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.

Drug Sensitive Test on Main Pathogenic Bacteria of Cow Recessiveness Mastitis Using Traditional Chinese Medicine Preparation “Zengrujianniusan”

According to the theory of Chinese veterinary medicine and characteristics of Chinese herbal medicine, four different preparations of compound Chinese medicine ＂Zengrujianniusan＂ were composed, and the prepared water decoction was used to carry on the bacteriostatic test on main pathogens of cow recessiveness mastitis. The results showed that the four different prescriptions of water decoction all had antibacterial effects. The prescription 3 was sensitive to Staphylococcus aureus and Streptococcus agalactiae, while the other three prescriptions showed high sensitivity, and the prescription 3 had the strongest bacteriostatic effects.

Screening and Efficacy Observation of Traditional Chinese Medicine Against Chicken Pathogenic Escherichia coli

[ Objective] The aim of this study was to lay a foundation for obtaining effective traditional Chinese medicine preparations controlling chicken colibacillosis. [ Method] With the western medicine Lomeflbxacin Hydrochloride and Sodium Chloride Injection as the control, drug sensitivity tests of 15 single traditional Chinese herbs and seven self-made Chinese herbal compounds were conducted. Subsequently, the single traditional Chinese herbs presenting good in vitro antibacterial effects against Escherichia coli and all the seven compounds were given to the chicks artificially infected with E. coil to observe their efficacies. [ Result] The results of drug sensitivity tests showed that all the 15 traditional Chinese herbs had certain antibacterial effect against E. coli, among which aloe, pomegranate rind and radix sanguisorbae were the best. Compound 1, 2 and 5 had good antibacterial effects in vitro. By in vivo test, traditional Chinese medicines showed superior efficacies on infected chicks than western medicine, and compound 1 and 2 performed well. [ConclusiOn] Traditional Chinese medicine preparations are good at controlling Chicken colibacillosis, but their bacteriostasis mechanism in vivo was different with that in vitro.

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.

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 infor- mation 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 spleno- cyte 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 antiturnor effects of SCP might be achieved by im- proving 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.

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。

Cohort Study on the Effect of a Combined Treatment of Traditional Chinese Medicine and Western Medicine on the Relapse and Metastasis of 222 Patients with Stage Ⅱ and Ⅲ Colorectal Cancer after Radical Operation

Objective： To evaluate the effectiveness of a comprehensive therapy of traditional Chinese medicine （TCM） in reducing the relapse and metastasis of stage Ⅱ and Ⅲ colorectal cancer based on conventional Western medicine （WM） therapy. Methods： Two hundred and twenty-two patients in total, diagnosed as stage Ⅱ and Ⅲ colorectal cancer from February 2000 to March 2006, were recruited from Xiyuan Hospital, China Academy of Chinese Medical Sciences and the General Hospital of Beijing Military Area. They were followed-up once every 3-6 months. Twenty cases dropped out from the cohort. The remaining 202 patients were all treated with routine WM treatment [including R0 radical operation, or chemotherapy or/and radiotherapy according to national comprehensive cancer network （NCCN） clinical guidelines]. These patients were assigned to two groups based on whether or not they were additionally treated with TCM comprehensive therapy （orally administered with a decoction according to syndrome differentiation, combined with a traditional patent drug over one year）. Ninety-eight patients from Xiyuan Hospital were treated with WM and TCM （combined group）, and 104 patients from the General Hospital of Beijing Military Area were treated with WM alone （WM group）. The demographic data at baseline were comparable, including the operation times, age, sex, TNM staging, and pathological types. The patients were followed-up for one to five years. Up to now, there are 98, 98, 77, 64, and 47 patients with 1, 2, 3, 4, and 5 years of follow-up in the combined group, respectively; and 104, 104, 97, 81, and 55 patients in the WM group, respectively. The results of the 5-year follow-up of all the patients will be available in 2011. Results： The relapse/metastasis rate of 1-, 2-, 3-, 4-, and 5-year were 0 （0/98）, 2.04% （2/98）, 11.69% （9/77）, 14.06% （9/64）, and 21.28% （10/47） in the combined group, and were 4.80%（5/104）, 16.35% （17/104）, 21.65% （21/97）, 25.93% （21/81）, and 38.18%（21/55） in the WM group, respectively. A significant difference was found in the second year between the two groups （X^2=12.117, P = 0.000）. Median relapse/metastasis time was 26.5 months in the combined group and 16.0 months in the WM group. Conclusion： The combined therapy of TCM and WM may have great clinical value and a potential for decreasing the relapse or metastasis rate in stage Ⅱ and Ⅲ colorectal cancer after conventional WM therapy.

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。

基于高分辨质谱的中药学本科实验课程教学探索

中药制剂是由多种中药配伍组成的,是一个复杂的分子体系,其分析鉴定工作存在较大难度。高效液相色谱与高分辨质谱联用系统(HPLC-HRMS)在中药复方的定性研究中发挥着重要作用。本论文通过探索将高分辨液相色谱质谱联用系统应用到中药学本科生实验教学实践中,建立了对中药制剂参松养心胶囊中5种特征性成分进行鉴定的实验教学方法。使学生了解高分辨质谱在中药制剂分析和鉴定中的重要应用,开阔了本校中药学专业本科生的科研视野,提高了学生对仪器分析的理解,对培养高素质高水平的药学本科生起到了积极作用。

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。

盐酸氨基葡萄糖片联合中药制剂制香片预防及治疗轻中度膝骨关节炎的效果观察

目的观察盐酸氨基葡萄糖片联合中药制剂制香片预防及治疗轻中度膝骨关节炎(KOA)的效果。方法选取2021年5月至2023年12月四川省骨科医院收治的110例轻中度KOA患者。完全随机分为常规组和联合组,各55例。其中常规组给予盐酸氨基葡萄糖片治疗,联合组在常规组的基础上加用中药制剂制香片治疗。比较2组患者膝关节疼痛视觉模拟量表(VAS)评分、西安大略和麦克马斯特大学骨关节炎指数(WOMAC)评分、膝关节功能、日常生活活动能力、临床疗效及不良反应。结果治疗后2组VAS评分均低于治疗前且联合组明显低于常规组[(2.4±0.6)分比(3.2±1.3)分],差异有统计学意义(t=3.491,P=0.003)。治疗后联合组WOMAC评分低于常规组,Lysholm膝关节功能评分中活动范围评分大于常规组,差异均有统计学意义(均P<0.05)。治疗6个月时联合组日常生活活动能力量表评分高于常规组[(95±5)分比(77±5)分],差异有统计学意义(t=19.986,P<0.001)。联合组总有效率高于常规组[90.9%(50/55)比76.4%(42/55)],差异有统计学意义(χ^(2)=4.251,P=0.039)。2组均无严重不良反应发生。结论盐酸氨基葡萄糖片联合中药制剂制香片预防及治疗轻中度KOA可有效促进患者疼痛缓解,改善日常生活活动能力和膝关节功能,减少膝关节活动功能受限,安全有效。

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.

耳针疗法辅助治疗急性期周围性面瘫疗效观察

目的观察耳针疗法辅助治疗急性期周围性面瘫的临床疗效。方法将94例急性期周围性面瘫患者按照随机数字表法分为2组,对照组47例采取常规西医治疗,治疗组47例在对照组基础上联合耳针疗法治疗。2组均治疗4周。比较2组治疗效果,比较2组治疗前后面部神经传导速度、红外热成像(前额区、耳周区、口角区、颧区及患侧全区温度)、面瘫改良Portmann评分、面部残疾指数躯体(FDIP)评分、免疫炎性指标[免疫球蛋白(IgA)、IgM、IgG、白细胞介素6(IL-6)、IL-21]水平及世界卫生组织生活质量测定量表简表(WHOQOL-BRFF)评分变化情况,治疗后随访1年,统计对比2组复发率。结果治疗组总有效率95.74%(45/47),对照组总有效率80.85%(38/47),治疗组临床疗效优于对照组(P<0.05)。2组治疗1、2、3、4周面部神经传导速度均较本组治疗前升高(P<0.05),且治疗组治疗1、2、3、4周均高于对照组同期(P<0.05)。2组治疗1、2、3、4周前额区、耳周区、口角区及患侧全区温度均较本组治疗前升高(P<0.05),且治疗组治疗1、2、3、4周均高于对照组同期(P<0.05);2组治疗1、2、3、4周颧区温度均较本组治疗前升高(P<0.05),但2组组间同期比较差异无统计学意义(P>0.05)。2组治疗1、2、3、4周改良Portmann、FDIP评分均较本组治疗前升高,且治疗组治疗1、2、3、4周均高于对照组同期(P<0.05)。2组治疗后血清IgA、IgM、IgG、IL-6、IL-21水平均较本组治疗前降低(P<0.05),且治疗组治疗后均低于对照组(P<0.05)。2组治疗后WHOQOL-BRFF各维度评分均较本组治疗前升高(P<0.05),且治疗组治疗后均高于对照组(P<0.05)。2组复发率比较差异无统计学意义(P>0.05)。结论采用耳针疗法辅助治疗急性期周围性面瘫患者,能显著提高治疗效果,进一步改善患者面部肌群恢复情况,有效改善患者面部温度、神经功能及面部神经传导速度,且能有效抑制免疫炎性损伤,降低复发率,有助于改善患者预后。

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。

镇痛中药的药学及药理研究进展

对现有文献的梳理和分析发现,镇痛中药在药学方面具有独特的性质和特点,如有效成分明确、制备工艺成熟等。在药理方面,镇痛中药具有显著的镇痛效果,且不良反应发生率低。本文主要从镇痛中药的研究现状和不足、镇痛中药的种类和制备方法、镇痛中药的药学研究进展、镇痛中药的药理作用及其机制等方面进行阐述,并对其研究进展进行总结和展望。

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。

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。