Study and Countermeasures on Safety Control of Traditional Chinese Medicines Industry Chain

I'm very grateful to Chinese Pharmaceutical Association and DIA for their elaborate organization,so that we are able to participate in the Sino-Europe Symposium.Yesterday and today,several professors have talked about various aspects.It is true that the effectiveness of traditional Chinese medicine is important,and safety is equally important.For this reason,our laboratory works on the effective test,and at the same time,since 2001,we have been focusing on the safety of traditional Chinese medicines,especially the research on exogenous pollution.Today,I would like to share with you some of the quality control of the whole industry chain of traditional Chinese medicine and some of our thoughts.

Distribution patterns and industry planning of commonly used traditional Chinese medicinal plants in China

Medicinal plants are the primary material basis for disease prevention and treatment in traditional Chinese medicine(TCM).The conservation and sustainable utilization of these medicinal plants is critical for the development of the TCM industry.However,wild medicinal plant resources have sharply declined in recent decades.To ameliorate the shortage of medicinal plant resources,it is essential to explore the development potential of the TCM industry in different geographical regions.For this purpose,we examined the spatial distribution of commonly used medicinal plants in China,the number of Chinese medicinal material markets,and the number of TCM decoction piece enterprises.Specifically,multispecies superimposition analysis and Thiessen polygons were used to reveal the optimal range for planting bulk medicinal plants and the ideal regions for building Chinese medicinal material markets,respectively.Furthermore,we quantitatively analyzed mismatches between the spatial distribution of commonly used medicinal plant richness,Chinese medicinal material markets,and TCM decoction piece enterprises.We found that the areas suitable for growing commonly used medicinal plants in China were mainly distributed in Hengduan Mountain,Nanling Mountain,Wuling Mountain,and Daba Mountain areas.The Thiessen polygon network based on Chinese medicinal material market localities showed there are currently fewer markets in southwestern,northwestern,and northeastern China than in central and southern China.TCM decoction piece enterprises are concentrated in a few provinces,such as Hebei and Jiangxi.We found that the distribution of commonly used medicinal plants,Chinese medicinal material markets and TCM decoction piece enterprises are mismatched in Henan,Shaanxi,Hunan,Hubei,Zhejiang,Fujian,Chongqing,and Xizang.We recommend strengthening development of the TCM industry in Henan,Hunan,Zhejiang,Shaanxi,Hubei,Chongqing,Fujian,and Xizang;building more Chinese medicinal material markets in southwestern,northwestern,and northeastern China;and establishing medicinal plant nurseries in resource-rich provinces to better protect and domesticate local medicinal plants.

Problems in the Development of Traditional Chinese Medicinal Materials Planting Industry in Shiyan City and Countermeasures

Through the analysis on the cultivation advantages and development problems of traditional Chinese medicinal planting industry in Shiyan City, Hubei Province, some measures were proposed to enlarge and enhance the traditional Chinese medicinal planting industry, namely, large-scale, standardized, market-oriented and regionalized planting, thereby making it the pillar industry for farmers to increase income.

Opportunities and challenges for the development of traditional Chinese medicinenursing under the new healthcare reform

随着医疗卫生改革的不断深化和人民群众对中医药服务需求的增加,中医药在卫生体制改革中的势逐步突显.中医护理作为中医药健康服务业的重要组成部分,其规范化、专业化的发展问题一直到业内学者和社会的广泛关注.文章通过对《关于深化医药卫生体制改革的意见》、《中医药发展略规划纲要（2016-2030年）》和国家中医药管理局发布的相关政策及中医护理发展相关文献的解读,章分析了新医改形势下中医护理在专业化发展过程中面临的机遇和挑战,并对其进行分析,以期为医护理专业化发展道路提供借鉴.

The Great Significance of Establishing Strategic Status of Traditional Chinese Medicine (TCM)

Traditional Chinese Medicine(TCM), based on the philosophic idea of “correlation between man and nature” and “balance of Yin and Yang” and characterized by “integrated concept” and “syndrome identification & treatment determination”, adjusts and activates the self-recuperating ability to rectify its differentiation from normality of human body to meet the goal of preventing and treating diseases mainly by means of traditional Chinese medicinal herbs, acupuncture and moxibustion, etc. The idea of “Human should be in harmony with Nature including bacterium, virus, etc., but not to exterminate microbe in a large scale”, held and promoted by TCM gives, rise to a delicate physiological equilibrium kept between man and microbe and this is just the development trend of medical science in future. For thousands years, TCM has made indelible contribution to the reproduction and prosperity of the Chinese nation, and under the countless attacks of pestilence has never made its people’s death in millions, not such as once occurred in Europe. TCM is also characterized by its “simple, convenient, cheap and effective”method of treatment” and is especially good at preventing and treating chronic diseases, complicate multi-system diseases and new-type virus diseases. Therefore, only when the sanitation and healthcare system is established can the health of 13 billion people in China and the problem of shortage of doctor and medicine for 900 million rural population and large number of poverty-stricken urban population be solved. It is strongly suggested that five promotion projects, namely: TCM policy and statute guarantee, TCM qualified personnel cultivation, TCM scientific research, development of TCM in rural areas and TCM administrative system reform should be carried out in real earnest to make TCM develop in a sustainable way.

Reason Analysis and Risk Prevention of Soaring Price of Traditional Chinese Medicinal Materials

In recent years,the price of traditional Chinese medicinal materials soars continuously,and the resulting price risk increasingly looms large,which has critically affected midstream and downstream industries and peoples' demand for drug,and imperiled healthy and orderly development of traditional Chinese medicinal industries.Based on the status quo of continuous skyrocketing price of traditional Chinese medicinal materials at present,we winkle out the root cause of soaring price as follows:the supply and demand lose balance;the production costs hike up;there are other factors responsible for soaring price.This paper further analyses the impact of sharp increase in price of traditional Chinese medicinal materials on all links of industry chain as follows:the medicinal herb growers never benefit from soaring price;the counterfeiters and forgers in midstream industry increase;the gross profit rate of Chinese medicine enterprises declines.In accordance with the risk arising from abnormal fluctuation in price of traditional Chinese medicinal materials,corresponding precautionary measures are put forward as follows:promote the quality of traditional Chinese medicinal materials through management of value chain;curtail the production and management cost of traditional Chinese medicinal materials through management of organization chain;stabilize price of traditional Chinese medicinal materials through management of information chain;reduce transaction cost of traditional Chinese medicinal materials through management of logistics chain.

陕西省第四次全国中药资源普查对秦药产业高质量发展的启示

通过对第四次全国中药资源普查陕西省相关工作成果进行梳理,明确了陕西省中药资源种类与构成情况,根据区域生境特点和生态适宜性提出秦药的适宜生产区划;总结了中药资源普查成果在陕西省乡村振兴和富民强省、中药产业合理布局和生产规划、中医药事业高质量可持续发展等方面的作用;最终,从加强种子种苗标准化研究、培育优良秦药品种,积极发展林下经济、构建中药材生态种植体系,引导秦药生产向绿色高效方向发展、促进秦药提质增效3个方面展望了秦药产业未来发展面临的挑战,为进一步聚焦秦药大品种、打造秦药全产业链、促进秦药产业绿色可持续发展提供科学参考。

中医特色护理门诊医护协作出诊实践分析

目的 探讨脾胃病专科中医特色护理门诊医护协作出诊开展的可行性及成效。方法 运用医院选拔原则确定出诊护师,与专科医师合作开设脾胃病专科中医特色护理门诊。通过对2023年医护协作出诊和2019年护师单独出诊的脾胃病专科中医特色护理门诊就诊患者进行问卷调查,分析对医疗护理服务的满意度。结果 脾胃病专科中医特色护理门诊医护协作出诊开展以来,护理门诊量由2019年的35人次/月上升到2023年的148人次/月,出诊时间由2019年的1次/周增设至2023年的3次/周。2023年护理门诊医护协作出诊的就诊患者对医疗护理服务的满意度高于2019年护师单独出诊,差异有统计学意义(P<0.05)。结论 脾胃病专科中医特色护理门诊医护协作出诊的开展,拓展了中医护理服务内涵,满足患者日益增长的个体化、多元化需求,提高患者对医疗护理服务的满意度。

基于产教融合理念的中药制药校企联合课程设计

通过任务驱动的探究式实践,教学团队将课程设计时空从校内实验室拓展到企业实践平台,课程设计内容延伸至企业生产实际,有力促进了课程设计与产业技术发展的联系,学生学会从技术可行性与经济合理性两个方面树立中药制药工艺及车间工艺设计原则与思想,综合应用能力及实践创新水平得以提升,从而为中药制药专业创新应用型人才的培养提供了有力支撑。

中医药产业技术创新联盟的构建动机及运行机制研究——以江西省为例

基于中医药在改善民生、转变经济发展方式、弘扬中华文化、建设生态文明等国家大局中日益凸显的作用,结合产业技术创新联盟在推动产业发展、突破关键共性技术这一显著特点,提出中医药产业技术创新联盟的内涵,分析联盟构建动机。以江西省为例,从全生命周期角度提出中医药产业技术创新联盟的运行机制,保障联盟的稳定发展。

基于中药质量标志物的中药产业高质量发展技术策略

中药质量是中药安全有效的保障,中药质量关乎国民生命健康,也关乎中药产业的健康发展。以往中药质量研究与质量控制模式难以满足中药复杂体系的质量控制要求,需要在理论、模式、技术方法和研究路径上实现质的突破。在对中药复杂体系和产业特点客观分析的基础上,针对中药质量研究与质量控制现实问题,提出基于中药质量标志物的中药产业高质量发展技术策略。以此建立与中药临床效用密切关联、特有专属、整体评价和面向中药全产业链的质量标准和质量控制体系,并为行业监管提供科学、有效的“监管工具”,对于提高我国中药质量标准和质量控制水平具有一定的参考意义。

中医药传统知识专门保护制度构建研究

中医药传统知识是中医药的核心内容,兼具卫生、经济、科技、文化、生态五重资源价值。目前中医药传统知识面临国外不当占有、盗用,国内传承、保护不力的双重困局,现行法律制度无法实现全面、系统保护,建立专门保护制度已成为必然选择。专门保护制度需要解决四个核心问题:对外防御侵占和不当占有,对内保护持有人权利并规范知识的获取与利用,化解持有人利益与社会公共利益之间的矛盾,处理与现行法律制度的衔接。在此基础上,提出构建中医药传统知识专门保护制度的四个机制,即阻却外国不当专利申请的防御机制、持有人权利保护机制、持有人利益与社会公共利益平衡机制、与现行法律制度的衔接机制,以更好促进中医药传统知识的保护、传承、创新、发展。

现代化中医药专利保护的制度困境与出路--基于对中医药特点与专利保护适应性的反思

符合西医药特点的专利保护制度在中医药现代化进程中难以适应。尽管现行专利制度已对涉及中药领域发明专利申请审查的特殊情形作出了具体规定,但在本土语境下据此保护主要根植于我国传统知识领域的中医药发明创造时,中医药的复杂性、整体性、道地性和时节性、差异性等特点仍未得到充分体现,并由此产生中医相关发明创造不具有专利适格性、专利审查缺乏一般性指导规则、申请文件难以通过合规性审查、申请主题的可专利性要求过高、关键性概念缺乏细化指导规则等问题。为此,可从专门审查标准的制定和商业秘密的补充保护两方面出发,寻求前述问题的具体解决方案,以应对中医药专利保护的适应性需求,从而完善中医药知识产权保护体系。

基于贯穿式创新创业教育的中药学人才培养全过程的探索与实践

创新是社会进步的灵魂,创业是推动经济社会发展、改善民生的重要途径。党的十八大以来,国家持续提升创新创业人才培养战略的重要性。在目前不可避免的国际竞争的环境下,我国的中药产业在多个方面仍面临着巨大的外部挑战。因此,在中药学人才培养中充分的融入创新及基于创新的创业教育,对今后国际竞争大环境下的中药产业可持续发展战略均具有重要意义。

医疗机构中药制剂立项评价体系的构建及应用

目的以新药转化为导向,构建医疗机构中药制剂备案立项评价体系,以提高医疗机构中药制剂的申报成功率,为后期新药转化奠定基础。方法我院研发小组运用文献研究法,采用头脑风暴法列举并整理医疗机构中药制剂立项评价的相关要素,确定初拟指标体系;采用德尔菲法进行专家函询,确定评价指标,根据各指标的重要性评分占比计算权重,赋予具体分值,并采用该指标体系对2023年4-7月我院各科室申请备案的31个中药制剂进行评价。结果向17位专家进行了两轮函询,最终确定的医疗机构中药制剂备案立项评价体系包括理论依据、临床研究基础、药学基础、处方、临床价值5项一级指标,以及处方来源、中医理论、临床定位等17项二级指标,其中人用经验为一票否决项。基于上述指标体系,我院进一步完善了医疗机构中药制剂备案立项流程,并从2023年4-7月各科室申请备案的31个中药制剂中,遴选出8个评分≥65分的中药制剂拟进行开发。结论本评价体系客观、全面,可操作性强,适用于医疗机构中药制剂研发前的遴选。

医疗机构中药制剂备案管理比较研究

目的:比较分析各医疗机构中药制剂备案管理工作的开展情况,为后续完善备案制度提供参考。方法:探析国家药品监督管理局发布的《关于对医疗机构应用传统工艺配制中药制剂实施备案管理的公告》(以下简称《公告》)与各省及直辖市出台的备案制实施细则和内容,选取8省市近5年来备案数据进行整理、比较和分析。结果:部分省市在《公告》基础上结合本地实际情况细化或扩充了备案范围、中药制剂品种取消备案、备案申报流程等内容。统计情况显示,2018-2020年各省市备案及备案机构数量呈逐年递增趋势,2021-2022年备案及备案机构数量有所减少。结论:通过分析发现医疗机构传统中药制剂存在相关制度不完善、申报配制制剂的医疗机构增长乏力、监管难度加大、中药制剂人才培养机制不健全等问题。建议落实各类激励政策,完善备案制制度;激励医疗机构配制中药制剂,加大投入;加强医疗机构中药制剂监管力度;加强专业人才队伍建设;加强宣传引导,引导医疗机构中药制剂向中药新药转化等。最终推动医疗机构中药制剂的良性发展,促进中医药事业的繁荣昌盛。

《中国医药产业高质量发展状况调研(2021-2023)》研究报告综述

目的:了解“十四五”以来我国医药产业高质量发展转轨和运行状况,梳理监管政策在产业高质量发展转轨中的影响和作用,探讨医药产业迈向高质量发展进程中面临的挑战,对进一步深化医药产业高质量发展提出思考和策略建议。方法:通过文献研究、问卷调查、访谈、专家咨询等方式,获取相关政策信息、数据、业界观点等,同时组织专家研讨作为项目研究支撑。结果:我国医药产业积极应对经济下行压力,表现出了良好的产业发展韧性,新药审评上市数量、审评速度与新药临床价值都跃升到新高度,与此同时,中药行业发展表现相对突出,药品制造升级稳步推进,监管科学项目成果丰富。结论:我国医药产业正在以高质量发展转型为方向积极进行深度调整,目前已在研发创新、制造升级、中药守正创新等方面取得了积极进展,同时在研发策略与资金支持、中药传承创新、国际化发展、保障供应链稳定可控等方面仍然存在挑战,建议在进一步转变研发策略、建立多元化筹资体系、完善国际化配套政策、坚持中药特色监管、深化监管科学行动计划、强化监管能力建设、促进“三医”协同等方面发力,有效助推医药产业高质量发展。

双高建设背景下中医类专业产教融合培育模式的探索

百年大计,教育为本。中医类专业实践性和综合性都极强,产教融合培育模式是培育中医类人才、发展中医类专业的重要模式。基于此,以“双高”建设背景下中医类专业产教融合培育模式为切入点,从其现存问题、模式内涵和探索途径三方面探究双高背景下中医类专业产教融合培育模式,以期为各界针对双高背景下中医类专业产教融合培育模式的探索发展的理论研究和教学实践提供一定参考。

中医药文化国际传播的“他者”机制研究

中医药是中华民族的瑰宝,始终植根于中华传统文化的土壤之中,其独特的理论体系和治疗方法在世界范围内得到广泛关注,是中华文化“走出去”的重要载体。研究中医药文化的国际传播机制,对于推动中医药文化走向世界,提升中国文化软实力和文化影响力具有重要的意义。通过对中医药文化国际传播的价值意蕴进行解析,深入研究和科学设计传播内涵的三重维度,即文化价值与哲学思考、传统医学知识与理论、临床诊疗技术,在此基础上以术传道,着力构建基于中医药海外中心、中医药服务贸易、中医药人际传播的跨文化“他者”传播机制,以期提升中医药文化的国际亲和力和传播力。

中药溯源技术助力乡村振兴的初步实践研究

在乡村振兴中,产业兴旺至关重要。中药材种植业近年在贫困地区崛起,成为引领农民增收、脱贫致富的重要产业。然而,当前中药材资源开发利用效率不高,地理优势尚未充分发挥。同时,中药材种植中存在着规范化生产不足、产业化进程较慢等问题。因此,该文旨在探讨四川省中药材种植业的现状和问题,重点分析中药溯源技术在此领域的应用,为进一步促进该产业的发展提供指导和参考。