Hasan S M Farid, Ahmed Tasneem, Talib Nasira, Hasan Fouzia
Jinnah Medical & Dental College, Karachi, Pakistan.
Pak J Pharm Sci. 2005 Jan;18(1):18-24.
Diclofenac sodium was administered as 50 mg tablets to four healthy male volunteers in a two-way randomized crossover study in which volunteers were either fasted or were given a standard breakfast immediately prior to dosing. Blood samples were obtained upto 9 hours period and drug concentration were determined by HPLC method. Besides a significantly delayed (at p > 0.1) peak in fed state; an increase in absorption rate constant was observed as the only significant (at p > 0.05) effect of food on biopharmaceutic characteristic of diclofenac sodium. However, the intrinsic absorption of diclofenac sodium is also fast and it is not being the rate limiting factor in the bioavailability of diclofenac sodium, its decrease upto about 18 minutes (0.31 +/- 0.05 hr) from 11 minutes (0.19 +/- 0.02 hr) produces a null difference as the net effect on bioavailability, particularly when the drug is to be used in multiple dosage regimen.
在一项双向随机交叉研究中,给4名健康男性志愿者服用50毫克双氯芬酸钠片剂,志愿者在给药前要么禁食,要么立即给予标准早餐。在长达9小时的时间段内采集血样,并通过高效液相色谱法测定药物浓度。除了在进食状态下峰明显延迟(p>0.1)外;观察到吸收速率常数增加是食物对双氯芬酸钠生物药剂学特性的唯一显著(p>0.05)影响。然而,双氯芬酸钠的内在吸收也很快,它不是双氯芬酸钠生物利用度的限速因素,其从11分钟(0.19±0.02小时)减少到约18分钟(0.31±0.05小时)对生物利用度的净效应产生零差异,特别是当药物用于多剂量方案时。