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藥品快速檢測技術(shù)研究與應(yīng)用(英文版)

藥品快速檢測技術(shù)研究與應(yīng)用(英文版)

定 價:¥298.00

作 者: 金少鴻 著
出版社: 化學工業(yè)出版社有限公司
叢編項:
標 簽: 暫缺

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ISBN: 9787122338532 出版時間: 2019-06-01 包裝: 精裝
開本: 16開 頁數(shù): 字數(shù):  

內(nèi)容簡介

  《藥品快速檢測技術(shù)的研究與應(yīng)用(英文版)》為國家十三五重點出版物,對化學藥品的快速檢測理論與方法進行了詳細的闡述,收錄了化學藥品近紅外快速分析技術(shù)和HPLC的快速檢測方法。本書由部門編寫,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。

作者簡介

  金少鴻,中國食品藥品檢定研究院,前副所長、研究員。從事化學藥品檢定工作30多年,是我國藥品檢定方面的專家。曾任中國藥品生物制品檢定所常務(wù)副所長、國家食品藥物監(jiān)督管理局藥品評價中心主任等職務(wù)。從事藥品質(zhì)量分析研究30年中,共獲國家科技進步獎3項,省部級科技進步獎8項。擔任中國藥學會理事、中國藥學會抗生素分科學會副主任委員、中國藥典委員會抗生素專業(yè)委員會主任委員、國家藥品監(jiān)督管理局藥品審評專家、農(nóng)業(yè)部獸用藥品審評委員、WHO西太區(qū)耐藥性監(jiān)測網(wǎng)監(jiān)測員、世界衛(wèi)生組織國際藥典和藥品專家委員會委員。同時,兼任《中國抗生素雜志》、《藥物分析雜志》、《中國藥事》、《中國新藥雜志》、《中國抗感染化療雜志》、《中國臨床藥理學雜志》等雜志編委。

圖書目錄

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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