论文部分内容阅读
以英国 Ｇｌａｘｏ Ｐｈａｒｍａｃｅｕｔｉｃａｌｓ生产的沙丁胺醇控释片（Ｖｏｌｍａｘ， ８ ｍｇ）为参比制剂，采用随机分组交叉试验设计方法，考察 ２０名健康男性志愿受试者单剂量和多剂量口服成都地奥公司生产的硫酸沙丁胺醇缓释胶囊（Ｓａｌｂｕｔａ， ８ ｍｇ）后的药代动力学和相对生物利用度，ＨＰＬＣ－紫外检测器测定血浆中沙丁胺醇的浓度。用３Ｐ８７药动学程序对结果进行处理。单剂量给药时，Ｓａｌｂｕｔａ和Ｖｏｌｍａｘ分别在５５０±０．８５ｈ和５．３０±０.９５ ｈ达到峰浓度１０.６１±３.９４ｎｇ·ｍＬ-１和１０．５２±２．５９ ｎｇ·ｍＬ-１，血药浓度曲线下面积分别为 １２４.７４±３３.８６ｈ·ｎｇ．ｍＬ－１和 １２６.０２±３８．１７ｈ·ｎｇ·ｍＬ－１，Ｓａｌｂｕｔａ的相对生物利用度为９８.９８±１２.０４％。多剂量给药达稳态时，Ｃ分别为１２.９４±３.３５ｎｇ·ｍＬ－１和１２.６±３.３６ｎｇ·ｍＬ．Ｃ 分别为５.８４±１.３４ ｎｇ·ｍＬ－１和６.１６±１.３３ｎｇ·ｍＬ-１，平均稳态血药浓度 Ｃａｖ分别为 ８.７２±２．１７ ｎｇ·ｍＬ-１和 ８．６７±２．１６ ｎｇ·ｍＬ-１，波动度 ＤＦ分别为 ８１.８２±１７.７４％和７６.０３±２０.４８％
Salbutamol controlled release tablets (Volmax, 8 mg) produced by Glaxo Pharmaceuticals in the United Kingdom were used as reference preparations. Randomized crossover design was used to investigate the effects of single and multi-dose oral administration of 20 doses of Chengdu Diao Pharmaceutical Co., Ltd. on healthy volunteers Pharmacokinetics and relative bioavailability after Salbuta Sulfate Sustained Release Capsules (8 mg) were determined by HPLC-UV detector for the concentration of salbutamol in plasma. The results were processed using the 3P87 pharmacokinetics program. At the single dose, Salbuta and Volmax reached peak concentrations of 10.61 ± 3.94 ng · mL-1 and 10.52 ± 2.59 ng · mL at 550 ± 0.85 h and 5.30 ± 0.95 h, respectively -1, and the area under the plasma concentration curve was 124.74 ± 33.86 h · ng respectively. mL-1 and 126.02 ± 38.17 ng · mL-1, the relative bioavailability of Salbuta was 98.98 ± 12.04%. When multi-dose administration reached steady state, C was 12.94 ± 3.35ng · mL-1 and 12.6 ± 3.36ng · mL, respectively. C were 5.84 ± 1.34 ng · mL-1 and 6.16 ± 1.33 ng · mL-1, respectively. The mean steady-state plasma concentration of Cav was 8.72 ± 2.17 ng · mL-1 and 8.67 ± 2.16 ng · mL-1, the volatility DF were 81.82 ± 17.74% and 76.03 ± 20.48%