Brief Introduction to Application of Dosage of Chinese Herbs

Accurate application of dosage of Chinese herbs based on differentiation of symptoms and signs is an important link for a better therapeutic result with less adverse effects. Some of the experiences are briefly introduced in the following aspects. ……

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.

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。

基于超高效液相色谱—串联质谱同时测定大鼠血浆中杜仲制剂的药代动力学研究

目的 建立用于血浆中杜仲各成分含量测定的超高效液相色谱—串联质谱的方法,并进行杜仲及其制剂各成分的药代动力学研究。方法 SD大鼠口服不同的杜仲制剂后,于不同的时间点收集血浆样品,以0.1%甲酸水溶液(A)-0.1%甲酸乙腈(B)为流动相,梯度洗脱,采用安捷伦SB C_(18)色谱柱(2.1 mm×50 mm, 1.8μm)进行分离;在多反应监测模式下,负离子模式测定;通过Phoenix Winnonlin 8.1软件计算药代动力学参数。结果 原儿茶酸、京尼平苷酸、松脂醇二葡萄糖苷、无梗五加苷、松脂醇葡萄糖苷、京尼平苷、绿原酸、咖啡酸分别在3.2-2000,3.3-2044,0.6-2028, 0.6-1770,0.3-2036,0.6-2004,0.5-1596,0.7-1090 ng/mL范围内,线性良好;专属性、准确度、精密度、稳定性、回收率和基质效应均符合生物样本检定要求。采用非房室模型分析,8个成分在AUC_(0-∞)、t_(1/2z)、T_(max)、C_(max)、V_(z)/F、Cl_(z)/F、MRT_(0-∞)方面均不相同。结论 该方法灵敏度高、专属性强、准确性好,可用于杜仲成分在大鼠体内的药代动力学研究。不同杜仲制剂在大鼠体内的释药速度、起效快慢及作用强度均不相同,在临床应用上具有指导意义。

三七总皂苷及其制剂治疗糖尿病视网膜病变的研究进展

糖尿病视网膜病变(DR)是糖尿病常见的并发症,也是导致糖尿病患者失明的主要原因,严重影响糖尿病患者的生活质量。目前,临床上治疗DR的主要手段包括手术治疗、激光治疗以及药物治疗。其中,药物治疗能够对病情发展的多个环节进行干预,并减少激光治疗和手术治疗引起的相关并发症。然而,由于眼部结构的特殊性,导致药物的生物利用度较低,迫切需要寻求和开发疗效好、毒副作用低的药物以及合适剂型。中药具有历史悠久、来源广泛、多靶点协同作用等优点,在治疗DR方面具有独特优势。三七总皂苷是从中药三七中提取的主要有效活性成分群,目前已被证实具有治疗DR的作用。文章对三七总皂苷治疗DR的机制及其临床应用于DR的剂型进行分析与归纳,对三七总皂苷的药物剂型开发前景提出展望。

《本草图经》药物剂型分析及对现代制剂的启示

目的:通过分析宋代药物剂型的应用状况,探究我国药物制剂的发展历程。方法:对北宋本草著作《本草图经》中相关中药剂型数据进行统计与分析。结果:《本草图经》中明确记载的药物剂型,主要有散剂、丸剂、膏剂、丹剂这传统的四大剂型,其中散剂最多(总计142种),丸剂其次(总计94种)。剂型的统计还呈现出一些规律:(1)植物药中,草类以丸剂为主,散剂次之;木类以膏剂为主;果部、菜部和米部以散剂为主;本经外草类与本经外木蔓类以散剂为主,其中均出现了贴剂的记载。(2)矿物药中,因其药物特殊性,主要以丹剂为主。(3)动物药中禽兽部和鱼虫部,主要以散剂为主,丸剂次之。(4)部分药物可适用于多种剂型,共有35种药适用于2种以上剂型,3种药适用于3种以上剂型。结论:《本草图经》药物剂型不仅反映了宋代以前中药传统剂型的应用状况,对现代药物制剂的古为今用、临床运用等具有较好的启示。

以中药促进《兽医药理学》课程的改革

《兽医药理学》作为动物医学专业的一门重要专业基础课,因其学时有限,内容多而散,导致学生学习兴趣不大,进而影响教学效果。中药具有辨证施治、多靶点干预的独特优势,目前本科生对其兴趣较大。故可在《兽医药理学》课程中引入中药,使学生产生浓厚的学习兴趣,以期改善教学效果。通过加强兽医中药药理学研究、促进兽医中药剂型的创新、强化实践教学环节、加大兽医中药实验课的比例等方面,引入兽医中药,有助于促进《兽医药理学》课程的改革。

以大学生创新能力培养为导向的中药生理生态学教学改革探索

中药生态农业的快速新发展,对中药学人才的创新能力要求越来越高,然而现有中药学专业课程的设置及教学模式无法兼顾中药生态农业理论与技术传授和创新能力培养。基于加强创新能力培养的目标,对甘肃医学院中药学专业特色课程中药生理生态学进行教学改革探索,分析了中药生理生态学作为创新教学改革的课程优势,提出了教学改革思路,阐述了教学改革实践,并对教学改革成效进行评价,探讨了提升大学生创新能力的思路,以期强化大学生创新能力培养。

变容与平衡:西药东渐背景下近代中国汤剂改良之争

近代大量西药入华,对中国传统医药市场产生持续冲击,中药的不足之处日显。部分中医药界人士顺应时代潮流,向西方学习,力图革新中药。汤剂与中医诊疗观念联系紧密,其革新过程不仅受到医界关注,还多次成为中西医论争的焦点。由于近代中国现实政治与客观研究能力的不足,汤剂改良未能实现科学化发展,但关于其改良过程的争论,亦展现了近代中西医在制药方面的平衡与近代中医药界对于西医学知识的收受与变容。

中药口服液体制剂中甜味剂的应用及发展难题探讨

中药口服液体制剂分散度高、吸收快、刺激性低、生物利用度高、药效迅速、易分剂量服用,适合各类人群特别是儿童和老年人等吞咽固体制剂有困难的特殊群体。但其口感不良成为亟待解决的问题。本文结合甜味剂的特性,对中药口服液体制剂常用的甜味剂、特别是具有开发潜力的天然甜味剂在应用和发展中面临的难题进行探析,以期为甜味剂合理应用提供参考。

2022年邵阳市中心医院门诊不同剂型中药饮片处方应用情况分析

目的:分析2022年邵阳市中心医院门诊不同剂型中药饮片处方应用情况。方法:选取2022年1—12月邵阳市中心医院门诊开具的1800张中药饮片处方作为研究对象,其中中药传统饮片、中药配方颗粒、中药破壁饮片处方各600张。分析三种剂型中药饮片处方平均药味数、平均剂数、平均单剂价格、不合理类型分布、有毒中药超剂量使用情况。结果:中药传统饮片平均药味数最多,中药破壁饮片平均剂数最多,中药配方颗粒平均单剂价格最高。1800张处方中,不合理处方149张(8.28%),其中中药破壁饮片最多。不合理类型包括临床诊断缺项或不全、超剂量使用、无特殊情况门诊处方>7 d用量或急诊处方>3 d用量、用药与辨证不符、配伍禁忌、用法用量不适宜。超剂量使用的有毒中药饮片处方31张,其中以中药传统饮片处方最多,有毒中药超剂量使用以附片、法半夏较多见。结论:2022年邵阳市中心医院门诊三种剂型中药饮片处方存在临床诊断缺项或不全、超剂量使用等问题,仍需加强临床管理,制定规范、科学合理的中药处方点评制度。

2023年烟台市蓬莱中医医院有毒中药饮片的使用情况分析

探究2023年烟台市蓬莱中医医院有毒中药饮片的使用情况,以期进一步规范有毒中药饮片的使用,促进合理用药。查询烟台市蓬莱中医医院2023年1月—2023年12月的门诊处方89920张,对处方中出现的“毒、小毒”中药饮片的毒性大小、使用频率以及超量使用频率等进行分析。结果显示,有毒和有小毒中药饮片处方57236张,超剂量处方13321张,占有毒处方总数的23.27%,占处方总数的14.81%。研究发现,2023年使用有毒中药饮片的处方量较大,需规范用法用量,使用时应平衡临床疗效和用药安全的关系,确保患者安全用药。

大思政背景下《中草药栽培技术》课程教学探索

中草药栽培技术是一门多学科融合并且实践性很强的专业核心课程,传统教学模式忽略了思政教育元素的融入。梳理本门课程的知识点不难发现课程中蕴含丰富的思政元素,包括弘扬中医药传统文化,树立道路自信和文化自信;坚持“绿水青山就是金山银山”的生态理念,促进中草药资源的可持续发展;加强素质教育,培养严谨细致、吃苦耐劳的职业精神,培养学生的社会责任感等等。文章针对“中草药栽培技术”教学目标及大学生实际学情,从知识、能力和思政三个维度细化教学目标,探索大思政背景下“中草药栽培技术”课程思政的实现路径。

Randomized Clinical Trials of Traditional Chinese Medicines for Treating Ulcerative Colitis:A Scoping Review

Objective:Traditional Chinese medicines(TCMs)are efficacious against ulcerative colitis(UC).In recent years,the number of randomized clinical trials(RCTs)of TCM has increased.Thus,it is very important to summarize the basic characteristics,quality,and types of TCM interventions in published RCTs.This scoping review was performed to systematically identify and describe the current situations about RCTs of TCMs for treating UC.Hope to express the focus and specifics of nowadays research in TCM interventions in RCTs and evaluate their common disadvantages exposed to help advance in TCM researching.Materials and Methods:A scoping review was conducted according to the PRISMA extension for scoping reviews.We searched two English databases and four Chinese databases from the date of establishment of each database to January 2020.Data from RCTs focusing on any TCM treatment for patients with UC were extracted and evaluated.Selection and characterization were performed by two independent reviewers using predefined forms.All discrepancies were resolved by consensus discussion with a third reviewer.Microsoft Excel 2010 was used to extract the following data from the included studies:(1)basic information of the included studies including research ID,article title,publication language,journal,year of publication,and funding information;(2)patient information including gender,age,disease course,disease stage,severity,sample size;and(3)information on intervention measures,types of intervention measures,drug dosage forms,and treatment courses.Results:The search identified 2225 RCTs published between1987 and 2020.These studies covered 36 provinces in China.The time frame of the RCTs was<28 days in approximately one-third of the RCTs(647,29.08%).Only one RCT was published in English.Nearly three-quarters of RCTs(1665,74.83%)did not report the severity of the disease.Three types of interventions were included in the RCTs:pharmacotherapy(2028,91.15%),nonpharmacotherapy(57,2.56%),and a combination of the two(140,6.29%).The administration modes of the intervention groups were evaluated.Drug therapy involved 12types of TCM dosage forms,which were decoctions,troches,powders,capsules,granules,pills,suppositories,ointments,injections,gels,oral liquids,and substitute tea according to the frequency of use.Nondrug intervention measures involved 10 treatment options,namely,acupuncture,moxibustion,hemospasia,auricular point,acupoint catgut embedding,acupoint injection,scrapping,tuina,acupoint application,and five-tone therapy according to the frequency of use.Most studies included in this review were low in quality.This underscores the need for improvement in the quality of trial methodology in TCM RCTs.

Effects of Agkistrodon in Different Dosage Forms on Collagen-Induced Arthritis in Rats

Objectives： To determine the effective dosage and formulation of agkistrodon in collagen-induced arthritis（CIA） rats. Methods： CIA was induced by injection of collagen in complete/incomplete Freund＇s adjuvant. Agkistrodon decoction, agkistrodon powder, and agkistrodon wine were administered daily starting from the onset of arthritis. Paw swelling degree was measured by using a volume-measuring instrument every 7 days after primary immunization. Arthritis index was measured and calculated using the ＂five scoring method＂ every 7 days. The levels of serum interleukin-1β（IL-1β） and type Ⅱ collagen Ig G antibodies were detected by enzyme-linked immunosorbent assay. Finally, all ankles were removed, and X-ray radiography was performed with In-vivo Imaging System FX. Samples were counterstained with hematoxylin and eosin for analysis. Results： Among the various dosage formulations of agkistrodon, high-dose powder, which was equivalent to an amount of 6 g/day in adults, showed better effects on the inhibition of joint swelling and reduction of arthritis index score. The relatively low levels of serum IL-1 and anti-type Ⅱ collagen Ig G antibodies, as well as the X-ray radiography and pathology results, further proved the superiority of the high-dose powder over the other formulations. The effect of decoction on inhibiting joint swelling was inversely proportional to the dosage. Other effects, such as reduction of arthritis index score and the levels of serum IL-1 and anti-type Ⅱ collagen Ig G antibodies, were directly proportional to the dosage. While the use of large dose agkistrodon wine led to negative effects. Conclusions： These data highlight the potential function of high-dose agkistrodon powder, which was equivalent to an amount of 6 g/day in adults. The powder can quickly relieve the symptoms of rheumatoid arthritis and prevent aggravation of disease, especially during the early period.

Are the release characteristics of Erzhi pills in line with traditional Chinese medicine theory?A quantitative study

Objective:Traditional Chinese medicine(TCM)has been widely used throughout China to prevent and cure diseases for thousands of years,and now it is a part of the integrative medicine field that is available in Western societies.To ensure the safety and quality of the herbal medicines that are a major part of the TCM tradition,they must be held to modern pharmaceutical standards.Erzhi pill(EZP)is a Chinese Pharmacopeia-listed herbal preparation that is used in the long-term clinical management of postmenopausal symptoms,osteoporosis and menstrual disorders.Until now,whether the drug release mechanism of EZP is in line with its intended TCM usage has not been studied.Methods:The release of specnuezhenide from three EZPs(self-made,Leiyunshang and Renhe)in simulated gastric fluid(SGF),acetate buffer(p H 4.5 buffer)and simulated intestinal fluid(SIF)was investigated in a dissolution test.The water uptake capacity and erosion extent of the three EZPs were investigated using swelling and erosion studies.The drug release mechanism was further assessed through statistical model fitting,using DDSolver software.Results:The release of specnuezhenide from all three EZPs in SGF was less than 50%within a 4 h period.However,over 70%of the specnuezhenide was released from each EZP in both p H 4.5 buffer and SIF in the same time.Analysis of the swelling and erosion behaviors and the drug release mechanism of the three EZPs confirmed that the release rate from EZP followed a sustained release profile,which was an interactive combination of swelling and erosion.Conclusion:This study showed that the release pattern from the pills was in line with the intended TCM use of EZP.TCM had not only theoretically considered sustained release from the pills,but also formulated them to achieve this release pattern.When establishing quality control standards for pills,the theoretical TCM usage and the actual release patterns need to be considered.

新型冠状病毒感染疫情中医药分级管理防控方案构建的科学思路

新型冠状病毒感染(简称新冠感染)疫情中医药分级管理防控方案以中医“五运六气”“体质学说”“三因制宜”“辨证论治”等理论为支撑,以定点(方舱)医院新冠患者、隔离点人群、社会面人群三类人群划分为分类标准,定点(方舱)医院新冠患者一人一策一方、一人一时一方进行特色用药、既病防变,遵循应服尽服原则;隔离点人群采用预防控治普适方、社会面人群采用代茶饮进行未病先防,遵循愿服尽服原则。阻断疫情传播、加快转阴时间,有效减少新冠感染患者的总体基数,形成多维度全方位的新冠感染疫情中医药防控分类管理方案及防控模式,有效应对不断出现的不同病毒株区域性的疫情,充分发挥中医药全程深度介入新冠疫情防控的重大作用。

形成性评价体系在中医护理PBL临床教学的应用

目的探讨形成性评价体系在中医护理PBL临床教学中的作用。方法选择在中国医科大学附属第一医院中医科临床护理实习的2018级和2019级中医护理大专学生为研究对象,2018级为对照组,采用传统终结性评价,2019级为观察组,采用形成性评价,并以实习结束后成绩和问卷调查进行效果评价。结果实习结束后观察组学生理论知识成绩和中医技能成绩明显高于对照组学生,观察组学生对教学效果的认同程度也明显优于对照组学生(P<0.05)。结论形成性评价体系应用于中医护理PBL临床教学中,对教师教学、学生学习均有促进作用。

福建省顺昌县药用植物资源多样性分析

目的:全面了解顺昌县药用植物资源现状,为后续制定有效保护和合理开发药用植物资源的策略提供科学依据。方法:根据第四次全国中药资源普查规范要求,采用样地和样线相结合的方式,收集药用植物的分布信息,通过查阅文献和咨询专家进行物种鉴定,统计分析药用植物资源的分布特征。结果:顺昌县药用植物共计1065种,隶属于176科618属;物种构成以小型科(2~5种)和单种科(1种)为主;生活型以多年生草本和灌木居多;蕨类植物和种子植物的热带地理成分明显。重点调查的药材中,106种为2020年版中国药典收载品种,42种为福建省特色中药品种。结论:顺昌县药用植物资源类型多样性特征明显,重点和特色药用植物资源丰富,但储量差异较大,建议加大特色野生药用植物资源的保护力度,重点开展仿野生抚育和栽培技术的相关研究。

基于“心与小肠相表里”理论探讨肠道菌群与高血压的关系

肠道菌群是影响高血压发生发展的重要因素,中医学认为心与小肠在经络上相互联系,生理上相互配合,病理上相互影响,即“心与小肠相表里”。基于“心与小肠相表里”理论,结合相关文献,探讨肠道菌群与高血压的相关性,以及中药通过调节肠道菌群对高血压的防治作用,以期为高血压的临床诊疗提供思路。