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。
Abstract
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
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Key words
parallel artificial membrane permeability assay (PAMPA) /
quetiapine fumarate tablet /
permeation rate /
cumulative permeation amount /
bioequivalence
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中图分类号：
R917
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参考文献
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脚注
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基金
国家“重大新药创制”科技重大专项资助(2017ZX09101001)
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