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目的了解食物对丹皮酚人体药代动力学的影响,以此为丹皮酚的给药方案提供科学、合理的理论依据。方法选择2011年3月到6月来我院查体的16名健康人为实验对象,将其随机分为进食组和禁食组,各8人,两组对象分别在进食及禁食两种处理后(即进行双周期交叉实验),口服160mg丹皮酚片,按设定时间取肘静脉血,建立HPLC法测定血浆中丹皮酚浓度[1-2]。结果两组健康志愿者服用丹皮酚片后的药代动力学参数t1/2、Tmax、Cmax、AUC0-t及AUC0-∞,进食组与禁食组间的相对应的参数比较差异有统计学意义(P<0.05)。结论进食组Tmax较禁食组明显延长,而t1/2,Cmax,AUC0～t,AUC0-∞则明显减少,可用于指导丹皮酚口服制剂的临床应用。
Objective To understand the effect of food on the pharmacokinetics of paeonol in human body and to provide a scientific and rational theoretical basis for paeonol administration. Methods Sixteen healthy volunteers from March 2011 to June in our hospital were selected as experimental subjects and randomly divided into eating group and fasting group, with 8 in each group. The two groups were treated with fasting and fasting respectively (Ie, a two-cycle crossover experiment), oral 160mg paeonol tablets, according to the set time to take elbow venous blood, the establishment of HPLC method for the determination of plasma concentration of paeonol [1-2]. Results The pharmacokinetic parameters t1 / 2, Tmax, Cmax, AUC0-t and AUC0-∞ of the paired healthy volunteers after taking paeonol tablets between the two groups were statistically significant Significance (P <0.05). Conclusion Tmax in the fed group was significantly longer than that in the fasting group, while t1 / 2, Cmax, AUC0 ~ t and AUC0-∞ decreased significantly, which could be used to guide the clinical application of paeonol oral preparation.