盐酸氟桂利嗪口腔崩解片的稳定性研究

Study on the Stability of Flunarizine Hydrochloride Orally Disintegrating Tablets

目的:研究盐酸氟桂利嗪口腔崩解片的稳定性,确定其储存条件及有效期。方法:采用高效液相色谱法测定制剂中主药和有关物质含量,并考察制剂在高温、高湿、光照等影响因素及加速试验和长期试验中的稳定性,计算其有效期。结果:样品除在高温条件下有关物质含量超标、吸湿性较强外,在其他稳定性试验中各项质量指标均符合要求;计算其最短有效期为2年。结论:盐酸氟桂利嗪口腔崩解片稳定性较好,宜置于阴凉干燥处保存,有效期暂定为2年。

OBJECTIVE： To study the stability of Flunarizine hydrochloride orally disintegrating tablets and to determine their storage conditions and validity. METHODS： HPLC method was adopted to determine the content of main component and related substances. The stability of preparation in influential factor test （high temperature, high humidity, strong light）, accelerated test and long-term test were investigated. The validity was calculated as well. RESULTS： The content of related substances exceeded the normal level with strong hygroscopicity under high temperature. In other stability test, all the indexes were up to the quality standard and the validity can be up to 2 years. CONCLUSION： Flunarizine hydrochloride orally disintegrating tablets with good stability should be stored in cool and dry place. The validity has been assigned as 2 years tentatively.