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药品快速检测技术研究与应用（英文版）
作者：金少鸿 著
出版社：化学工业出版社有限公司
出版时间：2019-06-01
ISBN：9787122338532
定价：¥298.00
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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。
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。
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
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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