Chung K C, Chin A, Gill M A
Department of Clinical Pharmacy, School of Pharmacy, University of Southern California (USC), Los Angeles 90033, USA.
Am J Health Syst Pharm. 1995 Jul 15;52(14):1541-3. doi: 10.1093/ajhp/52.14.1541.
The stability and sterility of granisetron hydrochloride in 5% dextrose injection or 0.9% sodium chloride injection when stored in a disposable elastomeric infusion device were studied. Granisetron was diluted to 0.02 mg/mL (as the hydrochloride salt) in 5% dextrose chloride injection. The solution was placed in the drug reservoir of a disposable elastomeric infusion device and refrigerated at 4 degrees C for 14 days. A total of eight pumps were prepared, four containing granisetron 0.02 mg/mL in 5% dextrose injection and four containing granisetron 0.02 mg/mL in 0.9% sodium chloride injection. The solutions were assayed for granisetron concentration by stability-indicating high-performance liquid chromatography at 0 hours, 24 hours, 48 hours, 7 days, and 14 days. Each solution was inspected for clarity, color, and precipitation, and sterility testing was performed. Throughout the study, the mean concentration of granisetron remaining was more than 92% of the initial concentration both in 5% dextrose injection and in 0.9% sodium chloride injection. Individual solutions in 0.9% sodium chloride injection consistently maintained more than 90% of the initial drug concentration for only seven days. No microbial growth was detected. No precipitation, color change, or haziness was seen. Granisetron 0.02 mg/mL (as the hydrochloride salt) was stable and free of microbial growth in 0.9% sodium chloride injection for up to 7 days and stable and free of microbial growth in 5% dextrose injection for up to 14 days when stored at 4 degrees C in a disposable elastomeric infusion device.
研究了盐酸格拉司琼在储存在一次性弹性输液装置中时，于5%葡萄糖注射液或0.9%氯化钠注射液中的稳定性和无菌性。将格拉司琼在5%葡萄糖注射液中稀释至0.02 mg/mL（以盐酸盐计）。将该溶液置于一次性弹性输液装置的药库中，并在4℃下冷藏14天。共制备了8个泵，4个含有5%葡萄糖注射液中0.02 mg/mL的格拉司琼，4个含有0.9%氯化钠注射液中0.02 mg/mL的格拉司琼。通过稳定性指示高效液相色谱法在0小时、24小时、48小时、7天和14天时测定溶液中的格拉司琼浓度。检查每种溶液的澄清度、颜色和沉淀情况，并进行无菌测试。在整个研究过程中，5%葡萄糖注射液和0.9%氯化钠注射液中剩余格拉司琼的平均浓度均超过初始浓度的92%。0.9%氯化钠注射液中的个别溶液仅在7天内始终保持超过初始药物浓度的90%。未检测到微生物生长。未见沉淀、颜色变化或浑浊。当在一次性弹性输液装置中于4℃储存时，0.02 mg/mL（以盐酸盐计）的格拉司琼在0.9%氯化钠注射液中长达7天稳定且无微生物生长，在5%葡萄糖注射液中长达14天稳定且无微生物生长。
