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目的:采用渗透泵技术,制备硝苯地平控释片,并进行体外释放研究。方法:采用单因素筛选处方,分别考察含药层高分子聚氧乙烯(PEO)相对分子质量、含药层渗透压活性物质、助推层中高分子PEO相对分子质量、助推层的含量、压力、包衣膜厚度和释药孔孔径等因素对释放度的影响。结果:通过系列研究,结果表明,衣膜的完整性、能否释放药物以及释药速度的快慢主要受含药层中高分子PEO的相对分子质量、渗透压活性物质和助推层中高分子PEO相对分子质量、含药层和助推层体积比及压力、孔径、半透膜等因素的影响。结论:自制的硝苯地平双层渗透泵控释片在体外释药条件下释药稳定,在3～14h内零级特征明显(r=0.9995)、平均释药量约为8%/h、衣膜完整。
OBJECTIVE: To prepare nifedipine controlled release tablets by osmotic pump technique and to study its in vitro release. Methods: A single factor screening prescription was used to investigate the relative molecular mass of drug-containing PEO, the osmotic pressure-sensitive substances of drug-containing layer, the relative molecular weight of PEO, the content of push layer, , The thickness of the coating film and pore size and other factors on the release of the degree of impact. Results: Through a series of studies, the results showed that the relative molecular mass of the PEO in the drug-containing layer, the osmotic pressure-sensitive active substance and the PEO in the push layer are relatively high Molecular weight, drug-containing layer and push-volume ratio and pressure, pore size, semipermeable membrane and other factors. CONCLUSION: The self-made nifedipine double-osmotic pump controlled-release tablets are stable in drug release in vitro and the zero-order characteristics are obvious (r = 0.9995) within 3 ~ 14h with the average release of about 8% / h. Film integrity.