摘要
目的 :对珠海许瓦兹公司生产的单硝酸异山梨酯缓释胶囊与德国麦克乐公司生产的缓释胶囊和瑞士阿斯特拉公司生产的缓释片剂进行药物动力学比较。方法 :采用气相色谱法 ,以对硝基苯乙腈为内标 ,测定受试者体内单硝酸异山梨酯 ( 5-ISMN )的血浆浓度 ,计算药物动力学参数。方法的线性范围为 :10～ 10 0 0 μg·L- 1,回收率为 ( 10 0± 3) % ;精密度RSD为 2 .3%。结果 :本品和缓释胶囊比较 ,AUC ,Cmax,T1/ 2 ,MRT ,MAT (P >0 .0 5) ,而在C10min,C2 0min,C30min,C4 5min,C60min,Tmax,Tlag(P <0 .0 5)。与缓释片比较 ,AUC ,Cmax,Tmax,T1/ 2 ,Tlag,MAT(P >0 .0 5) ,而在MRT ,C2 0min,C30min(P<0 .0 5)。结论 :本品的吸收显著快于
AIM: To study the pharmacokinetics of isosorbide mononitrate (ISMN) sustained release capsules (Schwarz product) which produced by Zhuhai Schwarz Pharma Co Ltd, using two ISMN sustained release preparations produced by German Maklo Pharma Co Ltd and Swiss Astla pharma Co Ltd as standard references. METHODS: The plasma concentration of ISMN was determined with gas chromatography method with 4 nitrobengyl acetomitrile as the internal standard. The kinetic parameters were calculated. The linear range of the method is 10-100 μg·L -1 ; the rate of recovery: (100±3)%; the precision of the method, RSD<2.3%. RESULTS: There was no statistical significant difference between Schwarz product and Reference 1 on AUC, C max , T 1/2 , MRT and MAT( P >0.05), but significant differences on C 10min , C 20min , C 30min , C 45min , C 60min , T max and T lag ( P <0.05) were observed. There was no statistical significant difference between Schwarz product and Reference 2 on AUC, C max , T max , T 1/2 , T lag and MAT ( P >0.05), but significant differences on MRT, C 20min C 30min ( P < 0.05) were obseved. CONCLUSION: The absorption of Schwarz product is much faster than both of the two references.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2001年第1期50-52,共3页
Chinese Journal of New Drugs and Clinical Remedies
关键词
单硝酸异山梨酯
气相色谱法
药物动力学
生物利用度
isosorbide mononitrate
gas chromatography
pharmacokinetics
biological availabilit
