| 引用本文: | 梅源,郑国钢,藏恒昌.伏立康唑胶囊人体药动学及相对生物利用度研究[J].中国现代应用药学,2013,30(5):499-502. |
| MEI Yuan,ZHENG Guogang,ZANG Hengchang.Study on Pharmacokinetics and Relative Bioavailability of Voriconazole Capsules in Healthy Volunteers[J].Chin J Mod Appl Pharm(中国现代应用药学),2013,30(5):499-502. |
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| 摘要: |
| 目的 研究健康受试者口服伏立康唑胶囊的药动学和相对生物利用度。方法 20名健康受试者随机服用伏立康唑受试胶囊剂和参比片剂各100 mg，用HPLC-MS/MS测定血浆中伏立康唑的浓度。结果 主要药动学参数，伏立康唑受试制剂与参比制剂的Tmax分别为(0.75±0.15)和(0.84±0.25)h，Cmax分别为(605.4±136.6)和(595.2±134.7)ng·mL-1；t1/2分别为(4.91±1.44)和(5.06±2.06)h，AUC0-15分别为(1737.6±325.1)和(1750.6±352.8)ng·h·mL-1。受试制剂与参比制剂的AUC0-15和Cmax经双单侧t检验，Tmax经非参数检验，差异均无统计学意义。结论 统计学结果表明，2种制剂生物等效。 |
| 关键词: 伏立康唑胶囊 高效液相色谱-质谱 药动学 生物等效性 |
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| Study on Pharmacokinetics and Relative Bioavailability of Voriconazole Capsules in Healthy Volunteers |
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MEI Yuan1,2, ZHENG Guogang3, ZANG Hengchang4
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1.School of Pharmaceutical Seciences Shandong University, Ji’nan 250100, China;2.Zhejiang Certification Center for Drug, Hangzhou 310012, China;3.Zhejiang Institute for Food and Drug Control, Hangzhou 310004, China;4.School of Pharmaceutical Seciences Shandong University, Ji’nan 250100
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| Abstract: |
| OBJECTIVE To study the pharmacokinetics and relative bioavailability of voriconazole capsules. METHODS A single oral dose of 100 mg voriconazole test capsules and reference tablets was given to 20 healthy male volunteers according to a randomized cross over design. Plasma concentration of voriconazole was determined by HPLC-MS/MS. RESULTS The main pharmacokinetic parameters of test capsules and reference tablets were as follows: Tmax(0.75±0.15) and (0.84±0.25)h, Cmax (605.4±136.6) and (595.2±134.7)ng·mL-1, t1/2 (4.91±1.44) and (5.06±2.06)h, AUC0-15 (1737.6±325.1) and (1750.6±352.8)ng·h·mL-1, respectively. Through the one or two-side test for AUC0-15 and Cmax, and Tmax with the Wilcoxon test, no significant difference was found. CONCLUSION The two formulations are bioequivalent. |
| Key words: voriconazole capsules HPLC-MS pharmacokinetics relative bioavailability |
