Barnes A R, Nash S
Pharmaceutical Sciences Institute, Aston University, Birmingham, UK.
Pharm World Sci. 1995 May 26;17(3):87-92. doi: 10.1007/BF01875437.
The stability of diamorphine (0.02 mg/ml as the hydrochloride) in 250 ml bupivacaine hydrochloride (0.15% wt/vol infusion) was studied by high pressure liquid chromatography at temperatures in the range 7 to 45 degrees C. Diamorphine hydrochloride was degraded by approximately 0.13% per day at 7 degrees C. No bupivacaine hydrochloride degradation was detectable during the study. The storage life of the combination at 7 degrees C, based on the lower 95% confidence limit of the time to 5% diamorphine hydrochloride degradation, was 14 days. The stability at 25 degrees C was adequate to allow transport and administration over 24 h at ambient temperature. Stability was also maintained for at least 24 hr at 32 and 45 degrees C. Infusion of the mixture with an ambulatory infusion pump which uses a standard polyvinyl infusion bag is therefore possible. A study of its compatibility with different infusion pump medication reservoirs was not undertaken. The drugs were also stable on frozen storage at -18 degrees C for up to 6 months.
通过高压液相色谱法，在7至45摄氏度的温度范围内，研究了二醋吗啡（以盐酸盐计为0.02毫克/毫升）在250毫升盐酸布比卡因（0.15%重量/体积输注液）中的稳定性。在7摄氏度时，盐酸二醋吗啡每天降解约0.13%。在研究期间未检测到盐酸布比卡因降解。基于盐酸二醋吗啡降解至5%时时间的较低95%置信限，该组合物在7摄氏度下的储存期为14天。在25摄氏度时的稳定性足以允许在室温下运输和给药24小时。在32和45摄氏度时也至少保持24小时的稳定性。因此，使用标准聚乙烯输液袋的便携式输液泵输注该混合物是可行的。未对其与不同输液泵药物储液器的相容性进行研究。这些药物在-18摄氏度冷冻储存长达6个月时也很稳定。
