Toledo M M, Cadwallader D E, Trissel L A, Flora K P
Department of Pharmaceutics, College of Pharmacy, University of Georgia, Athens 30602.
Am J Hosp Pharm. 1989 Oct;46(10):2043-6.
The stability of pibenzimol hydrochloride was evaluated after reconstitution, after addition to several intravenous fluids, and after filtration. Vials containing pibenzimol hydrochloride 50 mg were reconstituted with 2.5 mL of 0.9% sodium chloride injection to 20 mg/mL. For determination of drug stability in intravenous fluids, vial contents were further diluted to 0.15 mg/mL by injection into glass containers and polyvinyl chloride (PVC) bags containing 250 mL of 5% dextrose injection, 0.9% sodium chloride injection, or lactated Ringer's injection. Pibenzimol concentrations were determined immediately after preparation and at various intervals after storage at 4-6 degrees C or 25 degrees C by means of a stability-indicating, high-performance liquid chromatographic technique. Vial contents were inspected visually for color changes, and pH was measured. Determinations were also made of the stability of pibenzimol 0.15 mg/mL in 0.9% sodium chloride injection after simulated infusions using a 0.22-micron filter set at 25 degrees C. All study solutions and admixtures retained more than 90% of the initial pibenzimol concentration. The greatest loss of drug (6-7%) occurred after 24 hours in lactated Ringer's injection in both glass and PVC containers and in 0.9% sodium chloride injection in PVC bags. No drug loss occurred as a result of filtration. Reconstituted pibenzimol hydrochloride and admixtures of pibenzimol in 5% dextrose injection, 0.9% sodium chloride injection, or lactated Ringer's injection in glass or PVC containers are stable for at least 24 hours at 25 degrees C. Filtration has no effect on stability.
对盐酸匹苯齐莫在复溶后、加入几种静脉输液后以及过滤后的稳定性进行了评估。将含有50mg盐酸匹苯齐莫的小瓶用2.5mL 0.9%氯化钠注射液复溶至20mg/mL。为了测定在静脉输液中的药物稳定性，将小瓶内容物注入含有250mL 5%葡萄糖注射液、0.9%氯化钠注射液或乳酸林格氏注射液的玻璃容器和聚氯乙烯（PVC）袋中，进一步稀释至0.15mg/mL。通过一种稳定性指示高效液相色谱技术，在制备后立即以及在4-6℃或25℃储存后的不同时间间隔测定匹苯齐莫浓度。目视检查小瓶内容物的颜色变化，并测量pH值。还测定了在25℃下使用0.22微米滤器进行模拟输注后，0.15mg/mL匹苯齐莫在0.9%氯化钠注射液中的稳定性。所有研究溶液和混合物保留的匹苯齐莫初始浓度均超过90%。在玻璃和PVC容器中的乳酸林格氏注射液以及PVC袋中的0.9%氯化钠注射液中，24小时后药物损失最大（6-7%）。过滤未导致药物损失。复溶后的盐酸匹苯齐莫以及在玻璃或PVC容器中与5%葡萄糖注射液、0.9%氯化钠注射液或乳酸林格氏注射液混合的匹苯齐莫在25℃下至少稳定24小时。过滤对稳定性无影响。
