Center for Anti-Infective Research and Development, Hartford Hospital, 80 Seymour Street, Hartford, CT 06102, USA.
Am J Health Syst Pharm. 2010 Sep 15;67(18):1539-44. doi: 10.2146/ajhp090429.
The stability of doripenem 500 and 1000 mg in polyvinyl chloride (PVC) bags and elastomeric pumps at various storage temperatures was evaluated.
Commercially available doripenem vials were reconstituted and mixed with either 0.9% sodium chloride injection or 5% dextrose injection to produce 100-mL solutions with concentrations of 5 and 10 mg/mL. Six replicate solutions in either PVC bags or elastomeric pumps were prepared. Bags were sampled immediately after preparation and stored at 25 degrees C, 4 degrees C, or -20 degrees C. Those stored at 25 degrees C were sampled for an additional 48 hours, and bags stored at 4 degrees C were sampled for 12 days. Bags frozen at -20 degrees C for 14-28 days were allowed to thaw at either 25 degrees C for 4-6 hours or 4 degrees C for 24 hours and sampled for an additional 48 hours. Solutions retaining > or =90% of the initial concentration were considered stable.
At 25 degrees C, both concentrations were stable for 24 hours in 0.9% sodium chloride injection and for 16 hours in 5% dextrose injection. At 4 degrees C, 5-mg/mL solutions were stable for 10 days in both 0.9% sodium chloride injection and 5% dextrose injection, while 10-mg/mL solutions were stable for 10 days in 0.9% sodium chloride injection and 7 days in 5% dextrose injection. A white precipitate, which returned to solution by shaking, was noted after thawing the frozen containers. Whether thawed at 4 degrees C or 25 degrees C, both 5- and 10-mg/mL solutions were stable for 16 hours at 25 degrees C.
Doripenem 5- and 10-mg/mL solutions were stable for 24 hours at 25 degrees C when diluted in 0.9% sodium chloride injection. When diluted in 5% dextrose injection, the stability of both concentrations of doripenem decreased to 16 hours at 25 degrees C. When stored at 4 degrees C, 5-mg/mL solutions in either 0.9% sodium chloride or 5% dextrose injection were stable for at least 10 days, and all solutions containing doripenem 10 mg/mL were stable for at least 7 days. Both concentrations of doripenem were stable for 16 hours when previously frozen and thawed at 25 degrees C and 4 degrees C. The rate of doripenem degradation was similar between PVC and elastomeric containers.
评估多利培南 500 毫克和 1000 毫克在聚氯乙烯（PVC）袋和弹性泵中在各种储存温度下的稳定性。
将市售的多利培南小瓶进行再配制，并与 0.9%氯化钠注射液或 5%葡萄糖注射液混合，制成浓度为 5 和 10 毫克/毫升的 100 毫升溶液。在 PVC 袋或弹性泵中制备 6 份重复溶液。在制备后立即取样，并在 25°C、4°C 或-20°C 下储存。在 25°C 下储存的样品在另外 48 小时时取样，在 4°C 下储存的样品在 12 天时取样。在-20°C 下冷冻 14-28 天的袋子在 25°C 下解冻 4-6 小时或在 4°C 下解冻 24 小时，并在另外 48 小时时取样。保留初始浓度≥90%的溶液被认为是稳定的。
在 25°C 下，两种浓度在 0.9%氯化钠注射液中稳定 24 小时，在 5%葡萄糖注射液中稳定 16 小时。在 4°C 下，5 毫克/毫升的溶液在 0.9%氯化钠注射液和 5%葡萄糖注射液中均稳定 10 天，而 10 毫克/毫升的溶液在 0.9%氯化钠注射液中稳定 10 天，在 5%葡萄糖注射液中稳定 7 天。在解冻冷冻容器后，注意到一种白色沉淀物，通过摇晃后又回到溶液中。无论是在 4°C 还是 25°C 下解冻，5 毫克/毫升和 10 毫克/毫升的溶液在 25°C 下均稳定 16 小时。
多利培南 5 毫克/毫升和 10 毫克/毫升的溶液在 25°C 下用 0.9%氯化钠注射液稀释时，24 小时内稳定。当用 5%葡萄糖注射液稀释时，两种浓度的多利培南稳定性均下降至 25°C 时的 16 小时。在 4°C 下储存时，0.9%氯化钠或 5%葡萄糖注射液中的 5 毫克/毫升溶液至少稳定 10 天，所有含有 10 毫克/毫升多利培南的溶液至少稳定 7 天。先前在 25°C 和 4°C 下冷冻和解冻的两种浓度的多利培南都稳定 16 小时。多利培南的降解速度在 PVC 和弹性容器之间相似。
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