摘要
８名男性健康受试者交叉口服 １５０ｍｇ国产与进口盐酸二苯美仓片剂，进行国产片的药代动力学和相对生物利用度研究。血药浓度采用高效液相色谱法测定。结果表明：国产和进口片剂的血药浓度时间曲线符合血管外给药一室模型，国产片和进口片的主要药代动力学参数Ｃ_ｍａｘ分别为１１．３５±８．０３和１４．７４±１１．１２ｕｇ·Ｌ~－１，Ｔ_ ｐｅａｋ分别为３．２２±０．８９和２．８５±１．８６ ｈ， Ｔ_１／２Ｋｅ分别为２．７６±０．９１和３．０１±１．２４ ｈ，ＡＵＣ分别为１１０．８０ ± ７８．０６和１１４，７１± ８１．７９ ｕ ｇ·ｈ· Ｌ~－１。两种片剂的药代动力学参数经统计学分析无显著性差异（Ｐ＞０．０５）。国产盐酸二苯美仓片剂的相对生物利用度为９８．９６％±２３．４１％。结果提示国产与进口制剂基本生物等效。
The pharmacokinetic profiles and the bioavailability of domestic tablets of bifemelane hydrochloride were studied in & healthy male volunteers. A single oral dose of 150 mg bifemelane hydrochloride made in China or Japan was given according to a crossover design. Serum concentration of bifemelane was measured by HPLC. The concentrationtime curves of domestic and imported products were fitted to a one-compartment open model. Peak serum levels of domestic and imported tablets reached 11 .35 ± 8.03 and 14.74 ± 11.12 ug · L^-1, T_peak were 3.22 ± 0.89 and 2.85 ± 1.86 h,T1/2Ke were 2.76 ± 0.91 and 3.01 ± 1.24 h,AUC were 110.80 ± 78.06 and 114.71 ± 81.79 ug·h· L^-1, respectively. The pharmacokinetic parameters obtained from our studies showed no significant difference between two tablets, P>0.05. The relative bioavailability of domestic and imported tablets was 98.96 ± 23.41 %, which demonstrated that both formulations are bioequivalent.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2000年第1期49-51,共3页
The Chinese Journal of Clinical Pharmacology
