JMI Laboratories, North Liberty, IA 52317, USA.
Diagn Microbiol Infect Dis. 2009 Nov;65(3):319-22. doi: 10.1016/j.diagmicrobio.2009.06.012.
The experience with analyzing the potency of piperacillin/tazobactam generic formulations by a precise multiorganism in vitro assay was expanded to 46 lots (29 manufacturers, 17 countries). Across all generic lots, the range of activity compared with a reference branded lot (RLOT; Zosyn; Wyeth Pharmaceuticals, Philadelphia, PA) was +10% to -42% (average, -16%). Eight lots of Zosyn were also tested with a range of +7 to -19 (average, only -6%), and the reproducibility (13 replicates) of the RLOT assay was confirmed (+/-3%). This ongoing quality assurance project demonstrated wide activity variations in piperacillin/tazobactam generic lots with a consistent trend toward subpotent performance (-16%) compared with the branded product. Generic substitutions within hospital formularies should consider parameters of in vitro activity, in addition to applied chemical analyses and measures of bioavailability to avoid potential adverse clinical consequences.
将多器官体外精确检测法分析哌拉西林/他唑巴坦仿制药效价的经验扩展到 46 批（29 家制造商，17 个国家）。所有仿制药批的活性范围与参比品牌药批（RLOT；Zosyn；惠氏制药公司，费城，宾夕法尼亚州）相比为+10%至-42%（平均为-16%）。也用 8 批 Zosyn 进行了+7 至-19 的测试（平均仅为-6%），RLOT 检测的重现性（13 个重复）得到了确认（+/-3%）。正在进行的质量保证项目表明，哌拉西林/他唑巴坦仿制药批之间的活性变化很大，与品牌产品相比，其性能一直呈低效能趋势（-16%）。在医院处方中进行仿制药替代时，除了应用化学分析和生物利用度测量外，还应考虑体外活性参数，以避免潜在的临床不良后果。
