关于加强和完善药用辅料管理的建议

目的促进药用辅料监管,确保药品安全,对药用辅料监管工作提出建议。方法对目前国内药用辅料生产、使用、监管情况进行总结,对存在的问题进行分析。结果与结论对药用辅料监管工作,应在法律法规、管理体系、标准建设等多方面予以加强。     

七省市药用辅料使用管理情况调研报告

目的：调查我国药用辅料使用与管理的现状及存在问题,提出意见及建议,为生产监管、认证、检查提供参考。方法对我国七省市辖区内不同规模、生产不同制剂类型的70家药品生产企业药用辅料的使用情况以表格填报和现场检查相结合的方式进行调查,并对结果进行总结分析。结果目前我国药品生产企业药用辅料的使用和管理存在水平参差不齐、质量标准不统一、批准文号不统一等问题。结论根据我国辅料使用和管理实际情况,应从法规建设、标准建立、日常监管和药品 GMP 认证等方面,完善对药用辅料的管理。     

药用辅料行业发展现状分析与思考

目的：促进药用辅料行业健康发展,确保药品质量和用药安全。方法：回顾分析我国药品辅料的发展,结合目前国内药用辅料标准收载及药用辅料与药品关联审评对辅料的要求,分析辅料行业存在的问题,提出相关建议和对策。结果与结论：药用辅料行业发展相对落后,提高药用辅料标准,加强辅料的开发和生产应用,是确保药用辅料质量安全的有效措施。     

我国药用辅料的现状及监管建议

目的促进药用辅料行业健康发展,确保药品安全。方法对目前国内药用辅料生产、使用、管理制度等情况进行总结,分析存在的问题,介绍国外药用辅料的管理经验,提出相关监管建议。结果与结论我国药用辅料行业发展仍相对落后,药用辅料生产、应用、监管等各方面均应予以加强。     

我国药用辅料管理中存在的问题及应对策略

随着我国制药行业的快速发展,药用辅料在管理过程中存在的问题及相对落后局面初露端倪。文章对中美药用辅料的行政管理进行了比较,对我国药用辅料产业链管理中存在的问题进行汇总和分析,进而提出了具体的改进措施和完善管理制度的建议。     

中国药用辅料的监管问题浅析

药用辅料是药物制剂的基础材料和重要的组成部分。在制剂剂型和药品生产中起着关键作用。对药品质量起着至关重要的作用。目前我国药用辅料在质量监管和流通等方面存在许多问题，“齐二药厂药用辅料事件”暴露了药用辅料生产采购过程中的问题，它集中反映了药品安全的一些深层次问题，是关系到实现我党在十六大报告中提出的以人为本和构建和谐社会大目标的重要问题。该事件的发生，引发了我们对我国药用辅料的监管中存在问题的深入思考，在克分总结教训、借鉴国外成功经验的基础上，应逐步完善我国的药用辅料监督管理机制。本文阐述了我国药用辅料的监管现状，分析其问题原因所在，并介绍国外药用辅料的管理经验，从中探讨完善我国药用辅料的监管方式。     

关联审评制度下药用辅料质量标准浅析

目的：研究关联审评制度下药用辅料质量标准现状，帮助理解关联审评制度下药用辅料质量标准内涵和各质量标准间存在的关系。方法：详细介绍关联审评制度下药用辅料质量标准的分类及特点，着重对现行药用辅料备案管理制度和药用辅料备案标准的制定要求、状态、变更、效力和现状等进行系统归纳、阐述，同时也对药用辅料备案标准和药典标准间的关系进行了分析、探讨。结果与结论：药品辅料的质量标准是药用辅料质量的重要衡量尺度，包括药典标准、注册标准、备案标准和内控标准等，其中药用辅料药典标准是对该辅料质量控制的基本标准和门槛；关联审评新制度下产生的药用辅料备案标准是监管机构确认辅料质量的重要文件。在关联审评制度的新时期，在进一步加深对药用辅料各质量标准的内涵和关系理解的同时，一方面需要企业对其备案的药用辅料进行更加广泛、深入的研究，以便给审评人员在关联审评时提供更多的参考依据；另一方面需要监管机构持续完善我国药用辅料药典标准体系，促进国内药用辅料质量标准整体提升，有助于提高我国制剂整体质量、推进制剂创新发展。     

药用辅料中人工合成着色剂的标准体系现状分析

对药用辅料中人工合成着色剂的标准体系现状进行梳理,对存在问题进行分析,为加强药用辅料中人工合成着色剂监管提供技术参考。通过对人工合成着色剂产品标准的颁布年限、发布部门、标准范围、重金属等有害物质的控制情况进行比较,结合现行的法律法规体系,分析人工合成着色剂作为药用辅料在实际监管工作中存在的问题。建设药用辅料中人工合成着色剂标准体系,对科学监管具有重要的现实意义。     

对药用辅料监管现状的几点思考

目的 为建立符合我国制药行业发展的药用辅料监管方式提供参考.方法 对我国药用辅料的标准收载情况、行业以及行政管理现状进行分析,在借鉴欧美国家药用辅料监管经验的基础上,提出相应的监管对策.结果与结论 我国药用辅料行业存在法律法规体系缺失、质量标准不健全、行业准入门槛低、质量保证体系缺失等监管漏洞,建议通过建立健全相关法律法规、完善药用辅料备案档案（DMF）备案管理、实行第三方审计和建立制药企业辅料数据库等措施,加强我国药用辅料监管,确保药用辅料质量安全.     

药用辅料生产使用现状及问题

该文从广东省药用辅料生产企业的现状入手,对药用辅料的生产、使用状况进行研究和分析,探讨辅料行业存在的问题,并提出了规范药用辅料行业发展的建议。     

Mechanism for the high bias in the USP colorimetric assay for diazotizable substances in hydrochlorothiazide

The USP XX colorimetric assay for the determination of diazotizable substances in hydrochlorothiazide was studied. Colorimetric assay results of hydrochlorothiazide bulk powder and captopril-hydrochlorothiazide combination tablets were found to have a high bias when compared with HPLC. A kinetic study of the diazotization step in the colorimetric assay and extrapolation of the free amine content, i.e., 4-amino-6-chloro-1, 3-benzenedisulfonamide, to time zero provided results which correlated favorably with those obtained by HPLC. The high bias of the colorimetric assay was shown to result from the formation of 4-nitroso derivative of hydrochlorothiazide, which is formed by acid hydrolysis during the diazotization step. Bendroflumethiazide and flumethiazide also showed increasing free amine content when the time of diazotization was increased.     

Recent advances in the pharmacotherapy for hyperbilirubinaemia in the neonate

Jaundice is a common cause for diagnostic works-up and therapeutic intervention in neonates. This is motivated by the risk for severe neurological sequelae (kernicterus). The mainstays of treatment for the past decades have been exchange transfusion and phototherapy. Exchange transfusion is now becoming rare due to immune prophylaxis in Rhesus-negative women, and treatment of sensitised infants with intravenous immunoglobulin. Several different pharmacological approaches have been studied as far as the treatment of neonatal jaundice. Of these, the focus of attention in recent years has been on the haem oxygenase inhibitors (metal meso- and protoporphyrins). These are effective inhibitors of bilirubin production and have been shown to significantly reduce peak serum bilirubin levels in several clinical trials, both when used prophylactically and therapeutically. However, questions remain regarding long-term safety, as well as the advisability of whole-scale inhibition of bilirubin production. Nevertheless, in selected infants with a high risk of severe jaundice, the use of haem oxygenase inhibitors may be acceptable. Pharmacotherapy in jaundiced infants is fraught with risks, as many drugs may increase the entry of bilirubin into the brain and presumably, the risk for neurotoxicity. Both the displacement of bilirubin from its albumin binding and interference with the function of phosphoglycoprotein in the blood-brain barrier are documented mechanisms in this respect.     

Recent advances in the pharmacotherapy for hyperbilirubinaemia in the neonate

Jaundice is a common cause for diagnostic works-up and therapeutic intervention in neonates. This is motivated by the risk for severe neurological sequelae (kernicterus). The mainstays of treatment for the past decades have been exchange transfusion and phototherapy. Exchange transfusion is now becoming rare due to immune prophylaxis in Rhesus-negative women, and treatment of sensitised infants with intravenous immunoglobulin. Several different pharmacological approaches have been studied as far as the treatment of neonatal jaundice. Of these, the focus of attention in recent years has been on the haem oxygenase inhibitors (metal meso- and protoporphyrins). These are effective inhibitors of bilirubin production and have been shown to significantly reduce peak serum bilirubin levels in several clinical trials, both when used prophylactically and therapeutically. However, questions remain regarding long-term safety, as well as the advisability of whole-scale inhibition of bilirubin production. Nevertheless, in selected infants with a high risk of severe jaundice, the use of haem oxygenase inhibitors may be acceptable. Pharmacotherapy in jaundiced infants is fraught with risks, as many drugs may increase the entry of bilirubin into the brain and presumably, the risk for neurotoxicity. Both the displacement of bilirubin from its albumin binding and interference with the function of phosphoglycoprotein in the blood–brain barrier are documented mechanisms in this respect.     

老年高血压的药物治疗

本文摘译自COCHRANE L-BRARY 2004年2期“Pharmacotherapy for Hypertension in the Elderly”。以系统评价的方式对迄今为止已发表和未发表的老年高血压药物治疗的临床试验结果，按临床流行病学和循证医学文献评价的原则和方法，以及COCHRANE协作网文献质量要求，筛选出符合质量标准的文献进行定量合成，从而获得更可靠的老年高血压药物治疗证据(A级)，指导临床实践。     

西部医药发展对策的研究

中国人口近四分之一居住在西部地区，全国５５个少数民族人口的８５％都居住在中国西部。总体上来说，西部地区教育水平较低，加上历史原因和地域的限制，西部地区的医药业较东部及沿海发达地区相对落后。中央决定实施并加快西部大开发步伐，这对西部地区乃至全国都是一次绝佳的发展机遇。 西部医药概况 西部医药工业。就医药工业而言，西部总体来说低于全国平均水平，更低于东部及沿海发达地区。据《中国药学年鉴》２０００年卷报道，全国医药工业总产值平均增长速度为１５．４％，而西部医药工业总产值增长速度为１３．５５％，较平均增长…     

网络故障时门诊药房紧急行动预案探讨

目的为医院网络故障时门诊药房的紧急应对提供参考。方法分析医院在网络故障发生时的具体情况,从门诊药房紧急行动预案的制定、可行性、实施等方面进行探讨。结果门诊药房做好传统手工模式和网络模式之间的切换是关键。结论预先制定紧急预案可避免给医院和患者带来双重损失。     

Addressing Competencies for the Future in the Professional Curriculum

This paper reviews the literature, analyzes current and future practice, develops a list of competencies necessary for future pharmacists, and provides recommendations to pharmacy''s academic enterprise regarding curricula of the future. Curricula of the future will center around 3 functional roles for pharmacists: patient-centered care, population-based care, and systems management; and must also foster the development of 5 cross-cutting abilities in student pharmacists: professionalism, self-directed learning, leadership and advocacy, interprofessional collaboration, and cultural competency. Future curricula must be developed in an evidence-based manner, focus less on information storage and retrieval, engage student pharmacists in a variety of highly interactive learning experiences, and expand experiential learning opportunities throughout all years.