Kim Yu Chul, Lee Myung Gull, Ko Seong-Hee, Kim So Hee
College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University, San 56-1, Shinlim-Dong, Kwanak-Gu, Seoul 151-742, Korea.
J Pharm Pharmacol. 2003 Nov;55(11):1515-22. doi: 10.1211/0022357022034.
The effects of differences in the rate and composition of intravenous fluid replacement for urine loss on the pharmacokinetics and pharmacodynamics of torasemide were evaluated in rabbits. Each rabbit received 2-h constant intravenous infusion of 1 mg kg(-1) torasemide with 0% replacement (treatment 1, n=6), 50% replacement (treatment 2, n=9), 100% replacement with lactated Ringer's solution (treatment 3, n=8), and 100% replacement with 5% dextrose in water (treatment 4, n=6). Total body (4.53, 5.72, 10.0 and 4.45 mL min(-1) kg(-1) for treatments 1-4, respectively) and renal clearance (1.44, 1.87, 6.78 and 1.72 mL min(-1) kg(-1)) of torasemide, and total amount of unchanged torasemide excreted in 8-h urine (A(e 0-8 h): 694, 780, 1310 and 1040 microg) in treatment 3 were considerably faster and greater compared with treatments 1, 2 and 4. Although the difference in A(e 0-8 h) between treatments 1 and 3 was only 88.8%, the diuretic and/or natriuretic effects of torasemide were markedly different among the four treatments. For example, the mean 8-h urine output was 101, 185, 808 and 589 mL for treatments 1-4, respectively, and the corresponding values for sodium excretion were 10.1, 20.6, 89.2 and 29.9 mmol, and for chloride excretion were 14.5, 27.9, 94.0 and 37.2 mmol. Although full fluid replacement was used in both treatments 3 and 4, the 8-h diuretic, natriuretic and chloruretic effects in treatment 3 were significantly greater compared with treatment 4, indicating the importance of the composition of fluid replacement. Both treatments 1 and 4 received no sodium replacement, however, the 8-h diuretic, natriuretic and chloruretic effects were significantly greater in treatment 4 compared with treatment 1, indicating the importance of rate of fluid replacement for the diuretic effects. Therefore, the 8-h diuretic, natriuretic and chloruretic effects were significantly greater in treatment 3 compared with treatments 1, 2 and 4, indicating the importance of full fluid and electrolyte replacement. Some implications for the bioequivalence evaluation of dosage forms of torasemide are discussed.
在兔体内评估了尿丢失的静脉补液速率和成分差异对托拉塞米药代动力学和药效学的影响。每只兔接受2小时恒速静脉输注1mg kg⁻¹托拉塞米,补液量分别为0%(处理1,n = 6)、50%(处理2,n = 9)、用乳酸林格氏液100%补液(处理3,n = 8)和用5%葡萄糖水溶液100%补液(处理4,n = 6)。托拉塞米的全身清除率(处理1 - 4分别为4.53、5.72、10.0和4.45 mL min⁻¹ kg⁻¹)和肾清除率(1.44、1.87、6.78和1.72 mL min⁻¹ kg⁻¹),以及处理3中8小时尿中排泄的未变化托拉塞米总量(A(e 0 - 8 h):694、780、1310和1040μg)与处理1、2和4相比明显更快且更多。尽管处理1和3之间A(e 0 - 8 h)的差异仅为88.8%,但托拉塞米的利尿和/或利钠作用在四种处理之间明显不同。例如,处理1 - 4的平均8小时尿量分别为101、185、808和589 mL,相应的钠排泄量分别为10.1、20.6、89.2和29.9 mmol,氯排泄量分别为14.5、27.9、94.0和37.2 mmol。尽管处理3和4均采用了完全补液,但处理3的8小时利尿、利钠和利氯作用与处理4相比明显更大,表明补液成分的重要性。处理1和4均未补充钠,然而,处理4的8小时利尿、利钠和利氯作用与处理1相比明显更大,表明补液速率对利尿作用的重要性。因此,处理3的8小时利尿、利钠和利氯作用与处理1、2和4相比明显更大,表明完全补液和电解质补充的重要性。还讨论了对托拉塞米剂型生物等效性评估的一些启示。