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药品快速检测技术研究与应用(英文版)

药品快速检测技术研究与应用(英文版)

出版社:化学工业出版社出版时间:2019-06-01
开本: 16开 页数: 354
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药品快速检测技术研究与应用(英文版) 版权信息

  • ISBN:9787122338532
  • 条形码:9787122338532 ; 978-7-122-33853-2
  • 装帧:暂无
  • 版次:暂无
  • 册数:暂无
  • 重量:暂无
  • 印刷次数:暂无
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药品快速检测技术研究与应用(英文版) 本书特色

《药品快速检测技术的研究与应用(英文版)》为国家十三五重点出版物,对化学药品的快速检测理论与方法进行了详细的阐述,收录了化学药品近红外快速分析技术和HPLC的快速检测方法。本书由权威部门编写,内容原创。适用于从事药物质量监督与管理的人员。

药品快速检测技术研究与应用(英文版) 内容简介

《药品快速检测技术的研究与应用(英文版)》为国家十三五重点出版物,对化学药品的快速检测理论与方法进行了详细的阐述,收录了化学药品近红外快速分析技术和HPLC的快速检测方法。本书由很好不错部门编写,内容原创。适用于从事药物质量监督与管理的人员。

药品快速检测技术研究与应用(英文版) 目录

Rapid Analysis of Chemical Drugs Using the Near-infrared Spectroscopic Technology



Chapter 1 NIR Spectrometer / 7

Classification and Characteristics of NIR Spectrometer / 7

Key Performance Indicators of NIR Spectroscopic Instrument / 11

Acquisition of NIR Spectrum / 16

NIR Spectrometer in Mobile lab / 17



Chapter 2 Introduction Near-infrared Analysis Methods / 20

Spectral Data Preprocessing Methods / 21

Qualitative Analysis Method  / 25

Cluster Analysis / 31

Quantitative Analysis / 35

Conformity Test Analysis / 45

Correlation Coefficient Analysis / 49

Methods of Model Transfer  / 52



Chapter 3 Application of NIR Methods in Drug Analysis / 58

Analysis of Antibiotics Using NIR Methods / 59

CASE STUDY 1  Establishment of Qualitative NIR Models for the Analysis of Cephalosporin Injection Powder Products / 61

CASE STUDY 2  Rapid Determination of Cefuroxime Sodium Content Using NIR Analysis / 66

CASE STUDY 3  Construction of a Universal NIR Model for Quantitative Analysis of Cefradine Capsules / 73

CASE STUDY 4  Development of a Universal NIR Model for Quantitative Analysis of Phenoxymethylpenicillin Potassium Tablets / 79

CASE STUDY 5  Universal NIR Models for the Quantitative Analysis of Ceftriaxone and Water Contents in Ceftriaxone Sodium Injection Products / 85

Analysis of Chemical Drugs Using NIR Methods / 96

CASE STUDY 6  Construction of a Quantitative Model for Simvastatin Tablets / 98

CASE STUDY 7  NIR Models for Quantitative Analysis of Aminosalicylate and Water Contents in Sodium Aminosalicylate Injections / 102

CASE STUDY 8  Rapid Analysis of Potassium Dehydroandrographolide Succinate Injection Using NIRDRS  / 108

CASE STUDY 9  NIR Identification and Analysis of Compound Paracetamol and Amantadine Hydrochloride Tablets  / 115

Application of NIR Spectroscopy in the Analysis of Traditional Chinese Medicines (TCM) / 120

CASE STUDY 10  Establishment of a Qualitative NIR Model for Cortex Magnoliae officinalis / 122

CASE STUDY 11  Analysis of Water Content in Liuwei Dihuang Pills Using NIR Spectroscopy / 129

CASE STUDY 12  Qualitative Analysis of Different Brands of Jianwei Xiaoshi Tablets Using NIR Spectroscopy / 131

CASE STUDY 13  Identification of Decoction Pieces of Common Yam Rhizome by NIR Method  / 133

NIR Analysis of Illegal Additives in Medicinal Products / 143

CASE STUDY 14  Illegal Addition of Sildenafil Citrate into Chinese Patent Medicine / 144

CASE STUDY 15  Norfloxacin Addition in Lopermide Hydrochloride Capsules / 146

CASE STUDY 16  NIR Correlation Analysis of Illegal Added Phenformin Hydrochloride in Chinese Patent Medicines / 147

NIR Analysis of Liquid Formulations  / 152

CASE STUDY 17  Construction NIR Quantitative Model for Glucose Injection  / 154

Applications of NIR Methods on Mobile Laboratory Vehicles  / 161

CASE STUDY 18  The Establishment and Application of Blank Models Used for Spectra Comparison  / 164

CASE STUDY 19  Establishment and Application of the Characteristic Spectral Range Screening Method  / 171



Chapter 4 Prospect of NIR Analysis Methods / 184

Development Prospect of NIR Analytical Instruments  / 185

Prospect of the Application of NIR Analysis Method  / 186

Prospect of NIR Analysis Methods being Listed in the National Drug Standards of Different Countries / 190

References / 192



Rapid HPLC Forensic Analysis of Chemical Medicines



Chapter 5  Basic Principles and Methods for Rapid HPLC Analysis / 202

Identification  / 202

Content Determination / 202

Establishment and Validation of the Rapid HPLC Forensic Method / 203



Chapter 6 Applications of Rapid HPLC Analysis / 220

β-lactam Antibiotics / 221

Macrolide Antibiotics / 257

Quinolone Antibiotics  / 276

Adrenocortical Hormone Drugs / 290

Sex Hormone Drugs / 306

Antidiabetic Drugs / 318

Calcium Channel Blockers / 332



Chapter 7 Progress of Rapid HPLC Analysis / 347

Establishment of Reference Database and Applications / 347

Rapid Analysis by LC-MS / 349



References / 353
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药品快速检测技术研究与应用(英文版) 作者简介

金少鸿,中国食品药品检定研究院,前副所长、研究员。从事化学药品检定工作30多年,是我国药品检定方面的专家。曾任中国药品生物制品检定所常务副所长、国家食品药物监督管理局药品评价中心主任等职务。从事药品质量分析研究30年中,共获国家科技进步奖3项,省部级科技进步奖8项。担任中国药学会理事、中国药学会抗生素分科学会副主任委员、中国药典委员会抗生素专业委员会主任委员、国家药品监督管理局药品审评专家、农业部兽用药品审评委员、WHO西太区耐药性监测网监测员、世界卫生组织国际药典和药品专家委员会委员。同时,兼任《中国抗生素杂志》、《药物分析杂志》、《中国药事》、《中国新药杂志》、《中国抗感染化疗杂志》、《中国临床药理学杂志》等杂志编委。

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