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目的:在中国健康成年男性志愿者中比较研究黄杨宁分散片与黄杨宁片的相对生物利用度,评价二者的生物等效性。方法:20名健康男性志愿者随机交叉单剂量口服黄杨宁分散片与黄杨宁片3 mg,采用高效液相-质谱-质谱法分别测定血浆中环维黄杨星D的浓度,计算其药代动力学参数,评价这两种制剂的生物等效性。结果:受试制剂及参比制剂环维黄杨星D的Cm ax分别为(90.17±45.19)和(99.95±50.06)ng/L,Tm ax分别为(5.3±4.1)和(4.9±3.9)h,t1/2分别为(51.45±33.40)和(39.70±20.59)h;AUC0-tn分别为(3625.79±1619.20)和(3608.21±1320.07)ng.L-1.h,AUC0-∞分别为(4459.28±1965.11)和(4113.58±1560.08)ng.L-1.h,试验制剂黄杨宁分散片的相对生物利用度F0-tn,F0-∞分别为(102.03±22.79)%,(109.94±28.08)%。统计学分析显示,药代动力学参数AUC、Cm ax、Tm ax等的差异无显著性。结论:受试制剂和参比制剂具有生物等效性。
OBJECTIVE: To compare the relative bioavailability of Huang Yang Ning dispersible tablets and Huang Yang Ning tablets in healthy adult male volunteers in China, and to evaluate their bioequivalence. METHODS: Twenty healthy male volunteers were randomized to cross oral single doses of Huang Yang Ning dispersible tablets and Huang Yang Ning tablets 3 mg. The concentration of cyclovir-xybrinin D in plasma was determined by high performance liquid chromatography-mass spectrometry-mass spectrometry to calculate its pharmacokinetics. Parameters, evaluate the bioequivalence of these two formulations. RESULTS: The Cm ax of Cyclovirobuxine D was 90.17±45.19 and (99.95±50.06) ng/L, and the Tm ax was (5.3±4.1) and (4.9±3.9) h, respectively. The t1/2 were (51.45±33.40) and (39.70±20.59) h, the AUC0-tn were (3625.79±1619.20) and (3608.21±1320.07) ng.L-1.h, and the AUC0-∞ were (4459.28). ± 1965.11) and (4113.58±1560.08) ng.L-1.h. The relative bioavailability F0-tn and F0-∞ of the experimental formulation Huangyangning dispersible tablets were (102.03±22.79)%, (109.94±28.08)%, respectively. . Statistical analysis showed no significant differences in pharmacokinetic parameters AUC, Cm ax, Tm ax, etc. Conclusion: The test formulation and the reference formulation are bioequivalent.