Department of Pharmacy, Kuopio University Hospital, Kuopio, Finland.
J Clin Pharm Ther. 2013 Apr;38(2):104-8. doi: 10.1111/jcpt.12035. Epub 2013 Feb 26.
Admixtures of levobupivacaine, fentanyl and epinephrine are increasingly used in epidural pain management. Neither the compatibility nor the stability of levobupivacaine with fentanyl and epinephrine is known and therefore we examined the chemical, physical and microbiological stability of levobupivacaine-fentanyl-epinephrine and levobupivacaine-fentanyl admixtures prepared in the hospital pharmacy.
Fentanyl and epinephrine were added into commercial levobupivacaine infusion bags. The components were analysed by HPLC and assays were performed up to 60 days of storage of the bags both protected and exposed to light at room temperature and stored in the refrigerator. In addition, sterility, bacterial endotoxins, organoleptic properties, pH and mass of the admixture were determined.
Levobupivacaine, fentanyl and epinephrine concentrations remained within the ± 10% specification limit during 60 days storage in the refrigerator in tightly closed secondary packing material and protected from light and for at least 40 days at room temperature. The degradation of epinephrine exceeded 10% within 60 hours when exposed to light. The solutions were microbiologically and physically stable.
Epidural analgesic admixtures of levobupivacaine and fentanyl with or without epinephrine have to be stored in a tightly closed secondary package protected from light. The extended stability, up to 60 days, in a refrigerator enables the centralized preparation in the hospital pharmacy.
左布比卡因、芬太尼和肾上腺素混合物在硬膜外疼痛管理中越来越多地被使用。左布比卡因与芬太尼和肾上腺素的兼容性和稳定性都不清楚，因此我们检查了医院药房制备的左布比卡因-芬太尼-肾上腺素和左布比卡因-芬太尼混合物的化学、物理和微生物稳定性。
芬太尼和肾上腺素被加入到商业的左布比卡因输注袋中。通过 HPLC 分析各成分，并在室温下避光和冷藏条件下储存的袋子中储存 60 天内进行检测。此外，还测定了混合物的无菌性、细菌内毒素、感官特性、pH 值和质量。
在冰箱中用紧密密封的二级包装材料避光储存 60 天内，以及在室温下至少储存 40 天内，左布比卡因、芬太尼和肾上腺素的浓度均保持在±10%的规格范围内。当暴露在光下时，肾上腺素在 60 小时内降解超过 10%。溶液在微生物学和物理上均稳定。
含有或不含有肾上腺素的左布比卡因和芬太尼硬膜外镇痛混合物必须存放在避光的紧密密封的二级包装中。在冰箱中可延长至 60 天的稳定性，使医院药房能够集中制备。
