黄体酮制剂在Beagle犬体内的药动学研究  

Pharmacokinetic study of progesterone preparations in Beagle dogs

作　　者：李瑞 陈颖 陈迅 张自强 LI Rui;CHEN Ying;CHEN Xun;ZHANG Ziqiang(Nanjing Steril Pharmaceutics Technology Co.,Ltd.,Nanjing 210046,China)

机构地区：[1]南京斯泰尔医药科技有限公司,江苏南京210046

出　　处：《药学研究》2022年第11期709-712,共4页Journal of Pharmaceutical Research

摘　　要：目的建立快速测定雄性Beagle犬血浆中黄体酮浓度的方法,用于比较3种黄体酮制剂经肌内注射给药后在犬体内的动力学。方法以醋酸甲地孕酮为内标,血浆经乙腈沉淀处理后进行高效液相色谱-串联质谱(HPLC-MS/MS)分析。结果黄体酮制剂经肌内注射给药后,受试制剂与参比黄体酮-油剂的AUC_(INF_obs)、黄体酮-水剂的C_(max)无统计学差异(P>0.05),但与参比黄体酮-油剂的C_(max)、参比黄体酮-水剂的AUC_(INF_obs)有统计学差异(P<0.05)。结论建立的高效液相色谱-串联质谱法可以快速测定血浆中黄体酮浓度,用于评价不同黄体酮制剂之间的差异。Objective To establish a method to rapidly determine the concentration of progesterone in the plasma of male Beagle dogs,and compare the kinetics of three progesterone preparations in dogs after intramuscular administration.Methods HPLC-MS/MS analysis was performed after plasma was treated with acetonitrile precipitation.Results After intramuscular administration of progesterone preparations,there was no statistical difference(P>0.05)between the subject preparation and the AUC_(INF_obs)of the reference progesterone-oil agent and the C_(max)of the reference progesterone-water agent,but there was a statistical difference with the C_(max)of the reference progesterone-oil agent and the AUC_(INF_obs)of the reference progesterone-water agent(P<0.05).Conclusion The established HPLC-MS/MS method can quickly determine the progesterone concentration in plasma for evaluating the differences between different progesterone preparations.

关 键 词：黄体酮 药物动力学 高效液相色谱-串联质谱 血药浓度 

分 类 号：R969.1[医药卫生—药理学]