Elan Pharmaceuticals Inc., South San Francisco, CA, USA; Gilead Inc., Foster City, CA, USA.
Neuromodulation. 2007 Oct;10 Suppl 1:1-5. doi: 10.1111/j.1525-1403.2007.00131.x.
Objective. To determine the stability of an admixture combining ziconotide with bupivacaine hydrochloride during simulated intrathecal infusion under laboratory conditions at 37°. Materials and Methods. An admixture containing ziconotide (25 µg/mL) and bupivacaine hydrochloride (5 mg/mL) was stored in SynchroMed® II pumps at 37° and in control vials at either 37° or 5°. Using high-performance liquid chromatography, drug concentrations were determined from samples obtained at varying intervals during the 30-day study. Results. After 30 days, pump ziconotide and bupivacaine hydrochloride concentrations measured an average of 86.9% and 99.4% of their initial concentrations, respectively. Control vials displayed similar degradation rates for both drugs. Statistical evaluation of the ziconotide 95% confidence interval indicated that the ziconotide concentration would meet or exceed 90% and 80% of initial concentration for 22 days and 45 days, respectively. Conclusions. An admixture containing 25 µg/mL ziconotide and 5 mg/mL bupivacaine hydrochloride was 90% stable for 22 days and 80% stable for 45 days (extrapolated) in SynchroMed® II infusion pumps.
目的。在 37°C 的实验室条件下，模拟鞘内输注，确定将佐米曲坦与盐酸布比卡因混合后的稳定性。
材料和方法。将含有佐米曲坦（25µg/mL）和盐酸布比卡因（5mg/mL）的混合物储存在 SynchroMed® II 泵中，在 37°C 下储存，并在 37°C 或 5°C 的对照小瓶中储存。使用高效液相色谱法，在 30 天的研究过程中，从不同时间点获得的样品中测定药物浓度。
结果。在 30 天后，泵中的佐米曲坦和盐酸布比卡因浓度分别为初始浓度的 86.9%和 99.4%。对照小瓶中两种药物的降解速率相似。对佐米曲坦 95%置信区间的统计评估表明，佐米曲坦的浓度将在 22 天和 45 天分别达到或超过初始浓度的 90%和 80%。
结论。在 SynchroMed® II 输注泵中，含有 25µg/mL 佐米曲坦和 5mg/mL 盐酸布比卡因的混合物在 22 天内稳定 90%，在 45 天（推断）内稳定 80%。
