高效液相色谱法测定米非司酮制剂在家犬体内血药浓度及生物利用度Determination of plasma concentration and bioavailability of mifepristone in dogs by HPLC
赵春杰,戴礼苹,鄂蕴娟
ZHAO Chun jie 1; DAI Li ping 2; E Yun juan 3 (1. School of Pharmacy;
摘要(Abstract)：
目的测定米非司酮制剂在家犬体内药代动力学及生物利用度。方法于服药后不同时间内采血 ,用高效液相色谱法测定血药浓度。结果米非司酮胶丸 (被试制剂 1 )中米非司酮的Cmax为( 1 399 5 8± 396 87)ng/mL ;Tmax 为 ( 2 1 7± 0 98)h ;t1/ 2 (Ke) 为 ( 4 32± 0 4 1 )h ;AUC0→ 2 4 为( 1 1 0 4 3 75± 31 1 1 1 2 )ng/mL·h ;AUC0→∞ 为 ( 1 1 31 8 74± 30 99 0 4 )ng/mL·h ;米非司酮胶囊 (被试制剂 2 )中米非司酮的Cmax 为 ( 1 34 2 6 0± 1 35 76 )ng/mL ;Tmax 为 ( 1 33± 0 5 2 )h ;t1/ 2 (Ke) 为( 4 37± 0 4 9)h ;AUC0→ 2 4 为 ( 1 0 85 2 39± 1 936 98)ng/mL·h;AUC0→∞ 为 ( 1 1 0 90 2 8±1 989 95ng/mL·h ;米非司酮片 (对照制剂 )中米非司酮的Cmax为 ( 5 4 1 80± 1 5 2 79)ng/mL ;Tmax为( 0 92± 0 1 3)h ;t1/ 2 (Ke) 为 ( 3 1 4± 0 77)h ;AUC0→ 2 4 为 ( 2 72 0 2 8± 5 4 6 77)ng/mL·h ;AUC0→∞ 为( 2 72 0 2 8± 5 4 6 77)ng/mL·h。结论两种被试制剂与对照制剂比较 ,其米非司酮的Cmax、Tmax和AUC0→∞ 均有显著的统计学差异 (P <0 0 5 )。
Objective To determine the plasma concentration and bioavailability of mifepristone in dogs. Method Samples were extracted and determined by HPLC. The chromatographic conditions included: a Shim pack CLC ODS( 5 μm )reversed phase column( 6 mm × 150 mm ),a MeOH H 2O(78∶22)mobile phase, and UV detection at 302 nm .Results Pharmacokinetic parameters of the test of the mifepristone(1): C max ( 1 399 58± 396 87) ng/mL, T max (2 17±0 98)h, t 1/2( Ke ) (4 32±0 41)h, AUC 0→24 ( 11 043 75± 3111 12 )ng/mL·h, AUC 0→∞ ( 11 318 74 ± 3 099 04 )ng/mL·h.The test of mifepristone(2): C max ( 1 342 60 ± 135 76 )ng/mL, T max (1 33±0 52)h, t 1/2( Ke ) (4 37±0 49)h, AUC 0→24 ( 1 0852 39 ± 1 936 98 )ng/mL·h, AUC 0→∞ ( 11 090 28 ± 1 989 95 )ng/mL·h.The control of Mifepristone: C max (541 80± 152 79)ng/mL , T max (0 92±0 13)h, t 1/2( Ke ) (3 14±0 77)h, AUC 0→24 ( 2 720 28 ± 546 77 )ng/mL·h, AUC 0→∞ ( 2 720 28 ± 546 77 )ng/mL·h.Conclusion It appeared that the two test pharmaceutical preparations and control preparation had marked differences in C max , T max and AUC 0→∞ ( P <0 05).
关键词(KeyWords)：
米非司酮;生物利用度;高效液相色谱法
mifepristone; bioavailability; HPLC
基金项目(Foundation):
作者(Authors):
赵春杰,戴礼苹,鄂蕴娟
ZHAO Chun jie 1; DAI Li ping 2; E Yun juan 3 (1. School of Pharmacy;