2014-2018年安徽省中药饮片生产企业执行药品生产质量管理规范检查的缺陷分析

目的 为提高中药饮片生产质量管理提出改进措施与建议,为中药饮片生产监管提供思路与对策。方法 采用回顾性统计分析方法,对2014-2018年安徽省50家未通过药品生产质量管理规范（GMP）认证的中药饮片生产企业检查发现的严重缺陷及主要缺陷项目进行分析。结果 未通过GMP认证的中药饮片生产企业存在的主要问题集中在企业法人或者负责人法律意识淡薄,关键人员履职能力不足,生产记录或者检验原始数据不能追溯,物料管理混乱,生产管理系统或者质量控制系统不能有效运行等方面。结论 建议中药饮片生产企业应提高法律意识,加强诚信建设,注重人员培训,严格规范生产;监管部门应突出专业性和职业化,切实保证中药饮片质量安全。     

中西医结合医院门诊中药饮片处方点评及分析

摘 要 目的： 通过对中西医结合医院门诊中药饮片处方进行点评与分析,了解医院中药处方和中药临床使用存在的问题,为指导中药房调剂工作和临床合理用药提供参考。方法: 随机抽查我院2014年1～12月1 200张门诊中药饮片处方,对处方中不合理情况进行分析,提出合理应用中药的措施。结果: 中药饮片处方中存在临床诊断填写不全、临床诊断与用药不符、中药名称不规范、处方脚注不明确、用法用量不适宜、配伍禁忌等问题;单张处方药味数大于15个以上的处方占比为65.70%,处方平均剂量大于250g的处方占比为40.25%。结论:加强中药饮片处方的定期点评检查和质量监督,有利于提高处方质量,确保患者用药的安全和经济。     

中药饮片GMP检查典型缺陷分析及对中药饮片质量监管的启示

目的：为中药饮片生产企业实施GMP提出改进措施,为加强中药饮片生产监管提供对策建议。 方法：采用回顾性研究分析方法,以2018年1月至2021年6月福建省开展的33家次中药饮片GMP检查结果为研究对象,对检查发现的缺陷项目进行统计分析。结果：共发现检查缺陷项408项,其中主要缺陷29 项,一般缺陷379项,主要集中在机构与人员、质量控制与质量保证、厂房设施与设备、确认与验证、文件管理等方面。结论：企业应从强化人员培训、提升检验能力、扎实开展自检等方面着手完善质量管理体系。建议药品监督管理部门加强共性问题研究,运用智慧监管手段提升中药饮片监督检查效能,保障公众用药安全有效。     

上海市嘉定区16所公立医疗机构中药药事现状调查与分析

目的 了解上海市嘉定区公立医疗机构中药房建设与人员配备现状,提高我区中药药事管理质量。方法 采取全面调查的方法,对全区1所中医医院、3所综合医院、12所社区卫生服务中心,共16所公立医疗机构,调查中药房面积、中药饮片销售金额、中药饮片品种数、中药房相关规章制度、中药房负责人和中药饮片质量验收负责人资质、中药专业技术人员继续教育等现状。结果 嘉定区公立医疗机构中药饮片品种数量满足需求,中药房面积不符合国家规定,中药房相关规章制度不完善,中药饮片处方代煎监管不足,继续教育内容需要更新。结论 上海市嘉定区中药药事管理尚有可以完善之处,建议依照有关规定进行整改。     

基于药品飞行检查探析中药生产质量管理

目的：分析总结影响中药生产质量的原因,提出改进意见,促进中药生产质量的安全可靠,进一步保证患者用药安全。方法：对原国家食品药品监督管理总局发布的2015年3月至2017年3月关于中药类生产企业飞行检查的情况进行统计,分析对比2015年与2016年飞行检查的结果,着重分析2016年飞行检查发现的生产质量问题。结果：中成药生产企业存在擅自改变生产工艺,中药材、中药饮片物料管理混乱,做不到药品全检等问题。且中药饮片和人工牛黄生产企业也存在类似问题。结论：中药生产企业必须承担起社会责任,加强生产制度建设;要推进中药材生产标准化、产业化、规模化;监管部门应转变监管理念,丰富监管手段,变革监管方式,坚持问题导向和风险防控,加大对重点企业、薄弱环节、问题线索的飞行检查,深挖风险隐患,为中药生产质量管理保驾护航。     

失效模式和效应分析在住院药房药品调剂流程风险管理中的应用

目的 探讨失效模式与效应分析（failure mode and effect analysis,FMEA）在住院药房药品调剂流程风险管理中的应用效果,提高药品调剂质量。方法 对天津医科大学肿瘤医院住院药房口服药物调剂流程中各个环节进行FMEA,计算风险优先指数（risk priority number,RPN）。选出高风险等级的失效模式和中等风险等级中S≥4的失效模式,整理分析其失效原因,制定并实施改进措施。比较实施FMEA方法前后失效模式变化情况,分析改进效果。结果 住院药房药品调剂流程中共找出13个失效模式,其中高风险失效模式4项,极高风险失效模式2项。通过规范药物医嘱流程、优化HIS信息系统与摆片机对接执行程序、修订完善制度以及对药师、护士进行培训等方面干预,13项失效模式RPN均值由38降至15,降幅为60.53%。其中4项高等风险失效模式经改进后风险明显降低,且差异有统计学意义（P＜0.05）。结论 将FMEA应用于住院药房药品调剂流程风险管理,能够有效降低拆药过程药品损失、机器误差、HIS系统与摆片机信息对接失误和取药次数多、等候时间长等问题,提高药品调配的及时性和准确性,更好地服务于住院患者。     

中药饮片生产企业在质量管理方面的问题及建议

目的 研究中药饮片生产企业在药品GMP符合性检查中发现的检查缺陷,探讨中药饮片生产企业在质量管理方面存在的问题,为企业提升质量管理,确保产品质量提供借鉴和参考。方法 以2020年82家次中药饮片生产企业GMP符合性检查中存在的缺陷为研究对象,采用分析归纳的方法对缺陷项目进行分析。结果与结论 中药饮片生产企业在质量管理方面发现的严重缺陷所占比例最高,饮片生产企业应牢固树立质量主体责任意识,开展有针对性的改进措施,切实提升质量管理水平,确保中药饮片质量符合用药要求。     

地锦草饮片炮制问题探讨与质量改进对策

目的：揭示中药饮片质量面临的困境,提出中药饮片监管思路与方法。方法：以地锦草的炮制研究为例,分析中药饮片炮制存在的问题。结果与结论：目前地锦草混淆品较多且与地锦草难以区分,炮制过程中缺少相应的炮制规程及相应的控制手段。根据实际出现的问题,有针对性地提出建议：生产企业应加强中药材源头控制,有条件的生产企业应该统筹规划、协调发展,对于基原复杂的药材,应按照GAP要求进行种植;加强专业技术培训,提高饮片生产流通单位业务人员的中药材鉴别能力;加强中药炮制研究,统一炮制标准,保证饮片质量稳定均一。     

护国寺中医医院中药饮片库全流程管理模式探讨

目的：总结北京护国寺中医医院中药饮片库房管理的具体方法,为同道提高医院中药饮片库管理水平提供参考。方法：对我院中药饮片管理实践进行总结并借鉴他院的管理方法,对中药饮片库的科学管理模式进行探讨。结果：对中药饮片库实行全流程管理,包括：①采购计划管理;②药品信息管理;③饮片入库管理;④饮片养护管理;⑤账务管理;⑥人才管理。结论：实施全流程管理可以使中药饮片库房的管理水平明显提高。     

FMEA在降低自动口服摆药机调剂差错风险中的应用

目的：探讨失效模式和影响分析（failure mode and effect analysis,FMEA）在降低自动口服摆药机调剂差错风险中的应用。方法：运用FMEA识别自动口服摆药机调剂过程中的失效模式,分析其出现的原因,制定降低调剂差错的措施。结果：实施风险控制措施后,影响自动口服摆药机调剂差错风险失效模式的风险优先指数（risk priority number,RPN）值由119分降到55分,差异具有统计学意义（P<0.05）。结论：FMEA应用于自动口服摆药机调剂差错的风险管理,可有效降低调剂差错,提高药学服务质量。     

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.     

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.     

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.     

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.