正清风痛宁肠溶片的生物等效性研究

Bioequivalence of enteric coated tablet of Zhengqing Fengtongning

目的:研究2种正清风痛宁肠溶片在家兔体内的药代动力学,评价两者的生物等效性。方法:12只家兔随机交叉单剂量口服湖南正清风痛宁肠溶片(受试制剂)或西安正清风痛宁肠溶片(参比制剂),采用高效液相色谱法测定青藤碱的血药浓度,用3p97软件拟合处理数据。结果:2种药物在家兔体内药-时曲线呈一室模型,Tm ax分别为(0.81±0.34)h和(0.60±0.30)h,Cm ax为(11.16±0.58)μg.mL-1和(11.90±1.44)μg.mL-1,AUC0→t为(61.58±6.70)μg.h.mL-1和(60.56±6.67)μg.h.mL-1,2种制剂的主要药动学参数无显著性差异。相对生物利用度为(102.77±15.63)%。结论:2种正清风痛宁肠溶片具有生物等效性。

To explore the pharmacokinetics and bioequivalence of two kinds of enteric coated tablet of Zhengqing Fengtongning. Method： A single dose of 45 mg·kg^-1 test or reference preparation was administrated by randomized crossover way in 12 rabbits. The plasma concentrations of drug were determined by HPLC. The pharmacokinetics parameters and relative bioequivalence were calculated with 3p97 program. Result： The concentration curves based on drug-time of both test and control preparations were presented by one-compartment model, tmax were （0. 81±0. 34） ,（0. 60±0. 30） h respectively, Cmax were （11. 16±0. 58）,（11. 90±1. 44） μg·mL^-1 respectively, AUC0→t were （61. 58±6. 70） , （60. 56±6. 67） μg·h·mL^-1 respectively, relative bioavailability was （102. 77%±15. 63）%. Suggesting no significant diffirence between the main pharmacokinetic parameters of two prepations. Conclusion： The two preparations are bioequivalent.