| 引用本文: | 戴婕,李芳芳,陈庆强,谭焕君,胡晋卿,张明,温预关.富马酸喹硫平片人体生物等效性研究[J].中国现代应用药学,2013,30(6):614-619. |
| DAI Jie,LI Fangfang,CHEN Qingqiang,TAN Huanjun,HU Jinqing,ZHANG Ming,WEN Yuguan.Study on Bioequivalence of Quetiapine Fumarate Tablets in Healthy Vonlunteers[J].Chin J Mod Appl Pharm(中国现代应用药学),2013,30(6):614-619. |
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| 摘要: |
| 目的 研究国产富马酸喹硫平片的生物等效性。方法 20名健康男性志愿者按标准二阶段交叉试验方案设计，分别口服受试制剂和参比制剂各200 mg，并采集36 h内动态血标本，用HPLC-MS/MS测定血浆中喹硫平浓度，计算药动学参数，并判定2种制剂的生物等效性。结果 受试制剂和参比制剂的主要药动学参数Cmax分别为(984.9±323.0)μg·L-1和(989.6±332.4)μg·L-1，tmax分别为(0.6±0.3)h和(0.7±0.3)h，t1/2分别为(4.9±0.7)h和(5.2±1.2)h，AUC0-36分别为(2 998.7±541.7) μg·L-1·h和(3 054.1±632.7)μg·L-1·h，AUC0-∞分别为(3 013.0±542.3)μg·L-1·h和(3 071.7±630.4)μg·L-1·h，2种制剂的主要药动学参数经对数转换后进行方差分析及双单侧t检验，并计算90%置信区间，表明2种制剂生物等效。受试制剂的相对生物利用度为(99.1±8.9)%。结论 2种制剂生物等效。 |
| 关键词: 富马酸喹硫平 生物等效性 液相色谱-串联质谱法 |
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| 基金项目:国家自然科学基金(10926191)；广东省重大科技计划(2011A080300003)；广东省科技计划社会发展领域项目(00498500130062027)；广东省药学会(2012A02) |
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| Study on Bioequivalence of Quetiapine Fumarate Tablets in Healthy Vonlunteers |
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DAI Jie1, LI Fangfang2, CHEN Qingqiang2, TAN Huanjun2, HU Jinqing2, ZHANG Ming2, WEN Yuguan2
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1.Clinical Drug Trial Institution, Sun Yat-sen Memorial Hospital, Sun Yut-sen University, Guangzhou 510120, China;2.Clinical Drug Trial Institution, Guangzhou Brain Hospital, Guangzhou 510370, China
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| Abstract: |
| OBJECTIVE To study the bioequivalence of quetiapine fumarate in Chinese healthy volunteers. METHODS 200 mg test preparation and reference preparation were given to 20 male healthy vonlunteers in randomized two-way crossover design for the pharmacokinetic and relative bioavailability study. Plasma concentrations of quetiapine were determined by HPLC-MS/MS. RESULTS The primary pharmacokinetic parameters of two preparations were: Cmax(984.9±323.0) μg·L-1 and (989.6±332.4)μg·L-1, tmax(0.6±0.3)h and (0.7±0.3)h, t1/2(4.9±0.7)h and (5.2±1.2)h, AUC0-36(2 998.7±541.7)μg·L-1·h and (3 054.1±632.7)μg·L-1·h, AUC0-∞(3 013.0±542.3)μg·L-1·h and (3071.7±630.4)μg·L-1·h respectively. The results of statistical analysis demonstrated the bioequivalence of two preparations, and the relative mean bioavailability of test preparation were (99.1±8.9)%. CONCLUSION The two preparations are bioequivalent. |
| Key words: quetiapine fumarate bioequivalence LC-MS/MS |
