Bio-characteristic profiling related to clinic:A new technology platform for quality evaluation of Chinese materia medica

Quality evaluation is a bottleneck restricting the modernization and internationalization of Chinese materia medica (CMM). Due to characteristics of multi-component, multi-efficacy, multi-target, the existing quality evaluation system still cannot fully meet quality control needs of CMM. Hence, the author put forward “Bio-characteristic profiling related to clinic, BPRC” academic concept, meanwhile, fully take the advantage of analysis method with clinical monitoring superiority or profiling characteristics, build up “BPRC” new technology platform, in order to realize “real-time, dynamic and full-range monitoring” new technologies of CMM quality evaluation system and promote the further development of CMM industry.

Clinical metabolic analysis combined with traceability of biosynthetic pathway:a new approach to quality marker of Chinese materia medica

Quality marker(Q-marker)of Chinese materia medica(CMM)plays an important role in quality control of CMM products.However,its research strategy and technique remain unclear.Based on the fact that quality standard of CMM should be associated with clinical efficacy,taking Jinqi Jiangtang tablet treating type 2 diabetes as an example,the Q-marker related to activity via the reverse analysis of drug metabolism in clinic and traceability of botanic biosynthetic pathways is discovered and validated.Therefore,we proposed a new research strategy of Q-marker of CMM with"Discovery of clinical active constituents as guidance,Reverse analysis of metabolic transformations as link,and Traceability of biosynthesis pathways as key",to improve quality control of CMM products.

First ISO International Standard on Chinese Materia Medica

ISO 18662-1：2017, Traditional Chinese medicine - Vocabulary - Part 1： Chinese Materia Medica （CMM） was officially released recently. The standard is the first terminology standard published by ISO/TC 249, Traditional Chinese medicine, which provides an important basis to standardize and uniform the terminology of traditional Chinese medicine in the international community.

Characterization and Comparison Analysis of WHO Monographs on Selected Medicinal Plants and Iso Standards of Chinese Materia Medica

Medicinal plants or Chinese materia medica(CMM)are now attracting worldwide attention as they have increasingly prominent advantages over chemical drugs in disease treatment and healthcare.Since the 1990s,World Health Organization(WHO)and International Organization for Standardization established the Technical Committee of Traditional Chinese Medicine(ISO/TC 249)have carried out the development of quality standards on medicinal plants or CMMs respectively,and a considerable number of monographs and international standards have been published.Since the two international organizations adhere to different principles,the standards they develop naturally have different emphasis.Driven by market demand and international trade,ISO mainly takes quality,efficacy and safety into consideration when developing standards,while WHO pays more attention to clinical practice,quality control and medication guidance.Up to now,there is a lack of comparative analysis on the records,background,principles,basic content,and main requirements of quality standards on medicinal plants or CMMs respectively published by WHO and ISO.Therefore,based on international standards of CMM developed by ISO/TC 249 platform and WHO Monographs on Selected Medicinal Plants,this paper systematically compares the purposes,selected principles,standard-developing process,basic content,and main quality requirements to summarize their similarities and differences,and find their merits,aiming to serve as a reference to the development of international standards for CMMs that helps them go global.

中药饮片产业发展现状及供给侧问题与对策

分析了中药饮片产业及市场规模现状,相关法律、法规、政策等,从供给侧剖析产业发展瓶颈,解析中药饮片生产标准化、规模化程度低,技术及产品创新不足,缺少协调供需平衡的宏观统筹问题,提出加强炮制理论基础研究、提高中药饮片生产标准化水平的对策措施,包括提高中药炮制技术的标准化水平、完善质量控制标准、建立等级标准等,倡导提高产业规模化水平、实施大品种战略、鼓励科技创新、组建创新联合体,加快中药饮片数字化、智能化生产管理研发及新产品研发,并从调控供需平衡角度提出了推进中药饮片区域化生产与流通的措施等,以期构建以高品质中药饮片为核心的创新型产业发展格局,探寻振兴中药饮片产业高质量发展之路。

“五育”并举视域下基于中药商品学的研学课程改革与实践

“五育”是培养新时代人才的教育方式,课程建设是高校构建“五育”培养教育体系的基础。中药商品学是中药学专业的特色专业课,但教学过程中面临实践课时有限、授课方式单一、学生被动学习和实践训练薄弱等问题,该文通过建立“五育”并举视域下基于中药商品学的研学课程改革,使学生在每一个教学单元和每一次教学活动中得到全面培养,实现“五育”的有机融合与统一,提高学生综合素质和核心竞争力。

Development of Hong Kong Chinese Materia Medica(HKCMM) standards

The development of HKCMM standards is one of the achievements of developing Hong Kong into an intemational centre for Chinese medicine. In order to enable more people concerned to have an intimate knowledge of this standard, the author was invited to introduce the development of HKCMM standards to readers, including： 1） the history of the project and the basis for legislative supports; 2） the composition and operation of the regulatory division, the research institution and the evaluation committee; 3） the progress of HKCMM standards; 4） the contents and features of HKCMM standards.

一测多评法测定甘草及其不同炮制品中7种成分含量

为了实现对甘草药材及其炮制品成分的多指标质量评价,建立了一测多评测定甘草药材及3种炮制品中7种化学成分含量的方法。以甘草苷为内标,计算异甘草苷相对校正因子;以甘草酸为内标,计算芹糖甘草苷、芹糖异甘草苷、新异甘草苷、甘草素的相对校正因子,再测定各成分含量,并将计算结果与外标法测定结果进行比较。结果表明:一测多评法测定甘草及其不同炮制品中7种成分的含量具有可行性;甘草炮制后,其中的甘草苷、甘草酸、芹糖甘草苷、芹糖异甘草苷、新异甘草苷的含量均有所降低,且在不同炮制品中的含量呈现出相同的变化趋势,均为ω(甘草药材)>ω(炒甘草)>ω(甘草片)>ω(炙甘草)。所建立的一测多评法稳定、准确,且重复性好,可为甘草及其不同炮制品的质量评价提供参考。

五气朝阳草标准汤剂的制备及质量标准研究

为了实现五气朝阳草标准汤剂的质量控制,采用高效液相色谱法,以Waters Symmetry C_(18)(4.6 mm×250 mm,5.0μm)为色谱柱,乙腈-0.1%磷酸为流动相,梯度洗脱,流速为1.0 mL/min,检测波长为360 nm,柱温为35℃,建立五气朝阳草标准汤剂特征图谱及其指标成分鞣花酸的含量测定方法。结果表明:15批五气朝阳草标准汤剂的平均出膏率为17.8%;特征图谱相似度为0.793~1.000,共标定13个共有峰,并指认4个成分,分别为咖啡酸(峰4)、鞣花酸(峰8)、异槲皮苷(峰9)、木犀草苷(峰10);鞣花酸从五气朝阳草到其标准汤剂的平均转移率为45.90%,说明标准汤剂的质量得到了较好的控制。所提出的五气朝阳草标准汤剂的制备工艺可行,建立的标准汤剂特征图谱及含量测定方法稳定,可为五气朝阳草配方颗粒的质量标准研究提供依据。

内江天冬的产地加工、质量标准与产品开发策略

天冬始载于《神农本草经》,列为“上品”,临床上常与麦冬、地黄配伍,用于治疗肺阴虚、肾阴虚、热伤胃津等证。内江市东兴区是四川省天冬适宜种植区域之一,2023年“天冬膏熬制技艺”列入内江市第九批非物质文化遗产代表性项目名录。除了药用,在内江地区天冬还常作为食品原料。目前,天冬的采收、产地加工等环节仍需大量人工,去皮、干燥、切制、去心是产地加工的关键工序,去皮机、切药机、微波干燥机等相关中药炮制设备亟需优化升级。《中华人民共和国兽药典》2020年版二部天冬项下收载了性状、显微鉴别、水分检查、总灰分检查、二氧化硫残留量检查及浸出物测定,未收载含量测定项,质量标准有待进一步完善。液质联用、高光谱、近红外光谱、X射线等新技术可用于天冬的定性鉴别,建立内江天冬的特征图谱、指纹图谱可完善专属性分析。天冬的定量分析目前集中在皂苷、氨基酸、多糖,单一成分的含量测定并不能反映中药材的整体质量,故应对天冬药材的多组分进行含量测定,天冬产品则需结合适应症选取药效物质进行测定。另外,有关物质检查应增加5-HMF、农药残留、霉菌毒素、重金属及有害元素等测定项。目前天冬的应用形式单一,主要作为中药材原料,而其在提取物、配方颗粒、新饲料添加剂等领域也发挥着重要作用,具有广阔的市场前景。本文从天冬的产地加工、质量标准、产品开发等方面进行综述,为内江天冬进一步的研究与应用提供参考。

New sensor technologies in quality evaluation of Chinese materia medica:2010–2015

New sensor technologies play an important role in quality evaluation of Chinese materia medica(CMM) and include near-infrared spectroscopy,chemical imaging,electronic nose and electronic tongue.This review on quality evaluation of CMM and the application of the new sensors in this assessment is based on studies from 2010 to 2015,with prospects and opportunities for future research.

Biopotency Assays:an Integrated Application to Quality Control of Chinese Materia Medica

The current quality control（QC） pattern for Chinese materia medica（CMM） lacks suitable methods and indicators to evaluate their safety and efficacy effectively, which impedes the smooth development of CMM. In this review, main problems of the current QC pattern for CMM, principally focused on the content determination of constituents,were summarized and the inspiration from the QC of biological products was introduced. With the aim at introducing a suitable tool to the QC of CMM, biopotency assay and its feasibility in the QC pattern for CMM were analyzed and confirmed by relevant researches with years of practice. From the applications of biopotency assays in the QC of CMM in the last 10 years, we propose that biopotency assays should be an integral part of the QC pattern for CMM, for these assays can make the QC indicators related to the clinical safety and efficacy, supplementing the existed QC system of CMM.

中药学实验教学质量评价体系探析与实践

实验教学是人才培养的关键环节。应对区域和行业发展对中药学人才的更高要求,对实验课程教学质量和效果进行评价,通过评价引导、调节、激励实验教学,对提升实验教学质量、保障和促进中药学人才培养有重要意义。本文对我校中药学国家级实验教学示范中心在实验教学质量评价体系的设计理念、构成要素、优化使用等方面进行探析和实践。

中药追溯体系建设现状与建议

目的:促进我国中药追溯体系的完善,达到中药“来源可知、去向可追、质量可查、责任可究”,保障公众用药安全。方法:通过分析当前国内中药质量追溯体系建立的现状与难点,针对性地提出实质性建议。结果和结论:鉴于目前中药追溯平台搭建成本高、推广不足,追溯监管主体多元、法律制度不完善等情况可能还存在于现行的中药追溯体系,我国中药追溯体系的建立现仍处于研究和起步阶段,但是在中药的质量安全、中药材流通现代化和中药产业发展的强烈需求下,建立完善健全的中药追溯体系的目标势在必行。本研究提出了几条可行性建议,致力于逐步建立中药“从生产到消费”的质量可追溯体系。

中药生产中回收乙醇的质量风险分析及实例研析

中药生产中溶剂使用问题日益得到重视。本文通过文献回顾分析不同应用情况下影响乙醇回收质量的关键因素,还通过对参桂胶囊生产验证试验的实例数据和文献数据进行比较,证明乙醇的回收次数与质量之间无明显关联,建议研究重点应关注杂质或有害成分与限度的比值关系。

藏药“公巴嘎吉”本草考证

为明确藏药“公巴嘎吉”的传统基原,通过系统查阅《宇妥本草》《药名之海》《晶珠本草》《晶镜本草》等藏医药经典文献与相关汉译本书籍,并结合实地调研等方法,对藏药“公巴嘎吉”的名称、功效、性状、生境进行考证整理,为规范藏药“公巴嘎吉”的基原提供研究参考,并对提升其质量标准提供理论依据。

中药农药残留问题研究与思考

对目前中药农药残留研究状况进行分析讨论。通过对近期文献的查阅,对中药中农药残留污染现状、标准、脱除方法及农药安全使用的研究进行综述及讨论分析。建议应该加快残留农药检测方法和限量标准的研究工作,及时制订管理法规、加大监管力度,同时从生产源头抓起才能根本解决中药农药残留问题。

中药指纹图谱及其对中药发展的影响

简要介绍了中药指纹图谱的原理 ,探讨了建立中药指纹图谱对提高中药质量控制标准的水平、加快中药现代化的进程 ,建立中药材规范化栽培 。

在线近红外光谱在我国中药研究和生产中应用现状与展望

中药生产过程具有多单元复杂性特点,制剂生产的各个环节均会影响中药产品的最终质量,在线近红外光谱技术具有快速、无损和不污染环境等优势,能够作为一种快速评价中药生产过程中关键质量属性的分析技术。以院校相关研究为切入点,系统阐述了在线近红外光谱技术在中药生产过程分析与控制方面的应用,并结合院校中药生产在线近红外光谱分析平台搭建为例,以此为依据阐明中药在线近红外光谱分析技术应用的可行性。进而,从企业应用角度出发,较为全面的综述了目前国内大多数应用在线近红外光谱技术的中药生产企业的研究成果及其中药产品。按照中药产品的两大剂型(液体制剂与固体制剂)进行分类,以液体制剂不同生产环节(提取、浓缩及醇沉等)为区分点,以固体制剂不同成品剂型(片剂、胶囊剂及膏剂等)为区分点,分别对近10年来中药生产过程中在线近红外应用进行系统综述,阐明中药生产全过程在线近红外技术应用的可靠性,为中药生产现代化提供有效的技术支撑。

微量热法对不同生长年份黄连品质的评价

目的尝试构建基于生物热力学表达的中药品质评价方法体系。方法以不同生长年份黄连为例,利用微量热法,测定黄连作用于大肠杆菌生长代谢过程中的热功率图,建立生物热动力学模型,分析热动力学参数、生物活性与化学成分之间的相关性。结果在不同生长年份黄连的作用下,大肠杆菌生长代谢的热功率图不尽一致,呈现较明显的指纹特征;与正常对照组比较,不同生长年份黄连均能不同程度地使大肠杆菌生长速率常数减小,传代时间延长,最大产热功率降低,说明不同生长年份黄连对大肠杆菌生长代谢均有不同程度的抑制作用,其中以含总生物碱最高的四年生黄连的抑制作用最强。结论不同生长年份黄连作用于大肠杆菌生长代谢过程的部分热动力学参数与热生物活性和化学成分之间具有显著的相关性;是具有实时、在线、微量、高效、高通量、普适性好等特点的生物热力学方法和指标,既可以间接地反映黄连的生物活性,也可作为评价中药品质的一种新方法。