【摘要】 目的:以左旋延胡索乙素为指标,评价复方枣仁片的生物等效性。方法:21名男性健康受试者随机交叉单剂量口服试验制剂和参比制剂后,以HPLC法测定血清左旋延胡索乙素浓度,评价试验制剂中左旋延胡索乙素的相对生物利用度。结果:单剂量口服相等剂量(复方枣仁片2片/复方枣仁胶囊1粒)后,试验制剂和参比制剂的AUC0-12h分别为(627.0±228.8)和(614.0±205.4)μg.h.L-1;AUC0-∞分别为(698.8±236.4)和(681.7±224.5)μg.h.L-1;tmax分别为(1.4±0.3),(1.4±0.5)h;Cmax分别为(235.3±60.7),(227.5±65.5)μg.L-1。试验制剂的F0-12h为(108.0±43.3)%。对AUC0-24h、AUC0-∞、Cmax经对数转化后作方差分析、双单侧t检验,tmax作非参数法秩和检验,结果两组间差异无显著性。结论:以左旋延胡索乙素为指标,试验制剂复方枣仁片与参比制剂复方枣仁胶囊生物等效。更多还原

【Abstract】 OBJECTIVE To evaluate the bioequivalence of L-tetrahydropalmatine in Compound Zaoren tablet.METHODS 21 healthy male volunteers were administered with an oral single dose of test and reference products respectively in a random crossover study.The concentrations of L-tetrahydropalmatine in serum were determined by RP-HPLC using diazepam as internal standard.RESULTS The AUC0-12h for L-tetrahydropalmatine of test and reference were(627.0±228.8) and(614.0±205.4)μg·h·L-1;AUC0-∞ were(698.8±236.4) and(681.7±224.5)μg·h·L-1;Tmax were(1.4±0.3) and(1.4±0.5)h;Cmax were(235.3±60.7) and(227.5±65.50)μg·L-1,respectively after an oral single dose(2 tablets of Compound Zaoren tablet or 1 capsule of Compound Zaoren capsule).There was no significant difference between the main pharmacokinetic parameters and the relative bioavailability of the test was(108.0±43.3)%.CONCLUSION It is bioequivalent for L-tetrahydropalmatine in the two Compound Zaoren products after a single oral dose.更多还原