Integrating traditional Chinese (herbal) medicines into risk based regulation-With focus on non-clinical requirements to demonstrate safety

Within the public health sector of Hong Kong(China),there is a consensus around the important role of traditional Chinese medicines.For Hong Kong(China)to play a bridging role to bring Chinese medicines to the global market requires a concerted effort from the government,academic institutes and industries.The release of the final version of the European Medicines Agencies guidance document,which details the acceptance of minimum requirements to nonclinical package in bibliographical applications,grants the opportunity for well-established and traditional herbal medicines to demonstrate an‘acceptable safe’status for registration in the European Union.It is anticipated that this minimum nonclinical package can be applied to demonstrate the safe use of many traditional Chinese medicines regardless of their eligibility to be registered under the simplified procedure within the European Union.This paper conceptualizes an integration of a simplified evaluation route for eligible proprietary Chinese medicines(pCm)with long history of use into the existing drug regulatory framework in Hong Kong(China).Such integration utilizing the minimum nonclinical package,based on bibliographical data or expert report,as proof of evidence to demonstrate safety for pCm with long history of use requires less demand in scientific resources.With Hong Kong(China)conducting‘first hand’review for eligible pCm,it provides an option for overseas and local pharmaceutical companies to register their products in Hong Kong(China)without the need to rely on issuance of Certificate of Pharmaceutical Product from other countries.This could bring eligible pCm with long history of use to reach international risk-based standard and to be marketed globally as‘medicines’to reach their full therapeutic potential.An important process to positioning Hong Kong(China)to compete with other countries in promoting importation and exportation of pCm to better serve the global health.

A review on cocrystal of active ingredients in traditional Chinese medicine

In the development of new drugs products,especially the development of traditional Chinese medicine active ingredients,solubility and oral bioavailability are the main factors which are restricting the development of new drugs,whereas the physicochemical properties of active ingredients are the key element to affecting these factors.Pharmaceutical cocrystal provides an excellent opportunity to develop new drugs with excellent physical and chemical properties such as melting point,solubility,stability and bioavailability while retaining the pharmacological properties of individuals active pharmaceutical ingredients among pharmaceutical cocrystal compounds.Traditional Chinese herbal medicine has the characteristics of multiple pathways and multiple targets,mainly because it contains many active ingredients,like cocrystals thereof with many components.The active ingredients extracted from traditional Chinese herbal medicine have a wide range of pharmacological activities,but most of the active ingredients affect the development of traditional Chinese medicine active ingredients due to their physical and chemical properties such as solubility.Traditional Chinese medicine pharmaceutical cocrystals can not only improve the physical and chemical properties of drugs without changing the internal structure of drugs,so as to provide a new scheme for the development of traditional Chinese medicine active ingredients.This paper reviews the research progress of active ingredients of traditional Chinese medicine pharmaceutical cocrystal.The preparation methods of cocrystals are summarized and the advantages of cocrystals are illustrated with examples.

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.

A Review of Study of Yellow Water Disease in Tibetan Medicine Theory

Based on the Tibetan medical theory,the relevant information and diagnosis and treatment ideas of yellow water disease are discussed,and Mongolian medicine also takes its own basic medical theory as the starting point to discuss and explain,while traditional Chinese medicine has made less theoretical description of this disease,but there are also some understandings and treatment guidelines.This paper mainly discusses the cognitive aspects of this disease,starting from the essence,analyzes the relationship between this disease and traditional Chinese medicine diseases as well as modern medicine,and makes a theoretical description for a better understanding of the yellow water disease.

Medicinal Mushroom Products:Nutriceuticals and/or Pharmaceuticals?

Although the effectiveness of mushroom products(mushroom derivatives) has been confirmed repeatedly by numerous laboratory experiments and,in some cases,human trials,precisely how these products work is still a matter of conjecture.Studies on the effectiveness of mushroom products fall into two general categories.One approach has been to isolate and determine the bioactivity of individual mushroom components within a particular class of compounds(e.g.polysaccharides,lectins,triterpenoids,fungal immunomodulatory proteins).The active principal component is then sold in refined or purified form,e.g.the polysaccharide lentinan from the edible/medicinal mushroom Lentinula edodes.Such an approach is certainly valid if the objective is to focus on a single mushroom-derived substance for the treatment of specific disease conditions,e.g.cancers or strokes.In such cases,the products might be(and have been) developed and marketed as prescription drugs.However,an alternative approach is not to focus on a single component within a class of compounds but on groups of compounds that improve overall health and the general quality of life.These composite formulae,in which several different compounds together contribute to the beneficial effect of the mushroom,could then be used collectively as a dietary supplement(nutriceutical).Thus,the medicinal effects afforded by medicinal mushroom products may be attributable to several quite different types of compounds present in the mushrooms,e.g.polysaccharides,lectins,triterpenoids and fungal immunomodulatory proteins.These compounds,and possibly others yet to be identified,appear to act in concert in contributing to the documented anticancer,antitumour,antiviral,antibacterial and immunomodulating properties of the mushroom.Therefore,mushroom nutriceuticals may be deemed to have multifunctional values,the essence of which depends on the integrated effects of the various compounds.Certainly,the overwhelming majority of mushroom-based products currently available are not single components but combinations of several groups of compounds("crude extracts") that together contribute to the overall medicinal effect of the product.Therefore,it is important that future development of mushroom nutriceuticals places emphasis on investigating the functionality and interaction of the groups of compounds found in mushrooms.In some cases,it may be more desirable to consider the total medicinal effect(s) of mushroom "crude extracts"(comprising groups of compounds) and then to ascertain the contributions made to the overall activity by individual components.The consistency of the "crude extracts",both in terms of the overall chemical composition and in the actual levels of active components,between different batches could be standardized on the basis of one or two of the main components.This is essential for ensuring some degree of uniformity in prescribed dosages.Thus,while the minimum dosage of an active component required to bring about the desired therapeutic effect is often known for similar products,e.g.hypericin in extracts of St.John's Wort,this is generally not the case where mushroom "crude extracts" are concerned.This is an area where scientific validation can increase knowledge of the products themselves as well as contributing to product quality control.

中药智慧药学服务的实践与技术分析

目的 分析中药智慧药房的发展现状,总结中药智慧药学服务实践经验,概述其技术要求和发展方向。方法 成都中医药大学附属医院自2018年1月启动智慧中药房项目,建立中药智慧药房,承担门诊中药饮片调剂、煎药、配送等药学服务业务。结果 截至2023年5月已完成中药饮片代煎配送557.2万副,2022年度共服务患者23.14万人次。服务环节更简单,无需等候取药,无需二次到院取药,服务效率高,改善了患者就医体验。结论 中药智慧药学服务发展迅速,未来将依托技术进步建立全程化智慧服务体系。

正交偏最小二乘法探析大承气汤治疗急性胰腺炎多成分多药效关系

目的/意义分析大承气汤治疗急性胰腺炎实验数据,证实多成分多药效关系。方法/过程运用正交偏最小二乘法,分别探析配伍药味、煎煮液的药物成分、血液的药物成分与药效指标的关系。结果/结论配伍药味与药效指标之间、煎煮液的药物成分与药效指标之间、血液的药物成分与药效指标之间均存在一对多、多对一、多对多的作用关系。实验分析结果表明大承气汤治疗急性胰腺炎呈现多成分多药效的特点。

中药炮制学课程思政元素挖掘及教学设计案例分析

思政教学与专业教育的有机融合,不仅可以强化教师“立德树人”的教育理念,更能实现全程育人、全方位育人的教育目标。这就需要在实践过程中,根据中药学专业人才培养目标,深入挖掘课程思政元素,优化教学设计,创新教育教学方法,实现课程思政在中药学专业教育的全过程融入。本教学改革以水飞法为例,从思政元素的挖掘、思政元素映射与融入点的切入、教学方法的创新、思政教育的拓展与评价等方面进行了优化设计,深入挖掘课程思政教学内容和实现方式,并有效应用于教学实践过程,以期构建价值引领、知识传授、能力培养有机统一的中药炮制学教学模式,为中药学类专业课程思政建设及人才培养模式的改革提供借鉴参考。

一流课程建设背景下中药制药工艺学课程的建设与探讨

中药制药工艺学作为中药制药专业的专业核心课程,在中药制剂开发和生产中极为重要。在一流本科课程建设背景下,本文结合当前中药制药工艺学课程建设中存在的问题,从突出中医药思维培养、优化教学内容、加大综合性实验课程开设、强化讨论式教学、思政引领—制药工程与设备相结合的教学模式等方面进行中药制药工艺学课程建设探讨,有望为中药制药工艺学课程建设提供参考。

浅议仲景方之煎服法

东汉张仲景作《伤寒杂病论》,其条文论述精当,理、法、方、药具备,开后世中医辨证论治之先河。针对疾病和患病个体,辨证施治,立法选方而作仲景方,精简不杂、立意明确、疗效突出。并详细叙述了相应方剂的剂型、煎药溶媒、煎煮方法、给药方式、服药频次、服药时间、药后调理方法等,对疾病的治疗效果及预后调护亦发挥了重要作用。文章对仲景方的煎服法进行归纳及总结。

北京中医医院用药咨询服务五年回顾性分析与展望

目的回顾性分析首都医科大学附属北京中医医院五年用药咨询服务情况,发现用药问题规律,分享服务经验,提高服务质量。方法回顾北京中医医院用药咨询中心2015年—2019年的所有用药咨询记录,对咨询问题分类并采用帕累托图法进行统计和分析。结果北京中医医院五年用药咨询服务人数呈上升趋势,共计解答咨询问题61759例次,日均服务50例次。将咨询问题类型分为5类,分别为复杂用药问题(4283例,占6.93%)、简单用药指导(4892例,占7.92%)、非用药问题(6422例,占10.40%)、药品库存咨询(16291例,占26.38%)、中药煎服指导(29871例,占48.37%)。结论通过对门诊用药咨询记录的分类统计,可以看出咨询问题类型及比例相对稳定,帕累托分析有助于发现患者的主要需求,并促进药学部门不断进行改进,保障患者合理用药。

6种中药水提物对金黄色葡萄球菌体外生物被膜形成的影响

试验旨在探究苦参、连翘、白头翁、蒲公英、黄柏和五倍子等6种中药水提物对金黄色葡萄球菌生物被膜形成的影响。通过银染法和结晶紫染色法检测6种中药水提物对金黄色葡萄球菌生物被膜的黏附和抑制作用。结果显示,中药水提物减少了金黄色葡萄球菌生物被膜的黏附;与对照组相比,在6种中药水提物作用下,金黄色葡萄球菌生物被膜洗脱液的OD_(590nm)值均极显著降低(P<0.01),其中五倍子水提物的抑制效果最优,抑制率为74.9%。研究表明,6种中药水提物均能够抑制金黄色葡萄球菌生物被膜的形成,其中五倍子水提物效果最好。

消水圣愈汤治疗老年肺源性心脏病临床观察

目的探讨消水圣愈汤对老年慢性肺源性心脏病(CPHD)患者血栓前状态指标及血清白细胞介素-8(IL-8)和肽素(Copeptin)水平的影响。方法将117例老年CPHD患者随机分为对照组(58例)和试验组(59例)。对照组予常规对症治疗,试验组在对照组的基础上予消水圣愈汤治疗,两组均治疗4周。比较两组临床疗效、血栓前状态指标及血清IL-8、Copeptin水平。结果治疗后,试验组总有效率为94.92%(56/59),高于对照组的79.31%(46/58)(P<0.05)。与对照组比较,试验组治疗后血浆黏度、血浆纤维蛋白原(FIB)水平、血清D-二聚体(D-D)、血管性假血友病因子(vWF)、内皮素(ET-1)水平较低,血清IL-8、Copeptin水平较低(P<0.05)。结论消水圣愈汤能明显改善老年CPHD患者血栓前状态,减轻炎症反应,促进心功能恢复,临床疗效显著。

《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。

智能化中药栓剂灌装设备研制与试验

针对中药制药装备普遍存在的高耗能、低效率、非标准化等问题,研制基于柱塞泵工作原理的中药栓剂自动化灌装设备,以提高栓剂产品质量与生产效率,实现高效灌装。以灌装效率、药膏温度控制、定量精度为指标开展试验。结果表明:研制的智能化中药栓剂灌装设备能够保证产品质量,实现高效灌装,减少人工,灌注速率可达360支/min,定量误差约为±0.8%。

清热润湿方联合医用射线防护喷剂对放射性皮损防治的药学评价与药学监护

目的评价清热润湿方联合医用射线防护喷剂对放射性皮损的疗效及药学监护的实施与评价。方法选取本院放射性皮损患者57例,随机分为对照组与中药治疗组,对患者的创面修复疗效、疼痛缓解、舒适度进行评价,并进行药学监护与评价。结果清热润湿方联合医用射线防护喷剂对放射性皮损的疗效显著,可以改善创面(P<0.05)、缓解疼痛(P<0.01),提高患者舒适度(P<0.01),且药学监护可以提高患者湿敷的疗效。结论清热润湿方联合医用射线防护喷剂可以有效治疗放射性皮损,药学监护起重要作用。

运用《辅行诀》所载“汤液经法图”理论开展中药治疗痹证的药学监护及干预1例

《辅行诀》所载“汤液经法图”展示了一套以五脏虚实辨证结合五味补泻治疗为基础的辨证论治体系,体现了中医组方配伍的根本原理,可用于中药饮片处方审核和临床药师药学会诊。本文记载1例中药临床药师运用“汤液经法图”开展药学监护并进行药学干预的案例。患者老年女性,主因反复腰痛5余年,加重伴右下肢麻木2个月入住院。医师请药师采用“汤液经法图”进行联合会诊分析。药师运用“汤液经法图”理论体系,判定该患者为肝虚合并肾虚,虚实夹杂,处方应以补肝补肾为主,补泻兼施,药味以辛、苦为主,酸、甘为辅,并与医师联合拟定中药饮片处方一首,患者用药后治疗效果满意,出院后药学随访效果满意。此案例提示,临床药师运用“汤液经法图”开展中药饮片处方的药学评价和药学监护是可行的和有效的。

中药挥发油透皮促渗苷类成分效果与经皮水分散失量的相关性研究

目的研究中药挥发油透皮促渗苷类成分效果与对经皮水分散失量(Transepidermal water loss,TEWL)的相关性。方法采用HPLC法测定3种苷类成分(栀子苷、龙胆苦苷、芍药苷)的含量及油水分配系数,采用改良Franz扩散池法以离体SD大鼠腹部皮肤为透皮吸收屏障进行体外透皮实验,考察高良姜、干姜、薄荷、胡椒和吴茱萸5种中药挥发油对3种苷类成分的体外透皮促渗效果,采用经皮水分散失量评价5种中药挥发油对大鼠皮肤屏障功能的影响,通过相关性分析考察中药挥发油透皮促渗苷类成分效果与其对皮肤屏障功能影响之间的相关性。结果高良姜油、干姜油、薄荷油、胡椒油能促进3种苷类成分的透皮吸收,也能显著降低大鼠的皮肤屏障功能,相关性分析结果表明中药挥发油对苷类成分的透皮促渗效果与其对皮肤经皮水分散失量的影响显著相关。结论TEWL为中药挥发油透皮促渗剂的快速筛选提供了一种简便快捷的在体评价方法。

中药长效制剂的制备技术研究进展及其在驱杀外寄生虫方面的应用

长效制剂是一种疗效持久的药物制剂,具有给药次数少、用药剂量小、毒副作用低等优点。中药长效制剂是在传统中药制药技术的基础上,通过特殊的制剂工艺,将中药有效成分与载体材料相结合,形成一种能够持续释放药物的制剂。对中药长效制剂的研究进展及其在驱杀外寄生虫方面的应用进行综述,以期为抗虫中药长效制剂的进一步研究和临床应用提供参考。

从“水火失济”论治房颤

本文从君火、相火、肾水的关系探讨水火既济的过程,认为水火既济,体内如环运动,而水亏火旺、水盛火衰、君火不明相火失位皆可使水火失济,影响心神而发为心房颤动(房颤)。西医学认为自主神经功能紊乱是房颤的重要原因,交感神经绝对或相对兴奋,心房肌细胞自律性增强,房室传导加快,表现为快速性房颤;迷走神经兴奋亦会导致心房电重构,延缓房室传导,表现为慢心室率房颤。自主神经系统受中枢神经系统支配,二者之间相互作用亦可诱发房颤。针对水火阴阳的失衡结合西医学对房颤机制的研究,本文提出“滋阴潜阳以治火”“益火之源以培元”“益气镇惊以调神”,旨在促进心肾相交、水火相济、阴阳交感和合,恢复自主神经张力平衡,减少房颤发生的频次和持续时间,终止房颤的发作,拓宽临床治疗房颤的思路。