HPLC 法测定妇科调经片中芍药苷在大鼠体内的药代动力学研究

摘要

Objective To study the pharmacokinetics of paeoniflorin in Fuke Tiaojing tablets in rat plasma by HPLC. Methods Using the paeoniflorin standard and control product of gardenia to find the conditions of HPLC for the detection of the standard curve,and detection of specificity,the minimum detection limit,recovery rate,precision and stability. Twenty rats were divided into two groups:0. 2 g/ kg group and 0. 4 g / kg group,with 10 rats in each group. Plasma concentration(0. 2,0. 5,1. 0,1. 5, 2. 0,4. 0,6. 0,8. 0,12. 0,15. 0,18. 0 h after administration)was determined by HPLC and the phar-macokinetics were measured. Results ①The paeoniflorin standard and control product of gardenia had the good peak and specificity by HPLC;peak area of paeoniflorin(Y)on the concentration of sample (X)regression equation:Y =135. 598X +3. 520(R =0. 9999),the lowest detection limit was 0. 1 mg/ L, and had good measured recovery rate,precision and stability. ②The main pharmacokinetic of 0. 2 g / kg group and 0. 4 g / kg group were as follow:Cmax were(15. 80 ± 1. 30)and(21. 60 ± 1. 70)mg / L,Tmax were(3. 52 ± 0. 51)and(3. 61 ± 0. 64)h,AUC0 t were(4 312 ± 155)and(5 314 ± 142)(mg·h)/ L, AUC0 ∞ were(5 873 ± 209)and(6 719 ± 174)(mg·h)/ L. Conclusions The method of HPLC is simple,sensitive,accurate and suitable for content determination and pharmacokinetic of paeoniflorin in Fuke Tiaojing tablets.%目的：利用高效液相色谱（HPLC）法研究妇科调经片中芍药苷在大鼠体内的药代动力学。方法利用芍药苷标准品和栀子苷对照品寻找 HPLC 法检测条件，得出标准曲线，并检测专属性、最低检测限度、回收率、精密度及稳定性。将20只 SD 大鼠，随机分为0.2 g/ kg 和0.4 g/ kg 妇科调经片组，每组10只，采用 HPLC 法测定给药后0.2、0.5、1.0、1.5、2.0、4.0、6.0、8.0、12.0、15.0、18.0 h 血药浓度，计算药代动力学参数。结果①芍药苷与内标栀子苷峰形良好，专属性可；芍药苷的峰面积（ Y）对进样浓度（ X）回归方程 Y ＝135.598X ＋3.520（ R ＝0.9999），最低检测限度为0.1 mg/ L，测得的回收率、精密度及稳定性良好。②0.2 g/ kg 组与0.4 g/ kg 组的主要药代动力学参数分别为：药峰浓度（Cmax ）为（15.80±1.30）、（21.60±1.70）mg/ L，达峰时间（Tmax ）为（3.52±0.51）、（3.61±0.64）h，AUC0 t 为（4312±155）、（5314±142）（mg·h）/ L，AUC0∞为（5873±209）、（6719±174）（mg·h）/ L。结论 HPLC法适用于妇科调经片中芍药苷的药代动力学研究，且该方法操作简便，灵敏度高，结果准备可靠。