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目的:研究愈创木酚甘油醚在动物体内的药物代谢动力学行为,比较控释片与普通片的相对生物利用度。方法:色谱柱为Symm etryC18柱(5μm,46 mm×250 mm,KYA TECH);分析条件为:乙腈∶0.05 mol/L磷酸二氢铵溶液∶36%醋酸=28∶72∶0.5(V/V);检测波长为278 nm;流速1 m l/m in;柱温30℃。结果:控释片:Tm ax为(42.5±25.8)m in,Cm ax为(6.82±2.70)μg/m l,AUC(0-tn)为(1 085.9±416.6)μg.m in.m l-1;参比片:Tm ax为(37.5±12.5)m in,Cm ax为(5.01±1.86)μg/m l,AUC(0-tn)为(422±171)μg.m in.m l-1。结论:两制剂折成等剂量后AUC(0→∞)双向单侧t检验统计判断结果表明,T/R均值在(91.6±15.9)%,90%可信限在81.7%~100.5%,符合生物等效的80%~125%的规定,两者等效。建立的HPLC方法适用于愈创木酚甘油醚的动物药代动力学研究。
Objective: To study the pharmacokinetics of guaifenesin in animals and to compare the relative bioavailability of controlled release tablets with common tablets. Methods: The column was Symm etry C18 (5 μm, 46 mm × 250 mm, KYA TECH). The analytical conditions were as follows: acetonitrile: 0.05 mol / L ammonium dihydrogen phosphate solution: 36% acetic acid = 28:72:0.5 ); Detection wavelength was 278 nm; flow rate was 1 ml / min; column temperature was 30 ℃. Results: The controlled release tablets showed the following: Tm ax was (42.5 ± 25.8) m in, Cm ax was (6.82 ± 2.70) μg / ml, AUC was 085.9 ± 416.6 μg.m in.m l- 1; reference tablets: Tm ax was (37.5 ± 12.5) m in, Cm ax was (5.01 ± 1.86) μg / ml and AUC (0-tn) was (422 ± 171) μg.m in.m l-1 . Conclusion: AUC (0 → ∞) bi-directional unilateral t-test results show that the mean of T / R is (91.6 ± 15.9)% and the 90% confidence limits are 81.7% ~ 100.5% Bioequivalence of 80% to 125% of the provisions of the two equivalent. The established HPLC method is suitable for animal pharmacokinetics of guaifenesin.