Application and Practice of Traditional Chinese Medicine Characteristic Technology Inheritance in Research and Development of Traditional Chinese Medicine Preparations in Medical Institutions

Medical institution preparations play an important role in the development of hospitals,being one of the main forms of traditional Chinese medicine clinical characteristic medication,as well as an important carrier for the inheritance and innovation of traditional Chinese medicine.In recent years,the research and development of traditional Chinese medicine preparations has become a hot spot in the research and development of preparations by medical institutions.Traditional Chinese medicine preparations prepared by traditional processes and their entrusted preparation matters have changed from the current licensing management to filing management.The registration model of traditional Chinese medicine preparations has undergone significant changes,emphasizing more on real data and evaluation results from the objective world,respecting traditional medication experience,and emphasizing the inheritance and innovative development of traditional technological experience.In the process of following teachers in the inheritance project of traditional Chinese medicine,we combined the inheritance of traditional Chinese medicine characteristic technology with the research and development practice of traditional Chinese medicine preparations in medical institutions,and focused on the analysis and discussion of technical problems such as prescription screening,dosage form selection,process route design and clinical observation of traditional Chinese medicine preparations,hoping to provide reference for scholars in the same field of traditional Chinese medicine.

Discussion on the Quality Evaluation Method of Traditional Chinese Medicine Compound Preparations

As an important representative of the modernization of the Chinese medicine industry,traditional Chinese medicine(TCM)compound preparations are an indispensable part of the development of TCM.The complex ingredients and unclear action mechanism of TCM compound preparations restrict the development of TCM.In line with this problem,the modern TCM research has made extensive remarkable achievements.From the single indicator in the past to multiple indicator,the research on the combination of TCM fingerprints and pharmacodynamics also has made great progress.The introduction of quality evaluation methods such as the"quantitative analysis of multi-components by a single marker","dose-effect"indicator,"Bioactive Equivalent Combinatorial Components"(BECCs)and TCM quality markers have brought new ideas for quality control of TCM compound preparations.

Prescription and treatment rules for the prescriptions containing Poria cocos and Atractylodes macrocephala couplet medicine based on traditional Chinese Medicine inheritance support platform

Objectives:To provide a theoretical basis for the development of the new products of Poria cocos-Atractylodes macrocephala couplet medicine.Methods:All prescription preparations containing Poria cocos and Atractylodes macrocephala were collected from the Drug Standards of the Ministry of Public Health Drug Standard·Traditional Chinese Medicine Set Prescription Preparation(called Traditional Chinese Medicine Set Prescription Preparation for short).After standardization,the information of each prescription preparation was input into the Chinese Traditional Medicine Inheritance Support Platform(V2.5),and the relevant rules of the software were adopted.Data mining methods were used to analyze the frequency of drugs,main symptoms and diseases in prescriptions,and to analyze the regularity of prescriptions.The prescription rules of top 2 high frequency attending syndromes and diseases were analyzed.Results:There were total of 337 prescription preparations containing couplet medicine of Poria cocos and Atractylodes macrocephala,107 kinds of main symptoms and 66 kinds of diseases.The high frequency syndromes were deficiency of Qi and blood and weakness of spleen and stomach,and the high frequency syndromes were anorexia and irregular menstruation.Conclusion:The couplet medicine of Poria cocos-atractylodes macrocephala prescription is mainly used to treat digestive tract diseases and gynecological diseases;it mostly takes tonifying deficiency efficat.It can treat different diseases being compatible with different medicinal materials.The study can provide theoretical basis for clinical application and new drug development of the couplet medicine of Poria cocos-atractylodes macrocephala.

Determination of strychnine and brucine in traditional Chinese medicine preparations by capillary zone electrophoresis with micelle to solvent stacking

A novel micelle to solvent stacking on-line sample preconcentration technique in capillary zone electrophoresis（MSS-CZE） has been developed to determine the strychnine and brucine in traditional Chinese medicine preparations.The optimal running buffer was 30 mmol/L H_3PO_4 containing 20%acetonitrile at pH 4.0.The sample matrix was 8 mmol/L H_3PO_4 containing 5 mmol/L sodium dodecyl sulfate（SDS） at pH 3.0.The established MSS-CZE method afforded more than 50-fold improvements in concentration sensitivity compared with typical CZE-UV analysis.The calibration curve was linear in the range from 0.2 to 15.0μg/ mL for both strychnine and brucine,with correlation coefficients of 0.9984 and 0.9976,respectively.The limits of detection（5/ N = 3：1） for strychnine and brucine were 0.02 and 0.05μg/mL,respectively.The MSS-CZE method has been successfully applied to the analysis of strychnine and brucine in Chinese medicinal preparations.

Evaluation of Antitumor,Immunomodulatory and Free Radical Scavenging Effects of A New Herbal Prescription Seaweed Complex Preparation

Seaweed Complex Preparation(SCP) is a clinical traditional Chinese medicine preparation which is composed of seven traditional Chinese herbs,and it has been used for treatment of lung cancer,liver cancer and digestive cancer.However,little information is available about the pharmacodynamic basis.The antitumor,immunomodulatory and free radical scavenging effects of SCP were evaluated in this study.Transplanted tumor in vivo method was used to determine the antitumor effect.The effects on splenocyte proliferation and phagocytosis of macrophages in tumor-bearing mice were measured by the MTT method and the phagocytizing cock red blood cell(CRBC) method respectively.The scavenging activities of SCP on DPPH and hydroxyl radicals in vitro were investigated.It was found that the medium-dose and high-dose of SCP could significantly inhibit the growth of transplanted hepatic tumor of murine hepatocarcinoma cell line H22,and promote proliferation of splenocytes and phagocytosis of macrophages.SCP possessed noticeable scavenging activities on DPPH and hydroxyl radicals.The antitumor effects of SCP might be achieved by improving immune system and scavenging free radicals,which is in accordance with the viewpoint of traditional Chinese medicine in promoting the body resistance and eliminating pathogenic factors for cancer treatment.

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.

鼠李糖乳杆菌发酵中药制剂条件优化及对鸡球虫感染的疗效试验

为探究鼠李糖乳杆菌发酵中药组方(青蒿、常山、仙鹤草、何首乌、白头翁及白茅根)制剂的最佳条件及其对感染球虫鸡存活率、血便计分、每克粪便卵囊数(OPG)及免疫细胞等的影响,试验筛选了鼠李糖乳杆菌发酵中药组方制剂的最佳中药浓度、接菌量、培养时间和pH值。用在该条件下发酵的中药制剂对正阳三黄鸡进行抗球虫感染试验,试验鸡分为空白对照组、球虫攻毒组、地克珠利组、纯中药组、鼠李糖乳杆菌发酵中药组及鼠李糖乳杆菌组;21日龄时分别称量各试验组鸡的体重,计算存活率、OPG值及检测血便记分与血液中的CD4^(+)、CD8^(+)T淋巴细胞含量。结果显示:中药浓度为1.5 g/mL、接菌剂量为2%、培养时间为18 h、pH为6.5时,鼠李糖乳杆菌活性最高;鼠李糖乳杆菌发酵中药组试验鸡21日龄体重和14~21日龄平均日增重显著高于球虫攻毒组、纯中药组和鼠李糖乳杆菌组(P<0.05);鼠李糖乳杆菌发酵中药组血便记分和OPG值显著低于球虫攻毒组、纯中药组和鼠李糖乳杆菌组(P<0.05);鼠李糖乳杆菌发酵中药组CD4^(+)、CD8^(+)T淋巴细胞含量显著高于球虫攻毒组、纯中药组和鼠李糖乳杆菌组(P<0.05)。研究表明,鼠李糖乳杆菌有最佳的发酵中药条件,该条件下发酵的中药制剂能够在防治球虫感染鸡方面能够提高鸡的存活率、减少血便及卵囊排出,提高鸡CD4^(+)、CD8^(+)T淋巴细胞含量,并且比单独的中药组方及单独的鼠李糖杆菌具有明显优势。

高职院校“教学考评”一体化教学改革实践思考——以“中药制剂技术”为例

在数字中国背景下,教育数字化是数字经济的重要组成部分之一。同时,随着数字技术的发展,职业教育也将逐步升级和转型。各高校都积极打造教学一体化平台,以迎接信息时代数字化教学变革。文章以教育教学一体化平台为依托,以开展“中药制剂技术”课程数字化教学改革为例,探索了“教学考评”一体化数字化教育教学改革实践,并对实施情况进行分析:数字化教学改变了传统教育教学环节,对教师的数字素养提出了更高要求,方便学生时时处处皆可学习,提倡师生在交流中共同进步;注重过程性考核评价,为学生个性化的学习改进和教师教学改进提供方案。同时,数字化技术时代,职业院校希望更多企业参与办学,通过校企合作开发更优质的教学及实训资源。希望本研究能为当前高职院校数字化教学评价改革提供参考。

超临界流体萃取技术在中药提取物制备中的应用

本文综述了超临界流体萃取技术在生物碱类、黄酮类、萜类和挥发油、多糖类、蒽醌类等中药有效成分制备中的应用,有针对性地提出了超临界流体萃取技术在中药提取工艺领域的发展建议,以期促进该技术在中药提取物制备中的推广应用。

医疗机构基于“三结合”中药新药研发及管理体系的构建

目的:在中药审评审批制度改革的政策背景下,围绕医疗机构,探索中医药理论、人用经验和临床试验相结合(简称“三结合”)的审评证据体系落地举措,为医疗机构中药制剂及中药新药研发提供参考。方法:根据“三结合”审评证据体系下中药新药研发的相关要求,从机构层面加强人用经验研究相关配套建设,从管理层面搭建中药研发、成果转化服务平台,从临床层面规范开展人用经验研究,构建医疗机构中药新药研发及管理体系。结果:医疗机构中药新药研发及管理体系的构建,有助于将临床诊疗数据转变为支持中药新药注册的人用经验证据,通过提高中药研发水平促进中药新药转化。结论:在医疗机构构建基于“三结合”的中药新药研发及管理体系,是“三结合”审评证据体系落地、政策引导研发实践的路径之一。

中药调剂临方炮制对临床治疗效果的影响分析

目的 探讨中药调剂临方炮制对临床疗效的影响。方法 选取100例中药治疗的患者为研究对象,将其随机分为对照组与干预组,每组50例。对照组患者接受常规中药炮制治疗,干预组患者实行中药临方炮制治疗。对比两组治疗效果。结果 干预组患者治疗总有效率96.00%明显高于对照组的78.00%,差异有统计学意义(P<0.05)。结论 中药临方炮制对临床疗效具有积极影响,可以通过调整药物的配伍和炮制方法提高药材的活性成分和药效,以此提升治疗效果。

酵母硒复合制剂对蛋鸡生产性能及蛋品质的影响

为分析酵母硒复合制剂对蛋鸡生产性能及蛋品质的影响。试验选取300羽28周龄的海兰褐蛋鸡,随机分为4组,每组5个重复,每个重复15羽。对照组根据《海兰褐壳蛋鸡商品代饲养管理技术规程》(DB34/T1650~2012)配制基础日粮,试验组分别在基础日粮中添加100、200、300mg/kg酵母硒复合制剂。预饲期7d,正试期60d。结果表明:(1)1~30d阶段,随着基础日粮中酵母硒复合制剂添加水平的提高,产蛋率有增加趋势(P <0.10)。31~60d阶段,与对照组相比,基础日粮添加200、300mg/kg酵母硒复合制剂可显著提高蛋鸡的产蛋率、平均日产蛋重(P <0.05),且显著降低了蛋鸡的料蛋比(P <0.05)。(2)试验第30天,与对照组相比,基础日粮添加200、300mg/kg酵母硒复合制剂可显著提高蛋黄颜色(P <0.05)。试验第60天,与对照组相比,基础日粮添加200、300mg/kg酵母硒复合制剂可显著提高鸡蛋重量、蛋白高度(P <0.05),基础日粮添加100、200、300mg/kg酵母硒复合制剂可显著提高了蛋黄颜色(P <0.05)。由此可见,基础日粮中添加200、300mg/kg酵母硒复合制剂均能提高蛋鸡生产性能,有效改善蛋品质。

中医传统特色外治疗法在糖尿病周围神经病变患者中的应用进展研究

糖尿病周围神经病变(Diabetic Peripheral Neuropathy, DPN)广泛存在于糖尿病患者群体中,患者通常存在下肢麻木疼痛等感觉异常。DPN患者临床症状诸多,严重影响生活质量。临床针对DPN患者治疗方式多采用口服药物治疗为主,其临床应用效果具有一定局限性。中医传统特色外治法的出现为DPN治疗领域工作开展提供新思路,诸多特色外治疗法应用方式及功效均存在差异。该文主要从DPN发病机制及临床症状、中医对DPN的认识及中医传统特色外治疗法技术优势3个方面探究DPN及外治疗法临床应用意义,并从膏摩疗法、推拿疗法及针刺疗法3个维度探究外治法应用效果。以此为DPN患者治疗提供重要技术参考,满足DPN患者群体个性化治疗需求,凸显传统中医在治疗DPN领域中的价值。

自拟清化止痛汤联合中药灌肠治疗湿热瘀结型急性盆腔炎的临床效果观察

目的分析湿热瘀结型急性盆腔炎患者临床治疗过程中使用自拟清化止痛汤联合中药灌肠治疗的效果。方法选取60例急性盆腔炎(湿热瘀结型)患者,根据随机数字表法将患者分为两组,每组30例。对照组接受常规西药治疗,治疗组在对照组基础上接受自拟清化止痛汤联合中药灌肠治疗。对比两组治疗效果。结果相比对照组,治疗后治疗组症状缓解时间明显缩短(P<0.05),且主症评分和次症评分明显降低(P<0.05)。两组不良反应发生率比较,差异无统计学意义(P>0.05)。结论自拟清化止痛汤联合中药灌肠治疗湿热瘀结型急性盆腔炎具有较好的效果和安全性。

中药制剂在烧伤治疗中的应用进展

中药制剂主要分为中药合剂、方剂及单方等。其中,中药合剂具有抗休克、控制感染、促进创面愈合、控制瘢痕增生及瘙痒等作用,在烧伤治疗中应用广泛;方剂的剂型众多,临床上主要用于保护创面及促进创面修复;单方因其成分较为单一,故其种类繁多,多为民间流传,具有取材方便、用法简单等优点,主要应用于Ⅰ度Ⅱ度的烧伤创面的治疗。文章从中医角度辩证分析中药制剂的效用,并从促进皮肤组织生长、抑制炎症反应、抗休克、调控胶原蛋白代谢等角度阐述其加速创面愈合和抑制瘢痕增生的作用机制。未来,应进一步完善中药制剂作用机制和临床疗效评价体系的研究。

基于中医传承辅助平台与网络药理学探析《中华人民共和国药典》中含生石膏成方制剂的证治规律及作用机制

目的:研究2020年版《中华人民共和国药典》中含生石膏成方制剂的证治规律及作用机制。方法:将符合纳入、排除标准的成方制剂录入中医传承辅助平台,并基于中医传承辅助平台的频率统计、关联规则与聚类算法功能,探析含生石膏成方制剂的配伍原则、组方规律及新方组合,并提取核心用药;同时采用网络药理学方法,对证治规律研究中所筛选的主要中医疾病进行生石膏作用机制研究。结果:最终共纳入50条含生石膏成方制剂,涉及肺咳、肺炎喘嗽、感冒等中医疾病24种,痰热壅肺、肺经风热、热毒内盛等适宜证型22项,生石膏、甘草、黄芩、杏仁、麻黄等中药170味,同时提取“生石膏-甘草”“生石膏-黄芩”等核心药对4项,“生石膏-五味子-枳实-桔梗-桑白皮”等新方组合7条,以及“生石膏、麻黄、甘草、杏仁、黄芩、桔梗、陈皮”等核心用药6组;并筛选获得ALB、IL-1B、1L-6等“生石膏-主要中医疾病”交集靶点18个,以及肿瘤坏死因子(TNF)、白细胞介素-17(IL-17)、缺氧诱导因子-1(HIF-1)等主要信号通路3条。结论:2020年版《中华人民共和国药典》中含生石膏成方制剂主要以麻杏石甘汤为基础方化裁,其机制可能与生石膏抑制TNF、IL-17、HIF-1等信号通路,下调炎症反应过程,减少促炎因子释放有关。

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。

基于CiteSpace可视化下的国内医疗机构中药制剂研究热点与趋势分析

目的 探索20年来医疗机构中药制剂发展脉络趋势,以期为将来医疗机构中药制剂的发展提供路线参考。方法 通过CNKI检索2003~2023年医疗机构中药制剂相关文献,利用CiteSpace软件,将作者、发文机构、关键词等信息做可视化分析。结果 共检索文献666篇,随国家政策的变化,发文量在2010年后逐年增加,并于2021年迎来高峰,杨忠奇团队近年来发文量较多,且研究课题较为前沿,北京市药品审批中心为发文量最多的机构,且合作机构较多。结论 医疗机构中药制剂近年来发展迅速,研究热点从基本的工艺流程、临床研究、制剂分析向传统工艺中药制剂备案管理、新药孵化、质量控制、传承创新转换,未来长时间内新药孵化、备案管理、质量控制仍将作为本领域的研究热点及方向。

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。

中药材及饮片检测中人工智能应用探讨

目前,中药材及饮片的市场需求快速增长,其质量控制与安全保障更显迫切;传统的中药材及饮片检测手段存在主观经验依赖、检测精度有限、无法全面量化复杂成分等问题,难以满足中药材及饮片在准确分类与鉴别、精准成分测量等方面的需求,而人工智能技术的快速发展与广泛应用为中药材及饮片检测提供了新的解决方案。本文总结了中药材及饮片检测的现有方法及应用现状,系统梳理了人工智能技术在药材分类、真伪鉴别、产地溯源、有害成分测量、有效成分测量、药效测量等方面的典型应用,深入分析了当前面临的数据收集与标准化,检测数据共享机制,快速、无损、低成本检测技术需求,检测数据准确性,多模态检测数据融合等问题。研究认为,智能化、精准化、快速化是中药材及饮片检测未来的重点发展方向,需要持续完善检测标准与数据共享体系、深化人工智能技术研究与应用、强化多模态数据融合技术应用、引入新型传感技术、加强人工智能技术应用监管,以此推动我国中药材及饮片检测高质量发展,保障中医药产业的持续健康发展。