Adams Andréa I H, Morimoto Lucia N, Meneghini Leonardo Z, Bergold Ana M
University of Rio Grande do Sul, Porto Alegre, RS, Brazil.
Braz J Infect Dis. 2008 Oct;12(5):400-4. doi: 10.1590/s1413-86702008000500011.
Voriconazole is a novel broad-spectrum antifungal drug, employed in the treatment of invasive fungal infections, and represents an alternative to amphotericin B treatment. The manufacturer recommends that any unused reconstituted product should be stored at 2 masculineC to 8 masculineC, for no more than 24 h, but no recommendations about i.v. infusion solutions are given. Previous works have reported on the stability of voriconazole in polyolefin bags and just one in 5% dextrose polyvinyl chloride (PVC) bags, at a 4 mg.mL-1 concentration. In this work, the stability of voriconazole as an i.v. infusion solution in 0.9% sodium chloride and in 5% dextrose, in PVC bags, at 0.5 mg.mL-1, stored at 4 masculineC and at room temperature, protected from light, was evaluated. These infusion solutions were analyzed for a 21-day period. Chemical stability was evaluated by HPLC assay. Visual inspection was performed and pH of the solutions was measured. No color change or precipitation in the solutions was observed. The drug content remained above 90% for 11 days in 0.9% sodium chloride and for 9 days in 5% dextrose solutions. The i.v. infusion solutions stored at room temperature were not stable. At room temperature, the voriconazole content dropped down to 88.3 and 86.6%, in 0.9% sodium chloride or 5% dextrose solutions, respectively, two days after admixture. Assays performed at the end of the study suggest the sorption of voriconazole by the PVC bags. The results of this study allow cost-effective batch production in the hospital pharmacy.
伏立康唑是一种新型广谱抗真菌药物，用于治疗侵袭性真菌感染，是两性霉素B治疗的替代药物。制造商建议，任何未使用的复溶产品应在2℃至8℃下储存，不超过24小时，但未给出关于静脉输液溶液的建议。先前的研究报道了伏立康唑在聚烯烃袋中的稳定性，仅有一项研究报道了其在5%葡萄糖聚氯乙烯（PVC）袋中4mg/mL浓度下的稳定性。在本研究中，评估了伏立康唑在0.9%氯化钠和5%葡萄糖的PVC袋中作为静脉输液溶液，浓度为0.5mg/mL，在4℃和室温下避光储存时的稳定性。这些输液溶液进行了为期21天的分析。通过高效液相色谱法测定评估化学稳定性。进行了目视检查并测量了溶液的pH值。溶液中未观察到颜色变化或沉淀。在0.9%氯化钠溶液中，药物含量在11天内保持在90%以上，在5%葡萄糖溶液中保持在90%以上的时间为9天。在室温下储存的静脉输液溶液不稳定。在室温下，混合两天后，伏立康唑在0.9%氯化钠或5%葡萄糖溶液中的含量分别降至88.3%和86.6%。研究结束时进行的分析表明伏立康唑被PVC袋吸附。本研究结果有助于医院药房进行经济高效的批量生产。
