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目的研究由香港澳美制药有限公司生产的夫西地酸干混悬剂的相对生物利用度。方法采用双周期随机交叉试验设计。分别给予20名男性健康受试者试验制剂或参比制剂夫西地酸干混悬剂750 mg,采用HPLC法测定给药后不同时间的血药浓度。结果参比制剂与试验制剂的主要药物动力学参数Cmax、tmax、AUC0→48和AUC0→∞(均数±标准差)分别为:(30.91±5.24)、(30.25±5.82)μg.mL-1;(2.00±0.74)、(1.88±0.60)h;(443.0±136.3)、(435.6±105.2)μg.h.mL-1;(460.4±139.6)、(450.9±108.2)μg.h.mL-1。试验制剂对参比制剂的相对生物利用度F(以AUC0→48作为评价依据)为100%±13%(71%~125%)。结论经统计学分析,香港澳美制药有限公司生产的夫西地酸干混悬剂与丹麦利奥制药有限公司生产的夫西地酸干混悬剂参比制剂具有生物等效性。
Objective To study the relative bioavailability of fusidic acid in dry suspension produced by Hong Kong Amicorp Pharmaceutical Co., Ltd. Methods Double-cycle randomized crossover design was used. Twenty male healthy subjects were given 750 mg of the test preparation or the reference preparation of fusidic acid dry suspension respectively. The plasma concentration of the drug was measured by HPLC at different times after administration. Results The main pharmacokinetic parameters Cmax, tmax, AUC0 → 48 and AUC0 → ∞ (mean ± standard deviation) of reference preparation and test preparation were (30.91 ± 5.24), (30.25 ± 5.82) μg.mL-1 ; (2.00 ± 0.74), (1.88 ± 0.60) h; (443.0 ± 136.3), (435.6 ± 105.2) μg.h.mL-1; (460.4 ± 139.6), (450.9 ± 108.2) μg.h.mL- 1. The relative bioavailability of the test formulation to the reference formulation, F (based on AUC0 → 48) was 100% ± 13% (71% -125%). Conclusions According to statistical analysis, the fusidic acid dry suspension produced by Hong Kong Amicorp Pharmaceutical Co., Ltd. is bioequivalent to the reference formulation of fusidic acid dry suspension produced by Leo Pharmaceutical Co., Ltd. in Denmark.