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.

Pharmacokinetics of Two Ingredients of the Compound Chinese Herbal Medicine Transdermal Preparation in Cows

The topical administration of the compound Chinese herbal medicine transdermal preparation has been widely used in treating the mastitis of cows. In order to understand the metabolic process, four cows suffering from clinical mastitis were selected for the pharmacokinetic study. The transdermal preparation was applied to the diseased part of breast. Then the plasma and milk samples were collected respectively at 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, and 36 h, The concentrations of baicalin and phillyrin in plasma and milk were determined by HPLC and the data of time-concentrations were analyzed by the pharmacokinetic software. The results showed that two ingredients in the plasma were not detectable, but they in the milk had linear relationship with the time. The peak concentration of baicalin [（2.84 ±0.15）μg mL^-1] appeared at （4.93 ± 0.35） h, AUC0.1OQ was （27.32 ± 7.91） mg L^-1 h^-1, and the mean retention time was （28.31 ±0.49） h. The peak concentration of phillyrin [（0.49 ± 0.41） μg mL^-1] achieved at （3.68 ± 3.14） h, AUC0-LOQ was （4.10± 0.31） mg L^-1 h^-1, and the mean retention time was （14.52 ± 0.02） h. These suggested that two ingredients had slow absorbing speed and high absorbing degree. They could not be eliminated in a short time, thus exerted the topical curative effect.

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.

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.

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.

Effects of Fermented Nano Chinese Herbal Medicines Replacing Antibiotics on Production Performance and Carcass Quality of Growing-Finishing Pigs

[Objectives]To study the effects of fermented nano Chinese herbal medicines replacing antibiotics on the production performance and carcass quality of growing-finishing pigs.[Methods]200 healthy and disease-free Duroc-Landrace-Yorkshire(DLY)growing-finishing pigs with similar birth time(45±2 d)and body weight of about 31.5 kg were randomly divided into group A(fed with non-antibiotic basal diet),group B(fed with antibiotic basal diet),group C(fed with non-antibiotic basal diet+0.1%fermented nano Chinese herbal medicine preparation),group D(fed with non-antibiotic basal diet+0.3%fermented nano Chinese herbal medicine preparation)and group E(fed with non-antibiotic basal diet+0.5%fermented nano Chinese herbal medicine preparation).The experiment lasted for 90 d.At the end of the experiment,the production performance and carcass indicators were measured.[Results]Compared with group A,the final weight,average daily gain(ADG)and average daily feed intake(ADFI)of groups B,C,D and E were extremely significantly increased(P<0.01),while the feed-to-gain ratio(F/G)was extremely significantly decreased(P<0.01).Compared with group B,the ADG of group E was significantly increased(P<0.05),while the F/G was significantly decreased(P<0.05).Compared with group A,the slaughter rate and carcass length of pigs in groups B,C,D and E were extremely significantly increased(P<0.01);compared with group B,the slaughter rate of groups D and E was extremely significantly increased(P<0.01).[Conclusions]The fermented nano Chinese herbal medicine preparation has better effects in promoting growth than that of antibiotic additives,and it can significantly improve the carcass quality of growing-finishing pigs.

A Preparation Model of Chinese Medicine Decoction Placebo

Chinese medicine（CM）decoction placebo is one of the key factors restricting the placebo-controlled clinical trial of CM.In this article,based on the analysis of the difficulties in preparing CM placebo,the production requirements for placebo were put forward.Moreover,in accordance with clinical practices,a production method and evaluation process of CM decoction placebo was proposed,to provide a reference for clinical research.

Research Progress in Chinese Medicine Preparations for Promoting Blood Circulation and Removing Blood Stasis for Cirrhotic Patients with Portal Vein Thrombosis Following Splenectomy

This article presented an overview of the therapeutic effects of Chinese medicine(CM)preparations for promoting blood circulation and removing blood stasis for patients with portal vein thrombosis(PVT)after splenectomy.Based on published clinical researches of CM preparations for PVT after splenectomy in patients with cirrhotic portal hypertension(CPH),this paper evaluated the incidence of PVT,and explored potential active components and mechanisms of CM preparations.Safflower Yellow Injection,Danshen Injection,Danhong Injection,and Compound Danshen Dropping Pill achieved good curative effect alone or combined with anticoagulant therapy.In addition,Compound Biejia Ruangan Tablet and Anluo Huaxian Pill can also significantly improve the hemodynamic disorders of portal vein system in patients with cirrhosis.Considering the role of CM preparations in ameliorating the incidence of PVT after splenectomy in patients with CPH,we suggested that future research should provide more attention to CM alone or CM combined with anticoagulant for cirrhosis with PVT.

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.

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.

Clinical observation on treatment of cancer pain with TCM oriented drugs combined with oxycodone sustained-release tablets and nimesulide sustained-release tablets

Objective： To study the effect of the transdermal preparation of traditional Chinese medicine in treating cancer pain. Methods： From October 2016 to January 2018, 126 patients with cancer pain were enrolled and divided into 4 groups, 39 patients in group A （directed TCM permeation）, 26 patients in group B （oxycodone sustained-release tablets）, 32 patients in group C （Chinese medicine directed drug penetration ＋ oxycodone sustained-release tablets）, and 29 patients group D （Chinese medicine directed drug penetration ＋ oxycodone sustained-release tablets ＋ nimesulide sustained release tablets）, according to KPS scores. Results： Transdermal preparations of traditional Chinese medicine can significantly alleviate cancer pain. For the treatment of moderate to severe cancer pain, the Chinese medicine transdermal preparation can reduce the dosage of oxycodone sustained-release tablets. At the same time, the patient＇s KPS and NRS scores were significantly reduced. Moreover, the transdermal preparation of traditional Chinese medicine has a better therapeutic effect on visceral pain. Conclusion： The traditional Chinese medicine tra_nsdermal preparation combined with western medicine for the treatment of cancer pain may be a new method for the treatment of cancer pain.

兽用中药制剂工艺的传承与创新

为了推动兽用中药制剂工艺的传承与创新发展,本文在总结中兽医方剂传承基础上,研究兽用中药粉碎与超微粉碎、提取等现代工艺发展,剖析中药制剂剂型定位及生产投料存在的问题,探索兽用中药制剂工艺传承创新导向和途径,对《中国兽药典》制剂通则提出修改建议,为兽用中药制剂研究和2025年版《中国兽药典》编撰提供参考。

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。

Mixture prepared with Chinese medicines in terms of releasing exterior cold and clearing interior heat: its efficacy and safety in patients with seasonal influenza-a randomized controlled trial

OBJECTIVE: To assess the efficacy and safety in 105 patients with seasonal Influenza in Beijing, the mixture prepared with Chinese medicines follows the treatment regimen of releasing exterior cold andclearing interior heat.METHODS: Total 330 patients with seasonal influenza were enrolled and randomly and averagely divided into the Chinese herbal medicine, the western medicine and the Chinese patent medicine group. They were treated with Chinese medicine Oseltamivir Phosphate Capsules and the Scattering Wind and Resolving Toxins Capsules. The main efficacy indicators were the antifebrile onset time and recovery time of body temperature. The efficacy and safety of the mixture was scientifically evaluated. Comparisons of several variables were analyzed.RESULTS: Median antifebrile onset time of the Chinese herbal medicine group was significantly shorter than the western medicine group(P < 0.05) and the Chinese patent medicine group(P < 0.05). The median antifebrile recovery time of the Chinese herbal medicine group was significantly shorter than the Chinese patent medicine group(P <0.05). The groups evaluated by TCM symptom pattern effect, both the Chinese herbal medicine group and Western Medicine group were better than the Chinese patent medicine group(P <0.05). The disappearance rate of main symptoms and some minor symptom patterns of the Chinese herbal medicine group were higher than the other 2 groups.CONCLUSION: The mixture of releasing exterior cold and clearing interior heat could significantly shorten the fever time with safety.

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。

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。

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。