基于杂质谱的仿制药质量一致性评价流程研究_张明媛.pdf

  12 3 1*    1  200433    2   353000   3. 201206    PCAHCA 7 16 5     Evaluation procedure for quality consistency of generic drugs based on the impurity profile 12 3 1* Zhang Mingyuan  Zhang Jundong Lu Feng 1 School of Pharmacy, Second Military Medical University, Shanghai 200433; 2 Department of Pharmacy, the First Hospital of Naping, Fujian Medical University, Nanping 353000; 3 Shanghai Sine Pharmaceutical Laboratories Co., Ltd, Shanghai 201206 Abstract                                                               []   *  []  E‐mailfenglufeng@  []  12DZ1930504    OBJECTIVE To research a procedure to evaluate the quality consistency of generic drugs this based on the impurity profile and the similarity analysis methods. METHODS The data which purchased from 7 factories (16 batches) were calculated by correlation coefficient, cosine, principal component analysis (PCA), hierarchical clustering analysis (HCA) and weitht-correlation coefficient. RESULTS After screening by the procedure: choice of chromatographic methods, data collection and conformity test, evaluation of intra-batch similarity, evaluation of generic drugs with the original drug, and weighted similarity evaluation of generic drugs, the better generic factory was pick out. CONCLUSIONS This step-by-step is suitable for evaluating the consistency of generic drugs. Key Words impurity profile, consistency evaluation, chemometrics, nifedipine extended-release tablets [1, 2]