基于质量标志物的注射用益气复脉（冻干）质量评价与监测技术研究进展

介绍了以质量标志物（Q-marker）为目标开展的注射用益气复脉（冻干）（YQFM）质量评价与监测技术研究进展，为开展全面的YQFM质量评价与控制创造了必要条件，也为中药Q-marker理论成果向制药工业质量控制实践转化提供参考。包括在药品全生命周期内构建基于Q-marker的质量评价及监测体系技术路线，针对不同组方药材、生产工艺中间体以及成品中Q-marker的分析技术研究结果；基于近红外光谱技术的生产过程分析技术体系，在生产过程中对Q-marker实施监控，为药品生产全过程的质量评价提供技术支撑。     

CPPN中国西部医院用药分析与监测系统中成药分类与编码法研究

目的实现中国药房医药经济信息网(ChinaPharmacyPharmainfoNet,CPPN)中国西部医院用药分析与监测系统指标体系的多个项目的统计、分析功能。方法遵循中医药理、法、方、药理论,建立科、剂、亚剂、细亚剂、药名序、制剂、途径的4段7层9位的CPPN中成药分类与编码法。结果与结论其编码分层和CPPN西药编码分层的结构相一致,既可解决中成药一药多码和一码多药,还因编码到药品剂型和用药途径,方便统计、分析药品日剂量数和价值,扩展药品信息的使用范围。     

治疗糖尿病天然化合物研究进展

目的糖尿病即为中医的消渴病,对人类身心健康构成了严重的威胁。尽管西药对糖尿病具有较好的降血糖作用,然而存在着各种的毒副作用。中药在中医理论的指导下,治疗糖尿病及其并发症已有2000年的历史。随着天然药物化学和现代医学的发展,大量的天然活性化合物被分离出来,并通过各种机制作用于糖尿病。因此,本文主要对近期报道的治疗糖尿病的天然活性化合物进行了综述．包括了黄酮、生物碱、萜类、蒽醌类等。目的在于引起人们对天然化合物治疗糖尿病及其并发症的关注。     

中医清胰通腑泄热消胀特色疗法结合西医治疗急性胰腺炎的研究

目的：探讨中医“清胰通腑泄热消胀”特色疗法与西医疗法结合治疗急性胰腺炎（AP）的疗效。方法选取66例AP患者随机分为观察组与对照组,各33例,对照组予以常规西医治疗,观察组在对照组的基础上实施中医清胰通腑泄热消胀特色疗法,比较两组的疗效。结果观察组的治疗总有效率为93.9%,显著高于对照组的75.8%;主要症状消失时间、淀粉酶（AMS）恢复时间、首次排便时间、禁食时间、住院时间均较对照组显著缩短,差异具统计学意义（P＜0.05）。结论中医清胰通腑泄热消胀特色疗法与西医疗法结合治疗AP能够有效缓解临床症状,不良反应少,疗效显著,值得推广应用。     

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.     

不同新技术应用于中药配方颗粒

中药配方颗粒是以中药饮片为原料,利用现代制药技术对药材饮片进行提取、浓缩、干燥、制粒,从而精制成的供临床配方的中药颗粒状产品,通过各种分析技术监测实现质量控制。本文对不同新技术应用于中药配方颗粒生产与检验进行综述,同时也实现了在生产过程中对配方颗粒质量更为客观和准确的监测。     

中药的毛细管电泳指纹图谱的研究方法

目的介绍了毛细管电泳指纹图谱的优势，毛细管电泳指纹图谱的研究方法与评价方法及其在中药质量控制中的应用。方法以中药指纹图谱质量控制特征为基础，综述了毛细管电泳在中药指纹图谱方面应用的基础理论和方法。结果建立了一套完整的中药指纹图谱研究方法，包括实验条件的优化、系统适用性试验、电泳峰的指认与标定、双定性双定量相似度评价法等。结论数字化指纹图谱技术是数字中药质控的典型代表和核心技术，建立毛细管电泳数字化指纹图谱是实现中药现代质量控制的重要技术之一。     

Harnessing traditional Chinese medicine to improve cancer therapy: issues for future development

Traditional Chinese medicine (TCM) has recently yielded a number of chemical compounds with clinically significant anticancer activity. The theory of TCM formulas, however, unlike Western medicine, is based on the interactions of the various Chinese medicinal materials in the body, rather than the activity of a single purified chemical compound. Mechanisms for the possible synergistic anticancer effects of components in TCM formulas have recently been postulated. Advanced research on the clinical effects of TCM formulas, however, has been hampered by inconsistent dosage formulations and unreliable quality control. Scientific challenges in dosage formulation and methods for ensuring quality control of TCM products will be discussed.     

Characterization and mapping of the multi-component release kinetics of a Traditional Chinese Medicine dosage form using a modified LC/MS/MS method and chemomic release kinetic theory

It is essential to develop effective methods for the quality control of the traditional medicine with multiple components. However, few researches on the quality control have been conducted to interpret the holistic characteristics of the traditional medicine in terms of dissolution/release. In this study, the multi-component release kinetics of Traditional Chinese Medicine (TCM) dosage forms was characterized and mapped by multivariate analysis techniques in the field of “-omics”. The Liuweidihuang pill was used as a model formulation. The multi-component release kinetics of the concentrated and water-honeyed Liuweidihuang pills at rotation speeds of 50 and 100 rpm were analyzed by chemomic release kinetic theory and modified LC/MS/MS method. Mass features of 103 (concentrated pills) and 101 (water-honeyed pills) were selected with a linear correlation coefficient ≥0.99 between mass responses and concentrations. To compose the chemomic standard spectrum, the relative abundance of both mass features was no less than 1% as compared with an internal standard. The correlation coefficients between six samples of various solutions were in line with analytical requirements of precision (r≥0.985). The score plots of principal component analysis showed that the concentrated Liuweidihuang pills presented better chemomic release reproducibility than the water-honeyed pills. Conversely, the impact of rotation speed on the chemomic release was less obvious. The heat maps of hierarchical clustering analysis did not show significant changes in individual clusters of mass features along different time intervals, reflecting the release integrity of the mass features. Therefore, both multivariate analysis methods, the principal component analysis and the hierarchical clustering analysis, seemed to be effective techniques to demonstrate the multiple component release performance of TCM. The research provided the basis of a new strategy for the quality control procedures of the dissolution/release for the traditional medicine and multi-component natural products to address increasing regulatory requirements and scrutiny across the world.     

蛋白质组学在中药研究中的应用

系统生物学着眼于系统组成成分的构成、动态与发生,与中药对机体的整体而又动态的调节相符合,它的出现给中药研究带来了曙光。作为系统生物学的重要组成部分,蛋白质组学在中药研究中的应用已经越来越多。本文综述了蛋白质组学的常用技术以及近三年来这些技术在中药复方、中药有效部位和中药活性成分等方面的应用。     

2020年全国中药材种植面积统计分析

全国中药材生产统计是反映中药产业经济社会发展规律的重要手段,中药材生产统计数据是进行产业发展宏观管理和调控的基础.由中国中医科学院中药资源中心等单位发起、成立的中国中药协会中药区划与生产统计专业委员会,根据行业对全国中药材生产统计数据的需求,研编了《全国中药材生产统计报告(2020年)》.从全国中药材种植情况、省域中药...     

消渴变证临床疗效评价体系模式构建方法研究与思考

目的探讨中医理论指导下的消渴变证临床疗效评价体系模式构建思路与方法,为提高和完善消渴变证临床诊疗水平提供研究依据。方法采用中医证候疗效的半定量评价方法,在借鉴西医评价体系基础上,纳入评价中医证候的指标,对证型的主要症状进行半定量化统计与分析。结果提出消渴变证疗效指标量化与赋分标准,设定证候的分层指标与赋分值,形成符合中医辨证指导下的消渴变证疗效评价指标量化与权重表。结论提出基于中医理论和临床实际的消渴变证疗效指标量化与赋分标准,为进一步提高临床治疗消渴变证奠定研究基础。     

2010-2020年我国中成药药品说明书修订情况分析

目的:为进一步规范和完善中成药药品说明书、促进其临床安全合理使用提供依据.方法:查询国家药品监督管理局网站2010年1月-2020年6月发布的、药品说明书修订内容明确的中成药品种,归纳并分析修订内容、特点及不足,提出修改建议.结果与结论:在修订内容明确的107个中成药品种中,安全性项目为修订重点,修订"禁忌"项的有10...     

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.     

舒林酸纳米混悬剂的制备及其体内外抗肿瘤作用研究

目的制备舒林酸纳米混悬剂,并考察其对肿瘤组织的抗肿瘤作用。方法以油酸钠为稳定剂,通过反溶剂沉淀法制备舒林酸纳米混悬剂,考察其粒径大小、分散指数、电位及颗粒形状,采用MTT比色法使用乳腺癌细胞MCF-7、4T1进行体外抗肿瘤药效评价,采用4T1荷瘤小鼠进行体内抗肿瘤评价。结果舒林酸纳米粒形状为球形,分散指数值小于0.3,平均粒径为(264.1±2.9)nm。相比较于游离药物,纳米粒显著提高了舒林酸对乳腺癌细胞的抑制作用,对MCF-7、4T1的IC50值分别为(22.1±4.6)、(19.2±1.2)μg/m L,体内抑瘤率为(35.4±18.8)%。结论将舒林酸制备成纳米粒后,拓宽了舒林酸的给药途径,显著增强其抗肿瘤作用。     

中药配方颗粒临床应用医学理论商榷

目的探讨中药配方颗粒临床应用的科学性。方法通过对中药传统理论分析和药品管理法律法规的论述,对中药配方颗粒临床应用的科学性、产品质量的合法性进行讨论。结果中药配方颗粒临床应用缺乏医学理论依据,质量保证措施粗犷,合法性有待于进一步确认。结论目前,中药配方颗粒在临床大量推广应用的时机尚未成熟,临床应用医学理论有待商榷。     

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.     

曲类中药发酵炮制研究进展

曲类中药是一类临床常用的传统中药,然而由于各地区发酵曲类中药所使用的原料和发酵工艺不统一,各地自然菌种差异较大以及发酵过程菌群代谢的复杂性等问题导致曲类中药质量不稳定。因此,曲类中药的炮制工艺、炮制机理和质量控制方法一直是近些年中药炮制研究领域的热点。近年来,随着炮制化学、现代药理学和微生物基因组学等多学科的应用,曲类中药的炮制工艺、炮制机制和质量控制方法取得了一定成就。发酵炮制工艺逐渐从自然发酵转变为纯菌种协同发酵,进一步明确发酵工艺参数;炮制机制研究阐明了部分曲类中药药效物质基础和发酵菌种变化;采用薄层色谱、显微镜、HPLC、电子舌鼻等多技术为质量控制提供了新的方法。本文通过对曲类中药发酵炮制工艺、炮制机制以及质量控制方法的研究进展进行系统总结和分析,为其进一步研究提供参考。