Carlier M, Stove V, Verstraete A G, De Waele J J
Department of Clinical Chemistry, Microbiology and Immunology, Ghent University, Ghent, Belgium -
Minerva Anestesiol. 2015 Mar;81(3):283-7. Epub 2014 Sep 15.
Meropenem is a relatively unstable compound when dissolved. Currently, all available data have been derived from tests on the original product from Astrazeneca, and it is unsure if these data can be extrapolated to the stability of other commercially available vials. The aim of this study was therefore to assess the stability of four different brands of meropenem to be used as a prolonged or continuous infusion.
Commercially available meropenem vials were reconstituted and mixed with 0.9% sodium chloride to produce solutions with concentrations of 10.20 and 40 mg/mL in polypropylene syringes, which were kept at 25 °C. Samples were taken immediately after preparation and up to 12 hours. Solutions retaining >90% of the initial concentration were considered stable.
The stability was concentration-dependent. At 25 °C, all 10 and 20 mg/mL solutions were stable for 12 hours in 0.9% sodium chloride, while the 40 mg/mL solutions were stable for a maximum of 8 hours. Stability of the different vials of meropenem was comparable for the time period tested (related samples Friedman's two way of analysis of variance by ranks, P=0.282).
All tested commercially available vials of meropenem in a concentration of 10 and 20 mg/mL were stable for 12 hours at 25 °C when diluted in 0.9% sodium chloride. The 40 mg/mL solutions were stable for a maximum of 8 hours. This report is the first to show equivalent stability between different commercially available vials of meropenem.
美罗培南溶解后是一种相对不稳定的化合物。目前，所有可得数据均来自对阿斯利康原研产品的测试，尚不确定这些数据是否能外推至其他市售小瓶的稳定性。因此，本研究的目的是评估四种不同品牌的美罗培南用作延长或持续输注时的稳定性。
将市售美罗培南小瓶复溶，并与0.9%氯化钠混合，在聚丙烯注射器中制成浓度为10、20和40mg/mL的溶液，置于25°C保存。制备后立即取样，直至12小时。保留初始浓度>90%的溶液被认为是稳定的。
稳定性与浓度有关。在25°C时，所有10和20mg/mL的溶液在0.9%氯化钠中12小时均稳定，而40mg/mL的溶液最多稳定8小时。在所测试的时间段内，不同小瓶美罗培南的稳定性相当（相关样本采用弗里德曼双向秩方差分析，P = 0.282）。
所有测试的市售美罗培南小瓶，当在0.9%氯化钠中稀释时，浓度为10和20mg/mL在25°C下12小时均稳定。40mg/mL的溶液最多稳定8小时。本报告首次表明不同市售美罗培南小瓶之间具有等效稳定性。
