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Amphotericin B and its degradation products by HPLC and microbiological assay results of the magnitude of the unified determination

Author: WangYongHong
Tutor: HuChangQin;ShaoRongGuang;SongDanQing
School: Peking Union Medical College , China
Course: Microbial and Biochemical Pharmacy
Keywords: Amphotericin B Degradation products Structure confirmation Microbiological assay HPLC method
CLC: R927.2
Type: PhD thesis
Year: 2010
Downloads: 211
Quote: 2
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Abstract


Antibiotics is caused by bacteria, fungi or other microorganisms generated during the life with anti-pathogen or a class of other active substances, with the low concentration he selectively inhibit or kill microbes or tumor cells. Since 1941 penicillin used clinically since the parties microbiologists and biochemists efforts, so far, has been found in many types of antibiotics has reached thousands of species. According to the U.S. Centers for Disease Control file information, the current clinical use of antibiotics have more than one hundred and fifty kinds, efficacy related to anti-tumor, anti-fungal, anti-viral, anti-Gram-negative bacteria and so on. Its structure can be divided into: penicillins, cephalosporins, fosfomycin class, vancomycin class, rifamycin, polymyxin class, amino sugars, tetracyclines, macrolides, etc. . Polyene macrolide antibiotics as an important component of antibiotics in clinical use, occupy a pivotal position, commonly used in clinical polyene antibiotic nystatin, trichostatin, amphotericin B, etc., in which amphotericin Su B is mainly used for fungal infections. Polyene antibiotics, poor solubility, aggregation phenomena can occur. Since the complex structure, nature unstable, so the research is relatively slow. Amphotericin B through the clinical application of visit, I found that they are still in the treatment of fungal infection plays an irreplaceable role, so scientists from various countries for its determination, side effects, pharmacokinetics, and clinical applications to make unremitting Research and Exploration. Polyene antibiotics have similar mechanisms of action, through the cell membrane and fungal sterol binding, changes in membrane permeability, resulting in the outflow of the contents so that the membrane fungal cells. Domestic and foreign reports about the method for the determination of colorful, in addition to the pharmacopoeia microbiological assay, as well as new HPLC method, spectrophotometry and so on. Impurity control its little research is to further research efforts in the direction. Amphotericin B is a nodular Streptomyces (Streptomyces nodosus) produce a broad-spectrum anti-fungal antibiotic seven alkenes, MF C47H73NO17, its antifungal activity in 1956 was discovered in 1960 in the amphotericin B clinically used to treat a variety of fungal such as Candida albicans, Cryptococcus neoformans, Aspergillus and other causes of cardiac or systemic infection. For certain serious fungal diseases such as Cryptococcus neoformans meningitis, invasive aspergillosis, especially for immune deficiency or severe neutropenia treatment of patients as well as some endemic mycoses such as coccidioidomycosis, histoplasmosis fungal disease, dermatitis blastomycosis, etc. still apply amphotericin B, so far is a lot of deep fungal infections in critically ill treatment drug of choice, there is no appropriate alternative drugs, it has been hailed as the \In view of amphotericin B in clinical applications important position, the thesis of degradation products of amphotericin B for a more systematic study to explore, to get as much information impurities. Accelerated destruction under different conditions to obtain different amphotericin B degradation products and by appropriate separation means to be separated and purified measuring UV, NMR, MS data for the structural identification. For one of the degradation products of amphotericin B (5) We conducted a more systematic and comprehensive study, the use of microbial activity titer determination, and through the determination of the zebrafish animal model of its toxicity. This thesis is another important research purified by preparative liquid chromatography pure batch of amphotericin B, amphotericin B for establishing a simple and efficient HPLC method is superior to the EP and its method validation, The measured results and microbial purity HPLC potency assay results were unified measure, easy to use HPLC method replaces cumbersome and complex microbiological assay measuring the potency of amphotericin B, amphotericin B, so that the quality control is more convenient, rapid and reliable.

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CLC: > Medicine, health > Pharmacy > Pharmacopoeia Codex ( formulary ),drug identification > Drug identification > Determination of drug content
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