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
內容試閱：
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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