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目的:制备玉米须总黄酮提取物口腔崩解片并建立其质量控制方法。方法:采用粉末直接压片法制备,应用单因素试验考察压力、润滑剂和矫味剂;以崩解时限为参数,采用正交试验法优选崩解剂;以溶出度及含量均匀度为指标,考察其质量。结果:优选的处方为玉米须总黄酮提取物23%,交联聚乙烯吡咯烷酮(PVPP)15%,微晶纤维素(MCC)35%,桔子香精-甘露醇-阿司帕坦1.2∶5∶2,制得的口腔崩解片在30 s内崩解完全,口感良好。溶出度及含量均匀度都符合2010年版《中国药典》要求。结论:该制备工艺与质量控制方法简单可行。
OBJECTIVE: To prepare orally disintegrating tablet of total flavonoids of cornstarch and establish its quality control method. Methods: The powder direct compression method was used to prepare single-factor test pressure, lubricants and flavoring agents; disintegration time as a parameter, the use of orthogonal disintegration agent optimization; dissolution and content uniformity as an indicator , Examine its quality. Results: The preferred prescriptions were 23% of the total flavonoids of cornstarch, 15% of PVPP, 35% of microcrystalline cellulose (MCC), 1.2% of orange flavor-mannitol to aspartame 2, the prepared orally disintegrating tablets disintegrated completely within 30 seconds, good taste. Dissolution and content uniformity are in line with the 2010 edition of “Chinese Pharmacopoeia” requirements. Conclusion: The preparation process and quality control method is simple and feasible.