Okaniwa A, Hori M, Masuda M, Takeshita M, Hayashi N, Wada I, Doi K, Ohara Y
J Toxicol Sci. 1979 Feb;4(1):31-45. doi: 10.2131/jts.4.31.
Rats of various ages were treated orally or intraperitoneally with potassium aspartate. The dose required to induce hypothalamic lesion varied considerably by the age of animals and route of administration. Additional experiment, in which the animals were orally treated three times a day with potassium aspartate in dose levels between the maximum safety dose and minimum lesion-producing dose in the preceding single dose study, revealed no hypothalamic lesion at all in any animals of each age group. In this condition, the maximum safety dose was 3--5 times as large as that in single dosage administration experiment. Regarding the safety evaluation of potassium aspartate preparations, brief discussions on some points in extrapolation of the results of the present experimental study to the clinical use were made.
给不同年龄的大鼠经口或腹腔注射天冬氨酸钾。诱导下丘脑损伤所需的剂量因动物年龄和给药途径的不同而有很大差异。在额外的实验中,动物在前一项单剂量研究中,每天经口给予处于最大安全剂量和最小致损伤剂量之间的不同剂量水平的天冬氨酸钾三次,结果显示每个年龄组的任何动物均未出现下丘脑损伤。在此条件下,最大安全剂量是单次给药实验中最大安全剂量的3至5倍。关于天冬氨酸钾制剂的安全性评估,就将本实验研究结果外推至临床应用的一些要点进行了简要讨论。