肿瘤药学Issue(2)：147-153,7.DOI:10.3969/j.issn.2095-1264.2013.036
维A酸软胶囊在中国健康受试者体内的药动学研究★
Pharmacokinetics of Tretinoin Soft Capsules in Chinese Healthy Volunteers★
摘要
Abstract
Objective The pharmacokinetics of tretinoin test and reference soft capsules which were orally administrated by 30 healthy volunteers was investigated. Methods A LC-MS/MS method was established for the determination of tretinoin in plasma. A C18 column was used with acitretin as the internal standard. The analytes were detected in the positive ion mode and multiple reactions monitoring (MRM). Results The Cmax, Tmax, AUC0→10 and AUC0→∞ (average ± SD) of test capsules and reference capsules were 142.52±34.09 ng·mL-1 and 141.75±31.64 ng·mL-1, 2.1±0.3 h and 2.05±0.36 h, 352.67± 121.78 ng·h·mL-1 and 343.95±100.70 ng·h·mL-1, 353.91±120.71 ng·h·mL-1 and 345.67±98.96 ng·h·mL-1, respectively. The relative bioavailability of tretinoin soft capsules was 101.6%±18.5%. The Cmax, Tmax, AUC0→10 and AUC0→∞ (aver-age±SD) of test capsules and reference capsules after baseline being corrected were 141.59±34.09 ng·mL-1 and 140.79± 31.64 ng·mL-1, 2.07±0.29 h and 2.05±0.36 h, 343.19±121.56 ng·h·mL-1 and 334.11±100.32 ng·h·mL-1, 344.11±121.58 ng·h·mL-1 and 335.09±100.26 ng·h·mL-1, respectively. Conclusion The relative bioavailability of tretinoin soft capsules was 101.7%±19.1%. No significant difference was observed in the rate and degree of absorption, which indicated that the two preparations were bioequivalent.关键词
维A酸/LC-MS/MS/药代动力学/生物等效性研究Key words
Tretinoin/LC-MS/MS/Pharmacokinetics/Bioequivelence分类
医药卫生引用本文复制引用
陈秋华,张毕奎,王医成,李廷霞,彭静波,俞竞,彭向东,阳国平,谭志荣,欧阳冬生..维A酸软胶囊在中国健康受试者体内的药动学研究★[J].肿瘤药学,2013,(2):147-153,7.基金项目
国家自然科学基金青年科学基金项目资助(81001471) （81001471）
