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| 編輯推薦： |
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本书是十三五国家重点出版项目，书中内容具有原创性，对推广药品快检技术有积极意义。
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| 內容簡介： |
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《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。
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| 關於作者： |
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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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| 目錄：
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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
-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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| 內容試閱：
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The spread of substandard and falsified SF medicines,
as defined by the World Health Organization WHO, has been and continues to be
a growing global concern. SF is a global public health threat that has grown
fast in recent years due to more sophisticated counterfeiting methods and
remarkable similarity of falsified products to the genuine ones, which deceive
health professionals as well as patients. Their prevalence in the public,
private and informal market sectors threatens global public health by
jeopardizing patient safety, diminishing
confidence in health systems, increasing treatment failure, wasting valuable
resources and contributing to the development of drug resistance. Eliminating
SF is a considerable public health challenge. In order to detect poor quality
medicines, developing countries urgently need quick, easy-to-use and effective
screening methods to detect poor quality medicines throughout the supply chain
and in the field of rural areas.
In order to combat the SF and to protect the health of people living in rural
areas, following the instruction of the National Medical Products
Administration NMPA China, the National Institutes for Food and Drug Control
NIFDC collaborating with several provincial and district drug testing
institutes have been studying and developing a number of rapid drug testing
technologies which could be used at manufacturing plants, in the field, in
warehouses, at border crossings, and in pharmacies to empower regulators,
manufacturers, distributors, pharmacies, procurement agencies and other
stakeholders to screen for medicines.
The Rapid Drug Detection Technology RDDT described in this book
includesnoninvasive near-infrared NIR spectroscopy method and rapid HPLC
analysis. The main screening method is based on a NIR spectrometer and a
pre-developed standard library of NIR spectra of selected commonly used
pharmaceutical products in China. The confirmation method is based on patented
green HPLC system and a pre-developed database. RDDT has been widely used in
China, almost covered the whole geographical territory. Due to the simple, fast
and easy-to-grasp features on operation, RDDT is capable of rapid screening
chemical medicines and discriminating illegal chemicals in Chinese patent
drugs. In this case, making RDDT more accessible will have a great help on
controlling the proliferation of counterfeit and substandard medicine.
This book is a summary of the experiences and achievements of RDDT acquired
from our hands-on practices which could be used as teaching material for
technical staffs working in basic level drug supervision and also could be
served as reference book for drug regulatory authorities.
I sincerely wish the publication of the English version of this book would be
promoting the further development and application of RDDT and making these
technologies more accessible will help control the proliferation of SF
medicines to protect global public health.
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