利用qbd理论建立注射用阿奇霉素杂质谱的质控研究方法-establishing quality control research method of azithromycin impurity spectrum for injection by qbd theory.docxVIP

PAGE PAGE 10 关键词：QbD；注射用阿奇霉素；杂质谱；质量控制；液相色谱 Abstract In recent years, drug quality control model is changing constantly, after the long-term view that drug quality is injected into the products by testing, the QbD theory(Quality-by-Design, short QbD) that the drug quality is by design given becomes maturity. QbD theory advocates to understand the products and processes based on control strategies through the entire process to produce high-quality products.Quality control of this active thinking mode of drug administration and drug evaluation has injected new vigor, and with people for the concept of deepening understanding, QbD theory application is becoming more widespread. The rapid development of chromatographic theory create the possibility for the combination of the two theories. Drugs in clinical use in the process of addition to adverse reactions occurred in their pharmacological activity of drugs, the pharmaceutical impurities is the main factor affecting the quality. Therefore, the research of impurity content in the process of establishment in quality control analytical method is very important. For this special type of antibiotic drugs, most of its preparation is made by fermentation, compared with synthetic drugs, their structure, composition is more complex, therefore, the impurities of this type of drugs is its necessary components of quality control, is of great significance. In this paper, the representative drugs of macrolide antibiotics azithromycin as the research object, the QbD theory as the guiding ideology, establish quality control analytical methods for impurity profile in two chromatographic systems,and the two methods are compared. In the establishment in quality control analytical method development for the impurity profile of azithromicin injections in UV detection system, first of all based azithromycin production processes to predict industrial impurities and degradation impurity type; then by domestic azithromycin injection quality