Stewart J T, Warren F W, Johnson S M, Fox J L, Mullaney J
Department of Medicinal Chemistry, College of Pharmacy, University of Georgia, Athens 30602.
Am J Hosp Pharm. 1992 Nov;49(11):2765-8.
The stability of ceftazidime solutions (100 and 200 mg/mL) in plastic syringes and glass vials under various storage conditions was examined. Solutions of ceftazidime 100 and 200 mg/mL in sterile water were placed in polypropylene plastic syringes or glass vials and stored (1) at 21-23 degrees C for up to 8 hours, (2) at 4 degrees C for up to 96 hours, (3) at -20 degrees C for 28 days and then 21-23 degrees C for up to 8 hours, (4) at -20 degrees C for 28 days and then 4 degrees C for up to 96 hours, (5) at -20 degrees C for 91 days and then 21-23 degrees C for up to 8 hours, or (6) at-20 degrees C for 91 days and then 4 degrees C for up to 96 hours. Samples were withdrawn from each syringe and vial at designated times and assayed by high-performance liquid chromatography. Solutions were judged to be stable if drug concentrations remained above 90% of the initial values. The number of particles in each container under each storage condition was also evaluated. Ceftazidime was stable under all storage conditions. In all containers, particulate matter was within USP specifications for small-volume injections, with no change in particle count as a result of the freezing and thawing. Ceftazidime in sterile water in either glass vials or plastic syringes is stable for 8 hours at room temperature or 96 hours at 4 degrees C when such storage occurs (1) immediately after constitution, (2) after 28 days of frozen storage, or (3) after 91 days of frozen storage.
考察了头孢他啶溶液（100和200mg/mL）在塑料注射器和玻璃瓶中在各种储存条件下的稳定性。将100mg/mL和200mg/mL的头孢他啶无菌水溶液置于聚丙烯塑料注射器或玻璃瓶中，并进行如下储存：（1）在21 - 23℃下储存长达8小时；（2）在4℃下储存长达96小时；（3）在-20℃下储存28天，然后在21 - 23℃下储存长达8小时；（4）在-20℃下储存28天，然后在4℃下储存长达96小时；（5）在-20℃下储存91天，然后在21 - 23℃下储存长达8小时；或（6）在-20℃下储存91天，然后在4℃下储存长达96小时。在指定时间从每个注射器和玻璃瓶中取出样品，并用高效液相色谱法进行分析。如果药物浓度保持在初始值的90%以上，则判定溶液稳定。还评估了每种储存条件下每个容器中的颗粒数量。头孢他啶在所有储存条件下均稳定。在所有容器中，颗粒物均符合美国药典小容量注射剂的规格要求，冻融后颗粒计数无变化。玻璃瓶或塑料注射器中无菌水中的头孢他啶，在（1）配制后立即储存、（2）冷冻储存28天后或（3）冷冻储存91天后，在室温下可稳定8小时，在4℃下可稳定96小时。
