Munoz D M, Green E R, Chrymko M M, Mylotte J M, Kitrenos J G
Kaiser Foundation Health Plan Pharmacy, San Francisco, CA.
Clin Pharm. 1988 Apr;7(4):303-7.
Delivery of gentamicin via a new controlled-release intravenous infusion system was compared with conventional delivery via small-volume injections in minibags by measuring serum drug concentrations in 10 healthy men. Each volunteer received gentamicin (as the sulfate salt) 2 mg/kg. In phase 1, subjects randomly received the drug either as a 50-mL admixture in 5% dextrose injection (D5W) or from the controlled-release system (CRIS, IVAC Corporation), in which drug was diluted in a vial with 10 mL of sterile water for injection (density of drug solution, approximately 1.5% w/v) and was delivered when the primary solution (D5W; density, 5% w/v) displaced drug from the vial and infused it into the subject over 30 min; subjects were then crossed over. In phase 2, nine of the subjects received the drug via CRIS with the diluent changed to 10 mL of 5% dextrose and 0.9% sodium chloride injection (D5NS; density of drug solution, approximately 5.9% w/v). In phase 3, 10 men (seven of the original subjects) received the gentamicin dose via CRIS with 20 mL of D5NS as the diluent or via minibags in a crossover design. The amount of drug remaining in each vial used with the CRIS system was determined. Drug administration via CRIS with 10 mL of sterile water diluent resulted in serum concentrations approximately 35% of those obtained with the minibag system, and a substantial portion (71 +/- 8%) of the dose to be administered remained in the vials.(ABSTRACT TRUNCATED AT 250 WORDS)
通过一种新型控释静脉输液系统给予庆大霉素，并与通过小容量注射在微型袋中进行的传统给药方式进行比较，方法是测量10名健康男性的血清药物浓度。每位志愿者接受2mg/kg的庆大霉素（硫酸盐）。在第1阶段，受试者随机接受药物，要么是在5%葡萄糖注射液（D5W）中作为50mL的混合液，要么来自控释系统（CRIS，IVAC公司），在该系统中，药物在一个小瓶中用10mL注射用水稀释（药物溶液密度约为1.5%w/v），当主要溶液（D5W；密度5%w/v）从小瓶中置换出药物并在30分钟内输注到受试者体内时进行给药；然后受试者进行交叉。在第2阶段，9名受试者通过CRIS接受药物，稀释剂改为10mL 5%葡萄糖和0.9%氯化钠注射液（D5NS；药物溶液密度约为5.9%w/v）。在第3阶段，10名男性（7名原始受试者）通过交叉设计，以20mL D5NS作为稀释剂通过CRIS接受庆大霉素剂量，或通过微型袋接受。测定了与CRIS系统一起使用的每个小瓶中剩余的药物量。用10mL无菌水稀释剂通过CRIS给药导致的血清浓度约为微型袋系统所获浓度的35%，并且要给药剂量的很大一部分（71±8%）留在了小瓶中。（摘要截短于250字）
