复方盐酸伪麻黄碱双层缓释片研究

Studies on the Bilayed Sustained Release Compound Tablet of Ibuprofen and Pseudoephedrine Hydrochloride

研制了由布洛芬和盐酸伪麻黄碱组成的复方双层缓释片,用紫外分光光度法与酸性染料比色法分别测定体外的布洛芬和盐酸伪麻黄碱,对该缓释片进行了溶出度和稳定性试验,采用HPLC法与GC-MSD法分别测定血浆样品中的布洛芬和盐酸伪麻黄碱浓度,比较自制缓释片与美国市售Advil cold & sinus caplets标准品的生物利用度和药物动力学特征。结果表明,该制剂缓释效果显著,血药浓度更为平稳,持久,而生物利用度与参比对照品相当,且其体内外相关性良好。

Development of the bilayed sustained release compound tablets of ibuprofen and pseu doephedrine hYdrochloride was described. The spectific UV spectrophotometric and clorimetric methods were employed to determine ibuprofen and pseudoephedrine hydrochloride in vitro respectively, and the dissolution test and stability test were carried out. In vivo, the plasma concentration of ibuprofen and pseudoephedrine were determined separately by the HPLC method and GC with mass spectrum detec tot. The bioavailability and the pharmacokinetic characters of the bilayed sustained release tablets were compared with Advil cold & Sinus caplets as the standard. It was demonstrated by the results that the bilayed tablets exhibited good sustained release profile, and produced more stable and durable plasma concentration, while the bioavailability was the same as the standard caplets. Moreover, the in vitro and in vivo correlation of the sustained releae lablets was good.