Benvenuto J A, Anderson R W, Kerkof K, Smith R G, Loo T L
Am J Hosp Pharm. 1981 Dec;38(12):1914-8.
The stability of methotrexate, fluorouracil, cytarabine, dactinomycin, doxorubicin, bleomycin sulfate, mitomycin, mithramycin, vincristine sulfate, vinblastine sulfate, cyclophosphamide, dacarbazine, carmustine, and leucovorin calcium in underfilled plastic and glass administration containers was determined. Drugs were reconstituted according to manufacturers' instructions and added to 5% dextrose injection 50 ml in both polyvinyl chloride bags and glass partial-fill bottles. In addition, mitomycin was added to 0.9% sodium chloride injection 50 ml in both polyvinyl chloride bags and glass partial-fill bottles. All admixtures were stored at room temperature, not protected from light. Stability was determined over 24 hours (48 hours for doxorubicin and fluorouracil) by high-pressure liquid chromatography, except for cyclophosphamide (analyzed by mass spectrometry) and carmustine (analyzed by spectrophotometry). Methotrexate, leucovorin calcium, cytarabine, dactinomycin, mithramycin, vinblastine sulfate, cyclophosphamide, and dacarbazine were equally stable (10% or less change in concentration over 24 hours) in glass and plastic containers. Doxorubicin and fluorouracil were more stable in plastic containers than glass containers. The T90 value for doxorubicin in glass was 40 hours; there was no apparent decrease in plastic even after 48 hours. The T90 value for fluorouracil in glass was seven hours and in plastic, 43 hours. Vincristine sulfate, bleomycin sulfate, and carmustine were more stable in glass than plastic. The T90 value for vincristine sulfate in plastic was 10 hours. The T90 value for bleomycin sulfate in plastic was 0.7 hour. The T90 value for carmustine in plastic was 0.6 hour. Mitomycin dissolved in 0.9% sodium chloride injection was more stable in plastic. Mitomycin dissolved in 5% dextrose injection was not stable. Carmustine and bleomycin sulfate should be administered only in glass containers. Continuous infusions of doxorubicin and fluorouracil are more completely delivered from plastic containers. Mitomycin should not be dissolved in 5% dextrose injection.
测定了甲氨蝶呤、氟尿嘧啶、阿糖胞苷、放线菌素D、多柔比星、硫酸博来霉素、丝裂霉素、光辉霉素、硫酸长春新碱、硫酸长春碱、环磷酰胺、达卡巴嗪、卡莫司汀和亚叶酸钙在未装满的塑料和玻璃给药容器中的稳定性。按照制造商的说明将药物复溶,并加入到聚氯乙烯袋和玻璃部分填充瓶中的50ml 5%葡萄糖注射液中。此外,将丝裂霉素加入到聚氯乙烯袋和玻璃部分填充瓶中的50ml 0.9%氯化钠注射液中。所有混合液均在室温下储存,未避光。除环磷酰胺(通过质谱分析)和卡莫司汀(通过分光光度法分析)外,通过高压液相色谱法在24小时内(多柔比星和氟尿嘧啶为48小时)测定稳定性。甲氨蝶呤、亚叶酸钙、阿糖胞苷、放线菌素D、光辉霉素、硫酸长春碱、环磷酰胺和达卡巴嗪在玻璃和塑料容器中的稳定性相同(24小时内浓度变化10%或更低)。多柔比星和氟尿嘧啶在塑料容器中比在玻璃容器中更稳定。多柔比星在玻璃中的T90值为40小时;即使在48小时后,塑料中的含量也没有明显下降。氟尿嘧啶在玻璃中的T90值为7小时,在塑料中为43小时。硫酸长春新碱、硫酸博来霉素和卡莫司汀在玻璃中比在塑料中更稳定。硫酸长春新碱在塑料中的T90值为10小时。硫酸博来霉素在塑料中的T90值为0.7小时。卡莫司汀在塑料中的T90值为0.6小时。溶解在0.9%氯化钠注射液中的丝裂霉素在塑料中更稳定。溶解在5%葡萄糖注射液中的丝裂霉素不稳定。卡莫司汀和硫酸博来霉素应仅在玻璃容器中给药。多柔比星和氟尿嘧啶的持续输注从塑料容器中输送得更完全。丝裂霉素不应溶解在5%葡萄糖注射液中。