医院设立区域性"制剂中心"的构想之探讨

医院制剂是我国现阶段药学领域的一个重要组成部分。医院制剂室担负着本院临床所使用的、但市场上无供应或供应不足的药品的生产任务,同时还承担科研和开发新制剂、挖掘传统中医药及剂型改革等多重任务。所以医院制剂在一个较长的时期内,不仅不会消亡,而且还应该有所发展。但是,医院制剂室发展目前很不平衡,素质良莠不齐,在市场经济大潮的冲击下,也出现了一些新的情况,新的动向,可以探讨新的运作模式。１“制剂中心”的可行性 药政管理法规及《制剂室验收标准》,对制剂室软硬件均有严格的要求。由于不少医院制剂室长期投入不足,…     

从8家医院的调查看现有医院制剂室的缺陷

根据新的医院制剂验收标准,探讨制剂室在人员,厂房,设备,物料使用,管理,发展六个方面的不足,并提出改进措施,有助于医院顺利通过换证验收。     

介绍一种“灭菌制剂配制工艺记录卡”

1990年核发《制剂许可证》工作,使医疗单位制剂工作有了很大的突破和发展。许多医院花费几十万元资金新建、改造灭菌制剂室,添置净化设施、配齐生产设备及全部检验仪器,以便达到卫生部核发《制剂许可证》验收标准。笔者在验收换证中发现,许多医院制剂室的硬件建设基本达标,而制剂室的软件管理工作却存在着程度不同的漏洞。许多制剂室没     

建立区域性灭菌制剂中心的必要性

军队医院灭菌制剂室在为伤病员服务,提高药品质量,缓和供求矛盾等方面,做了大量有效的工作。近年来部队医院向社会开放,制剂室也获得了显著的社会效益和经济效益,对弥补卫生事业费不足起到了举足轻重的作用。但由于灭菌制剂实行新的验收标准,200床位以下医院面临着许多困难。一是编制限制,药剂人员不足,100～200床位医院,药剂人员编制5～8人,但开展的工作     

浅议医院普通制剂室的GMP管理

医院普通制剂室是药局的重要组成部分。医院自制制剂,其品种多,用途广,数量大,使用普遍。为确保自制制剂质量,我们对普通制剂室按GMP要求,着重从人员素质,生产环境,操作流程、原辅料及相应的软件方面进行了系统的整顿和治理,建立起一套比较完整,与制剂生产相适应的管理体系。经军区卫生部检查验收,达到制剂室验收标准要求。我们具体做法: 一、降低和减少不利因素,保证制剂质量稳定 1.提高人员素质,降低或减少人为差错。 《药品管理法》第十六条对人员要求作了     

医院制剂室存在问题及建议

根据国家药品监督管理局国药管安[2000]275号文件的要求,笔者参加了十余家医院制剂室的换证验收工作。鉴于《医疗机构制剂配制质量管理规范》(试行,以下简称《规范》)于2001年3月13日刚发布,首次按照《规范》要求对制剂室进行检查,各医院对《规范》要求尚了解不足,因此在检查开始之前,市药品监督管理部门对医院药剂科有关人员进行专项培训,认真学习标准,领会精神,并组织到上海等地医院及药厂参观学习,分次召开座谈会讨论如何准备接受验收检查。市药品监管部门事前组织对制剂室施工图纸进行审核,并对各医院软硬件改造采     

医院制剂软件管理的探讨

国家药品监督局颁发的《医疗机构制剂许可证》验收标准对医院制剂室的硬件部分与软件部分制定了较高的规范标准 ,各医院按照规范标准的要求正积极地筹备 ,迎接验收。然而 ,很多单位更多想到的是如何提高硬件建设 ,而对软件建设重视不足。本文结合工作实际 ,对医院软件建设的重要性和如何加强医院制剂的软件管理及有关问题提出我们的看法和体会 ,供各位同仁探讨。1　提高对加强软件管理重要性的认识1 1　加强软件管理是提高药品质量的保证　人们在过去的制剂生产实践中总结出这样的结论 :药品的质量是生产出来的 ,不是检验出来的。也就是说…     

谈医疗机构制剂室验收标准实施经验和体会

《医疗机构制剂室验收标准》是SFDA专门针对医院制剂室达标验收、许可证发放的行业标准。为了保证医院制剂的质量，使医院制剂生产有章可循，有法可依。由于验收标准条款多涉及面广，因此需要反复研读吃准吃透。     

关于医院制剂室验收换证工作中的几点体会

随着新《药品管理法》的颁布和《医疗机构制剂配制质量管理规范》(以下简称《管理规范》)的实施，国家药品监督管理局对医院制剂室的硬、软件要求越来越规范。《管理规范》于2001年3月颁布实施。自此，医疗机构制剂配制与检验有了基本准则。我们在2001年换证工作中，依据验收标准和细则，结合口腔专科制剂的     

以法管药提高医院制剂质量

医院制剂室近20年来发展很快,许多医院开展了以大输液为主的灭菌制剂工作.这对解决临床用药,补充市场供缺问题,起了积极的作用.尤其是《药品管理法》的颁布实施,经过整顿和验收,医院制剂室实行了《制剂许可证》制度以后,制剂室的条件得到不断地改善,自制大输液的质量较整顿验收前有了显著的提高.这就从根本上改变了过去那种不经批准,不讲条件,不顾质量,乱制大输液的局面,从而体现了以法管药取得的显著成效.     

Role of glutathione in reduction of arsenate and of gamma-glutamyltranspeptidase in disposition of arsenite in rats

Arsenate (AsV), the environmentally prevalent form of arsenic, is converted sequentially in the body to arsenite (AsIII), monomethylarsonic acid (MMAsV), monomethylarsonous acid (MMAsIII), and dimethylarsinic acid (DMAsV) and some trimethylated metabolites. Although the biliary excretion of arsenic in rats is known to be glutathione (GSH)-dependent, involving transport of arsenic-GSH conjugates, the role of GSH in the reduction of AsV to the more toxic AsIII in vivo has not been defined. Therefore, we studied how the fate of AsV is influenced by buthionine sulfoximine (BSO), which depletes GSH in tissues. Control and BSO-treated rats were given AsV (50 micromol/kg, i.v.) and arsenic metabolites in bile, urine, blood and tissues were analysed by HPLC-HG-AFS. BSO increased retention of AsV in blood and tissues and decreased appearance of AsIII in blood, bile (by 96%) and urine (by 63%). The biliary excretion of MMAsIII was also nearly abolished, the appearance of MMAsIII and MMAsV in the blood was delayed and the renal concentrations of these monomethylated arsenicals were decreased by BSO. Interestingly, appearance of DMAsV in blood and urine remained unchanged and the concentrations of this metabolite in the kidneys and muscle were even increased in response to BSO. To test the role of gamma-glutamyltranspeptidase (GGT) in arsenic disposition, the effect of the of the GGT inhibitor acivicin was investigated in rats injected with AsIII (50 micromol/kg, i.v.). Acivicin lowered the hepatic and renal GGT activities and increased the biliary as well as urinary excretion of GSH, but failed to alter the disposition (i.e. blood and tissue concentrations, biliary and urinary excretion) of AsIII and its metabolites. In conclusion, shortage of GSH decreases not only the hepatobiliary transport of arsenic, but also reduction of AsV and the formation of monomethylated arsenic, while not hindering the production of dimethylated arsenic. While GSH plays an important role in the disposition and toxicity of arsenic, GGT, which hydrolyses GSH and GSH conjugates, apparently does not influence the fate of the GSH-reactive trivalent arsenicals in rats.     

微透析取样技术在中药体内分析中的应用研究进展

本文综述了微透析取样技术在中药体内分析中的应用,介绍微透析取样技术的原理、组成、探针类型、特点,重点阐述了微透析取样技术在测定脑、血液、皮肤等组织器官中中药有效成分浓度的应用实例。表明微透析取样技术在中药药效研究中具有广阔的前景。     

应用PASS系统分析我院2010年住院医嘱

目的:了解我院2010年住院患者的合理用药情况,探讨如何利用合理用药监测系统( PASS)提高合理用药水平.方法:利用PASS对我院2010年15 966例住院患者的1 184 997条用药医嘱进行监测,以黑色警示医嘱为依据,收集不合理用药信息,并对监测结果进行统计、分析.结果:不合理用药医嘱50 261条,发生率为4.24％.绝对禁止黑色医嘱5441条,主要为药物相互作用(66.54％)、注射液体外配伍(17.86％)、用法用量(15.46％)、儿童警告(1.14％).结论:应用PASS系统能有效监测医嘱中的不合理用药情况,有利于提高临床合理用药水平,但PASS系统尚存在局限性,有待进一步完善.     

Changes in levels of dependency and predictors of mortality in elderly people in institutional care in Dunedin

The 1983 study of dependency of subjects in institutional care in Dunedin was repeated two years later. A significant increase in levels of dependency in residential homes, particularly in the Religious and Welfare sector was found. In 1983 there were 29 high dependency residents and 73 medium dependency residents in residential homes. In 1985 these numbers had increased to 55 and 86 respectively. There was no change in the number of low dependency residents. In 1983, 6 high dependency residents had been admitted to residential home care in the year prior to the study. In 1985 the number of high dependency residents recently admitted had increased to 23. There had also been a significant increase in the dependency of patients in Religious and Welfare continuing care hospitals. Of the 933 subjects in institutional care in 1983 who were able to be followed, 354 (37.9%) died in the following 2 years. Mortality rate was higher for those in hospital care (48.1%) than for those in residential home care (29.6%). Mortality rates were higher in more dependent subjects and this was evident for each measure of dependency.     

应用PASS系统对我院2008年住院医嘱的分析

目的监测分析2008年我院住院患者用药情况。方法将PASS系统嵌入医生工作站、临床药学工作站等子系统,构建合理用药计算机网络系统,对住院医嘱进行及时监测,将监测结果向医生反馈,并对其进行统计、分析。结果2008年共监测医嘱3 620 241条,不合理医嘱908条,占0.02%。不合理医嘱中,配伍禁忌(381条)占41.96%,用法用量(381条)占41.96%,药物相互作用(108条)占11.89%,儿童用药(38条)占4.19%。经与医生沟通后,更改不合理医嘱856条,占94.27%。结论PASS系统可有效监测医嘱中的不合理用药,通过与医生交流,大大减少药物不良事件的发生,值得临床推广应用,也为临床药师开展工作带来了极大的便利。但PASS系统尚存在局限性,有待进一步完善。     

Role of desacetylation in the detoxification of cephalothin in renal cells in culture

The toxicity of three cephalosporin antibiotics to rabbit kidney cells in culture was compared to their known nephrotoxic potential in vivo (cephaloridine greater than cefazolin greater than cephalothin). While cephalothin is considered to be a relatively nonnephrotoxic cephalosporin when administered to many species including humans and rabbits, in several in vitro systems involving rabbit renal tissue, cephalothin was comparatively more toxic than anticipated based on in vivo data. Cephalothin is extensively desacetylated in rabbits to a less microbiologically active metabolite, desacetylcephalothin. When a microsomal S9 fraction from rabbit kidney was added to the in vitro assay in cultured rabbit renal cells, cephalothin was desacetylated and its toxicity to kidney cells was reduced. The addition of S9 in vitro provided a toxicity ranking of the cephalosporins that correlated with their known in vivo nephrotoxic potentials (cephaloridine greater than cefazolin greater than cephalothin). The in vitro detoxification of cephalothin by S9 was blocked by the coadministration of the esterase inhibitor, aminocarb. Desacetylcephalothin was relatively nontoxic to rabbit renal tissue in vitro. These results suggest that the desacetylation of cephalothin in vivo represents a previously unrecognized mechanism of detoxification of this cephalosporin antibiotic. Furthermore, this mechanism of detoxification may be applicable to other acetylated cephalosporins.     

2009年某院住院患者抗真菌药用药调查

目的:分析讨论某院抗真菌药使用的合理性,为临床安全有效地使用抗真菌药提供参考。方法:回顾性统计分析某院2009年住院患者抗真菌药用药信息。结果:2009年某院住院患者抗真菌药DDDs排名前3名分别为:氟康唑、制霉菌素和伊曲康唑;使用金额排名前3名分别为:氟康唑、米卡芬净及卡泊芬净;更换一种抗真菌药进行治疗的患者数为176人,在全部患者中占13.4%。结论:应进一步强化用药指征的意识,提高标本送检率,同时改善某些抗真菌用药不合理更换的现象,以避免耐药性发生,从而更好更长远地体现抗真菌药的治疗价值。     

Kinetics of in vitro metabolism of methoxyphenamine in rats

1. Methoxyphenamine (MP) was metabolized in vitro by rat liver preparations to O-desmethylmethoxyphenamine (O-desmethyl-MP), N-desmethylmethoxyphenamine (N-desmethyl-MP) and 5-hydroxymethoxyphenamine (5-hydroxy-MP). These metabolic pathways were inhibited by SKF 525-A and carbon monoxide, which indicates that these reactions were mediated at least partly by an NADPH-dependent cytochrome P-450 system. 2. Strain differences in the metabolism of this drug in vitro were observed in female Lewis and Dark Agouti (DA) rats, which are proposed models for human debrisoquine phenotypes. Methoxyphenamine O-demethylase and 5-hydroxylase activity in DA rats were lower than those in Lewis rats. 3. The metabolic transformation of methoxyphenamine in vitro to O-desmethyl-MP was inhibited competitively by debrisoquine and sparteine. This indicates that the cytochrome P-450 isoenzyme mediating the metabolism of MP to O-desmethyl-MP is similar to that mediating metabolism of debrisoquine and sparteine. However, no inhibition was observed with methenytoin.     

Comparison of in vitro cell models in predicting in vivo brain entry of drugs

Although several in vitro models have been reported to predict the ability of drug candidates to cross the blood-brain barrier, their real in vivo relevance has rarely been evaluated. The present study demonstrates the in vivo relevance of simple unidirectional permeability coefficient (P(app)) determined in three in vitro cell models (BBMEC, Caco-2 and MDCKII-MDR1) for nine model drugs (alprenolol, atenolol, metoprolol, pindolol, entacapone, tolcapone, baclofen, midazolam and ondansetron) by using dual probe microdialysis in the rat brain and blood as an in vivo measure. There was a clear correlation between the P(app) and the unbound brain/blood ratios determined by in vivo microdialysis (BBMEC r=0.99, Caco-2 r=0.91 and MDCKII-MDR1 r=0.85). Despite of the substantial differences in the absolute in vitro P(app) values and regardless of the method used (side-by-side vs. filter insert system), the capability of the in vitro models to rank order drugs was similar. By this approach, thus, the additional value offered by the true endothelial cell model (BBMEC) remains obscure. The present results also highlight the need of both in vitro as well as in vivo methods in characterization of blood-brain barrier passage of new drug candidates.