中药现代化在系统生物学时代所面临的若干潜在危机

近几年系统生物学包括系统生物医学的发展很快。系统生物学相关学科的发展将在一定程度上逐步改进人们在生物技术上的研究手段和研制理念;系统生物医学正在逐渐把西药与中药联系起来,但是在这个联系的过程中蕴涵着中药现代化的重大危机。从其中的一个角度来看,中药是一种多位点定向或定点改变基因表达的技术;但是中药成分复杂,系统庞大,很难在几十年的时间内实现在基因水平上对中药的全面理解;而西药已经把基于基因网络和细胞信号传导系统结构的药物设计方法变成了常规技术。当基因网络相关的基础研究达到一定深度时,就可以发展一套成熟的多位点定向或定点改变基因表达的技术,很可能研制出中药化的配伍西药。从技术层面和研究资金强度上看,国际上大的生物制药公司实现西药中药化的目标已经准备了很好的条件,正在时间上与中药现代化进行赛跑并可能逐步与个体化医学接轨。     

What Has Been Overlooked on Study of Chinese Materia Medica in the West?

Chinese materia medica (CMM), including Chinese herbal, animal, and mineral medicine, has been widely researched in the past century for their biological and pharmacological activities. However, their mechanism and clinical efficacy studies did not always give expected results. For example, the most commonly used Chinese herb for menstrual disorders, Radix Angelicae sinensis, showed neither estrogenic nor progesteronic activity in laboratory and clinical studies. Its efficacy should not be denied simply based on such results, because it is mostly used together with other herbs in formulae. Moreover, its regulation on menstruation may take effect through other mechanisms, such as regulation of blood circulation. The key difference of Chinese medicine (CM) from conventional medicine is its unique holistic view on human body and diseases. CMM is mostly applied in clinic in the form of formulae. Study on individual CMM, simply using methods for development of conventional drugs, is unable to thoroughly reveal the power of CMM formulae. The reason may partly result from improper design due to the lack understanding about application principle of CMMs in CM, and/or to current lack of knowledge about the causes of some symptoms and diseases. This paper will introduce the importance of qi and blood in CM etiology and pathology, Zheng differentiation, formulation of CMMs, and explain why one formula can treat different diseases and one disease can be treated with different formulae. Examples in the paper will demonstrate that proper studies on Zheng and its corresponding clinically proven formulae could help scientists find new direction to explain and treat symptoms and diseases that so far modern medicine has been unable to, provided that the designer properly understands CM theories, etiology and pathology of CM, as well as modern medicine. Strategy suggestions about research methods for CMM and its formulae will be given at the end.     

中药及其成分配伍组方的研究方法探析

中药是依照七情和合、君臣佐使的原则组成方剂的。研究中药方剂配伍组方的方法很多,大致可分为传统模式和现代模式。中药的配伍组方研究已从传统模式发展到现代模式。其中,传统模式又分为全方研究和拆方研究,主要是在饮片层次从整体效果及拆方后药物的配伍组合对复方的作用机制进行剖析;而现代模式的研究主要是中药有效成（组）分的配伍组方研究,是在组分层次上的研究,并能实现药物配伍组方的定量分析。建立新的多成（组）分配伍模式和优化组合研究方法,将有可能使中药配伍组方从饮片层次上升到组分层次,并可能获得成分和作用靶点明确、作用环节及机制清楚的新组方,给中药方剂研究带来突破。     

无公害中药材生产HACCP质量控制模式研究

危害分析和关键控制点（hazard analysis and critical control points,HACCP）为控制农产品安全的一种有效方法与质量控制体系。介绍了HACCP质量评价体系,对该体系在无公害中药材生产领域中的应用进行了探讨与分析,HACCP对我国无公害中药材生产、保障民众安全健康,中药产业化和国际化具有重要的现实意义。     

中药实验医学研究中的关键基础科学问题--从肠内细菌生物转化确定中药有效和有毒化学成分

中药现代研究的核心问题之一是中药有效成分和有毒成分的问题,但其确定一直没有找到一条切实可行的方法,基本上处于探索阶段.结合中药的用药特色和现代药学研究成果,从中药原形化学成分的肠内细菌生物转化,到原形化学成分及其肠内细菌生物转化产物的肠吸收和转化、肝脏代谢、肾脏排泄等串联的研究模式来研究中药的有效成分和有毒成分,可能是一条适合中药特点的途径,亦是中药实验医学的重点内容之一.     

去粗取精去伪存真——宋立人教授谈本草文献研究

中医文献学是中医药学发展的先导,本草文献研究是中医文献研究中的一个最薄弱环节,这与我国历史悠久、地域广阔、各地药物使用情况不同有关。中药品种混乱、同名异物、真伪互用等现象的存在,不但影响了用药规范和药物的临床疗效,更严重地阻碍了中医药事业的发展,因此本草文献研究实乃当务之争。综合性本草的研究当以《证类本草》为起点,专题性本草可分食疗、炮制、民间药物、中药药性、中药药理、临床应用等类加以研究。在本草     

中草药中黄酮类化合物含量的测定方法研究进展

黄酮类化合物是一种广泛存在于植物中的天然有机化合物,在许多中草药中含量较为丰富。作为多种中药的主要有效成分之一,黄酮类化合物因其广泛的生理或药理活性在疾病治疗中发挥重要作用,广泛应用于临床。中草药中有效成分含量的测定是药品质量控制的重要环节之一,现对中草药中黄酮类化合物含量的不同测定方法作一综述。     

中药现代技术研究的缘起与流行及反思

从西方医学的传入及其对中药研究的影响,阐述中药现代技术研究的初衷与开端;从基源、性状、理化及计算机辅助鉴别方面分析中药鉴定的研究现状,并从中药化学成分、中药药学作用两方面概述中药药效物质基础研究的发展。现状表明:中药现代药效学研究与传统中药理论关联度低,与中医临床用药的整体观思路不合拍,值得我们反思和改进;未来研究应积极探索保持中医特色,充分发挥中医整体观念和辨证论治的长处,使中药的现代研究与更高层次上传统中药理论实现统一。     

Chinese herbal medicine in the treatment of nonalcoholic fatty liver disease

Chinese herbal medicine has developed new therapies for nonalcoholic fatty liver disease (NAFLD) based on its unique theory system and substantial herb remedies.In this review,21 traditional Chinese herbs were introduced for their potential benefit in the treatment of NAFLD.Majority of them are evaluated by experimental studies and few by multicenter clinical trials.Herbal monomers as berberine and resveratrol,extracts from Polygonum hypoleucum Ohwi,and Artemisia sacrorum Ledeb.,and formulae including Yinchenhao Decoction(茵陈蒿汤,YCHD),Qushi Huayu Decoction(祛温化瘀汤,QSHYD),and Danning Tablet (胆宁片) were discussed in detail on their therapeutic potentials.Most of these herbal medicines were proved to improve biochemical and histological changes of NAFLD both in vitro and in vivo.Also,their therapeutic activities were associated with inhibiting lipid accumulation through adenosine monophosphate-activated protein kinase activation or upregulating low-density lipoprotein receptor(LDLR) expression,alleviating lipid peroxidation,and reducing the production of inflammatory cytokines.Although the efficacy and safety of these herbal medicines needed to be evaluated in multicenter large-scale clinical trials,Chinese medicine is promising and effective for preventing and treating NAFLD disease.     

自拟汤药佐治溃疡性结肠炎的临床研究

目的 探讨自拟汤药佐治溃疡性结肠炎的临床疗效.方法 将70例溃疡性结肠炎患者随机分为研究组与对照组,各35例.研究组患者给予山莨菪碱和自拟汤药保留灌肠.对照组口服柳氮磺胺吡啶,0.75 g/次,4次/d.两组均10 d为1个疗程,4个疗程后做结肠镜和病理学检查,比较两组疗效.结果 研究组有效率为91％,对照组有效率为60％.研究组疗效显著优于对照组(P＜0.05).结论 山莨菪碱配合自拟汤药能有效治疗溃疡性结肠炎.     

Immune Homeostasis: Effects of Chinese Herbal Formulae and Herb-Derived Compounds on Allergic Asthma in Different Experimental Models

Allergic asthma is thought to arise from an imbalance of immune regulation, which is characterized by the production of large quantities of Ig E antibodies by B cells and a decrease of the interferon-γ/interleukin-4(Th1/Th2) ratio. Certain immunomodulatory components and Chinese herbal formulae have been used in traditional herbal medicine for thousands of years. However, there are few studies performing evidence-based Chinese medicine(CM) research on the mechanisms and efficacy of these drugs in allergic asthma. This review aims to explore the roles of Chinese herbal formulae and herb-derived compounds in experimental research models of allergic asthma. We screened published modern CM research results on the experimental effects of Chinese herbal formulae and herb-derived bioactive compounds for allergic asthma and their possible underlying mechanisms in English language articles from the Pub Med and the Google Scholar databases with the keywords allergic asthma, experimental model and Chinese herbal medicine. We found 22 Chinese herb species and 31 herb-derived anti-asthmatic compounds as well as 12 Chinese herbal formulae which showed a reduction of airway hyperresponsiveness, allergen-specific immunoglobulin E, inflammatory cell infiltration and a regulation of Th1 and Th2 cytokines in vivo, in vitro and ex vivo, respectively. Chinese herbal formulae and herbderived bioactive compounds exhibit immunomodulatory, anti-inflammatory and anti-asthma activities in different experimental models and their various mechanisms of action are being investigated in modern CM research with genomics, proteomics and metabolomics technologies, which will lead to a new era in the development of new drug discovery for allergic asthma in CM.     

Review of the Regulations for Clinical Research in Herbal Medicines in USA

In 2012,USA Food and Drug Administration（FDA） approved 39 new drugs,however,there are only two botanical drugs（one topical and one oral）approved by FDA since the publication of the FDA＇s industry guidelines for the botanical drug product in June 2004.The approval shows the Western guideline can be used for herbal medicines,authors investigate current regulation on herbal medicine clinical research,identify challenges conducting clinical trials,and seek to produce some guidance for potential investigators and sponsors considering a clinical trial in this area.Key words were formulated for searching on Medline and FDA website to locate relevant regulations for clinical research in herbal medicines to understand current environment for herbal medicine usage and examine the barriers affecting herbal medicine in clinical trials.Authors critically explore case study of the 1st FDA approved botanical drugs,Veregen（sinecatechins）,green tea leaves extract,a topical cream for perianal and genital condyloma.In consideration of current regulation environment in USA,based on the findings and analysis through the literature review and Veregen case study,authors produce and propose a Checklist for New Drug Application of Herbal Medicines for potential investigators and sponsors considerina in a herbal medicine clinical trial.     

中医药治疗艾滋病的最新进展和对策

近20年来，中医药在艾滋病研究方面取得了一定的成就。筛选了上百种具有抗艾滋病毒的中药；发现了数十种中药有抗逆转录酶作用；证实了部分中药有抗蛋白酶作用；金龙胶囊等复方治疗艾滋病获得了肯定的效果，并进一步证明了此类复方具有非特异免疫增强作用，有类同参茸补剂的作用。现代医学对抗艾滋病毒的药物研究已达到了相当高的程度，现有中草药的抗病毒研究都达不到这样的水平。目前国内外用中药治疗艾滋病的专家普遍认为，中医药对艾滋病的治疗除继续筛选抗病毒中药外，应将治疗研究的重点放在增强免疫力上，扬长避短，针对整体患者，辨证论治，从临床入手，从众多有效增强免疫功能的中草药中深入研究，并确切掌握增强此类免疫功能的药物，和病毒抑制剂相结合，组成强有力的复方免疫增强剂，必能对艾滋病起到良好的综合治疗作用。     

Oral herbal medicines for psoriasis: A review of clinical studies

Various forms of complementary and alternative medicine are used in psoriasis.Among these,herbal medicines are frequently used as systemic and/or topical interventions either as a replacement for or in conjunction with conventional methods.The benefit of such use is unclear.This review is to provide an up-to-date review and discussion of the clinical evidence for the main kinds of herbal therapies for psoriasis.Searches of the biomedical databases PubMed(including MEDLINE), EMBASE and CINAHL were conducted in December 2011 which identified 32 clinical studies,all published in English.Twenty of these primarily tested topical herbal medicines and were thus excluded.The 12 studies that evaluated systemic use of herbal medicines were included in the review.Four were case series studies and the other 8 were controlled trials.In terms of interventions,4 studies tested the systemic use of plant oils combined with marine oils and 8 studies tested multi-ingredient herbal formulations.The clinical evidence for plant and animal derived fatty acids is inconclusive and any benefit appears to be small.For the multi-herb formulations,benefits of oral herbal medicines were shown in several studies,however,a number of these studies are not controlled trials,a diversity of interventions are tested and there are methodological issues in the controlled studies.In conclusion,there is promising evidence in a number of the studies of multi-herb formulations.However,well-designed,adequately powered studies with proper control interventions are needed to further determine the benefits of these formulations.In addition,syndrome differentiation should be incorporated into trial design to ensure effective translation of findings from these studies into Chinese medicine clinical practice.     

中药材国际市场营销的包装策略研究

伴随着中药材国际市场的蓬勃发展,中药材包装策略成为中药材国际市场发展的重要因素,通过对中药材国际市场营销的包装现状和策略的研究,发挥中药材包装策略的优势,让中药材包装策略为中药材国际市场的发展做出重要贡献。     

Exploring Traditional Chinese Medicine by A Novel Therapeutic Concept of Network Target

Traditional Chinese medicine (TCM) holds a holistic theory, and specializes in balancing disordered human body using numerous natural products, particularly Chinese herbal formulae. TCM has certain treatment advantages for patients suffering from various complex diseases. However, due to the complex nature of TCM, it remains difficult to unveil such holistic medicine by the current reductionism research strategies, which treat both herbal ingredients and targets in isolation. Recently, an emerging network pharmacology approach has been introduced to tackle this bottleneck problem. A TCM-derived novel therapeutic concept, "network target", which is different from the Western medicine's "onetarget" concept, has been proposed from China. The network target strategy is able to illustrate the complex interactions among the biological systems, drugs, and complex diseases from a network perspective, and thus provides an innovative approach to access ancient remedies in a precision manner and at a systematic level, which also highlights TCM's potential in current medical systems.     

对加强管理促进中药国际化的几点建议

在全球性回归自然的今天,天然药品成为继化学药物、生物制品之后,最具发展前景的药物,各个国家予以高度的重视。日本和德国代表着植物药发展的较高水平,在天然药品的现代化方面走到了前列。我国在天然药物方面具有优势,有几千年的中医药文化积淀,丰富的临床实践,我国中药企业正逐步走向世界。但是我国中药产业在国际化的进程中面临着各种壁垒,还存在着各种各样的管理问题。从日本和德国植物药管理与发展现状中吸取经验,针对我国现行的中药管理存在的问题,提出了加强管理以促进中药产业国际化的几点建议。     

论历代本草著作之中药分类方法

中药分类是学习、应用和研究药物的一种手段,合理的分类方法有助于促进中药教学、临床应用和科研的发展。自我国现存第一部本草专著《神农本草经》记载的三品分类法始,如何对中药进行合理的分类就成为历代本草著作中的一项重要内容。随着对中药理论认识的逐渐深入,古代医家对中药分类进行了不断的研究和探索,促使中药分类更加全面合理。文章通过梳理历代代表性本草著作中记载的中药分类方法,试图分析各种方法的优点和不足之处,为进一步研究中药理论奠定基础。