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抗生素质量分析研究(Quality analysis of antibiotics)
抗生素质量分析研究(Quality analysis of antibiotics)
Abstract: the paper introduces the application characteristics of antibiotic loaded varieties collected China Pharmacopoeia 2010 edition and the new technology and new method in the new edition of the Pharmacopoeia; and drug registration requirements of international coordination technology will ICH the latest addition to the guiding principle is introduced; the anti several major misunderstanding in the development of varieties of pigment China is also briefly introduced the latest developments of antibiotics; analysis method.
Key words: Chinese Pharmacopoeia 2010 Edition; international registration of human drugs registration requirements (ICH); misunderstandings; new trends of analysis methods
Advances, in, quality, analysis, of, antimicrobial, agents
ABSTRACT This paper revieued as follows: (1) the characteristics of antimicrobial agents monographs and the application of new techniques and methods used in the Chinese Pharmacopoeia 2005 Edition; (2) the recent relevant additional guidelines issued by International Conference on Harmonization (ICH); (3) the key domain mistakes of consciousness found in the research and development of antimicrobial agents in domestic market; (4) the recent advances in quality analysis of antimicrobial agents.
KEY WORDS The Chinese Pharmacopoeia edition; International Conference on Harmonization (ICH); Domain mistakes of consciousness; Advances in methods analytical
Antibiotic drugs is one of the most widely used in clinical medicine, play an extremely important role in the treatment of infectious diseases, its quality is directly related to the drug in clinical use is safe and effective. With the development of science and technology, the application of modern analytical techniques and instruments of antibiotics and the quality analysis efforts of workers, in China in recent years the research of antibiotic quality has made many new progress, promote the development of our country to impro
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