新冠肺炎疫情防控药学应急管理工作模式的构建与应用

目的提升医院药剂科新型冠状病毒肺炎(简称新冠肺炎)疫情防控的药学应急能力。方法根据国家、上海市及医院的相关文件规定和要求,结合既往医院药学管理经验及具体实际情况,构建具有该院特色的疫情防控药学应急管理工作模式并实践。结果成功构建了新冠肺炎疫情防控药学应急管理工作模式,并应用于疫情防控相关知识培训,药学人员和工作环境防护,保障药品供应,捐赠药品管理,更新制度流程,"线上处方"药品供应服务,药学咨询及科普,远程药学服务,药品不良反应监测,治疗药物监测,科研教学等方面。结论新冠肺炎疫情防控药学应急管理工作模式的开展,利于日后医院应对公共卫生突发事件时药学工作的规范化管理。     

新型冠状病毒肺炎疫情下医院发热药房防控措施研究

目的总结医院发热药房应对新型冠状病毒肺炎疫情的防控措施与管理对策,为全国医院药学工作者应对突发公共卫生事件提供参考。方法参考官方发布的发热门诊与医院药学相关的各项疫情防控政策,及时制订并调整医院发热药房的疫情防控方案,包括物资准备、人员培训及流程优化,关注药学人员疫情防控措施的落实情况,预防员工心理健康问题的发生,全面提升疫情防控期间发热药房管理水平,丰富药学服务内涵,强化药学服务能力。结果作为浙江省新型冠状病毒肺炎救治的省级定点医疗机构,发热药房的工作每日有序运行,截至目前实现了工作人员"零脱岗""零感染",在一定程度上保障了发热门诊的战"疫"工作。结论疫情防控期间必须加强发热药房管理,实施精准心理干预与人文关怀,及时调整、优化管理策略并严格落实,可为疫情防控期间的工作规范和管理提供有力保障。     

新型冠状病毒肺炎疫情防控下的医院药事管理和药学服务

目的：梳理总结当前新型冠状病毒感染肺炎（COVID-19）防控下医院药事管理和药学服务实践，为疫情特殊时期的医院药学工作提供参考。方法：根据疫情防控政策和要求，结合查阅文献，阐述COVID-19疫情防控时期医院药事管理和药学服务的具体实践和探索。结果：COVID-19疫情进入防控的关键时期，医院药学相关工作人员要根据不同岗位工作特点，加强工作防护；从药品供应保障、特殊药品管理、临床试验用药管理、捐赠药品管理、超说明书用药管理等方面加强药事管理工作；积极参与COVID-19诊治医疗活动，重点做好处方审核、药物疗效及不良反应监测工作，参与MDT讨论，提供用药咨询，开展对COVID-19治疗用药的科普宣传。结论：面对COVID-19突发疫情事件，及时调整医院药学工作应对策略，对保障疫情防控期间安全合理用药具有重要意义。     

新型冠状病毒肺炎疫情防控常态化下门诊药房日常防控措施及工作模式探索

目的在新型冠状病毒肺炎疫情防控常态化下,探索保障医院药学工作顺利开展,及药品在药房各环节中的安全工作模式。方法通过参考相关指南意见及文献,结合医院工作实际情况,明确门诊药房日常工作重点环节的具体防控措施及要点,探索调整工作管理模式。结果研究制订出门诊药房在日常防控措施、工作管理模式等方面的新举措。结论新型冠状病毒肺炎疫情防控常态化下,制定门诊药房日常防控措施及工作管理模式,并在医院工作中得到验证和完善,实现门诊药房药学服务改进。     

新型冠状病毒肺炎疫情期间发热门诊开展药学服务模式探索

目的结合新型冠状病毒肺炎(简称新冠肺炎)疫情防控特点,探讨医院发热门诊开展药学服务的工作模式。方法回顾整理新冠肺炎疫情防控期间发热门诊的药学服务工作,针对薄弱环节进行持续改进。结果与结论医院发热门诊在疫情防控第一时间实施电子处方,采取岗前培训、医师诊疗系统药学信息服务支持、推进发热门诊实时互动审方、探索通过互联网平台实现患者离院后药学服务延伸等有力措施,推动发热门诊药学服务工作的深入开展,保障了发热门诊患者用药安全性和有效性。随着"互联网+诊疗"模式的迅速兴起,"互联网+药学服务"平台亟待建立。     

新冠肺炎疫情期间武汉市三级定点医院药学服务调研及分析

目的：研究新型冠状病毒肺炎疫情期间武汉市19家三级定点医院药学服务开展情况,分析疫情期间药学服务内容及存在的问题,提出医院药学发展建议。方法：通过在线填写问卷的方式,对武汉市 19家三级定点医院药学服务进行调查,搜集在新型冠状病毒肺炎疫情防控期间各医院运行的基本资料, 统计分析药品供应与调剂、药师岗位调动、临床药学服务、药学科研四方面工作的开展情况。结果：在疫情防控期间,武汉市19家三级定点医院的药学服务主要以药品调剂工作为主,存在部分新型冠状病毒肺炎药品短缺、药师岗位调整、临床药学服务内容简单且形式单一,以及科研开展少等问题。结论：建议提升医院药学服务内涵、加强药学人才培养力度、推进药学信息化建设、丰富临床药学服务模式和内容,为以后在重大卫生公共安全事件下各医院开展药学服务提供参考。     

《新型冠状病毒感染：医院药学工作指导与防控策略专家共识》解读

目的:为广大医院药学工作者更好地理解和认识《新型冠状病毒感染:医院药学工作指导与防控策略专家共识》(以下简称"专家共识"),并在具体工作中进行应用和实践,发挥药师作用、助力抗击疫情提供参考。方法:对该专家共识的制定和修订背景进行介绍,对其主要内容和观点进行解读。结果与结论:专家共识正文共分8个部分,主要包括疾病诊疗[严重急性呼吸综合征冠状病毒2(SARS-CoV-2)感染相关背景、临床表现与诊断、治疗]、医院药学(防控策略、工作指导)、药品和设施保障管理(关键药品/设施/设备保障、特殊情况下的药品管理与使用),以及信息来源和相关资源等方面的内容,较为全面、详细地对如何发挥药师的作用,做好不同药学岗位工作人员的防护、应对疫情的药品保障工作、开展药学服务等方面的医院药学工作提供了有关SARS-CoV-2感染防控的相关信息、具体工作指导和防控策略。由于到目前为止,医药界对SARS-CoV-2的了解还相对有限,该专家共识将基于疫情防控工作中不断积累的经验和进展,持续进行更新、完善,以不断为医院药学人员提供指导和帮助。     

基于5M1E分析法建立应对新型冠状病毒感染的医院药学防控策略

目的:为新型冠状病毒(SARS-CoV-2)感染所致肺炎疫情期间的医院药学防控管理提供参考。方法:基于5M1E分析法,根据疫情防控需要,应对工作中医院药学工作的相关要素,对人员、设备与材料、方法、环境以及监测等5个方面存在的风险进行分析,并针对相应的风险建立新型冠状病毒肺炎(COVID-19)疫情应对的医院药学感染防控策略。结果与结论:人员策略包括开展药师感染防控培训、关注感染防控中药师身心健康;设备与材料策略包括加强设备消毒管理、加强感染防控物资管理;方法策略包括制订感染防控的应急预案、加强感染防控的个人防控;环境策略包括做好工作环境清洁消毒管理、医疗相关物品感染暴露管理、加强医疗废物管理;监测策略包括加强药师感染监测、评估药师防控效果。建立应对COVID-19疫情的防控策略,可以有效地指导药师开展疫情防控工作。     

定点医院药学部门应对新型冠状病毒肺炎疫情的策略与效果分析探讨

在全面抗击新型冠状病毒肺炎疫情工作中,承担救治任务的医院是抗击疫情主要阵地,而药品是感染者救治的物资基础之一,药学服务是感染者救治的重要技术支持。因此,医院从人员管理、药品供应、药品管理、调剂环境管理以及用药安全等方面着手,制定一系列措施,建立起应对疫情的医院药学服务与药品保障模式,有效保障疫情诊治和防控工作的有序开展。     

新型冠状病毒感染患者定点收治医院疫情防控的药学应急服务模式探讨

目的 探讨新型冠状病毒肺炎感染防控形势下,定点收治医院开展针对疫情防控的药学应急服务模式,为本地区医疗机构疫情防控的药学应急保障提供参考。方法 针对疫情期间定点收治医院药学面临的以及可能的难点与关键问题,结合实际情况,制定药学应急服务方案与措施,对方案与措施进行详细解释。结果 研究发现在新冠疫情防控中,药学应急服务面临三大难点,即疫情的应急响应对药学提出高要求、应急用药存在一定风险与药品的科普需求需重视。医院药学部门通过运行短缺药品预警机制、应急药品的供应与配送、用药安全与用药监测、药学指导服务机制的启动、新冠感染患者药学监护重点与新型药学服务模式构建六个方面做出应急保障,予以应对。结论 新型冠状病毒感染疫情防控的药学应急服务保障模式是一项综合性、专业性、系统性强的复杂工程,需要各方面的协调与有序推进,并随着疫情形势的变化进行相应的修改、补充与完善。     

Safety assessment of poloxamers 101, 105, 108, 122, 123, 124, 181, 182, 183, 184, 185, 188, 212, 215, 217, 231, 234, 235, 237, 238, 282, 284, 288, 331, 333, 334, 335, 338, 401, 402, 403, and 407, poloxamer 105 benzoate, and poloxamer 182 dibenzoate as used in cosmetics

Poloxamers are polyoxyethlyene, polyoxypropylene block polymers. The impurities of commercial grade Poloxamer 188, as an example, include low-molecular-weight substances (aldehydes and both formic and acetic acids), as well as 1,4-dioxane and residual ethylene oxide and propylene oxide. Most Poloxamers function in cosmetics as surfactants, emulsifying agents, cleansing agents, and/or solubilizing agents, and are used in 141 cosmetic products at concentrations from 0.005% to 20%. Poloxamers injected intravenously in animals are rapidly excreted in the urine, with some accumulation in lung, liver, brain, and kidney tissue. In humans, the plasma concentration of Poloxamer 188 (given intravenously) reached a maximum at 1 h, then reached a steady state. Poloxamers generally were ineffective in wound healing, but were effective in reducing postsurgical adhesions in several test systems. Poloxamers can cause hypercholesterolemia and hypertriglyceridemia in animals, but overall, they are relatively nontoxic to animals, with LD(50) values reported from 5 to 34.6 g/kg. Short-term intravenous doses up to 4 g/kg of Poloxamer 108 produced no change in body weights, but did result in diffuse hepatocellular vacuolization, renal tubular dilation in kidneys, and dose-dependent vacuolization of epithelial cells in the proximal convoluted tubules. A short-term inhalation toxicity study of Poloxamer 101 at 97 mg/m(3) identified slight alveolitis after 2 weeks of exposure, which subsided in the 2-week postexposure observation period. A short-term dermal toxicity study of Poloxamer 184 in rabbits at doses up to 1000 mg/kg produced slight erythema and slight intradermal inflammatory response on histological examination, but no dose-dependent body weight, hematology, blood chemistry, or organ weight changes. A 6-month feeding study in rats and dogs of Poloxamer 188 at exposures up to 5% in the diet produced no adverse effects. Likewise, Poloxamer 331 (tested up to 0.5 g/kg day(-1)), Poloxamer 235 (tested up to 1.0 g/kg day(-1)), and Poloxamer 338 (at 0.2 or 1.0 g/kg day(-1)) produced no adverse effects in dogs. Poloxamer 338 (at 5.0 g/kg day(-1)) produced slight transient diarrhea in dogs. Poloxamer 188 at levels up to 7.5% in diet given to rats in a 2-year feeding study produced diarrhea at 5% and 7.5% levels, a small decrease in growth at the 7.5% level, but no change in survival. Doses up to 0.5 mg/kg day(-1) for 2 years using rats produced yellow discoloration of the serum, high serum alkaline phosphatase activity, and elevated serum glutamicpyruvic transaminase and glutamic-oxalacetic transaminase activities. Poloxamers are minimal ocular irritants, but are not dermal irritants or sensitizers in animals. Data on reproductive and developmental toxicity of Poloxamers were not found. An Ames test did not identify any mutagenic activity of Poloxamer 407, with or without metabolic activation. Several studies have suggested anticarcinogenic effects of Poloxamers. Poloxamers appear to increase the sensitivity to anticancer drugs of multidrug-resistant cancer cells. In clinical testing, Poloxamer 188 increased the hydration of feces when used in combination with a bulk laxative treatment. Compared to controls, one study of angioplasty patients receiving Poloxamer 188 found a reduced myocardial infarct size and a reduced incidence of reinfarction, with no evidence of toxicity, but two other studies found no effect. Poloxamer 188 given to patients suffering from sickle cell disease had decreased pain and decreased hospitilization, compared to controls. Clinical tests of dermal irritation and sensitization were uniformly negative. The Cosmetic Ingredient Review (CIR) Expert Panel stressed that the cosmetic industry should continue to use the necessary purification procedures to keep the levels below established limits for ethylene oxide, propylene oxide, and 1,4-dioxane. The Panel did note the absence of reproductive and developmental toxicity data, but, based on molecular weight and solubility, there should be little skin penetration and any penetration of the skin should be slow. Also, the available data demonstrate that Poloxamers that are introduced into the body via routes other than dermal exposure have a rapid clearance from the body, suggesting that there would be no risk of reproductive and/or developmental toxicity. Overall, the available data do not suggest any concern about carcinogenesis. Although there are gaps in knowledge about product use, the overall information available on the types of products in which these ingredients are used, and at what concentration, indicates a pattern of use. Based on these safety test data and the information that the manufacturing process can be controlled to limit unwanted impurities, the Panel concluded that these Poloxamers are safe as used.     

HPLC法测定抗妇炎胶囊中木兰花碱、黄柏碱、药根碱、巴马汀、小檗碱、槐果碱、苦参碱、氧化槐果碱、槐定碱和氧化苦参碱

目的 采用高效液相色谱（HPLC）法同时测定抗妇炎胶囊中木兰花碱、黄柏碱、药根碱、巴马汀、小檗碱、槐果碱、苦参碱、氧化槐果碱、槐定碱和氧化苦参碱10种活性成分。方法 采用InerSustain AQ-C₁₈色谱柱（250 mm×4.6 mm,5 μm）,流动相A：乙腈–无水乙醇（80∶20）,流动相B：0.1%磷酸溶液,梯度洗脱,检测波长220 nm,体积流量1.0 mL/min,柱温30℃,进样量10 μL。结果 木兰花碱、黄柏碱、药根碱、巴马汀、小檗碱、槐果碱、苦参碱、氧化槐果碱、槐定碱和氧化苦参碱分别在2.69～134.50、1.95～97.50、0.63～31.50、0.86～43.00、11.95～597.50、0.59～29.50、6.08～304.00、4.85～242.50、1.66～83.00、19.79～989.50 μg/mL线性关系良好（r≥0.999 3）;平均回收率分别为99.11%、98.23%、96.95%、97.78%、100.02%、97.21%、99.66%、99.52%、98.81%、100.08%,RSD值分别为1.04%、1.23%、1.37%、1.65%、0.70%、1.28%、0.65%、0.81%、1.11%、0.63%。结论 建立的HPLC法可用于抗妇炎胶囊中10种活性成分的测定,作为抗妇炎胶囊质量控制方法。     

Arformoterol: (R,R)-eformoterol, (R,R)-formoterol, arformoterol tartrate, eformoterol-sepracor, formoterol-sepracor, R,R-eformoterol, R,R-formoterol

Sepracor in the US is developing arformoterol [R,R-formoterol], a single isomer form of the beta(2)-adrenoceptor agonist formoterol [eformoterol]. This isomer contains two chiral centres and is being developed as an inhaled preparation for the treatment of respiratory disorders. Sepracor believes that arformoterol has the potential to be a once-daily therapy with a rapid onset of action and a duration of effect exceeding 12 hours. In 1995, Sepracor acquired New England Pharmaceuticals, a manufacturer of metered-dose and dry powder inhalers, for the purpose of preparing formulations of levosalbutamol and arformoterol. Phase II dose-ranging clinical studies of arformoterol as a longer-acting, complementary bronchodilator were completed successfully in the fourth quarter of 2000. Phase III trials of arformoterol began in September 2001. The indications for the drug appeared to be asthma and chronic obstructive pulmonary disease (COPD). However, an update of the pharmaceutical product information on the Sepracor website in September 2003 listed COPD maintenance therapy as the only indication for arformoterol. In October 2002, Sepracor stated that two pivotal phase III studies were ongoing in 1600 patients. Sepracor estimates that its NDA submission for arformoterol, which is projected for the first half of 2004, will include approximately 3000 adult subjects. Sepracor stated in July 2003 that it had completed more than 100 preclinical studies and initiated or completed 15 clinical studies for arformoterol inhalation solution for the treatment of bronchospasm in patients with COPD. In addition, Sepracor stated that the two pivotal phase III studies in 1600 patients were still progressing. In 1995, European patents were granted to Sepracor for the use of arformoterol in the treatment of asthma, and the US patent application was pending.     

欧洲刺柏（Juniper）

活性成分与药理作用欧洲刺柏药用部位是其浆果，具有促水排泄、防腐、抗胃肠胀气和抗风湿作用，还可改善胃功能。用作促水排泄药可增加尿量（水丢失），但不增加钠排泄。成分萜品烯-4-醇可增加肾小球滤过率，但刺激肾。欧洲刺柏浆果对单纯疱疹病毒体外显示抗病毒活性，并具抗真菌活性。动物实验显示，欧洲刺柏浆果提取物具有堕胎、抗生育、抗炎、抗胚胎植入、降血压、升血压和降血糖作用。欧洲刺柏浆果油具有兴奋子宫的活性，以及利尿、胃肠道抗菌和刺激作用，该油对平滑肌有阻止解痉作用。     

Oral Presentations (LDD, LPES, LNM, LPAT, LNT, LPPT, LPM)

Probiotic microorganisms have been shown to provide specific health benefits when consumed as food supplements or as food components. The main problem of such products is the poor survival of the probiotic bacteria in the low pH of gastric fluid. However the use of synthetic excipients for enteric coating to prevent the exposure of microorganisms to gastric fluid is limited in food supplementary industry. Therefore the aim of this study was to develop an enteric coating formulation containing shellac as a natural polymer. Shellac possesses good resistance to gastric juice; the major disadvantage of this polymer is its low solubility in the intestinal fluid [1, 2]. Thus films containing different ratios of shellac and water-soluble polymers (sodium alginate, hydroxypropyl methylcellulose (HPMC) and polyvinylpyrrolidon (PVP)) or plasticizers (glycerol and glyceryl triacetate (GTA)) were prepared in order to analyse the films’ melting temperatures (T_m), the changes in enthalpy (ΔH), their capability of taking up water, and their solubility in different media. The release characteristics of the films were studied by loading pellets with Enterococcus faecium M74 and coating them with formulations containing different amounts of shellac and polymer or plasticized shellac. Using dissolution tests, performed according to USP XXXI paddle method, the resistance of the coatings to simulated gastric fluid (SGF, pH 1.2) and the release of cells in simulated intestinal fluid (SIF, pH 6.8) was investigated.The trials showed that an increasing amount of plasticizer results in a decrease of T_m and ΔH of the films whereat glycerol had a superior plasticization effect to GTA. The compatibility of films made of water-soluble polymers and shellac was also concentration dependent. HPMC and PVP showed superior compatibility with shellac compared to sodium alginate, since films containing shellac and more than 10% [w/w] sodium alginate tended to separate into two phases. In the end five formulations containing shellac and either 5% [w/w] glycerol, 10% [w/w] PVP, 20% [w/w] PVP, 10% [w/w] HPMC, or 5% [w/w] sodium alginate emerged as feasible for enteric coating purposes.