Walker Scott E, Law Shirley, Perks William, Iazzetta John
MScPhm, is Director of Pharmacy, Sunnybrook Health Sciences Centre, and Associate Professor, Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario.
DipPharmTech, is a Research Assistant in Quality Control, Department of Pharmacy, Sunnybrook Health Sciences Centre, Toronto, Ontario.
Can J Hosp Pharm. 2015 Mar-Apr;68(2):121-6. doi: 10.4212/cjhp.v68i2.1437.
Prophylactic administration of ertapenem as a single 1-g IV dose has been shown to reduce sepsis after prostate biopsy.
To evaluate the stability of ertapenem after reconstitution with 0.9% sodium chloride to a final concentration of 100 mg/mL and storage in the manufacturer's original glass vials or polypropylene syringes.
On study day 0, 100 mg/mL solutions of ertapenem were retained in the manufacturer's glass vials or packaged in polypropylene syringes and stored at 4°C or 23°C without protection from fluorescent room light. Samples were assayed periodically over 18 days using a validated, stability-indicating liquid chromatographic method with ultra-violet detection. A beyond-use date was determined as the time for the concentration to decline to 90% of the initial (day 0) concentration, based on the fastest degradation rate, with 95% confidence.
Reconstituted solutions stored in the manufacturer's glass vials or polypropylene syringes exhibited a first-order degradation rate, such that 10% of the initial concentration was lost in the first 2.5 days when stored at 4°C or within the first 6.75 h when stored at room temperature (23°C). Analysis of variance showed differences in the percentage remaining due to temperature (p < 0.001) and study day (p < 0.001) but not type of container (p = 0.98). When a 95% CI for the degradation rate was calculated and used to determine a beyond-use date, it was established that more than 90% of the initial concentration would remain for 2.35 days at 4°C and for 0.23 day (about 5 h, 30 min) at room temperature.
A 100 mg/mL ertapenem solution stored in the manufacturer's glass vial or a polypropylene syringe will retain more than 90.5% of the initial concentration when stored for 48 h at 4°C and for an additional 1 h at 23°C.
已证明静脉注射1克厄他培南单剂量进行预防性给药可降低前列腺活检后的败血症发生率。
评估厄他培南用0.9%氯化钠复溶至终浓度100毫克/毫升后，在生产商原装玻璃瓶或聚丙烯注射器中储存时的稳定性。
在研究第0天，将100毫克/毫升的厄他培南溶液保留在生产商的玻璃瓶中或包装在聚丙烯注射器中，于4°C或23°C储存，不采取防荧光室内光线措施。使用经过验证的、具有紫外检测功能的稳定性指示液相色谱法，在18天内定期对样品进行检测。根据最快降解速率，以95%的置信度确定超出使用日期为浓度降至初始（第0天）浓度的90%的时间。
储存在生产商玻璃瓶或聚丙烯注射器中的复溶溶液呈现一级降解速率，即4°C储存时，在前2.5天内初始浓度损失10%；室温（23°C）储存时，在前6.75小时内损失10%。方差分析显示，剩余百分比因温度（p < 0.001）和研究天数（p < 0.001）存在差异，但容器类型无差异（p = 0.98）。计算降解速率的95%置信区间并用于确定超出使用日期时，确定4°C下初始浓度的90%以上可保持2.35天，室温下可保持0.23天（约5小时30分钟）。
储存在生产商玻璃瓶或聚丙烯注射器中的100毫克/毫升厄他培南溶液，在4°C储存48小时并在23°C额外储存1小时后，将保留初始浓度的90.5%以上。
