茶碱缓释片的人体生物利用度

Bioavailability study of theophylline sustained release tablets in human volunteers

用高效液相色谱（ＨＰＬＣ）法测定茶碱血药浓度。ＹＷＧ－Ｃ１８化学键合相为固定相，流动相为甲醇∶０．０５ｍｏｌ·Ｌ－１醋酸铵溶液（２５∶７５），内标为对乙酰氨基酚。ＵＶ２７３ｎｍ检测，线性浓度范围０．２～２０μｇ·ｍｌ－１，方法回收率９８．６７％～１０１．６８％。应用本法研究了茶碱缓释片研制品和对照品的人体生物利用度，结果表明，两种制剂的ＡＵＣ，Ｔｍａｘ，Ｃｍａｘ及波动系数之间差异无显著性。

high performance liquid chromatography method was developed for determining theophylline in human plasma. Waters model 481 instrument equipped with an ultraviolet detector(273nm) and a column(150mm× 4.6 mm) filled with YWG C 18 were used. The mobile phase consisted of methanol and 0.05 mol·L -1 ammonium acetate solution at a ratio of 25∶75, paracetamol was selected as internal standard. The calibration curve was linear in the concentration range of 0.2 ～20μg·ml -1 . The average recoveries varied from 98.67 ～ 101.68% . A crossover bioavailability study of two theophylline sustained release tablets in 18 healthy volunteers was carried out. AUC , C max, T max and Fluctuate Index of two formulations did not show significant differences( P > 0.05 ).