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《Chinese Journal of Clinical Pharmacology and Therapeutics》 2010-06
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Pharmacokinetics of Huperzine A substain-release tablets after multiple doses in healthy volunteers

WEI Zhen-man1,DING Jin-biao1,HU Lin1,CHEN Hong-ge1,WU Rong-rong1,LIU Wan-hui2,SHA Chun-jie2 1 Department of Clinical Pharmacology,302 Hospital,Beijing 100039,China;2 Pharmacy College of Yantai University,Yantai 264005,Shandong,China  
AIM:To evaluate the pharmacokinetics of Huperzine A sustained-release tablets after multiple doses in Chinese healthy volunteers.METHODS:In a randomized crossover trial,24 healthy subjects received multiple oral doses of either Huperzine A sustained-release tablets or a common Huperzine A tablet for 7 days.The plasma concentrations were determined by LC/MS/MS.Pharmacokinetic parameters were obtained using DAS program.RESULTS:The major pharmacokinetic parameters of test and reference Huperzine A tables were as follows:Css min were (0.54±0.21) and (0.79±0.20)ng/mL,Css max were (1.65±0.45)and (1.83±0.37)ng/mL,Css were (1.05±0.28) and (1.22±0.28)ng/mL,tmax were (3.5±1.9) and (1.1±0.4) h,AUC0-t(ss) were (31±8) and (35±9)ng·mL-1·h,AUC0-∞(ss) were (37±10)and (41±11)ng·mL-1·h,AUCss were (25±7)and (15±3)ng·mL-1·h,respectively.The relative bioavailability of test tablet as estimated by AUC0-t(ss) was (88±12) %.There was significant difference in tmax between two tablets.CONCLUSION:The results show that the Huperzine A substain-release tablets clearly have the characteristic of slow releasing properties.
【Fund】: 国家科技部十一五重大新药创制课题(2008ZX09312-011)
【CateGory Index】: R969.1
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