藥品快速檢測(cè)技術(shù)研究與應(yīng)用（英文版）
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- 作者：金少鴻 主編 李波、胡昌勤、尹利輝 副主編
- 出版時(shí)間：2019/6/1
- ISBN：9787122338532
- 出 版 社：化學(xué)工業(yè)出版社
- 中圖法分類：R927.11
- 頁(yè)碼：354
- 紙張：
- 版次：01
- 開本：小16開精
《藥品快速檢測(cè)技術(shù)的研究與應(yīng)用（英文版）》為國(guó)家十三五重點(diǎn)出版物，對(duì)化學(xué)藥品的快速檢測(cè)理論與方法進(jìn)行了詳細(xì)的闡述,收錄了化學(xué)藥品近紅外快速分析技術(shù)和HPLC的快速檢測(cè)方法。本書由權(quán)威部門編寫,內(nèi)容原創(chuàng)。適用于從事藥物質(zhì)量監(jiān)督與管理的人員。
金少鴻，中國(guó)食品藥品檢定研究院，前副所長(zhǎng)、研究員。從事化學(xué)藥品檢定工作30多年，是我國(guó)藥品檢定方面的專家。曾任中國(guó)藥品生物制品檢定所常務(wù)副所長(zhǎng)、國(guó)家食品藥物監(jiān)督管理局藥品評(píng)價(jià)中心主任等職務(wù)。從事藥品質(zhì)量分析研究30年中，共獲國(guó)家科技進(jìn)步獎(jiǎng)3項(xiàng)，省部級(jí)科技進(jìn)步獎(jiǎng)8項(xiàng)。擔(dān)任中國(guó)藥學(xué)會(huì)理事、中國(guó)藥學(xué)會(huì)抗生素分科學(xué)會(huì)副主任委員、中國(guó)藥典委員會(huì)抗生素專業(yè)委員會(huì)主任委員、國(guó)家藥品監(jiān)督管理局藥品審評(píng)專家、農(nóng)業(yè)部獸用藥品審評(píng)委員、WHO西太區(qū)耐藥性監(jiān)測(cè)網(wǎng)監(jiān)測(cè)員、世界衛(wèi)生組織國(guó)際藥典和藥品專家委員會(huì)委員。同時(shí)，兼任《中國(guó)抗生素雜志》、《藥物分析雜志》、《中國(guó)藥事》、《中國(guó)新藥雜志》、《中國(guó)抗感染化療雜志》、《中國(guó)臨床藥理學(xué)雜志》等雜志編委。
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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