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目的:优选叶黄素微囊分散片的成型处方。方法:以外观、混悬性、崩解时间及溶出度为综合评价指标,采用单因素试验确定填充剂及润滑剂种类和用量、崩解剂、润湿剂及溶胀性辅料的种类,通过正交试验优选叶黄素微囊分散片的成型工艺处方。结果:最佳处方为以25%羧甲基淀粉钠(CMS-Na)-交联聚乙烯吡咯烷酮(PVPP)(1∶1.5)为崩解剂,6%羟丙基纤维素(HPC)为溶胀性辅料,70%乙醇溶液为润湿剂,所制备的分散片在80 s内完全崩解,10 min溶出度>90%。结论:优选的处方辅料种类及比例适宜、片面光洁,崩解迅速、溶出度高,具有良好的开发前景。
Objective: To optimize the forming prescription of lutein microcapsule dispersible tablets. Methods: The appearance, suspension, disintegration time and dissolution rate were comprehensive evaluation indexes. The type and amount of filler and lubricant, disintegrating agent, wetting agent and swelling auxiliary material were determined by single factor test. The best choice of lutein microcapsule dispersible tablets molding process prescription. Results: The best prescription was that 25% sodium carboxymethyl starch (CMS-Na) -crosslinked polyvinylpyrrolidone (PVPP) (1: 1.5) as disintegrating agent and 6% hydroxypropylcellulose The excipients and 70% ethanol solution were wetting agents. The disperse tablets were completely disintegrated in 80 s and the dissolution rate was> 90% in 10 min. CONCLUSION: The optimal formulation and proportion of prescription materials are suitable, the surface is smooth, the disintegration is rapid, the dissolution rate is high, and the development prospect is good.