A holistic strategy for quality and safety control of traditional Chinese medicines by the “iVarious” standard system

An effective quality control system is the key to ensuring the quality, safety and efficacy of traditional Chinese medicines(TCMs). However, the current quality standard research lacks top-level design and systematic design,mostly based on specific technologies or evaluation methods. To resolve the challenges and questions of quality control of TCMs, a brand-new quality standard system, named "iVarious", was proposed. The system comprises eight elements in a modular format. Meaning of every element was specifically illustrated via corresponding research instances. Furthermore, frankincense study was taken as an example for demonstrating standards and research process, based on the "i Various" system. This system highlighted a holistic strategy for effectiveness,security, integrity and systematization of quality and safety control standards of TCMs. The establishment of"i Various" integrates multi-disciplinary technologies and progressive methods, basis elements and key points of standard construction. The system provides a novel idea and technological demonstration for regulation establishment of TCMs quality standards.

Research of Quality Standards for Stachydrine Hydrochloride in Chinese Medicine TJF Granule

A high-performance liquid chromatographic method was applied to the determination of stachydrine hydrochloride concentration in TJF granule (Chinese name: Tiao-Jing-Fang), using a mobile phase of methanol-acetonitrile (50:50, v/v) by the Agilent Kromasi NH2 column (250 mm × 4.6 mm, 5 μm, S/N: 22N25110). Detection wavelength was 201 nm. The result revealed good linearity of stachydrine hydrochloride and was obtained within the range of 0.20 - 1.98 μg/mL (R = 0.9995). The average recovery was 97.01%;the relative standard deviation (RSD) was 0.19%. To the best of our knowledge, this is the first report dedicated to the determination of stachydrine hydrochloride by the evaporative light scattering detector-high-performance liquid chromatographic (ELSD-HPLC) method.

Considerations on the Quality Standards Reflecting the Characteristics of Compound Preparations of Traditional Chinese Medicine

Objective To study the current quality standard of traditional Chinese medicine(TCM)and its limitations in China,and encourage enterprises to take more responsibility to promote the development of this industry.Methods Based on the analysis of the status quo and problems of the quality standard system of TCM,the quality control mode,as well as the problems found in the reevaluation after marketing,some suggestions were put forward for adjusting the current quality standard of TCM.Results and Conclusion Through strengthening the quality control of the source,and under the premise of ensuring the safety,effectiveness and stability of TCM,the quality standards of TCM can be improved greatly.

International expert consensus on clinical application of traditional Chinese medicine formula granules

Guided by the theory of traditional Chinese medicine(TCM),TCM formula granules are made through the optimal process of extraction,concentration,drying,and granulation by combining modern new preparation technologies and pharmaceutical technologies.TCM formula granules are stable,safe,convenient,and effective.Compared with TCM decoction pieces,TCM formula granules can achieve the full process control of its industry chain from field to workshop and standardize the management of the origin of medicinal materials,processing of decoction pieces,processing technology,quality inspection,sales,and products distribution.TCM formula granules can partially replace Chinese patent medicines.Only available for around 800 common varieties of TCM,TCM formula granules cannot replace decoction pieces for many types which are not commonly used in clinical practice.A large number of formula granules are used in clinical and animal studies so that investigators no longer need to extract and control the quality of TCM decoction pieces.How to improve the production process,establish the quality standard,perfect the regulatory system,and expand the clinical application are the problems we need to solve as soon as possible for the better development of formula granules.

Preliminary Study on the Training Mode of Chinese Pharmacy Professionals Based on the National Standard of Teaching Quality

With the promulgation of the National Standard for the Teaching Quality of Undergraduate Majors in Ordinary Colleges and Universities, the state has made clear regulations on the standard for the cultivation of Chinese pharmacy talents. Based on their own actual conditions, major colleges and universities have implemented different talent training modes, including talent training modes of running talent classes, "2+1+1", "Chinese Medicine Research Practice Class", employment-oriented professional talent training mode, three-level three-type diversified talent training mode, and talent training mode oriented with adapting to the characteristics of ethnic regions. Various talent training modes have different training objectives, and corresponding training programs are formulated to meet the requirements of the National Standard for the Teaching Quality of Undergraduate Majors in Ordinary Colleges and Universities. In addition, according to the notice on Solidly Promoting Labor Education into the "National Standard for the Teaching Quality of Undergraduate Majors in Ordinary Colleges and Universities" issued by the Department of Higher Education of the Ministry of Education, the introduction of labor education to the teaching of Chinese pharmacy majors will be a trend, and Chinese pharmacy professionals are required to achieve comprehensive and coordinated development of morality, intelligence, physique, beauty, and labor. How to integrate labor education with high quality and high efficiency into the training of Chinese pharmacy professionals is a problem that major universities will think about.

Discussion on Ideological and Political Theories Teaching in Traditional Chinese Medicine Courses Based on National Standard for Teaching Quality

This paper analyzes the necessity and existing problems of ideological and political theories teaching in traditional Chinese medicine courses,and puts forward some suggestions,such as improving the ideological and political ability of professional teachers,perfecting the evaluation mechanism,and exploring ideological and political elements based on the characteristics of courses,so as to provide the basis for ideological and political theories teaching in traditional Chinese medicine courses under the National Standard for Teaching Quality.

Teaching Reform and Practice of Traditional Chinese Medicine Course Based on National Standard and Ideological and Political Theories Teaching in All Courses

Under the new situation,how to integrate the ideological and political theories teaching in all courses for Chinese medicine major and meet the requirements of national standards for teaching quality,improve the training quality of Chinese medicine talents and strengthen the connotative development of Chinese medicine higher education are urgent issues to be solved in Chinese medicine colleges.This paper introduces the practical experience of teaching reform of traditional Chinese medicine courses based on national standards of teaching quality and ideological and political theories teaching in all courses from the aspects of curriculum setting,teaching content,teaching methods and teaching practice,which can provide reference for teaching reform of other professional courses based on national standards of teaching quality and ideological and political theories teaching in all courses.

子宫内膜异位症患者的中医慢病护理门诊管理

目的评价中医慢病护理门诊对子宫内膜异位症患者的管理效果。方法采用历史对照法,将2020年1-12月行腹腔镜手术的子宫内膜异位症门诊就诊的痛经患者88例作为对照组,按常规行术后门诊复诊及随访;2021年1-12月行腹腔镜手术的门诊就诊的88例痛经患者为观察组,在对照组基础上实施子宫内膜异位症中医慢病护理;干预3个月。干预后3、6、12个月评估干预效果。结果两组各85例患者完成研究及随访。两组痛经评分、自我管理能力评分及生存质量评分比较,组间效应、时间效应及交互效应差异有统计学意义(均P<0.05)。结论对子宫内膜异位症患者实施中医慢病护理门诊管理,可更有效地改善痛经症状,提高疾病自我管理能力和生存质量。

中药跌打膏质量标准提升与安全性研究

目的 建立中药跌打膏质量控制方法,验证中药跌打膏安全性,为临床提供参考。方法 根据配方组成,采用薄层色谱法(TLC)对方中川乌、草乌、大黄、续断、泽兰进行定性鉴别,采用高效液相色谱法(HPLC)定量测定中药跌打膏中大黄素,以用于对中药跌打膏的质量控制;此外,通过皮肤急性毒性实验、皮肤刺激性实验、皮肤过敏性实验以及豚鼠皮肤组织病理学检查对中药跌打膏的安全性进行评价。结果 该实验中川乌、草乌、大黄、续断、泽兰定性鉴别方法操作简便,分离度好,专属性强。大黄素平均加样回收率为84.917 3%,RSD为1.466 1%。大黄素含量范围为1.099 9%~1.123 8%;精密度、稳定性、重复性试验的RSD分别为0.229 4%、1.835 9%、1.025 0%,均小于3.00%(n=6);安全性实验中,中药跌打膏对小鼠皮肤无刺激性,对小鼠体质量、肝肾功能无影响。一次给药后,14 d观察期间各组小鼠行为活动、精神状态、饮食情况及排便均未出现异常;给药14 d后,取小鼠血液进行血常规检查,后对小鼠进行解剖取血,血常规各项指标及肝肾功能无异常,各脏器未出现肉眼可见病理变化;中药跌打膏干预后的豚鼠皮肤病理检查均未见组织病理学改变。中药跌打膏对豚鼠皮肤无刺激性,中药跌打膏对豚鼠皮肤无明显致敏。结论该实验建立的中药跌打膏中川乌、草乌、大黄、续断、泽兰的TLC鉴别方法和大黄素含量测定方法有良好的精密度、稳定性和重复性,可用于中药跌打膏的质量控制。中药跌打膏对小鼠局部皮肤无毒性,对豚鼠皮肤无刺激性,对豚鼠皮肤无致敏性,说明中药跌打膏外用治疗疾病安全可靠。

我国中药材生产质量管理中存在的问题与对策

为推动完善中药材质量管理体系、促进中药材产业高质量发展,对中药材种植过程中投入品使用、加工、存储、质量等级标准、质量追溯体系等方面的现状及标准缺乏等问题进行归纳分析,提出应加强中药材质量监管、完善质量标准、加快良种繁育及搭建合作平台的建议,以期解决中药材质量管理过程中存在的问题,确保中药材的安全性与有效性,推动中药材产业高质量发展。

中药配方颗粒质量控制的研究进展

随着中药配方颗粒试点工作宣告结束、部分品种中药配方颗粒的国家标准正式发布,中药配方颗粒正式进入“标准化”的新时代。在中药配方颗粒快速发展的过程中,如何有效对其进行质量控制一直是众多学者研究的重点。文章以质量标准的现状为切入点,分析质量标准难以建立的主要问题,并通过文献查阅总结目前中药配方颗粒的质量控制模式及未来发展的新思路,为推动中药配方颗粒的国际化、标准化发展提供参考。

中药制剂国际注册质量标准要求与对策

自“一带一路”倡议实施以来,中药出口贸易额呈逐年上升趋势。现如今国际药品主流国家和地区包括美国、欧盟、加拿大、澳大利亚等均已将天然药品/植物药(含中药制剂)纳入非处方药管理。但因我国中药制剂现行标准无法在国际注册中与上述国家和地区药品监管完全对标,导致无法顺利完成注册。本文着重从中药制剂标准的监管角度,对比上述国家和地区对天然药品/植物药质量标准中农药残留、重金属及有害元素、黄曲霉毒素、微生物检验项目的规定,并从原料把关、检验检测方法学建立和制剂质量标准提升等方面提出建议。

中成药投料规范性问题分析及质量风险防控策略

近年来,中成药质量总体向好.但是,由于部分品种的质量标准不够完善,未按标准工艺投料亦可生产出符合规定的产品.中成药质量风险具有客观性,生产环节是全生命周期监管的关键点.为确保中成药质量可控性、使用安全性、治疗有效性,基于投料规范性监测中成药的质量风险迫在眉睫.结合工作实践经验和文献报道,分析了中成药投料规范性问题、探讨了风险管理的挑战与策略,旨在提高中成药生产投料规范性,防控质量风险,促进中成药产业高质量发展.

中药材及其饮片质量标准研究进展

中药材及其饮片是我国传统中医中药发展的基础物质,中药材及其饮片的质量标准是决定中医中药临床应用有效性和安全性的重要保障。中医中药的发展进程中,中药材及其饮片的质量标准是评价和控制中药质量的重要依据,对中药质量的发展具有引领和推动作用。中药材是中药饮片及中成药生产的原始材料,而中药饮片是中成药生产和临床用药的直接材料,两者的质量将直接影响成品药的临床疗效和质量。因此,中药材及其饮片的质量标准制定对中药发展具有十分重要的意义。但中医中药理论较为深邃,且中药作用机制的临床研究尚未透彻,导致中药材及饮片的质量标准科学性证据不足,使其标准的合理性和科学性备受争议。本文基于中药材及其饮片的质量标准的研究现况,分析中药材及其饮片质量标准研究中存在的问题,提出制定合理、有效、实用的质量标准的原则及具体措施,应用科学性、合理性和可行性的质量标准,推动和引领中药产业的高质量发展和中药材资源的可持续性利用。

层级管理模式在中医住院医师规范化培训中的应用效果

目的探讨层级管理模式在中医住院医师规范化培训中的应用效果。方法选取2022年9月威海市中医院的44名中医住院医师规范化培训学员为研究对象,按照随机数字表法分为直管组(22例)与层级管理组(22例),直管组采用常规管理方法,层级管理组采用层级管理方法,两组学员均培训6个月。比较两组的核心胜任力、病历档案库质量评分、考试成绩,核心胜任力涵盖职业素养、知识技能、患者照护、沟通合作。结果培训6个月后,层级管理组的知识技能得分[(18.55±1.10)分]、患者照护得分[(18.73±0.63)分]、病历档案库质量评分[(99.09±0.23)分]均高于直管组[(17.18±1.05)、(17.55±1.41)、(97.35±0.35)分],差异有统计学意义(P<0.01);两组的职业素养、沟通合作、考试成绩比较,差异无统计学意义(P>0.05)。结论在中医住院医师规范化培训中应用层级管理模式,有利于中医住培学员的核心胜任力培养,可有效提高管理效率。

探究中医思想指导下的质量改进团队管理模式在老年科护理管理中的应用成效

目的探讨在中医思想指导下落实质量团队管理在老年科护理管理中的应用成效。方法选取2022年1月—2023年12月麻城市人民医院中医老年科任职的30名护士作为研究对象,根据时间的不同分为两组,2022年1—12月设为对照组(实施常规护理管理),2023年1—12月设为研究组(在护理管理中引入中医思想、质量改进团队管理模式)。对比两组护士的考核成绩、综合能力评分、工作压力评分、职场正念评分、职业满意度评分。结果研究组护士的考核成绩、综合能力评分均高于对照组,差异有统计学意义(P均<0.05)。研究组阶段护士的工作压力评分低于对照组,差异有统计学意义(P<0.05);研究组护士的职场正念评分、职业满意度评分均高于对照组,差异有统计学意义(P均<0.05)。结论在医院老年科护理管理中,在中医思想指导下落实质量团队管理,不仅能够有效提高老年科护士对护理理论知识、操作技能的掌握度,培养其综合护理能力,还能减轻护士在护理工作中的压力,使其职场正念和职业满意度得以提高。

“10S”管理法在中药房工作管理的应用效果评价

目的 本研究旨在验证“10S”管理法在提高中药房工作效率方面的效果。方法 采用对照试验法,以“10S”管理实施前(2022年1至7月)作为对照组,“10S”管理实施后(2023年1至7月)作为试验组,比较中药房日常用品开支、场所环境、药师药学服务胜任力、调剂工作质量与效率、调剂差错率、患者满意度等内容。结果 在实施“10S”管理后,中药房日常开支减少,场所更整洁有序,药师药学服务胜任力明显提高,调剂工作的质量和效率显著改善,调剂差错率降低,患者的满意度进一步提升。数据显示,中药房工作繁忙阶段调剂时间由(7.77±0.21)min缩减至(6.64±0.27)min,工作繁忙阶段平均发药时间由(32.44±1.32)min缩减至(17.05±2.23)min。结论 “10S”管理法建议在中药房推广应用,以提高中药师工作效率和服务质量。

中药饮片调剂在中药合理用药中的价值

目的探究中药饮片调剂在中药合理用药中的价值。方法选择2022年7月—2023年6月平度市白沙河街道办事处麻兰卫生院的10名药师为研究对象,抽取200张中药饮片处方进行研究。2022年7—12月开出的100张中药饮片处方未实施中药饮片调剂,进行常规管理为对照组;2023年1—6月开出的100张中药饮片处方实施中药饮片调剂为观察组。对比两组不规范处方发生率、处方质量评分、管理满意度。结果观察组不规范处方发生率小于对照组,处方质量评分高于对照组,差异有统计学意义(P均<0.05)。两组管理满意度比较,差异无统计学意义(P>0.05)。结论中药饮片调剂可减少不规范处方,提高中药饮片处方质量,让药师对管理满意。

黔产钓杆草质量标准研究

目的:为了建立钓杆草的质量标准。方法:参考2020年版《中国药典》的质量控制方法对钓杆草的质量控制进行探索研究。实验结果:3批钓杆草的水分在4.80%~6.48%,平均值为5.47%;总灰分为4.03%~4.71%,平均值为4.40%,浸出物为30.42%~33.74%,平均值为31.66%,薄层色谱通过方法学验证,且方法简单可行,结果准确。结论:该试验方法可以用于钓杆草的质量控制。

实施中药质量规范化管理的效果及满意度评价

目的评估在中药房中实施中药质量规范化管理的效果以及患者对中药房服务的满意度。方法将2020年1月—2021年12月在本院中药房取药的600例患者分为对照组(300例)和观察组(300例),对比两组各项观察指标水平。结果与对照组相比,观察组对中药房的服务满意度、药材质量评分、药房环境评分、调剂准确率均明显升高,而退药率则明显下降,药材调剂时间和患者等待时间明显缩短(P<0.05)。结论中药房实施中药质量规范化管理能够显著提高药房管理质量和患者的满意度,降低药物管理和调剂错误。