Mendez Andreas S L, Dalomo Jean, Steppe Martin, Schapoval Elfrides E S
Programa de Pós-Graduação em Ciências Farmacêuticas, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.
J Pharm Biomed Anal. 2006 Jun 16;41(4):1363-6. doi: 10.1016/j.jpba.2006.02.017. Epub 2006 Mar 14.
The stability of broad-spectrum antibiotic meropenem was studied in order to investigate the kinetics of degradation of this drug in powder for injection and reconstituted sample. Carbapenem was submitted to conditions of accelerated thermal decomposition. Degradation of meropenem was adequately modeled by specific equations for order rate kinetics. The analyses of the degraded samples were performed by high-performance liquid chromatographic (HPLC) method and microbiological assay. At higher temperatures, the decomposition reactions of meropenem in powder for injection could be described by first-order kinetics. The higher rate of degradation was observed in meropenem reconstituted in 0.9% sodium chloride, and the thermal decomposition obeyed also first-order kinetics. The results obtained confirm the reliability of chromatographic method for determining the kinetics run of meropenem in the presence of its degradation products. The present study reveals the thermal lability of the drug, especially as reconstituted sample. Thus, appropriate thermal protection is recommended during the storage and handling.
为了研究广谱抗生素美罗培南在注射用粉末和复溶样品中的降解动力学，对其稳定性进行了研究。碳青霉烯类药物经受加速热分解条件。美罗培南的降解通过一级速率动力学的特定方程进行了充分建模。对降解样品的分析采用高效液相色谱（HPLC）法和微生物测定法。在较高温度下，注射用粉末中美罗培南的分解反应可用一级动力学描述。在0.9%氯化钠中复溶的美罗培南观察到较高的降解速率，热分解也遵循一级动力学。所得结果证实了色谱法在存在美罗培南降解产物时测定其动力学过程的可靠性。本研究揭示了该药物的热不稳定性，尤其是作为复溶样品时。因此，建议在储存和处理过程中采取适当的热保护措施。
