硫酸吗啡口腔崩解片的稳定性研究

发布时间：2018-08-09 06:53

【摘要】：目的:考察硫酸吗啡口腔崩解片制剂的稳定性,确定其贮藏条件和有效期。方法:以性状、崩解时限、主药含量和有关物质为考察指标,根据《中国药典》相关方法要求对硫酸吗啡口腔崩解片模拟上市包装样品进行影响因素试验(强光4500 lx,高温60℃,25℃、相对湿度75%,10 d)、加速试验(40℃、相对湿度75%、6个月)及长期试验(24个月)。结果:3种试验中,各指标与0天(0月)比较未见明显变化;本品对光、热、湿均较稳定,但有一定吸湿性。结论:建议硫酸吗啡口腔崩解片于阴凉处密闭保存,保质期为2年。
[Abstract]:Objective: to investigate the stability of morphine sulfate orally disintegrating tablets and determine the storage conditions and validity period. Methods: the characters, disintegration time, main drug content and related substances were used as indexes. According to the requirements of the Chinese Pharmacopoeia, the influence factors of morphine sulfate oral disintegrating tablets on the simulated market packaging samples were tested (high light 4500 LX, high temperature 60 鈩，

本文编号：2173246