Department of Pharmacy, Kyushu University Hospital, Fukuoka, Japan.
Am J Health Syst Pharm. 2010 Feb 1;67(3):223-6. doi: 10.2146/ajhp090031.
The stability of cetuximab and panitumumab in glass vials and polyvinyl chloride (PVC) bags stored at 4 degrees C for up to 14 days was studied.
Sixty milliliters of cetuximab was drawn directly from a commercially available vial, and 20 mL was injected into each of three sterile, empty, 100-mL PVC bags through a preattached 0.22-microm filter. Three milliliters of panitumumab and 21 mL of 0.9% sodium chloride injection were mixed, and 8 mL of the mixture was injected into each of three empty PVC bags through a preattached 0.22-microm filter. Samples were analyzed immediately after preparation and again after storage at 4 degrees C for 7 and 14 days. Cetuximab and panitumumab concentrations were measured using a modification of a previously described enzyme-linked immunosorbent assay method. Stability was defined as the mean concentrations of the test solutions being within assay variability of the initial concentration. Solution appearance and color were assessed by observing the samples against black and white backgrounds.
The percentages of initial concentration of cetuximab and panitumumab were over 90% stored at 4 degrees C after 14 days. No changes in color or turbidity were observed in any of the vials and the prepared solutions.
Cetuximab 2 mg/mL was stable when stored for 14 days in a glass vial and in PVC bags at 4 degrees C. Panitumumab 20 mg/mL in a glass vial and 2.5 mg/mL in 0.9% sodium chloride injection in PVC bags was also stable when stored for 14 days at 4 degrees C.
研究在 4°C 下玻璃小瓶和聚氯乙烯（PVC）袋中储存长达 14 天的西妥昔单抗和帕尼单抗的稳定性。
直接从小瓶中抽取 60 毫升西妥昔单抗，通过预连接的 0.22 微米过滤器将 20 毫升注入三个无菌、空的 100 毫升 PVC 袋中。将 3 毫升帕尼单抗和 21 毫升 0.9%氯化钠注射液混合，通过预连接的 0.22 微米过滤器将 8 毫升混合物注入三个空的 PVC 袋中。样品在制备后立即进行分析，并在 4°C 下储存 7 天和 14 天后再次进行分析。使用先前描述的酶联免疫吸附测定方法的修改版测量西妥昔单抗和帕尼单抗的浓度。稳定性定义为测试溶液的平均浓度在初始浓度的测定变异性内。通过观察样品在黑白背景下的外观和颜色来评估溶液的外观和颜色。
在 4°C 下储存 14 天后，西妥昔单抗和帕尼单抗的初始浓度百分比超过 90%。在任何小瓶和制备的溶液中均未观察到颜色或浊度的变化。
西妥昔单抗 2 毫克/毫升在 4°C 下玻璃小瓶和 PVC 袋中储存 14 天是稳定的。在 4°C 下储存 14 天，玻璃小瓶中的帕尼单抗 20 毫克/毫升和 0.9%氯化钠注射液中的 2.5 毫克/毫升 PVC 袋中的帕尼单抗也很稳定。
