药品快速检测技术研究与应用（英文版） 下载 极速 rtf epub 在线 word txt pdf

《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。

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

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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编辑推荐

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。

书摘插图

前言

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.