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目的:优化尼美舒利缓释片的制备方法。方法:采用正交试验设计,以体外累积释药百分率为指标,以HPMC(K100-LV CR)、乳糖、PVP(K30)的处方用量作为影响因素筛选缓释片的最佳处方,并测定3批优化处方的体外释放度。结果:优化处方结果为HPMC K100-LV CR为100 mg,乳糖为50 mg,黏合剂为5%PVP无水乙醇溶液3 mL;尼美舒利缓释片在12 h释放量达97%以上,没有时滞、突释等现象。其体外释药动力学符合零级方程。结论:尼美舒利缓释片处方合理,制备工艺可靠,体外释药效果良好,质量可控。
Objective: To optimize the preparation of nimesulide sustained-release tablets. Methods: Orthogonal experimental design was used to determine the best prescription of sustained-release tablets by the prescription of HPMC (K100-LV CR), lactose and PVP (K30) Batch optimization of prescription in vitro release. Results: The optimum formulation was 100 mg of HPMC K100-LV CR, 50 mg of lactose and 5 mL of 5% PVP in absolute ethanol. The release of nimesulide sustained-release tablets was above 97% in 12 h, No delay, burst and other phenomena. Its in vitro release kinetics conforms to zero-order equation. Conclusion: The formulation of nimesulide sustained-release tablets is reasonable, the preparation process is reliable, the drug release in vitro is good and the quality is controllable.