摘要
目的:制备头孢呋辛酯片,并评价其稳定性。方法:用正交试验设计方法对处方工艺进行筛选与优化,制备头孢呋辛酯片,并通过加速试验和长期试验考察其稳定性。结果:以优选处方工艺制备的产品均符合美国药典23版标准,但稳定性试验表明干法制粒者的稳定性明显好于湿法制粒者。结论:制备关孢呋辛酯片的最优处方工艺为:以微晶纤维素、羧甲淀粉钠和十二烷基硫酸钠等为辅料,通过干法制粒后压片。所得产品质量稳定,能够替代进口,满足临床用药需要。
Objective:To prepare cefuroxime axetil tablets and evaluate their stabilities. Method:The optimization of formulations and manufacturing technology of cefuroxime axetil tablets were earned out by the method of orthogonal design of experiments. The stabilities of the tablets were investigated by accelerated experiments and shelf- life test. Results: The tablets prepared by the optimized formulation and technology complied with USP23, but the tablets prepared by dry granulation were better than those prepared by wet granulation in stability. Conclusion: The most optimal for the preparation of the tablets is dry granulating the active ingredient with prescribed amounts of microcrystalline cellulose, carboxymethylatarch sodium and sodium lauryl sulfate as the main excipients, and finally film coating the tablets with Hydroxypropylmethylcellulose ( HPMC ) . The product show good stability under various experimental conditions and will meet the need in clinical practice.
出处
《中国医药导刊》
2001年第5期388-389,390,共3页
Chinese Journal of Medicinal Guide
