复方维A酸乳膏化学稳定性研究及有效期预测

发布时间：2018-02-24 10:17

  本文关键词： 复方维A酸乳膏 稳定性 有效期 HPLC　出处：《中国新药杂志》2015年02期 　论文类型：期刊论文

【摘要】：目的:研究复方维A酸乳膏的化学稳定性并预测其有效期。方法:HPLC法同时测定复方维A酸乳膏中3组分(维A酸,尿囊素和维生素E)的含量及异构化产物异维A酸。对高湿、光照和热稳定性进行考察;从4个不同温度避光条件下不同时间测得的含量,求出各温度的反应速率常数;按Arrhenius方程求出25℃下的t0.9,从而预测其有效期。结果:该复方乳膏高湿条件下稳定,当其常温条件下暴露于4 500 Lx照度下光照5和10 d,其中维A酸含量分别下降至85%和70%左右,同时测得异维A酸含量相应上升。其他2种成分含量未见明显下降,单方维A酸乳膏在此条件下,降解显著。3种成分的受热降解符合一级动力学。该复方乳膏25℃避光条件下维A酸、维生素E和尿囊素的t0.9分别为370,476,482 d,单方维A酸的t0.9仅为253 d。根据加速试验预测40℃下放置1个月的降解与实测值吻合。正常条件下存放亦与预测相符。结论:3种成分中维A酸最不稳定,易见光异构化,对热则相对稳定;组成复方制剂后,维A酸化学稳定性较其单方大有提高,该复方乳膏的有效期在1年左右,应避光保存。
[Abstract]:Objective: to study the chemical stability of compound retinoic acid cream and to predict its validity period. Methods: the contents of three components (retinoic acid, allantoin and vitamin E) and isomerization product isoretinoic acid in compound retinoic acid cream were determined by HPLC. The light and thermal stability were investigated, and the reaction rate constants were obtained from the contents measured at four different temperatures and at different times. According to the Arrhenius equation, the t0.9 at 25 鈩，

本文编号：1529865