Maddaleno Aldo, Maturana Matías, Pokrant Ekaterina, Martín Betty San, Cornejo Javiera
Laboratory of Veterinary Pharmacology, Faculty of Veterinary and Animal Sciences, University of Chile, Santiago 8820808, Chile.
Programa de Doctorado en Ciencias Silvoagropecuarias y Veterinarias, Campus Sur Universidad de Chile, Santa Rosa 11315, La Pintana, Santiago 8820808, Chile.
Animals (Basel). 2021 Jun 16;11(6):1797. doi: 10.3390/ani11061797.
Antimicrobials premixes are the presentation of choice to administer drugs simultaneously to groups of animals in intensive husbandry systems that require treatment for pathologies of bacterial origin. Among the premixes available for use in poultry, florfenicol and oxytetracycline are commonly administered via food or water. However, their actual concentration in premixes must meet on-label statements to ensure plasma concentrations reach effective therapeutic levels. Hence, this work was designed for the purpose of verifying whether the concentration of antimicrobial present in five premixes matched their on-label statement. Three oxytetracycline premixes, and two of florfenicol, were analysed using a Xevo TQ-S micro UPLC-MS/MS, and an ABSciex API4000 HPLC-MS/MS, respectively. Analytical methodologies were implemented and validated, showing an R ≥ 0.99 for the calibration curves. Oxytetracycline was detected in these premixes at concentrations exceeding on-label statements by 13.28%, 21.54%, and 29.68%, whereas florfenicol concentrations detected in premixes were 13.06% and 14.75% lower than expected. Consequently, this work shows that the concentration of active ingredients that are present in commercial formulations effectively differ from those stated on premix labels, and it also highlights how unpredictable their range of variability might be. This must be addressed through solid and updated laws that guarantee an effective pharmaceutical product.
抗菌药物预混剂是在集约化养殖系统中同时给动物群体给药的首选剂型,这些动物群体需要治疗细菌性疾病。在家禽可用的预混剂中,氟苯尼考和土霉素通常通过食物或水给药。然而,它们在预混剂中的实际浓度必须符合标签声明,以确保血浆浓度达到有效的治疗水平。因此,这项工作旨在验证五种预混剂中抗菌药物的浓度是否与其标签声明相符。分别使用Xevo TQ-S micro UPLC-MS/MS和ABSciex API4000 HPLC-MS/MS对三种土霉素预混剂和两种氟苯尼考预混剂进行了分析。实施并验证了分析方法,校准曲线的R≥0.99。在这些预混剂中检测到的土霉素浓度比标签声明高出13.28%、21.54%和29.68%,而在预混剂中检测到的氟苯尼考浓度比预期低13.06%和14.75%。因此,这项工作表明,商业制剂中活性成分的浓度与预混剂标签上声明的浓度有效不同,并且还突出了其变异性范围可能有多不可预测。这必须通过确保有效药品的坚实且更新的法律来解决。