质量合格.指纹图谱质量控制模式能综合反映某一特定药材各主要组分及其相对含量.因此它比测定任何一种或几种成分所提供的信息都丰富和有用的多.中药提取物在给定的实验条件下所得到色谱指纹图谱反映了该中药的化学组成及其含量分布状况,其特征峰可作为鉴别中药的依据.本文研究结果表明,利用色谱指纹图谱的相关参数来对中药原药材的质量进行控制,进而使中成药的质量得到保证,此方法的运用是切实可行的.另外,在有效成分不明确的前提下,利用色谱指纹图谱来评价中药的质量是有其意义的.色谱指纹图谱作为控制中药质量的新手段将在推进中药现代化进程上起到积极的作用.本文利用高效液相色谱建立了地黄的色谱指纹图谱.采用反相C18柱(5μm,150 mm×4.6 mm)、流动相甲醇:水(V/V=5:95)、检测波长为280 nm、流速1.0 mL/min进行试验.根据相对保留值和相对面积值对色谱指纹图谱进行分析对比研究,建立了控制地黄药材质量的新方法.该法为中药样品的鉴定提供了较全面的信息.     

中药组方指纹图谱研究方法和思路

中药组方就是将单味中药按照一定的规律配伍成方,因剂量配伍差异会导致组方理化性质的改变,从而导致组方功效强弱、性质方面发生变化,甚至产生新的化学成分。中药组方鉴别与质量控制一直是困扰中药工作者的一个难题。指纹图谱技术具有宏观、准确、稳定等优点,已被广泛用于中药领域。中药组方指纹图谱是解决中药合理组方配伍的最有效手段,其对中药质量控制已经得到普遍关注和重视。由于指纹图谱具有整体定量功能和特征性鉴别作用,对于成分复杂的中药组方能够全面地定性与定量评价。本文就中药组方指纹图谱的研究意义与目的进行了综述,并详细阐述了组方指纹图谱的研究方法与思路,以此为中药及其组方指纹图谱研究提供参考。     

中药质量控制的研究策略和色谱技术

综述了色谱技术作为现代高效分离分析技术在中药药效物质基础研究和中药质量控制中的重要作用。提出中药药效物质组学研究策略,以实现中药药效物质基础与作用机理研究的一体化,进而从深层次揭示和全面控制中药的内在质量。论述结果表明,现代色谱及其联用技术是中药质量研究的重要技术平台之一。     

Chemometrics and modernization of traditional Chinese medicine

Development of chromatographic fingerprinting and its related chemometric methods in the research of quality control of traditional Chinese medicines(TCMs) are discussed. The quality control methods for guarantying the authentication and stability of products and semi-products of TCMs are firstly assessed. The technique based on chromatographic fingerprinting is essentially a kind of high-through put and integral tools to explore the complexity of herbal medicines. In order to further control the comprehensive quality of TCMs,confirmation and identification of their important chemical components are necessary. Some new strategies are proposed to trace the chemical changes of chromatographic fingerprints both in product processing and/or after their administration by modern chromatographic techniques and chemometrics. Combined with systems biology and bioinformatics,it seems possible for one to reveal the working mechanism of TCMs and to further control their intrinsic quality comprehensively.     

Recent analytical approaches in quality control of traditional Chinese medicines—A review

Traditional Chinese medicines (TCMs) are gaining more and more attention all over the world, due to their specific theory and long historical clinical practice. But the uncontrollable quality is a bottleneck for its modernization and globalization. This paper reviewed the recent analytical methods in the quality control of TCMs, including screening strategies of bioactive markers from TCMs through biochromatographic methods, the traditional chromatographic methods, DNA methods, as well as the spectroscopic methods, including FT-IR, NIR and NMR. The comprehensive methods, such as fingerprint and multi-component quantification are emphasized; hyphenated techniques, like HPLC-MS, GC-MS, CE-MS, LC-NMR, chemometric methods, and combination of chemical and biological methods, such as biofingerprint, metabolic fingerprint are now more and more widely used in TCMs. In a few word, the analysis and quality control of TCMs are moving towards an integrative and comprehensive direction, in order to better address the inherent holistic nature of TCMs.     

Recent developments in sample preparation techniques for chromatography analysis of traditional Chinese medicines

Traditional Chinese medicines (TCMs) have a long history dating back thousands of years. Recently, there has been increasing interest worldwide in the use of TCMs for the prevention and treatment of various illnesses. In China, a large number of analytical tools, especially chromatographic techniques have been used to analyze the constituents of TCMs in order to control their quality and discover new bioactive compounds. In this paper, recent developments in sample preparation techniques for the extraction, clean-up, and concentration of analytes from TCMs are compared. These techniques include headspace solid-phase microextraction (HS-SPME), headspace liquid-phase microextraction (HS-LPME), microwave-assisted extraction (MAE), supercritical-fluid extraction (SFE), pressurized-liquid extraction (PLE), and microwave distillation (MD).     

Chromatographic fingerprinting and metabolomics for quality control of TCM

Chromatographic fingerprinting technique of traditional Chinese medicine (TCM) has proved to be a comprehensive strategy for assessing the intact quality of herbal medicine. In general, one could use the chromatographic techniques to obtain a relatively complete picture of herbal medicines, which are in common called chromatographic fingerprints of herbal medicines to represent the so-called phytoequivalence. Based on this, the features of chromatographic fingerprints of herbal medicines have been discussed in some detail. The technique based on chromatographic fingerprinting is essentially a kind of high-throughput and integral tools to explore the complexity of herbal medicines. In order to further control the comprehensive quality of TCMs, some new strategies are proposed to trace the chemical changes of chromatographic fingerprints both in product processing and/or after their administration by modern chromatographic techniques and chemometrics. Combined with metabolomics, it seems possible for one to reveal the working mechanism of TCMs and to further control their intrinsic quality. Finally, the intensive study of chromatographic fingerprinting coupled with multivariate analysis tools developed in bioinformatics and chemometrics are emphasized in order to achieve the aim to reveal the working mechanisms of TCMs and to further control and strengthen TCMs' intrinsic quality in a comprehensive manner.     

Qualitative and quantitative analysis in quality control of traditional Chinese medicines

Separation techniques with high efficiency and sensitive detection have been widely used for quality control of traditional Chinese medicines (TCMs). High-performance liquid chromatography, gas chromatography, and capillary electrophoresis are commonly used to separate various components in TCMs. Ultraviolet detection, fluorescence detection, evaporative light-scattering detection, mass spectrometry and nuclear magnetic resonance can be applied to separation techniques for qualitative and quantitative analysis of TCMs. The development of quality control for TCMs based on quantitative and qualitative analysis from 2000 to 2007 are reviewed; the fingerprint technique is also discussed due to its broad application in the quality control of TCMs. Prospects for further research based on our primary results are also discussed.     

中药中农药残留量研究状况及安全控制

总结了中药中农药残留量研究现状, 概述了农药的种类、提取、净化及其分析方法, 并就中药中农药残留的安全控制作了初步探讨。     

中药质量控制技术发展展望

本文从中药产业需求、现代化需求、技术需求、机遇与挑战等方面概括了中药质量控制技术发展的背景;讨论了中药质量控制技术对于提高中药药效和安全性、推动产业发展和推进中药国际化的意义;综述了中药质量控制技术的现状,分析了在过程控制、安全性控制、标准品和对照品制备、指纹图谱技术等方面的不足;提出了中药质量控制技术应重点发展以分离和表征技术为主的中药质量控制关键技术、中药安全性控制技术、中药质量控制标准体系、中药质量控制原创性技术和中药标准品、对照品生产技术,制定技术标准,建立具有中药特色的过程控制和产品质量控制标准。     

Chromatographic fingerprinting and related chemometric techniques for quality control of traditional Chinese medicines

Development of chromatographic fingerprint (CF) and related chemometric methods and their applications to quality control of traditional Chinese medicines (TCMs) were discussed. CF is essentially a kind of quality control method for TCMs (or Chinese herbal medicines). Also, it is a quality‐relevant‐data high‐throughput and integral tool to explore chemically the complexity of TCMs. With the help of chemometrics, some difficulties in evaluation and analysis of CFs, such as calculation of information content, peak alignment, pattern analysis, deconvolution of overlapping peaks, etc. could be well solved. To further explore TCMs synergic quality, intensive study of CF coupled with chemometrics will create the possibility to achieve the aim to reveal the working mechanisms of TCMs and to further control and strengthen TCMs' intrinsic quality in a comprehensive manner.     

色谱及相关技术在中药质量评价中的应用

对中药物质基础的研究方法——化学物质组学,以及中药质量评价的关键技术——指纹图谱技术做了介绍,并在此基础上综述了中药化学信息获取的关键技术——色谱及相关技术在中药质量评价中的应用。论述的结果表明,以化学物质组学为指导,结合色谱及相关技术获取指纹图谱信息及多指标成分定量信息的研究模式,对中药质量评价体系的建立具有指导意义。