首页|叶下珠配方颗粒、饮片汤剂药动学特性及生物等效性评价

叶下珠配方颗粒、饮片汤剂药动学特性及生物等效性评价

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目的 评价叶下珠配方颗粒、饮片汤剂药动学特性及生物等效性.方法 12 只大鼠随机分为2 组,分别灌胃给予叶下珠配方颗粒、饮片汤剂溶液(0.428 2、2.000 g/kg),于 0.083、0.167、0.25、0.5、0.75、1、2、3、4、8、12、24、36 h采血,UPLC-MS/MS法测定没食子酸、柯里拉京、鞣花酸血药浓度,计算主要药动学参数.再考察这 2种制剂的生物等效性.结果 2 种制剂AUC0~∞、AUC0~t、MRT0~∞、MRT0~t、t1/2、Tmax、CL、Cmax比较,差异无统计学意义(P>0.05),其Cmax、AUC0~∞比值或对数均数的差值均在 90%置信度下符合生物等效标准.结论 叶下珠配方颗粒、饮片汤剂药动学特性接近,具有生物等效性.
Evaluation for pharmacokinetic properties and bioequivalency of Yexiazhu Formula Granules and Decoction
AIM To evaluate the pharmacokinetic properties and bioequivalency of Yexiazhu Formula Granules and Decoction.METHODS Twelve rats were randomly assigned into two groups and given intragastric administration of the solutions of Yexiazhu Formula Granules and Decoction(0.428 2,2.000 g/kg),respectively,after which blood collection was made at 0.083,0.167,0.25,0.5,0.75,1,2,3,4,8,12,24,36 h,UPLC-MS/MS was adopted in the plasma concentration determination of gallic acid,corilagin and ellagic acid,and main pharmacokinetic parameters were calculated.Subsequently,the bioequivalency of these two preparations was investigated.RESULTS No significant differences in AUC0-∞,AUC0-t,MRT0-∞,MRT0-t,t1/2,Tmax,CL and Cmax were observable between the two preparations(P>0.05),whose Cmax,AUC0-∞ ratios or logarithmic mean differences accorded with bioequivalence standard at the 90%confidence level.CONCLUSION Yexiazhu Formula Granules and Decoction demonstrate approximate pharmacokinetic properties and display bioequivalency.

Yexiazhu Formula GranulesYexiazhu Decoctionpharmacokinetic propertiesbioequivalencyUPLC-MS/MS

朱仙慕、黄群、陈丹、谢平、马国萍

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福建中医药大学药学院,福建 福州 350122

叶下珠配方颗粒 叶下珠饮片汤剂 药动学特性 生物等效性 UPLC-MS/MS

福建省科技计划福建省科技引导性项目福建省科技引导性项目

2010Y20042019Y00372019Y0038

2024

中成药
国家食品药品监督管理局,信息中心中成药信息站,上海中药行业协会

中成药

CSTPCD北大核心
影响因子:1.217
ISSN:1001-1528
年,卷(期):2024.46(5)
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