关于综合性药品检验机构质量管理体系内部审核的探究

目的： 探究如何科学有效地在规模大、内设实验室多、专业领域范围广的综合性药品检验机构开展内部审核。方法： 从内部审核的策划、实施、后续纠正措施及关闭、内部审核记录与报告等过程进行分析,探讨每个环节实施过程的有效性。结果与结论： 内部审核是药品检验机构质量管理体系中的重要组成部分,也是实验室自身核查的良好契机。药品检验机构本身应充分认识到内审的重要意义,通过这一手段对实验室的管理体系存在的问题进行梳理。。     

2011～2014年药品检测实验室测量审核分析

摘 要 目的： 了解药品检测实验室的检验技术和质量管理现状。方法: 对2011～2014年测量审核的项目概况、项目通过率及参加实验室类型进行统计分析。结果: 申请项目数逐年增加,半数以上集中在含量测定项目,整体通过率在80%以上。结论: 测量审核对实验室意义巨大,应进一步加强并规范测量审核工作。     

浅谈如何提高药检机构内部审核工作有效性

实验室质量管理体系内部审核（内审）也称第一方审核,是由实验室自己进行的,是为了确定质量体系及其各要素的活动和结果是否与有关评审准则或文件相符合,及时发现质量管理体系运行中存在的问题,通过纠正、预防和改进措施,不断完善和改进质量管理体系,使实验室工作的每个过程都处于受控状态,工作质量不断得到提高。内审是实验室内部质量管理自我完善、自我改进、保持质量管理体系持续有效运行的一种重要的管理手段,因此,真正起到推动实验室管理水平提高作用的内部审核,才是一个成功的有效地审核。本文结合内审工作中的实践,就如何提高内审工作有效性谈一些粗浅的认识。     

非临床研究中大分子生物分析方法验证报告审核方法

目的：掌握大分子生物分析方法验证报告审核的方法和原则,确保验证报告的科学性、合规性和完整性。方法：将完整的生物分析方法验证报告和原始记录拆分为原始记录、数据及数据处理、验证报告,分别对三部分进行全面系统性审核,最后将审核的结果进行分析和汇总。结果与结论：通过系统性的审核,熟练掌握审核的方法和要点,提高大分子生物分析方法验证报告的审核效率,提升报告质量,满足机构SOPs和国内外法律法规的要求,推进客户药物研发和申报进程。     

药品批发企业质量管理体系运行中内审问题分析与对策研究

目的： 分析药品批发企业质量管理体系运行中存在的普遍问题,提出改善药品批发企业质量体系内审管理水平的具体实施建议,持续改进批发企业质量管理水平,控制药品经营环节风险,保证药品质量。方法： 对328家药品批发企业GSP认证申报资料及现场检查报告中发现的企业内审工作中存在的具体问题进行汇总、整理、分析原因,发现当前企业普遍存在的问题,并探讨改进措施。结果与结论： 药品批发企业应通过完善内审管理,建立完整严谨的标准和工作流程,强化企业内审工作的权威性和独立性,建立企业全员参与机制,提高内审人员的综合素质和能力;寻找质量管理体系文件贯彻执行的偏差;在体系关键要素发生重大变化或调整后,完善新经营环境下质量管理体系。从而确保企业在药品采购、储存、销售、运输等日常经营过程中均严格执行药品GSP,确保企业质量管理体系保持健康正常的运行。     

品管圈在静脉用药调配中心提高审核分科速度中的应用

目的：通过在静脉用药调配中心开展品管圈活动,提高静脉用药调配中心早八点静脉输液的审核分科速度,确保患者准时用药,安全输液。方法：以自愿方式参加组成小组,按照品管圈的十大步骤、七大手法和PDCA循环进行活动。结果：静脉用药调配中心早八点输液审核分科速度从每小时每人794.3瓶提升到每小时每人1028.4瓶,进步率提高29.5%。结论：通过品管圈活动提高了参与者的责任心、团队精神、沟通能力、荣誉感、解决问题能力、品管手法,提高了静脉用药调配中心的审核分科速度,更好服务于病区。     

新入临床药师的审方带教模式研究

目的 探讨新入临床药师带教审方药师模式存在的问题和改进措施,进一步提高新入临床药师的工作能力。方法 通过新入临床药师在事前处方审核及审方带教工作中发现的部分问题,提出改进建议及对应措施。结果 新入临床药师的专业知识和独立工作能力有了进一步的提高,同时带教审方药师,逐步统一审方标准,提出需要完善审方系统的部分功能,实现预审核系统和人工审核相结合的审方模式,提高审方效率和审方质量,保证患者用药安全。结论 临床药师需要在长期的实践中培养临床药学思维,逐步提高在临床药学工作中的能力,进一步完善带教审方药师模式,同时完善信息化预审核系统加人工审核的新型审核模式,全方位为患者的用药安全保驾护航。     

北京协和医院静脉药物配置中心实时审核干预不合理医嘱分析及对策

目的：分析北京协和医院静脉药物配置中心实时干预的不合理医嘱,并探讨解决对策。方法：回顾性统计2018年我院静脉药物配置中心审方药师根据《临床药物治疗学》、药品说明书、MICROMEDEX及Up To Date等相关资料对长期医嘱和临时医嘱进行实时前置审核所发现的不合格医嘱类型与数量,计算干预率。结果：从实时审核医嘱中共发现不合理医嘱174份,主要涉及药物用法用量不适宜、录入错误、溶媒不适宜及药物浓度不适宜等,干预率达100%。结论：通过静脉药物配制中心药师对医嘱的实时审核和干预,能有效地降低和避免不合理用药的产生,促进临床合理用药。     

GLP体系下对实验动物供应商审核的要求

目的：规范实验动物供应商管理。方法：依据《药物非临床研究质量管理规范》（GLP）等相关法规要求,对实验动物供应商审核相关流程和要求进行了论述。结果与结论：实验动物在药物安全性评价中占有极其重要的地位。通过规范实验动物供应商审核流程,加强动物来源控制,可以有效地提高药物非临床原始资料的有效性和真实性,充分发挥GLP体系下实验动物供应商审核的优越性,保证非临床研究水平。     

2017年1～9月南京医科大学附属儿童医院静脉用药集中调配中心审核干预医嘱分析

目的 对南京医科大学附属儿童医院静脉用药集中调配中心审核干预的医嘱进行统计分析,为临床儿科合理用药提供参考依据。方法 将2017年1~9月南京医科大学附属儿童医院静脉用药集中调配中心34 807组医嘱数据进行归类统计。结果 审核的医嘱中不合理医嘱占1.59%,主要因素包括溶媒选用不当、配制药品浓度不当、给药剂量不当,用法不当和录入错误,构成比分别为7.58%、11.73%、15.88%、6.32%和58.48%。结论 药师通过审核医嘱,能及时介入不合理医嘱并进行干预,降低临床静脉给药不良反应的发生率,保证儿童用药合理性和安全性,提升儿科用药的专业化。     

Efficacy of gut lavage,hemodialysis, and hemoperfusion in the therapy of paraquat or diquat intoxication

Clinical and in vitro investigations were carried out to test the efficacy of gut lavage, hemodialysis, and hemoperfusion in the treatment of poisoning with paraquat or diquat. In a patient suffering from diquat intoxication 130 times more diquat was removed by gut lavage 30 h after ingestion than was removed by complete aspiration of the gastric contents.Determination of in vitro clearances for paraquat and diquat by hemodialysis showed that, at serum concentrations of 1–2 ppm, such as are frequently encountered in poisoning in man, toxicologically relevant quantities of herbicide cannot be removed from the body. At a concentration of 20 ppm, on the other hand, hemodialysis proved to be effective, the clearance being 70 ml/min at a blood flow rate of 100 ml/min. The efficacy of hemoperfusion with coated activated charcoal was on the whole better. Especially at concentrations around 1–2 ppm, the clearance values for hemoperfusion were some 5–7 times higher than those for hemodialysis.In a patient suffering from paraquat poisoning, both hemodialysis as well as hemoperfusion were carried out. The in vitro results could be confirmed: At serum concentrations of paraquat less than 1 ppm no clearance could be obtained by hemodialysis while by hemoperfusion with activated charcoal quite high clearance values were measured and the serum level dropped down to zero.

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Zusammenfassung Klinische Untersuchungen und Laboratoriumsversuche wurden durchgeführt, um die Wirksamkeit von Darmspülung, Hämodialyse und Hämoperfusion bei Paraquat- und Deiquat-Vergiftungen zu prüfen.Bei einem Patienten wurde 30 Std nach Deiquat-Aufnahme durch Darmspülung 130mal mehr Deiquat entfernt als durch vollständige Aspiration des Mageninhaltes. In vitro-Versuche ergaben, daß bei Blutserumkonzentrationen von 1–2 ppm, die bei Vergiftungen oft gemessen werden, durch Hämodialyse keine toxikologisch relevanten Paraquat- oder Deiquat-Mengen entfernt werden können. Dagegen erwies sich die Hämodialyse bei 20 ppm und einer Blutumlaufgeschwindigkeit von 100 ml/min mit einer Clearance von 70 ml/min als wirksam. Die Hämoperfusion mit beschicheter Aktivkohle war in diesen Versuchen aber eindeutig überlegen, denn insbesondere bei Konzentrationen um 1–2 ppm waren die Clearance-Werte 5–7mal höher als bei der Hämodialyse.Die in vitro-Ergebnisse wurden bei einem Patienten mit einer Paraquat-Vergiftung bestätigt: Bei Konzentrationen unter 1 ppm war die Hämodialyse wirkungslos, während durch Hämoperfusion relativ hohe Clearance-Werte erreicht wurden, so daß der Serumspiegel rasch unter die Nachweisgrenze abfiel.

     

In vitro studies on sterically stabilized liposomes (SL) as enzyme carriers in organophosphorus (OP) antagonism

This study describes a new approach for organophosphorous (OP) antidotal treatment by encapsulating an OP hydrolyzing enzyme, OPA anhydrolase (OPAA), within sterically stabilized liposomes. The recombinant OPAA enzyme was derived from Alteromonas strain JD6. It has broad substrate specificity to a wide range of OP compounds: DFP and the nerve agents, soman and sarin. Liposomes encapsulating OPAA (SL)* were made by mechanical dispersion method. Hydrolysis of DFP by (SL)* was measured by following an increase of fluoride ion concentration using a fluoride ion selective electrode. OPAA entrapped in the carrier liposomes rapidly hydrolyze DFP, with the rate of DFP hydrolysis directly proportional to the amount of (SL)* added to the solution. Liposomal carriers containing no enzyme did not hydrolyze DFP. The reaction was linear and the rate of hydrolysis was first order in the substrate. This enzyme carrier system serves as a biodegradable protective environment for the recombinant OP-metabolizing enzyme, OPAA, resulting in prolongation of enzymatic concentration in the body. These studies suggest that the protection of OP intoxication can be strikingly enhanced by adding OPAA encapsulated within (SL)* to pralidoxime and atropine.     

Steroidal sapogenin contents in some domestic plants

In order to find out the values of the steroid resources for the future use. the compositions and contents of steroidal sapogenins from 13 domestic plants have been investigated. As a result,Dioscorea nipponica, D. quinqueloba andSmilax china were found to have large amount of diosgenin. And pennogenin inTrillium kamtschaticum andParis verticillata, yuccagenin inAllium fistulosum, hecogenin inAgave americana and neochlorogenin inSolanum nigum were appeared to be major steroidal sapogenins.     

Aquatic Insects and Trace Metals: Bioavailability,Bioaccumulation, and Toxicity

Abstract

The uptake of metals from food and water sources by insects is thought to be additive. For a given metal, the proportions taken up from water and food will depend both on the bioavailable concentration of the metal associated with each source and the mechanism and rate by which the metal enters the insect. Attempts to correlate insect trace metal concentrations with the trophic level of insects should be made with a knowledge of the feeding relationships of the individual taxa concerned. Pathways for the uptake of essential metals, such as copper and zinc, exist at the cellular level, and other nonessential metals, such as cadmium, also appear to enter via these routes. Within cells, trace metals can be bound to proteins or stored in granules. The internal distribution of metals among body tissues is very heterogeneous, and distribution patterns tend to be both metal and taxon specific. Trace metals associated with insects can be both bound on the surface of their chitinous exoskeleton and incorporated into body tissues. The quantities of trace meals accumulated by an individual reflect the net balance between the rate of metal influx from both dissolved and particulate sources and the rate of metal efflux from the organism. The toxicity of metals has been demonstrated at all levels of biological organization: cell, tissue, individual, population, and community. Much of the literature pertaining to the toxic effects of metals on aquatic insects is based on laboratory observations and, as such, it is difficult to extrapolate the data to insects in nature. The few experimental studies in nature suggest that trace metal contaminants can affect both the distribution and the abundance of aquatic insects. Insects have a largely unexploited potential as biomonitors of metal contamination in nature. A better understanding of the physico-chemical and biological mechanisms mediating trace metal bioavailability and exchange will facilitate the development of general predictive models relating trace metal concentrations in insects to those in their environment. Such models will facilitate the use of insects as contaminant biomonitors.     

Pharmacological treatment of COVID-19: an opinion paper

The precocity and efficacy of the vaccines developed so far against COVID-19 has been the most significant and saving advance against the pandemic. The development of vaccines has not prevented, during the whole period of the pandemic, the constant search for therapeutic medicines, both among existing drugs with different indications and in the development of new drugs. The Scientific Committee of the COVID-19 of the Illustrious College of Physicians of Madrid wanted to offer an early, simplified and critical approach to these new drugs, to new developments in immunotherapy and to what has been learned from the immune response modulators already known and which have proven effective against the virus, in order to help understand the current situation.     

Alzheimer’s disease – current trends in basic and clinical research. Highlights from the 16th ECNP

Advances in the molecular biological knowledge of neuronal nicotinic acetylcholine receptors (nAChRs) have led to a growing interest by the pharmaceutical industry in the development of novel compounds that selectively modulate nAChR function. The ability of (-)-nicotine, an activator of nAChRs, to enhance attentional aspects of cognition in animals and humans, to exert neuroprotective and anxiolytic-like effects, and presumably to mediate the negative correlation between smoking and Alzheimer's (and Parkinson's) Disease, has focused interest on the potential therapeutic utility of modulators of nAChR function for treatment of some of the deficits associated with these progressive, neurodegenerative conditions. Numerous compounds are known which activate nAChRs and which might serve as lead compounds toward the development of such agents. The pharmacologic diversity of neuronal nAChR subtypes suggests the possibility of developing selective compounds which would have more favourable side-effect profiles than existing agents. This broader class of agents, collectively called cholinergic channel modulators (ChCMs), is anticipated to encompass compounds which would have more favourable side-effect profiles than existing agents, which generally exhibit low selectivity. This selectivity may be achieved by preferentially activating some subtypes of nAChRs (i.e., Cholinergic Channel Activators, ChCAs) or inhibiting the function of other subtypes (Cholinergic Channel Inhibitors, ChCIs). An overview of the biology of nAChRs and the rationale for the use of ChCMs for the treatment of dementia related to neurodegenerative diseases are presented, followed by a discussion of lead compounds and compounds under consideration for clinical evaluation.