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Jingdong book

药剂学(第4版)

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药剂学(第4版)

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《药剂学(第4版)》本着药剂学是一门综合性应用学科的宗旨,在编写中注重阐明药剂学的基本知识、技术与理论,注重反映现代药物制剂研发及生产的实践,严格遵循目前药品管理法律法规。同时,在编写中也努力涵盖新型药物剂型与新制剂的发展,以及药剂学与相关学科日益紧密的衔接。
Author Description

平其能,生于1946年8月,江西省南丰县人,中国药科大学教授。曾任药剂学教研室主任、药学院院长、校学位委员会副主席,中国药学会常务理事、药剂专业委员会副主任委员,江苏省药学会常务理事、药剂专业委员会主任委员,曾受聘为中国军事医学科学院毒物与药物研究所、江西中医学院、河南大学客座教授。是《药学学报》、《J Pharmacy Pharmacology》、《PDA Pharm Science Tech》等12种国内外期刊编委。长期从事药剂学教学和药物新剂型、新技术研究,承担国家和部省级科技课题28项和企业产品研发项目50多项。开设和讲授药剂学、物理药剂学、药用高分子材料学、现代药剂学等课程。培养药剂学博士52人,社会与管理药学博士7人,药剂学硕士180余人。主编《现代药剂学》、《药剂学发展与展望》、《中药成分胃肠转运与剂型设计》等6本,副主编、参编《药剂学》等5本,发表国际期刊论文80篇,国内期刊论文300多篇。享受国务院特殊津贴,获全国优秀教师和江苏省优秀研究生导师荣誉称号、国家级教学成果二等奖和江苏省教学成果一等奖、国家优秀科技图书二等奖、江苏省及湖北省科技进步二等奖,新药证书9种,授权中国发明专利14项。

屠锡德,生于1931年2月,浙江黄岩人,1955年毕业于浙江医学院药学系,1958年南京药学院(现中国药科大学)药剂学研究生毕业并留校任教,1986年晋升为教授,原药剂学教研室主任。曾任《药学学报》编委,卫生部第七届药典委员会委员。长期从事药剂学和生物药剂学的教学和科研工作。先后给本科生、国内外研究生开设《药剂学》、《生物药剂学》和《药剂学选论》等课程。主编《生物药剂学》、《药剂学》,副主编《药剂学》和《工业药剂学》、《药剂学》等著作6部。培养国内外研究生55名,博士生2名。1974年以来主要研究生物药剂学及单方和复方的缓释控释制剂。主持并完成“七五”、“八五”国家重点科技攻关缓释控释制剂项目两项,省、部级缓释控释制剂各一项,自选课题多项。获新药证书13本。1989年被评为全国优秀教师,1991年被评为江苏省优秀研究生教师,1996年获江苏省教委“红杉树”园丁银质奖章。曾获省级缓释控释制剂二等奖三项、三等奖一项,市级一等奖和三等奖各一项,1992年起享受国务院特殊津贴。

张钧寿,博士生导师。曾任中国药科大学药剂研究室主任。现为江苏省新药评审委员。教学上,承担过硕士和博士等多层次的教学工作,指导过师资进修班,朝鲜和越南进修生,至今已指导博士10名,硕士59名。2000年获省优秀课程一等奖(本人排名第一)。主编了全国执业药剂师资格考试培训教材1996年版《药剂学》;联合主编第3版《药剂学》。科研方面主持过国家重点项目——“七五”、“八五”、“九五”攻关课题共六项。在缓控释制剂、结肠定位释药系统、水性包衣技术、含药纳米乳、气雾剂CFC替代等领域里有较深入的研究。申请专利十项(已获得专利证书三项),发表论文一百余篇。1995年获江苏省教委颁发的科技先进工作者称号;研发的高效尼莫地平胶囊剂与双氯芬酸钠缓释胶囊(英太青)分别获国家医药局96’、97’科技进步三等奖。
Catalogue

第一章 总论
第二章 溶解与溶出现象
第三章 表面现象与表面活性剂
第四章 药物的多晶型现象
第五章 流变学基础与应用
第六章 粉体学基础与应用
第七章 药物制剂的稳定性
第八章 提取与分离
第九章 粉碎与混合
第十章 浓缩与干燥
第十一章 冷冻干燥技术
第十二章 灭菌法
第十三章 药剂的着色与矫味
第十四章 液体药剂
第十五章 注射剂
第十六章 输液剂
第十七章 眼用制剂
第十八章 散剂与颗粒剂
第十九章 片剂
第二十章 胶囊剂
第二十一章 软膏剂
第二十二章 栓剂
第二十三章 干粉吸人剂、气雾剂和雾化剂
第二十四章 浸出药剂
第二十五章 硬膏剂
第二十六章 丸剂
第二十七章 膜剂、海绵剂、骨蜡和中药传统剂型
第二十八章 注射给药系统
第二十九章 口服缓释与控释给药系统
第三十章 口服速释给药系统与相关新技术
第三十一章 经皮给药系统
第三十二章 鼻腔给药系统
第三十三章 制剂辅料的应用
第三十四章 药用功能高分子材料
第三十五章 制剂包装材料与包装设备
第三十六章 药物吸收
第三十七章 药物分布
第三十八章 药物代谢
第三十九章 药物排泄
第四十章 药物制剂的生物利用度
第四十一章 药动学
Book Abstract

资料7药学研究资料综述,即申请药物的药学研究(合成工艺、剂型选择、处方筛选、结构确证、质量研究和质量标准制定、稳定性研究等)的试验和国内外文献资料的综述。
资料8原料药生产工艺的研究资料,包括工艺流程和化学反应式、起始原料和有机溶媒、反应条件(温度、压力、时间、催化剂等)和操作步骤、精制方法、主要理化常数及阶段性的数据积累结果等,并注明投料量和收得率以及工艺过程中可能产生或引入的杂质或其他中间产物,尚应包括对工艺验证的资料。
资料10质量研究工作的试验资料及文献资料。
资料11药品标准及起草说明,并提供标准品或者对照品。
资料12样品的检验报告书。
资料13原料药、辅料的来源及质量标准、检验报告书。
药用辅料在《中华人民共和国药品管理法》(简称《药品管理法》)中的定义:除了主要药物活性成分以外一切物料的总称,是药物制剂的重要组成成分。
国际药用辅料协会(IPEC)将辅料定义为:药物制剂中经过合理的安全评价的不包括有效成分或前体的组分,它的作用包括:在药物制剂制备过程中有利于成品的加工;提高药物制剂的稳定性、生物利用度和患者的顺应性;有助于从外观上鉴别药物制剂;改善药物制剂在贮藏或应用时的安全性和有效性。
药用辅料数在不同国家、地区的使用有较大的区别,我国约有543种药用辅料用于制剂中。它们是不同种类的化合物,从简单分子(水)到复杂的天然产品,半合成产品或合成产品的混合物,大致可被分为3类。第一类为被认可的辅料:源于食品工业(通常被认为是安全的:美国FDA列入GRAS)或者应用于制药工业中已经有相当长的时间;第二类:新辅料,包括通过对已证实或已用于食品或化妆品工业的辅料进行结构修饰得来的材料;第三类:为新化合物,它们从未被用于制药领域。2010年版《中国药典》共收载132种药用辅料。
辅料标准由于历史原因,来源不一,标准参差不齐,需调研及进行大量实验室复核工作。主要依据标准有:①《药品管理法》第十一条;②《中华人民共和国药品管理法实施条例》;③《国务院对确需保留的行政审批许可的决定》。
资料14药物稳定性研究的试验资料,包括影响因素试验、采用直接接触药物的包装材料和容器共同进行的稳定性试验。
资料15直接接触药品的包装材料和容器的选择依据及质量标准。
资料27非临床药动学试验资料及文献资料。包括所申请药物的体外和体内(动物)药动学(吸收、分布、代谢、排泄)试验资料和文献资料。
溶出度对于剂型选择、处方筛选、质量研究和质量标准制定、稳定性研究及体内吸收研究等具有重要指导意义。而药物制剂生物等效性试验已成为国内外药物仿制或移植品种的重要评价内容,也成为药物制剂开发研究中最有价值的评价指标而广泛应用。现就制剂处方工艺、稳定性、溶出度、生物利用度4项内容作概念性介绍。细节将在本书有关章节中专门讨论。
……

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