硫辛酸口腔崩解片的制备及质量研究  

Preparation and Quality Study of Lipoic Acid Orally Disintegrating Tablets

作　　者：易蕾[1] 程德珍[1] 

机构地区：[1]武汉科技大学附属天佑医院,武汉430064

出　　处：《中国药房》2015年第28期3983-3985,共3页China Pharmacy

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。OBJECTIVE：To prepare Lipoic acid orally disintegrating tablets,and to evaluate its quality. METHODS：Lipoic acid orally disintegrating tablets were prepared with direct compression after wet granulation. With disintegration time and dissolu-tion as index,the constituents of disintegrating agent,filler and lubricant were screened by single factor test combined with orthogo-nal test. The tablet weight,hardness,disintegration time,accumulative rate and percentage content were investigated. RESULTS：The optimal formulation was MCC 167.58 mg,L-HPC 23.94 mg,PVPP 47.88 mg,mannitol 60 mg,lipoic acid 300 mg and mag-nesium stearate 0.6 mg. The parameters of prepared disintegrating tablets was as follows as （0.59 ± 0.05） g in weight,（20.32 ± 0.16）kg in solidity and（23.5±0.4）s in disintegration time,101.49% in 3 min accumulative dissolution rate,96.34% of labeled content. CONCLUSIONS：Lipoic acid orally disintegrating tablets are prepared successfully and controllable in quality.

关 键 词：口腔崩解片 硫辛酸 制备工艺 崩解时限 

分 类 号：R943[医药卫生—药剂学]