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目的:考察尼麦角林分散片与尼麦角林片剂的生物等效性。方法:采用双周期自身随机交叉试验设计。24名健康男性志愿者单剂量口服试验制剂或参比制剂,血浆样品采用高效液相色谱-串联质谱测定(HPLC-MS-MS),以内标法计算血药浓度。结果:受试制剂及参比制剂尼麦角林实测平均血药峰浓度Cmax分别为(16.31±13.16),(16.78±14.36)g·L-1;实测平均达峰时间Tmax分别为(0.60±0.21),(0.91±1.12)h;受试制剂及参比制剂t1/2(ke)分别为(4.89±3.67),(4.46±1.88)h;AUC0～tn平均值分别为(68.60±66.25),(63.84±59.71)μg·L-1.h;AUC0～∞平均值分别为(71.08±67.66),(66.25±61.90)μg·L-1·h;试验制剂尼麦角林分散片的相对生物利用度F0～tn,F0～∞分别为(110.05±27.57)%,(111.53±29.84)%。结论:试验制剂和参比制剂具有生物等效性。
OBJECTIVE: To investigate the bioequivalence of nicergoline dispersible tablet and nicergoline tablet. METHODS: A two-cycle random crossover trial design was used. Twenty-four healthy male volunteers were given a single dose of oral test formulation or reference formulation. The plasma samples were analyzed by HPLC-MS-MS and plasma concentrations were calculated by internal standard method. Results: The mean peak plasma concentration (Cmax) of test preparation and reference preparation was (16.31 ± 13.16) and (16.78 ± 14.36) g · L-1, respectively. The average measured peak Tmax was (0.60 ± 0.21 ) And (0.91 ± 1.12) h, respectively. The values of t1 / 2 (ke) of test preparation and reference preparation were (4.89 ± 3.67) and (4.46 ± 1.88) (63.84 ± 59.71) μg · L-1.h; the average AUC0 ~ ∞ were (71.08 ± 67.66) and (66.25 ± 61.90) μg · L-1 · h, respectively. The relative bioavailability The degrees F0 ~ tn and F0 ~ ∞ were (110.05 ± 27.57)% and (111.53 ± 29.84)%, respectively. Conclusion: The test and reference formulations are bioequivalent.