中国药业2016,Vol.25Issue(7):13-16,17,5.
氨酚曲马多缓释片的研制及体外释放度考察
Preparation and in Vitro Drug Release of Paracetamol and Tramadol Hydrochloride Substained Release Tablets
何文 1伯古 1谈弋2
作者信息
- 1. 武汉大学人民医院,湖北 武汉 430060
- 2. 武汉大学药学院,湖北 武汉 430071
- 折叠
摘要
Abstract
Objective To prepare paracetamol ( PT ) and tramadol hydrochloride ( TH ) sustained release tablets and study the in vitro drug release. Methods Hydroxypropyl methylcellulose ( HPMC K4M ) was used as the matrix to prepare PT granules, and ethyl cellulose ( EC ) combined with HPMC4M was applied as the matrix to prepare tramadol hydrochloride granules, and single factor investigation was used to optimize the granules. The above two granules were mixed in the proper proportion ( respectively 250 mg and 60 mg per tablet ) and compressed for the preparation of paracetamol and tramadol hydrochloride sustained release tablets. The quality of the tablets was investigated, and an HPLC method was used to determine the two drugs simultaneously. The in vitro release behavior of the sustained release tablets was studied using a basket method, and compared with that of the marketed common tablets. Results The quality of paracetamol and tramadol hydrochloride sustained release tablets met the requirements in Chinese pharmacopeia. The established HPLC method could be used for the simultaneous determination of the two drugs. The in vitro release behavior of the sustained release tablets fitted first-order equation, suggesting notable sustained release property when compared with that of the common tablets. Conclusion The preparation of paracetamol and tramadol sustained release tablets is simple with promising quality, reliable content determination method and notable sustained release property.关键词
对乙酰氨基酚/盐酸曲马多/缓释片/制备/体外释药Key words
paracetamol/tramadol hydrochloride/sustained release tablets/preparation/in vitro drug release分类
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何文,伯古,谈弋..氨酚曲马多缓释片的研制及体外释放度考察[J].中国药业,2016,25(7):13-16,17,5.