Stability of sufentanil and levobupivacaine solutions and a mixture in a 0.9 % sodium chloride infusion stored in polypropylene syringes

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• 作者：Jä ; ppinen ; Annaliisa ; Turpeinen ; Miia ; Kokki ; Hannu ; Rasi ; Anu ; Ojanen ; Tarja ; Pelkonen ; Olavi ; et. al.
• 关键词：Stability ; Sufentanil ; Levobupivacaine ; Polypropylene ; Syringes ; Bacterial contamination
• 刊名：European Journal of Pharmaceutical Sciences
• 出版年：2003
• 出版时间：May, 2003
• 年：2003
• 卷：19
• 期：1
• 页码：31-36
• 全文大小：119 K

文摘

We have evaluated the chemical and microbiological stability of sufentanil citrate, levobupivacaine hydrochloride and a mixture in a 0.9 % sodium chloride infusion in order to provide background information on the storage of a sufentanil–levobupivacaine mixture in polypropylene (PP) syringes. Chemical assays were performed by HPLC on days 0, 1, 2, 3, 8, 14, 23, 28 and 30 after storage at 4, 21, and 36°C. Microbiological stability was evaluated under aseptic conditions using a laminar air flow station, with a grade A environment and a B background. The samples taken for microbiological analysis were collected immediately after preparation of the solutions and then after 7, 14, 21 and 28 days storage. At 4°C the sufentanil citrate solution was stable for 23 days. At 21°C the sufentanil citrate solution maintained chemical stability for 3 days, but thereafter the concentration of sufentanil decreased 15 % from day 3 to day 8. At 36°C a similar decrease was noticed from day 1 to day 3. On the contrary, the levobupivacaine hydrochloride solution maintained chemical stability for 28 days at 4 and 21°C and for 23 days at 36°C. The sufentanil–levobupivacaine mixture maintained chemical stability for 28 days at 4, 21 and 36°C. The sufentanil and levobupivacaine solutions and the mixture studied maintained microbiological stability for 28 days. According to the chemical and microbiological stability studies, the sufentanil–levobupivacaine mixture in PP syringes could be stored for 28 days at 4 and 21°C.