Chinese proprietary medicine in Singapore: regulatory control of toxic heavy metals and undeclared drugs.

Traditional Chinese medicine (TCM) is gaining popularity as a form of complementary and alternative medicine. Reports of efficacy of TCM are increasing in numbers. TCM includes both crude Chinese medicinal materials (plants, animal parts and minerals) and Chinese proprietary medicine (CPM) [final dosage forms]. Despite the belief that CPM and herbal remedies are of natural origin, unlike Western medicine, and are hence safe and without many adverse effects, there have been numerous reports of adverse effects associated with herbal remedies. Factors affecting the safety of herbal medicines include intrinsic toxicity, adulteration, substitution, contamination, misidentification, lack of standardisation, incorrect preparation and/or dosage and inappropriate labelling and/or advertising. Hence, new regulations on the control of CPM were enforced in Singapore with effect from 1 September 1999. These include licensing and labelling requirements, as well as control of microbial contamination. This article also reviews reports of excessive toxic heavy metals and undeclared drugs in CPM in Singapore between 1990 and 1997. The names, uses, toxic heavy metal or drug detected and the year of detection are tabulated. Information on the brand or manufacturer's name are provided whenever available. The public and healthcare professionals should be better informed of the basic concept of TCM and its usefulness, as well as the potential adverse effects associated with its use. Greater control over the safety and quality of CPM could be achieved through good manufacturing practice, regulatory control, research, education, reporting usage of Chinese medicine (as in drug history) as well as reporting of adverse events.     

Therapeutic potential of traditional Chinese medicine for the treatment of NAFLD:A promising drug Potentilla discolor BungeOA

Nonalcoholic fatty liver disease(NAFLD) is characterized by excessive accumulation of hepatic lipids and metabolic stress-induced liver injury.There are currently no approved effective pharmacological treatments for NAFLD.Traditional Chinese medicine(TCM) has been used for centuries to treat patients with chronic liver diseases without clear disease types and mechanisms.More recently,TCM has been shown to have unique advantages in the treatment of NAFLD.We performed a systematic review of the me...     

Critical success factors for acceptance of multi-herbal Chinese medicine in Europe

Chinese medicine is one of the treasures of Chinese intellectual contributions to mankind. The characteristics that distinguish Chinese medicine from conventional Western medicine find its roots in the philosophical(Daoism)concepts of organizing principles to understand the body, health and disease. Key for worldwide acceptance of traditional Chinese medicine(TCM) is the ability to provide scientific evidence in combination with a quality control system based on the bioactive ingredients. Plant quality in relationship to a bioactivity approach is described that is comprised of a variety of novel approaches based on Systems Biology to tackle these issues. Modern scientific technology tools are now available to accomplish standardization of TCM products in order to achieve a high level of efficacy and safety, enhancing the introduction into the international markets. The complexity of the many ingredients and the aspect of synergistic bioactivities in TCM, limited the analysis for quality control so far only to the major components for each herb and did not provide evidence for a direct relationship with bioactive components. The systems Biology approach, a multi dimensional chemical and pharmacological approach enables linking of the complex metabolic profile of herbs with biological effects and is therefore a key for quality control of TCM material medica, while providing simultaneous scientific evidence for the underlying efficacy and worldwide acceptance of TCM products.Furthermore, a concept of a business gateway comprising several key steps to unlock the business potential of TCM on Western markets will be presented, including the role of European pharmacopeia as well as community monographs of the European Medicinal Agency.     

中草药中发现新抗癌药物的途径

中草药的使用已有数千年的历史,对于各种疾病包括肿瘤的治疗都取得了十分宝贵的人体经验.丰富的中草药资源也为寻找新抗癌药提供了重要的物质基础.从传统中医药理论结合现代科学发现从4个方面阐述了进一步从中草药中发现新抗癌药的途径,以期对天然产物来源的新抗癌药物的发现起到一定的启发与促进作用.这4个方面分别是:根据传统中医理论发现抗癌药,包括清热解毒药、活血化瘀药、调节免疫药(补气扶正药)及有毒中草药(以毒攻毒);从近年发现的抗肿瘤先导化合物中寻找;通过普筛或高通量筛选从中草药提取物中寻找和依据药用植物亲缘学的原理寻找.     

谱-效关系在中药质量控制中的应用及问题分析

中药是多成分复杂体系,如何整体、全面的控制中药质量一直是中药现代化研究的重点、难点.近年来,很多学者针对中药质量控制研究进行探索,本文对近年谱-效关系在中药质量控制中的应用进行综述,以期为中药国际化进程提供借鉴和参考.     

基于《中国药典》中药片剂质量控制项目变化趋势分析

基于《中国药典》2015年版与2020年版,系统性分析比较2版《中国药典》收载的中药片剂质量控制项目的相关内容,详细梳理性状、鉴别、检查项、含量测定、浸出物检测、特征图谱与指纹图谱等中药片剂的质量控制项目的差异。在2015年版的基础上,2020年版中对多项质量控制项目进行了完善和细节补充,提升了《中国药典》的科学性、规范性、权威性和实用性。同时针对目前《中国药典》在中药片剂质量控制项目方面的不足,对中药片剂的未来发展和质量管理提出了具体的思考和建议,为提高中药片剂的质量控制水平提供重要参考,也为新版《中国药典》中药片剂的编写和修订提供科学依据。     

Traditional Chinese medicine in COVID-19

COVID-19 pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has spread across the globe, posing an enormous threat to public health and safety. Traditional Chinese medicine (TCM), in combination with Western medicine (WM), has made important and lasting contributions in the battle against COVID-19. In this review, updated clinical effects and potential mechanisms of TCM, presented in newly recognized three distinct phases of the disease, are summarized and discussed. By integrating the available clinical and preclinical evidence, the efficacies and underlying mechanisms of TCM on COVID-19, including the highly recommended three Chinese patent medicines and three Chinese medicine formulas, are described in a panorama. We hope that this comprehensive review not only provides a reference for health care professionals and the public to recognize the significant contributions of TCM for COVID-19, but also serves as an evidence-based in-depth summary and analysis to facilitate understanding the true scientific value of TCM.     

Herbal formula enhances 5-fluorouracil activity through suppression of thymidylate synthase

Traditional Chinese herbal medicine(TCM) has been shown to enhance the efficacy of standard anticancer agents. However, there are only a limited number of well-controlled preclinical and clinical studies documenting the potential benefit of TCM. OBJECTIVE To identify biologically active formulas that were effective against colorectal cancer(CRC)by screening TCM formulas in in vitro and in vivo animal models. METHODS Cell growth assays, cell cycle analysis,immunoblot analysis and q RT-PCR were performed to investigate the mechanism(s) of action of the formulason human CRC cells. In vivo animal models were used to evaluate the antitumor activity of formulasalone and in combination with5-FU. RESULTS We identified Huangqin Gegen Tang(HQGGT) which suppressed the in vivo growth of human CRC HT-29 xenografts. HQGGT significantly inhibited the growth of CRC cell lines. HQGGT enhanced the cytotoxicity of5-FU against human 5-FU-resistant cells(H630 R1) and mouse colon cancer cells(MC38). This synergy was the result of suppression of thymidylate synthase expression by HQGGT. HQGGT significantly enhanced the antitumor effect of5-FU in mice bearing MC38 xenografts. Ongoing studies have identified Huangqin as the herb responsible for TS inhibition. CONCLUSION These findings provide support for the potential role of HQGGT as a novel modulator of fluoropyrimidine chemotherapy for CRC treatment.     

A comprehensive review of integrative pharmacology-based investigation: A paradigm shift in traditional Chinese medicine

Over the past decade, traditional Chinese medicine (TCM) has widely embraced systems biology and its various data integration approaches to promote its modernization. Thus, integrative pharmacology-based traditional Chinese medicine (TCMIP) was proposed as a paradigm shift in TCM. This review focuses on the presentation of this novel concept and the main research contents, methodologies and applications of TCMIP. First, TCMIP is an interdisciplinary science that can establish qualitative and quantitative pharmacokinetics–pharmacodynamics (PK–PD) correlations through the integration of knowledge from multiple disciplines and techniques and from different PK–PD processes in vivo. Then, the main research contents of TCMIP are introduced as follows: chemical and ADME/PK profiles of TCM formulas; confirming the three forms of active substances and the three action modes; establishing the qualitative PK–PD correlation; and building the quantitative PK–PD correlations, etc. After that, we summarize the existing data resources, computational models and experimental methods of TCMIP and highlight the urgent establishment of mathematical modeling and experimental methods. Finally, we further discuss the applications of TCMIP for the improvement of TCM quality control, clarification of the molecular mechanisms underlying the actions of TCMs and discovery of potential new drugs, especially TCM-related combination drug discovery.KEY WORDS: Integrative pharmacology-based traditional Chinese medicine, PK–PD correlations, Big data, Mathematical modeling, Multidimensional association network     

动物类中药材使用情况及常见质量问题探讨

目的：动物类中药材在中国具有悠久的应用历史,在中医药宝库中占有重要的地位,但部分动物药材品种在炮制加工、贮藏、使用方法等方面尚存在一定的安全风险。本文梳理了动物类中药材可能存在的质量安全风险点,以期对保障动物类中药材的质量和控制生物安全隐患提供借鉴。方法：本文通过对动物类中药材相关标准及文献的整理研究,发现可能存在的质量安全风险点。结果与结论：目前动物类中药材存在质量标准不完善,药材在运输、保存过程中受污染、变质,缺少相关指导原则的问题。对此,应提高、完善质量标准,加强动物类中药材在贮藏、流通、运输过程的管理,制定相关质控指导原则,保障人民用药安全。     

中药注射剂超适应证用药情况分析

目的:调查中药注射剂超适应证使用的情况,为合理使用中药注射剂提供建议。方法:抽取我院2013年9月的242份出院患者病历,对其中的中药注射剂超适应证用药情况进行分析,并结合用药实例,从中药注射剂超适应证用药出现的原因、风险规避等方面进行了讨论。结果:我院中药注射剂超适应证用药占10.19%,大部分超适应证用药为合理用药。结论:临床医师应结合中医理论及临床疗效辨证用药,同时遵守医院相关规定,规避风险;中药注射剂生产厂家应尽快对药品说明书进行修订,并加强对传统中药剂型和中药注射剂的基础研究。     

中药配方颗粒监管存在的问题与对策

目的：为中药配方颗粒产业健康发展和监管工作提供参考。方法：回顾国内外中药配方颗粒产业和监管情况,分析我国中药配方颗粒产业和监管存在的问题,提出相关对策。结果与结论：随着国家对传统中医药产业的重视,中医药利好政策不断发布,中药配方颗粒行业迎来快速发展期,且在生产、流通和使用方面逐步规范。然而市场份额的快速增长,对中药配方颗粒研发、生产、流通、使用等各环节的监管带来挑战。中药配方颗粒生产企业和使用单位应加强质量管理,药品监管部门应对中药配方颗粒的生产、流通、使用等方面加强监管,以保证中药配方颗粒质量安全有效,满足人民群众多样化的健康需求。     

中药复方与组分中药

复方配伍用药不仅是中医药学优势之一,而且日益受到西医药的重视。组分中药是中药复方用药一个重要发展方向,其具有药效化学物质基础基本清楚、质量可控性强、作用机制较明确等特点。文中对组分中药的研究内容和可能的研究途径以及当前在药品注册管理上存在的问题进行重点论述。     

Approaches to establish Q-markers for the quality standards of traditional Chinese medicines

Traditional Chinese medicine (TCM) has played a pivotal role in maintaining the health of Chinese people and is now gaining increasing acceptance around the global scope. However, TCM is confronting more and more concerns with respect to its quality. The intrinsic “multicomponent and multitarget” feature of TCM necessitates the establishment of a unique quality and bioactivity evaluation system, which is different from that of the Western medicine. However, TCM is investigated essentially as “herbal medicine” or “natural product”, and the pharmacopoeia quality monographs are actually chemical-markers-based, which can ensure the consistency only in the assigned chemical markers, but, to some extent, have deviated from the basic TCM theory. A concept of “quality marker” (Q-marker), following the “property-effect-component” theory, is proposed. The establishment of Q-marker integrates multidisciplinary technologies like natural products chemistry, analytical chemistry, bionics, chemometrics, pharmacology, systems biology, and pharmacodynamics, etc. Q-marker-based fingerprint and multicomponent determination conduce to the construction of more scientific quality control system of TCM. This review delineates the background, definition, and properties of Q-marker, and the associated technologies applied for its establishment. Strategies and approaches for establishing Q-marker-based TCM quality control system are presented and highlighted with a few TCM examples.     

一测多评法研究进展

中药现代化对中药标准研究和质量控制提出了更高要求.一测多评法是通过采用一种内参物检测多种成分的方法,由于该法具有节约、准确等特性,得到了推广和应用.该文对近年一测多评理论与应用的研究进展进行探讨,可为中药质量控制提供参考.     

液质联用技术在中药化学成分定性分析中的研究进展

中药化学成分复杂,寻找中药化学成分快速识别与定性的方法是亟待解决的问题。液质联用技术具有分离能力强、检测灵敏度高和专属性强等特点,在中药研究中发挥重要作用。为了寻找快速定性中药化学成分的方法,加快中药现代化的步伐,从四级杆飞行时间串联质谱、静电场轨道阱质谱和离子淌度质谱3种质谱技术以及诊断离子、分子网络、最佳碰撞能、碰撞截面、定量结构-保留关系模型5种研究方法对近年来液质联用技术在中药化学成分定性分析方面的发展进行综述,以期为中药质量控制和中药现代分析提供新的思路和方法。     

Application of mid-infrared spectroscopy in the quality control of traditional Chinese medicines

Chinese herbal medicines are often referred to as Chinese materia medica (CMM). Composite formulae containing mixtures of CMM are prescribed for treatment and prevention of diseases in the practice of traditional Chinese medicine (TCM). Some of the well-known CMM formulae (Fufang in Chinese) are manufactured and marketed as proprietary Chinese medicines (PCM). Quality assessment and assurance of these products are difficult; they are a challenging task. Mid-infrared spectroscopy, a classic molecular structure analysis method, has been innovatively applied in the quality control of TCM, and has gained significant impact and advancement in analytical fields. Infrared fingerprinting features appear particularly suitable for the identification of multicomponent matrices in samples whose chemical integrity has not been altered or destroyed because no extraction procedure is needed. This review summarizes and gives an overall view on the application of mid-infrared and two-dimensional correlation infrared (2D-IR) spectroscopy as well as chemometric techniques in the identification of CMM, investigation of TCM processing procedures, and analysis of herb extracts and preparations.     

强心汤治疗慢性心衰初探

目的：观察强心汤联合西药常规治疗慢性心力衰竭对中、西医临床疗效及患者生活质量的影响。方法40例慢性心力衰竭的患者随机分为治疗组20例和对照组20例。对照组根据病情给予西医常规基础治疗,治疗组在对照组治疗基础上加服自拟强心汤,疗程为14 d,观察治疗后临床疗效,以及治疗前后中医疗效量表及明尼苏达生活量表的比较。结果治疗组与对照组比较,患者临床疗效及生活质量均有所改善,差异有统计学意义（P＜0.05）。结论强心汤能明显提高临床疗效,改善慢性心力衰竭患者临床疗效及生活质量。     

Traditional Chinese medicine (TCM): are polyphenols and saponins the key ingredients triggering biological activities?

The number of herbal formulae considered to be clinically effective and recorded in the Chinese medical literature is huge. The scientific basis for the remedial effects of these herbal formulae is not yet understood, nor has a clear need been given as to how to make use and combine traditional Chinese medicine (TCM) and Western medicine in an effective way. In this context, it is of interest to ascertain what individual constituents are responsible for the bioactive properties, and thus to extract the common characters of composition of huge formulae to provide a scientific explanation for their modes of action. We consider polyphenols and saponins as the key ingredients in TCM remedies responsible for most of the observed biological effects, reflecting the specific requirements within the TCM philosophy of treatment based on the investigation of its chemical composition.     

复方中草药进入欧洲市场的关键成功因素

中医药是中国人民为人类贡献的宝贵财富之一。中医药在全球范围内被接受的关键是能够提供基于生物活性成分的质量控制系统作为科学证据的能力。目前现代科学技术完全可以实现中草药全产业链的标准化生产,确保药品的质量、有效性和安全性,从而打入国际市场。中草药以药品的身份进入欧盟有多种途径,但是无论哪一种选择,药物的质量都是最重要的。迄今为止,中草药成分的复杂性和其生物活性协同作用的复杂性,对药物质量控制来说仍然是一个挑战。特别是复方中草药的质量控制难度更大。系统生物学方法是一种多维化学和药理学方法,能够将复杂的中草药成分与生物活性联系起来。因此,系统生物学在中药领域的应用是中草药现代化研究领域的关键组成部分,它可以为中医的诊断和中草药的传统使用提供科学证据,从而大力提高中草药产品在全球的接受度。本文讨论了中草药特别是复方中草药进入欧洲的关键点,强调了质量标准的重要性,以及为保障质量标准的落实,执行不同类型的良好的质量管理(GXP)的重要性。同时,介绍了欧洲对植物药安全性和有效性的理解,以及采取的相应管理方法。此外,本文也为说明中草药在欧盟市场上的商业潜力,介绍了一些欧盟成员国常见疾病的OTC市场的情况,他们是注册中草药进入欧盟的主流市场,我们需要对这样的市场规模有一个准确的了解。