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本文研究了长效茶碱片(SRTT)的处方组成,制备工艺,溶出速率;并应用改进的紫外分光光度法测定了l2名健康受试者口服SRTT后的体内血药浓度,实验数据按单室模型用电子计算机进行处理得各药物动力学参数。SRTT单剂量给药(300 mg),3.8小时达有效血药浓度,可维持5μg/ml以上23小时;多剂量给药,3小时达有效血药浓度,至第三天已达稳态血药浓度13.78±0.47μg/ml。将SRTT与世界名牌产品Theo-Dur进行对照试验,表明两制剂为生物等效。本文采用脱卷积法计算体内外相关性,理论值与实测值基本相符。
In this paper, the prescription composition, preparation process and dissolution rate of long-acting theophylline tablets (SRTT) were studied. The in vivo plasma concentrations of oral SRTT in 12 healthy subjects were determined by the improved ultraviolet spectrophotometry. Room model computerized by the computer pharmacokinetic parameters. SRTT single dose (300 mg), 3.8 hours of effective blood concentration, can maintain 5μg / ml more than 23 hours; multiple doses, effective blood concentration reached the third hour until the third day has reached steady-state blood drug The concentration of 13.78 ± 0.47μg / ml. A controlled trial comparing SRTT with Theo-Dur, a world famous brand, showed that both formulations were bioequivalent. In this paper, the deconvolution method was used to calculate the in vitro and in vivo correlation, the theoretical value and the measured value basically consistent.