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??OBJECTIVE To explore the statistical METHODS for proficiency testing in the drug control field. METHODS The statistical METHODS were sorted out with data processing used in inter-laboratory and proficiency testing by various industries both at home and abroad.The Grubbs test and Dixon test in classical statistical method were focused on as well as quartile method and iterative method in the robust statistical method, and the characteristics of the different statistic METHODS was summarized respectively.RESULTS Every method has its advantages and application conditions.CONCLUSION It is suggested that proper statistical method be chosen according to the data characteristics of the test RESULTS.     

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??OBJECTIVE To analyze the connotation and composition of the clinical value of drugs, and to build the index system for the evaluation of drug's clinical value, hence to provide references for its scientific evaluation. METHODS We designed the preliminary constructs index system referencingmedicine clinical evaluation indicatorsof German and French firstly. And then the expert interview and Delphi survey were used to analysis to determine the index system and index weight of medicine clinical evaluation. RESULTS The classified index system of the clinical value was established, which was composed of 2 first-grade indexes including clinical value and innovation value and 15 grade two indexes. Experts were invited to assess the value ranking according to the background information of rosuvastatin, atorvastatin and simvastatin statin drugs by their generic names. The expert's scoring results were summarized to determine the sequence. And it were compared with the average market prices in Germany, France, Britain, the United States, South Korea, Japan and analyzed. CONCLUSION The clinical value of drugs is an international standard for determining the reasonable price of drugs. This research method is feasible to determine the drug prices sequencing by the classified clinical value of drugs in the same kind of product. The price sequencing of some generic names of statin drugs did not correspond with its clinical value sequence, and the price can not reflect its value. The integrity and authenticity of the background data directly determine the classification of the clinical value. Various parties are needed to participate in providing detailed data and information.     

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??The goals of developing health service industry were enacted by Chinese government. To develop Chinese medicine health industry was one of the important contents in which. The contribution of dietary Chinese medicines for the development of the TCM health industry had become a new bright spot. Application of novel food raw materials and approved dietary Chinese medicines are introduced in this paper to provide a new path and idea for the development of traditional Chinese medicines.     

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??Chrysanthemum morifolium has a long history of culture and use in China. Due to different germplasm resources, producing areas, and processing methods, many cultivated varieties have formed now. The varieties and processing methods of C. morifolium are affected by economic interests and processing cost, which change gradually. On the basis of spot investigation and related literature study, the changes of the varieties and processing methods of C. morifolium were summarized in this paper. It will provide theoretical evidence for the culture, processing, quality evaluation, and clinical application of C. morifolium.     

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??OBJECTIVE To establish the fingerprint of Aconitum Flarum Hand. Mazz Busch. METHODS UPLC analysis was performed on ACQUITY UPLC BEH C₁₈ column(2.1 mm??50 mm,1.7 ??m). Gradient elution was conducted. Mobile A was 0.2% formic acid and 0.005% TFA in water; mobile B was methanol; and mobile C was acetonitrile. The flow rate was 0.3 mL??min^-1. The detection was carried out at 275 nm. The column temperature was maitained at 35 ??. The injection volume was 1.0 ??L. RESULTS The UPLC fingerprint of Aconitum Flarum Hand. Mazz was established, and 14 common peaks were found including the peaks of two major constituents. The similarity factors ranged from 0.850 to 0.980. In addition, there was significant difference between wild and cultivated samples. CONCLUSION This UPLC method has satisfactory precision, stability, repeatability and specificity. It provides a scientific method for identifying wild and cultivated Aconitum Flarum Hand. Mazz using fingerprint.     

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??OBJECTIVE To study the safety and feasibility of using stems and leaves of Panax notoginseng and flowers of Panax notoginseng as new food ingredients. METHODS The edible history, nutrition and quality standards of Panax notoginseng's stems, leaves and flowers were summarized. Then toxicological test was conducted in mice to investigate the toxicity. RESULTS The stems and leaves of Panax notoginseng and flowers of Panax notoginseng have a long edible history, rich in vitamins, minerals, proteins, amino acids and other nutrients. Pharmacological experiment results showed that they were safe and nontoxic, without obvious organ damages. CONCLUSION It is of great value to use the stems, leaves and flowers of Panax notoginseng as new food ingredients under the recommended dosage. This study provides reference to the utilization of the non-medicinal parts of other Chinese herbal medicines.     

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??OBJECTIVE To optimize the formula of celecoxib gel by studying the effects of different doses of penetration enhancers on the penetration of celecoxib through skin in vitro. METHODS With sodium alginate as the gel base, factorial design method was used to choose the optimal formula of penetration enhancers among four different formulas to prepare celecoxib gels. The release rate of celecoxib in the release media was detected by modified Franz diffusion cells method, and the steady percutaneous speed (J), permeability coefficient (K_p) and the accumulative permeation quantity (Q) in 12 h were calculated. RESULTS The accumulative permeation quantity (Q) in 12 h of celecoxib from the gels made with the four different formulas were 27.93,25.12,18.79 and 19.35 ??g??cm^-2, respectively. The gel with 1% azone and 1% menthol as penetration enhancers had the maximum Q value, 27.93 ??g??cm^-2, its penetration process conformed to Higuchi equation, and the steady percutaneous speed (J) and permeability coefficient(K_p)were also higher than the other three experimental groups. CONCLUSION With sodium alginate as the gel base, azone and menthol have a synergistic effect on the percutaneous penetration of celecoxib gels, and the best formula is 1% azone and 1% menthol.     

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??OBJECTIVE To search the orphan drug list from the countries which had initiated orphan drug policies and give reference to improve the orphan drug accessibility in our country. METHODS We searched the official medicine management websites of the United States??Singapore??Japan?? Australia??European Union?? Chinese Taiwan and South Korea and extracted information of orphan drugs which had been approved to the market. Then those orphan drugs were investigated whether had been imported and reimbursed in China, through the website of China Food and Drug Administration. Drug classification was according to the ??pharmacopoeia of the People's Republic of China?? (2010 version). Disease classification was according to the ICD-10.Insurance information was according to the ??national basic medical insurance?? employment injury insurance and maternity insurance drug catalogue??(2009 version).RESULTS The United States??Japan and Australia had launched orphan drug list. A total of 1 133 drugs were improved to the market, covering 26 diseases. 329 anticancer drugs??168 endocrine, nutritional and metabolic disease drugs??122 hematologic disease drug ranked in the top three, accounted for 29.04%??14.83% and 10.77% of all drugs respectively. China has imported no more than 30%, with the anticancer drugs??infectious and parasitic diseases drugs??endocrine, nutritional and metabolic disease drugs ranking in the top three. In the imported drugs, 33 were included in the insurance list.CONCLUSION Orphan drug accessibility is lack in our country. To improve this status, the related department were suggested to develop national drug policies for orphan drugs, evidence-based select the orphan drug list appling to burden of disease, establish priority approach for approval of imported orphan drug and motivate the R&D enthusiasm of local companies.     

实体微针透皮给药的安全性研究

 目的 探索实体微针刺入皮肤后对皮肤的影响及其安全性。方法 将实体微针刺入裸鼠皮肤,然后进行固化、染色、切片等处理,再置于显微镜下观察不同针尖形状的微针在皮肤上形成的孔道。用实体微针处理小鼠皮肤,然后用金黄色葡萄球菌(Staphylococcus aureus,Sa)进行感染,24 h后检测其血象,以对照针处理小鼠为对照。考察实体微针刺入新生大鼠皮肤后对于皮肤纤维连接蛋白(fibronectin,FN)特殊结构域A(EⅢA+,526 bp)mRNA表达变化的影响,以探明皮肤在分子水平上的损伤情况,并与对照针处理皮肤对比。最后将微针应用于志愿者皮肤,以伊文思蓝(Evans blue)为模型药物,观察微针刺入健康志愿者皮肤后刺入部位的变化情况。结果 实体微针刺入皮肤后能够在皮肤上形成真实的穿过皮肤角质层的孔道,且针形不同形成的孔道也不同。微针在皮肤上形成的孔道不会促进Sa进入小鼠机体而引起感染,也不会引起新生大鼠皮肤能够反映皮肤损伤的EⅢA+片段(526 bp)的异常表达。微针应用于志愿者皮肤后,不会引起不良反应,且形成的孔道在皮肤上保持时间较长。结论 实体微针刺入皮肤后能够在皮肤上形成一定大小的真实孔道,这些孔道可充当药物透皮吸收的通道;微针处理皮肤后不会引起机体感染和皮肤损伤。因此,微针是一种高效、安全的促进药物透皮吸收的新技术,可与透皮贴剂结合而将具有广泛的应用前景。     

对急诊科护士进行层级培训的有效性研究

目的:研究对急诊护士进行层级培训的有效性。方法:以2017年2月~2019年1月急诊科护士38名作为研究对象。2017年2月~2018年1月实施常规培训对急诊科护士进行培训,为实施前。2018年2月~2019年1月实施层级培训对急诊科护士进行培训,为实施后。比较实施前后护士的考核成绩(基本理论知识、基本技能操作、基本操作时间)与护理满意度。结果:实施后患者的基本理论知识、基本技能操作、基本操作事件均优于实施前(P<0.05);实施后患者的护理满意度高于实施前(P<0.05)。结论:在急诊科当中,对护士进行层级培训具有一定的针对性,可显著提升护理人员的考核成绩与操作知识,提升护理满意度,具有较高的应用价值。     

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??OBJECTIVE To enhance the level of drug emergency inspection managements, and provide new ideas to deal with the drug incidents. METHODS Firstly, the management courses of our drug emergency inspection were sorted out. Secondly, the solution ideas to the typical drug emergency incidents were analyzed. Thirdly, the relational experiences of developed countries were researched. RESULTS The emergency management of our country had experienced from zero to full, and the responsible institution experienced from the point to surface. Although the emergency network had been basically established, each component was insufficient. We formulated a series of measures to strengthen the management with the analysis results on typical cases and the experiences of developed countries. CONCLUSION A special solution idea and four innovative measures were made by a combination of theory and practice. The firstly, a whole system management plan was drawn up which could form a system cohesion and reverse the individual combat. The secondly, the technical plan was proposed which could provide the reasonable path to find reason. The thirdly, three effective measures were designed which could provide supplementary resources for management plan and technical plan. The fourthly, the government and enterprises strategies were suggested which could prevent from the source. In brief, our emergency management ability would be significantly enhanced by implementing the mentioned measures.
     

全国中药特色技术传承人才培训项目学习实践与思考

目的:分析全国中药特色技术传承人才培训项目江西樟树天齐堂中药饮片有限公司基地学习安排的合理性和实际效果,为其他基地的培训学习提供参考。方法:报名参加全程培训,按培训要求进行学习、思考和总结。结果:课程安排基本符合项目要求,能认真完成课程学习,基本能达到项目培训目的。结论:项目基地应围绕其特色技术,精心安排理论和实践课程,并适当综合各方意见,充实、优化培训方案。     

基于核心能力模型的妇产科临床药师培训大纲的构建

目的 构建适合妇产科需求的临床药师岗位培训大纲。方法 基于文献检索和医院药师核心能力模型,构建函询表;采用德尔菲法对16名专家进行函询,确定妇产科临床药师岗位核心能力要素和培训内容体系,并对指标的重要性进行赋值,建立妇产科临床药师培训大纲。结果 两轮函询的专家积极系数均别为93.75%,专家权威系数为0.77。经过2轮函询,确定包含6个一级指标和17个二级指标的核心岗位要素,以及34项培训内容的指标体系。结论 本研究采用的方法科学,专家积极性高,内容合理,对于为妇产科临床药师的岗位培训和人员考核提供了科学依据。     

中药注射剂安全性研究的关键问题

中药注射剂起效快、作用强,尤其在危重疾病急救及感染性疾病、心脑血管疾病、恶性肿瘤等疾病的治疗上具有一定的优势。但是,由于中药安全性的研究没有跟上去,至今已发生多起严重不良反应。找出致敏原,改进致敏试验方法、提高准确率和保证临床合理用药是中药注射剂安全性研究的关键问题。     

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??OBJECTIVE To improve the method of national drug sampling and testing system, Enhance the work efficiency of national drug sampling and testing, improve early warning ability of drug quality risk. METHODS By using relevant data of national drug sampling and testing in the past 3 years, to analysis the tredency of drug quality situation. Through summarizing the effect of national drug sampling and testing work, put forward suggestions and countermeasures.RESULTS AND CONCLUSION Strengthening efforts on sampling and testing, improving the efficiency by using varied and flexible sampling form, enhancing the application effects of sampling and testing through multi forms and channels, further perfect drug quality announcement releasing mechanism, enriching the form and content of drug quality announcement, increasing the interpretation and analysis of sampling data, in order to enhance the effective cohesion between the sampling and testing work and supervision management.     

我国药品安全黑名单制度的相关问题探讨

目的:分析我国药品安全黑名单制度存在的问题并提出完善策略。方法:借鉴FDA黑名单制度的经验,结合我国药品管理现状及相关法律法规进行分析。结果:我国药品安全黑名单制度存在覆盖范围小、惩戒力度不够、操作性不强等问题。结论:建议从扩大覆盖范围、与药品安全信用体系建设有机结合、完善相关条款等方面完善黑名单制度。     

糖尿病肾病肾功能不全防治优化方案的有效性和安全性研究

目的：优化糖尿病肾病（DN）肾功能不全防治方案，评价中医辨证论治方案保护肾功能的作用和安全性。方法：采用随机、单盲、平行对照和多中心临床研究方法，将人选的221例DN肾功能不全患者随机分人中医辨证论治方案组（A组）、氯沙坦治疗方案组（B组）和中医辨证论治加氯沙坦治疗方案组（C组），疗程3个月。结果：治疗3个月末与基线差值比较．A组血清肌酐清除率（Ccr）升高幅度高于B组（P〈0．05），血清肌酐（SCr）下降幅度高于B组（P〈0．01）和C组（P〈0．05）；3组尿素氮（BUN）和24小时尿蛋白定量组间差值比较差异无显著性意义（P均〉0．05）；安全性指标显示，3个月末各组患者血清谷氨酸氨基转移酶（ALT）、心电图及肝、胆、脾、胰B超检查与基线差异均无显著性意义（P均〉0．05）．各组之间差异亦无显著性意义（P均〉0．05）。结论：建立在饮食、降糖、对症治疗基础上的中医辨证论治方案在改善肾功能方面具有较好的疗效和安全性，在升高Ccr和降低SCr方面优于氯沙坦方案。     

从抗氧化反应探讨“药食同源”的含义

本文选择六种食品(常用于配方单味药;小红枣、山楂、鲜蒜、鲜姜、桔皮和绿茶)观察其水提液的抗氧化作用,其目的企图从它们所含有的抗氧化成分探讨"药食同源"的含义。结果指出:这些食物的水提取液都有清除 O自由基、抑制小鼠肝脏(整体和离体)脂质过氧化反应,减低经 O诱导的透明质酸解聚作用,其混合液还可抑制鼠肝(整体)腺苷脱氨酶活性,上述这些作用都符合我们以前报道的中药补益复方和单味药的实验结果。