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目的:研制醋氯芬酸缓释片,评价其体外释药性质及释放机制。方法:采用不同的高分子材料,按照均匀设计得到不同的处方,制成亲水凝胶骨架片,测定其释放度,并用SAS统计软件进行分析。结果:处方R324h释放达95%以上,具有很好的缓释作用,其释放机制符合HixonCrowell方程,为亲水凝胶溶蚀与药物扩散共同作用的结果。结论:该制剂体外释药性质主要受HPMCK4M和Carbopol934p的量及压力的影响。
OBJECTIVE: To develop aceclofenac sustained-release tablets and evaluate its in vitro drug release and release mechanism. Methods: Different polymer materials were used to obtain different formulations according to uniform design. Hydrophilic gel matrix tablets were prepared and their release rates were determined. SAS statistical software was used to analyze the results. Results: The release of prescription R324h reached more than 95% with good sustained release. The release mechanism accorded with HixonCrowell equation, which was the result of interaction between hydrophilic gel dissolution and drug diffusion. Conclusion: The in vitro drug release properties of this preparation are mainly affected by the amount and pressure of HPMCK4M and Carbopol934p.