Lindenbaum J
Clin Pharmacol Ther. 1975 Mar;17(3):296-301. doi: 10.1002/cpt1975173296.
The bioavailability of single doses from 4 randomly selected lots of digoxin from a single manufacturer that were recently marketed in the United States was compared. In a crossover study in 6 normal volunteers, serum digoxin concentrations for 0 to 6 hr and urinary glycoside excretion for 24 hr after 0.5-mg doses were measured by radioimmunoassay. The variation in bioavailability between the 4 lots was no greater than that seen when one of them was taken twice. Intersubject variation in areas under the serum concentration-time curves and in the 24-hr urinary digoxin measurements was more than twice that of intrasubject variation. The variability of the urinary digoxin determinations was somewhat less than that of the areas under the serum concentration-time curves.
比较了来自一家制造商最近在美国上市的4个随机选择批次地高辛单剂量的生物利用度。在一项针对6名正常志愿者的交叉研究中，通过放射免疫分析法测量了0.5毫克剂量后0至6小时的血清地高辛浓度以及24小时的尿苷排泄量。4个批次之间生物利用度的差异不大于其中一批被服用两次时所观察到的差异。血清浓度-时间曲线下面积和24小时尿地高辛测量的受试者间差异是受试者内差异的两倍多。尿地高辛测定的变异性略小于血清浓度-时间曲线下面积的变异性。
