3种交沙霉素片剂的生物等效性研究

Comparison of bioequivalence of three kinds of josamycin tablets in healthy volunteers

目的 :研究 3种交沙霉素片剂在 12名男性健康受试者中的药物动力学和生物等效性。方法 :采用反相高效液相色谱法检测血浆中交沙霉素的浓度。结果 :交沙霉素的药 -时曲线经 3P97拟合符合开放性一室模型 ,A片的 AUC0 - t、AUC(0 -α) ,cmax、tmax、T1 /2 (ke) 分别为 (2 870 .75± 15 0 1.5 7) h· ng/ m l、(2 982 .0± 15 40 .91) h· ng/ m l、(115 8.2 8± 5 83.17) ng/ m l、(1.33± 0 .33) h、(1.18± 0 .40 ) h;B片分别为 (2 879.49± 136 5 .14) h· ng/ m l、(2 949.12± 140 4) h· ng/ ml、(130 8.40± 5 17.40 )ng/ ml、 (1.5 8± 0 .42 ) h、(1.19± 0 .2 3) h;C片分别为 (2 40 6 .77± 10 2 7.0 3) h· ng/ ml、 (2 482 .4± 10 2 8.2 8) h· ml、(1148.2 9± 784.0 3) ng/ m l、(1.5 8± 0 .19) h、(1.17± 0 .30 ) h。3种交沙霉素片剂的所有药物动力学参数经统计学 (SPSS软件的方差分析 )处理均无统计学差异 (P>0 .0 5 )。以片剂 B作为参比制剂 ,交沙霉素片剂 A和 C的生物利用度分别为 89.36 %和78.5 5 %。结论

AIM: To compare the pharmacokinetics and bioequivalence of 3 josamycin tablets (A,B,C) in 12 healthy male volunteers. METHODS: Plasma concentrations of josamycin were measured with high performance liquid chromatography (HPLC). RESULTS: The concentration time curves of josamycin fitted to a one compartment model. The AUC 0-t , AUC 0-α , c max , t max , T 1/2(Ke) of A were ( 2 870 75 ± 1 501 57 ) h·ng/ml, ( 2 982 0 ± 1 540 91 ) h·ng/ml, ( 1 158 28 ±583 17) ng/ml, (1 33±0 33) h, (1 18±0 40) h, respectively; B were ( 2 879 49 ± 1 365 14 ) h·ng/ml, ( 2 949 12 ± 1 404 ) h·ng/ml, ( 1 308 40 ±517 40) ng/ml, (1 58±0 42) h, (1 19±0 23) h, respectively and C were ( 2 406 77 ± 1 027 03 ) h·ng/ml, ( 2 482 4 ± 1 028 28 ) h·ng/ml, ( 1 148 29 ±784 03) ng/ml, (1 58±0 19) h, (1 17±0 30) h, respectively. Compared to tablet B, the relative bioavailability of A and C is 89 36% and 78 55% respectively. CONCLUSION: There are no significant differences between 3 tablets ( P >0 05). The 3 preparations are bioequivalent.