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药物质量控制与检测技术

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Jingdong book

药物质量控制与检测技术

Name: 药物质量控制与检测技术
Brand: Jingdong book
SKU: 3117005351
Price: 27.15 USD
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《药物质量控制与检测技术》是多所院校老师和企业人员集体智慧的结晶，融入了新的标准，精选实用案例。

Content Description

《药物质量控制与检测技术》从职业岗位需求出发，围绕药物制剂生产链将药品质量控制重心前移至生产过程中，通过强化药品生产过程控制来保证药品质量，构建“原料药入厂检验—制剂生产过程监控--成品检验”的一体化符合生产岗位群特点的教材体系。教材内容紧跟我国新版《中国药典》、《GMP》与《国家药品安全“十二五”规划》等新的标准、新要求，融合了《药物质量检测技术》国家精品课程及国家教学资源库的建设成果，有配套的数字化教学资源。
教材即可作为高职高专药品质量检测技术、化学制药技术、药物制剂技术、药学等专业的药物质量检测技术课程讲授教材，也可作为医药行业的职业培训教材或药物检验初级、中级、高级工考试培训教材，同时对广大药品检验工作者以及兽药、化妆品及食品等行业的检验工作者也将起到一定的参考作用。

Author Description

张佳佳，浙江医药高等专科学校，教授/药学院院长，张佳佳，女，中共党员，2013“感动宁波高校十大人物”，浙江省教坛新秀；省“新世纪151人才”第三层次；宁波市领军和拔尖人才第二层次；宁波市企业技术创新团队负责人；国家执业药师工作专家。
教学效果：
先后获得全国教师教学比赛一等奖两项、创新奖一项，浙江省青年教师教学技能比赛奖一项。
教学改革：
近年来主持了精品课程、教学资源库子项目、浙江省精品课程等各级各类教研教改项目5项。完成了精品课程转型升级，改革成果获得宁波市教学成果一等奖，受教育部委托在2010、2011年全国高职骨干教师培训班宣讲课程教学改革理念。
积极开展数字化教学资源建设，主持开发的仿真教学软件及网络课程获得全国职业院校信息化教学大赛一等奖、浙江省教学软件比赛一等奖及浙江省网络课程比赛二等奖，为教学建设节约仪器购置和维护经费数十万元。
科学研究：
近年来主持浙江省自然科学基金、浙江省科技厅公益项目、宁波市自然科学基金、宁波市工业择优委托重大项目等各级各类纵向科研项目7项，核心期刊发表学术论文20余篇，申请国家发明专利9项，获得宁波市科技进步奖二等奖一项，浙江省高等学校科研成果三等奖一项。
社会服务：
主持研发的抗肿瘤活性成分黑乳海参皂苷nobilisideB1实现销售额3200万元，新增利税736万元。该成果拥有自主知识产权，填补了国内海参三萜皂苷类药物治疗肿瘤的空白。作为宁波市首批企业技术创新团队负责人，主持完成了“固液混悬空化萃取三叶青总黄酮”项目获得宁波市发明创新大赛银奖。

Catalogue

模块一药品检验的知识储备 / 1
学习情境一药品检验的工作性质及工作任务1
学习情境二药品质量标准和检验操作规程8
学习情境三常用容量仪器的洗涤、检定及使用方法15
学习情境四检验误差、有效数字及检验报告书26
学习情境五OOS的调查与分析33
模块二分析样品前处理技术 / 39
学习情境一中药样品的前处理技术39
学习情境二生物样品的前处理技术42
学习情境三药品质量标准分析方法验证47
模块三药品专项检测技术 / 53
项目一药物性状检测53
学习情境一旋光度测定法53
学习情境二折射率测定法58
学习情境三熔点测定法62
项目二药物鉴别技术75
学习情境一化学鉴别法75
学习情境二光谱鉴别法79
学习情境三色谱鉴别法83
项目三药物杂质检查技术87
学习情境一药物杂质检查87
学习情境二一般杂质检查90
学习情境三特殊杂质检查法107
项目四药物制剂检查技术115
学习情境一崩解时限检查法115
学习情境二重量差异和装量差异检查法119
学习情境三最低装量检查法123
学习情境四含量均匀度检查法126
学习情境五溶出度测定法130
学习情境六可见异物检查法138
项目五容量分析法测定药物的含量149
学习情境一酸碱滴定法154
学习情境二氧化还原滴定法159
学习情境三配位滴定法165
学习情境四非水溶液滴定法170
项目六仪器分析法测定药物的含量180
学习情境一紫外可见分光光度法在药品含量测定中的运用180
学习情境二高效液相色谱法在药品含量测定中的运用186
学习情境三气相色谱法在药品含量测定中的运用191
模块四药物检验综合实例 / 197
学习情境一原料药全检197
学习情境二中间产品的检验225
学习情境三片剂的全检229
学习情境四注射剂的全检241
学习情境五胶囊剂全检250
学习情境六乳膏全检271
学习情境七复方制剂全检283
参考文献 / 292

Introduction

本教材内容紧跟2015年版《中华人民共和国药典》与2010年版《GMP》的新标准、新要求，融合了《药物质量检测技术》国家精品课程及国家教学资源库的建设成果，以“模块、项目、学习情境”组织教材的理论内容，以“教案例、学案例、做案例”组织教材的技能部分，以“背景知识、职业拓展”组织教材的拓展部分，构建了组合型新体例。
全书共分四个模块，37学习情境。内容涵盖：药物分析与检验概述、药品质量和质量标准、药物鉴别、药物杂质检查、药物含量测定、药物制剂分析与检验实例。编写与现行药品质量标准、执业药师考试、职业技能鉴定及质检岗位紧密相连。注重对学生基本实验操作技能的训练，通过一定学时的专项药物检验综合实例学习，使学生对实际工作有感性认识，初步具备独立完成药品检验工作的能力，突出高职高专培养重实践的特点。
本教材由浙江医药高等专科学校、辽宁医药职业学院、四川化工职业技术学院、河北化工医药职业技术学院、山东医学高等专科学校、山东药品食品职业技术学院、山西药科职业技术学院、浙江华海药业股份有限公司、山西省药品检验研究院联合编写，融合了多所国家、省市示范校的课程建设成果及企业行业先进技术标准。
本书既可作为高职高专药品质量检测技术、化学制药技术、药物制剂技术、药学等专业的药物质量检测技术课程教材，也可作为医药行业的职业培训教材或药物检验初级、中级、高级工考试培训教材，同时对广大药品检验工作者以及兽药、化妆品及食品等行业的检验工作者也将起到一定的参考作用。
本教材目前属于初创阶段，加之编写时间仓促、水平有限，书中不妥之处在所难免，恳请广大师生批评指正。
编者
2015年8月

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