摘要
为了研究Beagle犬经口给予受试制剂灯盏花素口崩片和参比制剂灯盏花素片的药动学,对比分析了两制剂的药代动力学参数,评价了灯盏花素口崩片的相对生物利用度。6只Beagle犬,分为两组,每组3只,分别给予两种制剂,自身双交叉实验,采用HPLC-MS/MS法检测Beagle犬血浆中灯盏花乙素苷元。结果表明,灯盏花素口崩片和灯盏花素片主要的药动学参数分别是:Cmax为(235.08±112.53)ng/m L、(267.90±111.04)ng/m L,tmax为(6.33±6.05)h、(4.33±1.92)h,AUC(0-t)为(1554.58±548.49)ng/(m L·h)、(1628.08±408.78)ng/(mL·h)。受试制剂灯盏花素口崩片的相对生物利用度为102%。两制剂的tmax、Cmax和AUC(0-t)差异均无统计学意义(p>0.05),灯盏花素口崩片与的灯盏花素片具有相似的生物利用度。
Objective:To study the pharmacokinetics of the test preparation breviscapine orally disintegrating tablets and the reference preparation breviscapine tablets in Beagle dogs,to compare and analyze the pharmacokinetic parameters of the two preparations,and to evaluate the breviscapine oral disintegration Relative bioavailability of tablets.Methods:6 Beagle dogs were divided into two groups,3 dogs in each group.Two preparations were given respectively.The double-crossover experiment was performed by itself,and the scutellarin aglycone in the plasma of Beagle dogs was detected by HPLC-MS/MS.Results:The main pharmacokinetic parameters of scutellarin orally disintegrating tablets and scutellarin tablets were:Cmax(235.08±112.53)ng/m L、(267.90±111.04)ng/m L,tmax(6.33±6.05)h、(4.33±1.92)h,AUC(0-t)(1554.58±548.49)ng/(m L·h)、(1628.08±408.78)ng/(m L·h).The relative bioavailability of the tested preparation breviscapine orally disintegrating tablets was 102%.Conclusion:There is no statistically significant difference in tmax,Cmaxand AUC(0-t)between the two preparations(p>0.05).Breviscapine orally disintegrating tablets and breviscapine tablets have similar bioavailability.
作者
陈鹏
崔佳丽
周艺佳
张培培
赵高琼
梅晶
刘红斌
王京昆
Chen Peng;Cui Jiali;Zhou Yijia;Zhang Peipei;Zhao Gaoqiong;Mei Jing;Liu Hongbin;Wang Jingkun(Dali Universiy,Dali 671000,China;Yunran Ihnstitute odf Pharmacdlogy,Kunming 650111,China;Key Laboratory of the Estabishment of New Chines Medicine and National Medicines in Yunnan Province,Yunnan Kunming 65011l;Schol of Phamacy,Kunming Vocational College of Health,Kunming 650600,China)
出处
《云南化工》
CAS
2021年第3期19-22,共4页
Yunnan Chemical Technology
基金
云南省科技计划高层次科技人才培引工程(2011HA003)
