多剂量口服给药后辅酶Q_(10)缓释片和普通片在健康人体内的血药浓度  

Determination of total coenzyme Q_(10) in plasma following dose oral administration of 50 mg coenzyme Q_(10) sustained release tablets and regular tablets in healthy volunteers

作　　者：周田彦[1] 孙华东[1] 张大卫[1] 郑黎[1] 吕万良[1] 张强[1] 

机构地区：[1]北京大学药学院药剂系,北京100083

出　　处：《中国药学杂志》2002年第3期189-192,共4页Chinese Pharmaceutical Journal

摘　　要：目的　比较辅酶Q10 缓释片与辅酶Q10 普通片多剂量给药后的经时变化过程。方法　将 2 0名男性健康志愿受试者等分为两组 ,一组受试者每人每天 po 5 0mg的辅酶Q10 缓释片 ,连服 15d ,另一组受试者每人每天 po 5 0mg的辅酶Q10 普通片 ,服药期间及服药前后 ,在规定的时间内采取静脉血 ,测定血浆中辅酶Q10 总含量。血浆经甲醇沉淀蛋白后 ,以正己烷提取 ,分离水相和有机相 ,收集有机相 ,氮气吹干 ,将所得残渣溶于 10 0 μL无水乙醇中 ,进行HPLC检测。检测波长为 2 75nm ,流动相为乙醇 甲醇 (9∶1) ,内标物为辅酶Q9。结果　建立的体内HPLC UV分析方法简便、稳定、适宜于进行生物样品分析。受试者经过 15d po辅酶Q10 缓释片和普通片 ,每天 po一次 ,每次剂量为 5 0mg ,测得血浆中总辅酶Q10 浓度表明 ,受试者服缓释片后血浆中辅酶Q10 浓度高于对照组服普通片后的血药浓度。结论　多次服用缓释片的稳态血药浓度高于普通片的稳态血药浓度 ,原因在于缓释片可持续释放、持续吸收 ,从而保持血浆中较高的浓度。OBJECTIVE: To investigate the total coenzyme Q10 concentrations in the human plasma following multiple oral 50 mg doses administered as coenzyme Q10 sustained release tablets and regular ones, respectively. METHODS: Twenty healthy male volunteers were included and were divided into two equal groups. Each subject received multiple oral doses of coenzyme Q10 as sustained release tablets or regular tablets respectively 50 mg once daily for fifteen days. The blood samples were taken prior to the administration and at specified times after administration. After precipitated by methanol for removing the proteins, the plasma samples were extracted with hexane. The organic phase was collected after low speed centrifugation, dried under nitrogen gas stream and dissolved into 100 μL of ethanol. The solution was injected into HPLC-UV system. The ODS (10 μm, 250 mm × 4.6 mm) reverse phase column was used and heated to 30°C for analysis. The mobile phase was consisted of methanol-ethanol 9:1 with the flow rate at 1.5 mL. min-1 and the detection wavelength at 275 nm. Coenzyme Q9 was used as the internal standard. RESULTS: The established HPLC method was simple, stable and suitable for analysis of biological samples. The total coenzyme Q10 concentrations in plasma following oral administration of sustained release tablets were higher than those in plasma following oral administration of regular tablets. CONCLUSION: The higher levels of total coenzyme Q10 following the administration of sustained release tablets may be related to the slow release and continuous absorption.

关 键 词：辅酶Q10 缓释片 高效液相色谱法 血药浓度 多剂量 口服给药 普通片 

分 类 号：R977.3[医药卫生—药品] R969.1[医药卫生—药学]