| 宋菁景,张丹丹,崔景霞,陈德俊,李华,刘伟.利用平行人工膜比较硝苯地平缓释片的生物等效性[J].中国药事,2023,(2):192-198 |
| 利用平行人工膜比较硝苯地平缓释片的生物等效性 |
| Bioequivalence of Comparative Formulations Based on Parallel Artificial Membrane Permeability Assay of Nifedipine Sustained-release Tablets |
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| DOI：10.16153/j.1002-7777.2023.02.010 |
| 中文关键词: 平行人工膜 硝苯地平缓释片 渗透速率 生物等效性 仿制药一致性评价 |
| 英文关键词: PAMPA nifedipine sustained-release tablet permeation rates bioequivalence consistency evaluation of generic drugs |
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| 摘要点击次数: 693 |
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| 中文摘要: |
| 目的：采用平行人工膜对硝苯地平缓释片渗透速率进行研究，比较仿制药一致性评价前后样品的渗透速率，预测其人体生物等效性。方法：利用MacroFluxTM药物渗透性测定仪，测定通过一致性评价的制剂和未通过一致性评价的制剂的渗透速率。结果：通过一致性评价的制剂渗透速率为 84.3%~113.2%，累积渗透量为85.9%~110.9%；未通过一致性评价的制剂渗透速率为73.7%~94.1%，累积渗透量为71.8%~92.6%。结论：初步预测通过一致性评价的制剂与参比制剂生物等效，仿制药一致性评价工作提升了产品质量。 |
| 英文摘要: |
| Objective: To study the permeation rate of nifedipine sustained-release tablets by using parallel artifi cial membranes, to compare the permeation rates of samples before and after the consistency evaluation of generic drugs, and to predict their bioequivalence in humans. Methods: Using the MacroFluxTM drug permeability tester, the permeation rates of the preparations that passed the consistency evaluation and the preparations that did not pass the consistency evaluation were measured. Results: The permeation rate of the preparations that passed the consistency evaluation was 84.3%-113.2%, the cumulative permeation was 85.9%-110.9%, the permeation rate of the preparations that did not pass the consistency evaluation was 73.7%-94.1%, and the cumulative permeation was 71.8%-92.6%. Conclusion: It is preliminarily predicted that the preparations that pass the consistency evaluation are bioequivalent to the reference preparations, and the consistency evaluation of generic drugs improves the product quality. |
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