采用平行人工膜测定不同厂家富马酸喹硫平片体外渗透速率  

Using Parallel Artificial Membrane Permeability Assay to Test the in Vitro FLUX of Quetiapine Fumarate Tablets from Different Manufacturers

作　　者：马玲云[1] 汪路楠 张广超 黄寅[2] 牛剑钊[1] 许鸣镝[1] MA Ling-yun;WANG Lu-nan;Zhang Guang-chao;HUANG Yin;NIU Jian-zhao;XU Ming-di(National Institutes for Food and Drug Control,Beijing 100050,China;China Pharmaceutical University,Nanjing 210009,China)

机构地区：[1]中国食品药品检定研究院,北京100050 [2]中国药科大学,南京210009

出　　处：《中国药学杂志》2023年第14期1327-1333,共7页Chinese Pharmaceutical Journal

基　　金：国家“重大新药创制”科技重大专项资助(2017ZX09101001)。

摘　　要：目的采用平行人工膜渗透测定法测定不同厂家富马酸喹硫平片的渗透速率和累积渗透量,初步预测其生物等效性。方法在空腹和饱腹条件下,使用Macro Flux TM药物渗透测定仪,对富马酸喹硫平片的渗透速率进行测定。结果在空腹和饱腹条件下,原研进口、原研地产化、未进口原研的参比制剂、3家国产仿制制剂的渗透速率和累积渗透量的90%置信区间均落在80.00%~125.00%之间。结论采用平行人工膜渗透测定法测定渗透速率,初步预测结果表明,不同来源富马酸喹硫平片的参比制剂和国产仿制制剂属于生物等效。同时,实验数据表明,平行人工膜渗透测定法可以对富马酸喹硫平片的人体生物等效性试验的预测提供数据支撑。OBJECTIVE To predict the bioequivalence of quetiapine fumarate tablets from different manufacturers,test the permeation rate and cumulative permeation amount by parallel artificial membrane permeation assay.METHODS Macro Flux TM drug penetration tester was used to measure the permeation rate of quetiapine fumarate tablets in fasting and fed states.RESULTS Among the reference preparations and domestic generic preparations from different sources,the 90%confidence intervals of the permeation flux and permeation amount in fasting and fed states were all in the range of 80.00%-125.00%.CONCLUSION By using parallel artificial membrane permeation assay to measure the permeation rates of the reference preparations and domestic generic preparations of quetiapine fumarate tablets from different sources,the bioequivalence between them can be preliminarily predicted.At the same time,according to the experimental data,the parallel artificial membrane permeation assay can provide data support for the prediction of human bioequivalence test of quetiapine fumarate tablets.

关 键 词：平行人工膜(PAMPA) 富马酸喹硫平片 渗透速率 累积渗透量 生物等效 

分 类 号：R917[医药卫生—药物分析学]