养血清脑颗粒对丙戊酸在人体内血药浓度和药代动力学的影响

目的研究养血清脑颗粒(YXQNG)对丙戊酸(VPA)血药浓度和药代动力学参数的影响,为临床癫痫患者同时使用YXQNG和VPA的合理用药提供理论依据。方法 8例健康志愿者,4男4女,禁食10h后于清晨分别单剂量口服丙戊酸钠片0.5g。采用高效液相色谱法(HPLC)测定给药后不同时间点的VPA血药浓度。7d后,开始口服YXQNG,每天3次,每次4g。在服用YXQNG后7d清晨再次服用VPA0.5g,按上述时间点采集血样,采用HPLC方法测定血药浓度。对所得数据用Kinetica 5.0软件处理,计算出相应的药动学参数。对相应数据采用SPSS13.0进行统计分析。结果 VPA合用YXQNG与单独服用VPA相比:(1)同一受试者在单剂量服用VPA0.5g后9h时间点,VPA血药浓度下降明显,差别有统计学意义(P<0.05),其它时间点VPA血药浓度虽均有所下降,但差异无统计学意义;(2)VPA药代动力学参数(Tmax,Cmax,T1/2,AUC0-t,CL)差异无统计学意义(P>0.05)。结论YXQNG可以降低人体内VPA的血药浓度,对VPA药代动力学参数无明显影响,二者合用时要及时监测VPA血药浓度,适当调整VPA的用量。

Effect of Yangxueqingnao particles on the the blood drug level and pharmacokinetics of valproic acid in healthy volunteers

Objective To study the effect of Yangxueqingnao particles on the the blood drug level and pharmacokinetics of valproic acid(VPA)in healthy volunteers.It provides a theoretical basis of using both Yangxueqingnao particles and valproic acid for clinical patients of epilepsy.Method A single oral dose of 0.5g of valproic acid tablets was administrated to eight healthy volunteers(four men and four women)in the morning after fasted ten hours.Valproic acid concentrations in the plasma were determined by HPLC at different time.Yangxueqingnao particles were taken 7 days latter with third a day and 4g once.Then valproic acid(0.5g)was oral administrated again.Blood was drew at the same time again.HPLC was used to determine the concentration of valproic acid.Kinetica 5.0 was used to calculate the pharmacokinetic parameters.The date was carried out by statistical analysis using SPSS 13.0.Result The VPA blood level of the same subjects in the same time points were declined,while at the time points of 9h after taking valproic acid in a single dose of 0.5g,the blood drug level of valproic acid were significantly decreased,and the difference was statistically significant(P<0.05).There was no significant difference between the two groups in the pharmacokinetic parameters of valproic acid,such as Cmax,Tmax、AUC0-t and CL(P>0.05).Conclusion Yangxueqingnao particles may have the effect of reducing the blood drug level of valproic acid,while has no significant effect on the pharmacokinetic parameters of valproic acid.When using valproic acid combined with Yangxueqingnao particles,the blood drug level of valproic acid should be monitored timely and then adjusted the dosage of VPA.