药物分析-诸论-2012幻灯片.pptVIP

Introduction Definition Drugs are special products used for prevention and therapy of diseases, and for promotion of the functionality of human body. particularity of drug The Dual character specificity Extreme importance - quality control Professional Pharmaceutical Analysis Pharmaceutical analysis is an applied science dealing with the establishment and development of quality control methods of drugs and their preparations. Importance Analysis of drugs and Quality control are very important means to guarantee their safe and effective use. The relationship between Pharmaceutical Analysis and Analytical Chmistry. The key is analysis. Duties Duties Duties Difficulities Complicated ingredient：Chinese tratidional medicine The amount is very small（microamount, trace amount)。 The tendency of modern pharmaceutical analysis 药品管理理念 分析对象 分析技术 Drug Standardization Pharmacopoeia of the People’s Republic of China(，Chinese Pharmacopoeia, Ch.P ) （中华人民共和国药典，简称中国药典）-National drug standards Ministerial Drug Standards（国家药品标准，简称为局标准）-as supplements to the national pharmacopoeia Chinese Pharmacopoeia A legal technological specification。 Nine History of Ch.P Since the founding of China, eight edition:1953、1963、1977、1985、1990、1995、2000 ,2005 and 2010. The ninth edition is 2005。 Chinese Pharmacopoeia Commission。 History of Chp 1953年 531 monographs of drugs 1963 1310 monographs (Volume I and II) 1977 1925 monographs 1985 1489 monographs （English version) 1990 1751 monographs （临床用稿须知，药品红外光谱集） 1995 2375 monographs （中药彩图） 2000 2691 monographs （首次收载指导原则） 2005 3214 monographs, with 525 new admissions（Volume I, II and III） 2010 4567 monographs (volume I: 2165; volume II: 2271; volume III: 131) 《中国药典》（2010版） Ch.P.(2010版）2010年1月出版，10月1日正式实施。 Main methods of seven Ch.P 历版药典含量测定中HPLC的使用情况 USP The Pharmacopoeia of the United States of American (USP) The newest edition is USP(34)-NF(29) (The National Formulary (NF) Publication date: Novem