阿霉素、表阿霉素、柔红霉素、比阿霉素四种蒽环类药物与PVC输注袋的稳定性及相容性研究。

T Dine, J C Cazin, B Gressier, M Luyckx, C Brunet, M Cazin, F Goudaliez, M L Mallevais, I Toraub
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引用次数: 5

摘要

采用C18 Hypersil ODS色谱柱,采用荧光检测的高压液相色谱(HPLC)技术,建立了四种蒽环类药物(阿霉素、表阿霉素、柔红霉素和吡阿霉素)在静脉注射溶液中的快速等密度分析方法。这些药物通过PVC输液袋通过PVC给药装置从溶液中输注的可用性和相容性已经进行了检查。在使用PVC输液袋和给药组的24小时模拟输注过程中(n = 4)未观察到明显的药物损失。除吡柔比星外,两种输注溶液(5%葡萄糖或0.9% NaCl)间无显著差异。比柔比星在0.9% NaCl中不可能重构,因为我们观察到化合物在溶液中有沉淀。还研究了药物在溶液中的稳定性,在4℃下避光储存后,在PVC袋中。结果表明,无论输注溶液(5%葡萄糖或0.9% NaCl)如何,阿霉素、表阿霉素和柔红霉素在7 d内的稳定性均令人满意。以吡柔比星为例,在5%葡萄糖中储存5天,药物的稳定性令人满意,但超过5天,我们观察到该化合物在输液液中降解,形成阿霉素。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Stability and compatibility of four anthracyclines: doxorubicin, epirubicin, daunorubicin and pirarubicin with PVC infusion bags.

A rapid isocratic technique was developed for the analysis of four anthracyclines (doxorubicin, epirubicin, daunorubicin and pirarubicin) in parenteral solutions using high pressure liquid chromatography (HPLC) with fluorescence detection and a C18 Hypersil ODS column. The availability and compatibility of these drugs from solutions infused via PVC infusion bags through PVC administration sets have been examined. No significant drug loss was observed during simulated infusions (n = 4) for 24 h using PVC infusion bags and administration sets. No significant difference was found between infusion solutions (5% glucose or 0.9% NaCl), except for pirarubicin. The reconstitution of pirarubicin in 0.9% NaCl was impossible, because we observed a precipitation of the compound in solution. The stability of the drugs was also studied in solution, in PVC bags after storage at 4 degrees C with protection from light. The results show the stability of doxorubicin, epirubicin and daunorubicin during 7 days of storage to be satisfactory, irrespective of the infusion solution (5% glucose or 0.9% NaCl). In the case of pirarubicin, the stability of the drug was satisfactory during 5 days of storage in 5% glucose, but beyond, we observed a degradation of the compound with formation of doxorubicin in the infusion solution.

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