Sorrieul Jérémy, Robert Julien, Chapel Fanny, Gossye Thomas, Devys Catherine
Pharmacy Department, Institut de Cancérologie de l'Ouest Paul Papin, Angers, France.
Int J Pharm Compd. 2020 Mar-Apr;24(2):156-162.
Intrathecal analgesia is a method using various molecules alone or in combination. Among these, a preparation of sufentanil-ropivacaine-baclofen is widely used. Instead of moving patients to the few expert centers taking charge of these specific preparations, it could be beneficial to transport syringes to peripheral centers who manage pump refills. The objective of this study was to determine the physicochemical compatibility and stability of a preparation of sufentanil, ropivacaine, and baclofen in polypropylene syringes. Drugs were mixed together at different concentrations and stored with light protection at 5°C ± 3°C and 25°C ± 2°C. The stabilities were determined by visual inspection, turbidity, pH measurement, and ultra-high-pressure liquid chromatography assay of drug concentrations. The concentrations of ropivacaine, baclofen, and sufentanil were stable after 7 days at 5°C ± 3°C and no degradation of product appeared. The drug mixtures were clear in appearance and no color change or precipitation was observed. Throughout this period, the absorbance and the pH value of samples remained stable. The preparations of sufentanil, baclofen, and ropivacaine remained stable for at least 7 days when stored in polypropylene syringes at 5°C ± 3°C.
鞘内镇痛是一种单独或联合使用多种分子的方法。其中，舒芬太尼-罗哌卡因-巴氯芬制剂被广泛使用。相较于将患者转运至少数负责这些特定制剂的专家中心，将注射器转运至负责泵补充的周边中心可能更有益。本研究的目的是确定舒芬太尼、罗哌卡因和巴氯芬制剂在聚丙烯注射器中的物理化学相容性和稳定性。将药物以不同浓度混合，并在5°C ± 3°C和25°C ± 2°C下避光储存。通过目视检查、浊度、pH测量和药物浓度的超高压液相色谱分析来确定稳定性。罗哌卡因、巴氯芬和舒芬太尼的浓度在5°C ± 3°C下7天后保持稳定，且未出现产品降解。药物混合物外观澄清，未观察到颜色变化或沉淀。在此期间，样品的吸光度和pH值保持稳定。舒芬太尼、巴氯芬和罗哌卡因制剂在5°C ± 3°C下储存在聚丙烯注射器中时至少可稳定保存7天。
