Sun Hsin-Yun, Liao Hsiao-Wei, Sheng Meng-Huei, Tai Hui-Min, Kuo Ching-Hua, Sheng Wang-Huei
Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
School of Pharmacy, College of Medicine, National Taiwan University, Taipei, Taiwan.
Diagn Microbiol Infect Dis. 2016 Jul;85(3):347-351. doi: 10.1016/j.diagmicrobio.2016.04.015. Epub 2016 Apr 27.
Generic agents play a crucial role in reducing the cost of medical care in many countries. However, the therapeutic equivalence remains a great concern. Our study aims to assess the in vitro antimicrobial activity and bioequivalence between generic and brand-name levofloxacin. Enantiomeric purity test, dissolution test, and in vitro antimicrobial susceptibility against seven clinically important pathogens by the agar dilution method were employed to assess the similarity between four generic products and brand-name levofloxacin (Daiichi Sankyo). All the generic and brand-name levofloxacin passed enantiomeric purity test. The results of dissolution tests were not similar among the generic products and the brand-name levofloxacin. Compared with the generic products, the brand-name levofloxacin had the smallest mean variations (-25% to 13%) with reference standard (United States Pharmacopeia levofloxacin Reference Standards). Variations were observed particularly in dissolution profiles and in vitro activity between generic products and brand-name levofloxacin.
在许多国家，仿制药在降低医疗成本方面发挥着关键作用。然而，治疗等效性仍然是一个备受关注的问题。我们的研究旨在评估仿制药和品牌名左氧氟沙星之间的体外抗菌活性和生物等效性。采用对映体纯度测试、溶出度测试以及通过琼脂稀释法对七种临床重要病原体进行体外抗菌药敏试验，以评估四种仿制药产品与品牌名左氧氟沙星（第一三共）之间的相似性。所有仿制药和品牌名左氧氟沙星均通过了对映体纯度测试。仿制药产品与品牌名左氧氟沙星之间的溶出度测试结果并不相似。与仿制药产品相比，品牌名左氧氟沙星与参考标准品（美国药典左氧氟沙星参考标准品）的平均差异最小（-25%至13%）。在仿制药产品与品牌名左氧氟沙星之间，尤其在溶出曲线和体外活性方面观察到了差异。
