注射用鲑鱼降钙素的人体生物利用度

Study on the human bioavailability of injectable salmon calcitonin

目的 :评价注射用鲑鱼降钙素人体生物利用度和生物等效性。方法 :男性健康志愿者 2 0名 ,采用自身交叉方式单剂量注射鲑鱼降钙素与密钙息 2 0 μg,以放射免疫法测定其血药浓度。结果 :试验制剂注射用鲑鱼降钙素与参比制剂密钙息的主要药动学参数 :Cmax分别为 (1 54 .5± 35 .2 )ng·L- 1 和 (1 53 .8± 2 8.1 )ng·L- 1 ;Tmax为 (0 .52± 0 .1 9)h和 (0 .48± 0 .1 4 )h ;AUC0～ 1 0 为 (344 .6± 46 .8)ng·h·L- 1 和 (339.4± 40 .6)ng·h·L- 1 ,AUC0～∞ 为 (356 .4± 48.3)ng·h·L- 1 和 (350 .5± 41 .7)ng·h·L- 1 。两种制剂的主要药动学参数差异无显著性 (P >0 .0 5)。注射用鲑鱼降钙素对密钙息的相对生物利用度为 (1 0 2 .0±7.6) %。结论 :两种制剂具有生物等效性。

OBJECTIVE To study the relative bioavailablity and bioequivalence of injectable salmon calcitonin .METHODS The plasma concentration of calcitonin was determined by radioimmunoassay after a single dose( 20μg ) of two kinds of preparation, injectable salmon calcitonin and Miacalcic, were given intramuscularly to 20 healthy male volunteers in a randomized cross-over test. RESULTS The pharmacokinetic parameters of two preparations were as follows:C max ( 154.5 ± 35.2 )ng·L -1 and ( 153.8 ± 28.1 )ng·L -1 .T max ( 0.52 ± 0.19 ) h and ( 0.48 ± 0.14 ) h. AUC 0～10 ( 344.6 ± 46.8 ) ng·h·L -1 and( 339.4 ± 40.6 )ng·h·L -1 ,AUC 0～∞ ( 356.4 ± 48.3 )ng·h·L -1 and ( 350.5 ± 41.7 )ng·h·L -1 。The pharmacokinetic parameters showed no significant difference between two products ( P > 0.05 ). The relative bioavailablity of injectable salmon calcitonin was( 102.0 ± 7.6 )%. CONCLUSIONS Injectable salmon calcitonin and miacalcic are bioequivalent.