硫辛酸口腔崩解片的制备及质量研究

发布时间：2018-04-24 23:32

本文选题：口腔崩解片 + 硫辛酸　；参考：《中国药房》2015年28期

【摘要】：目的:制备硫辛酸口腔崩解片,并评价其质量。方法:采用湿法制粒后直接压片制备硫辛酸口腔崩解片,以崩解时间、溶出度为指标,采用单因素试验联合正交试验筛选崩解剂组成、填充剂、润滑剂。考察所制片剂的片质量、硬度、崩解时间、累积溶出度和占标示量百分含量。结果:处方为微晶纤维素167.58 mg、低取代羟丙甲纤维素23.94 mg、交联聚乙烯吡咯烷酮47.88 mg、甘露醇60 mg、硫辛酸300 mg、硬脂酸镁0.6 mg;制得口腔崩解片的片质量为(0.59±0.05)g,硬度为(20.32±0.16)kg,崩解时间为(23.5±0.4)s,3 min的累积溶出度为101.49%,含量为标示量的96.34%。结论:成功制得硫辛酸口腔崩解片,且其质量可控。
[Abstract]:Objective: to prepare oral disintegrating tablets of lipoic acid and evaluate its quality. Methods: lipoic acid oral disintegrating tablets were prepared by wet granulation and direct pressing. The disintegrating time and dissolution rate were used to screen disintegrant composition, filler and lubricant by single factor test and orthogonal test. The tablet quality, hardness, disintegration time, cumulative dissolution and percentage of marked amount were investigated. Results: microcrystalline cellulose 167.58 mg, low substituted hydroxypropyl methyl cellulose 23.94 mg, crosslinked polyvinylpyrrolidone 47.88 mg, mannitol 60 mg, lipoic acid 300 mg, magnesium stearate 0.6 mg. The cumulative dissolution for 23.5 卤0.4 min was 101.49, and the content was 96.34% of the marked amount. Conclusion: lipoic acid oral disintegrating tablet was successfully prepared and its quality was controlled.
【作者单位】：武汉科技大学附属天佑医院;
【分类号】：R943

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