辅酶Q_(10)片药动学与人体相对生物利用度试验  

Studies on relative bioavailability and pharmacokinetics of coenzyme-Q_(10) tablets

作　　者：张伟英 李士敏[2] 王彤文[2] 金玲琳 金杨君 徐星娥 

机构地区：[1]东阳市人民医院,浙江东阳322100 [2]浙江大学药学院,浙江杭州310006

出　　处：《中国医院药学杂志》2004年第9期527-529,共3页Chinese Journal of Hospital Pharmacy

摘　　要：目的 :研究浙江万马药业有限公司研制的辅酶Q10 片与沈阳卫材制药有限公司相同产品的生物利用度和生物等效性。方法 :8名男性健康志愿者随机分成 2组 ,分别服用两个厂家生产的辅酶Q10 片剂 10 0mg ,用反相高效液相色谱法测定其血药浓度 ,并计算药动学参数。结果 :浙江万马药业有限公司研制的辅酶Q10 片与市售沈阳卫材制药有限公司生产的辅酶Q10 片 ,口服后达峰时间分别为 (3.8± 0 .7)和 (3.6± 0 .9)h ,达峰浓度分别为 (1.3± 0 .5 )和 (1.3± 0 .5 )mg·L-1,AUC分别为(2 8.2± 12 .4 )和 (2 7.2± 11.6 )mg·L-1·h。结论 :以沈阳卫材制药有限公司能气朗片为参比片 ,浙江万马药业有限公司研制的辅酶Q10 片人体相对生物利用度为 10 4 .3% ,经统计分析 ,两者无显著差异 ,证明生物等效。OBJECTIVE The relative bioavailability and pharmacokinetics of Zhejiang Wanma test coenzyme-Q _10 tablet or Shengyang Weicai control coenzyme-Q _10 tablet were studied. METHODS 8 healthy male volunteers,who were randomly divided into two grups received a single dose of 100 mg test and control preparation respectively. The plasma drug levels were determined by RP-HPLC and the pharmacokinetics parameters were analyzed. RESULTS The main pharmacokinetics parameters of test and control preparations, T _max was (_3.8±_0.7) and (_3.6±_0.9)h;C _max was (_1.3±_0.5) and (_1.3±_0.5) mg·L_-1;AUC was (_28.2±_12.4) and (_27.2±_11.6)mg·L_-1·h,respectively. CONCLUSION The relative bioavailability of test preparation was _104.3%.The result of statistical analysis on above parameters showed that there was no significant differance between the two preparations.The two preparations is bioequivalence.

关 键 词：辅酶Q10片 高效液相色谱法 生物利用度 生物等效性 

分 类 号：R969.1[医药卫生—药理学]