JMI Laboratories, North Liberty, IA, USA.
Diagn Microbiol Infect Dis. 2013 May;76(1):110-2. doi: 10.1016/j.diagmicrobio.2013.01.024. Epub 2013 Mar 13.
An ongoing program of international generic antimicrobial potency assays for piperacillin/tazobactam has been summarized here through December 2010, and the initial results for meropenem generic lots from the United States are also presented. Fifteen additional piperacillin/tazobactam generic lots revealed an average of -10% activity (range, +3 to -23%) compared to the branded product (Zosyn®; Wyeth-Pfizer), a finding consistent with prior reports (46 lots) of -16%. In contrast, meropenem branded and generic products had equivalent assay results (5 generic lots from 2 manufacturers [Hospira and Sandoz]). In conclusion, potencies for generic lots of parenteral broad-spectrum β-lactams can vary widely when directly compared to branded products, requiring documentation by chemical, in vitro activity (potency assays as measured here), and purity testing before considering their addition to a hospital formulary.
本文总结了截至 2010 年 12 月的哌拉西林/他唑巴坦国际通用抗微生物效价检测的进展情况，同时还呈现了来自美国的美罗培南仿制药批的初始检测结果。与品牌产品（Zosyn ®；惠氏-辉瑞）相比，另外 15 个哌拉西林/他唑巴坦仿制药批的平均活性下降了 10%（范围为+3% 至-23%），这一发现与先前的报告（46 个批）中的-16%一致。相比之下，美罗培南品牌药和仿制药具有等效的检测结果（来自 2 家制造商[贺斯哌拉和山德士]的 5 个仿制药批）。总之，当与品牌产品直接比较时，注射用广谱β-内酰胺类药物的仿制药批的效价可能有很大差异，在考虑将其添加到医院处方集之前，需要通过化学、体外活性（如本文中所测量的效价检测）和纯度检测来证明其合理性。
