莫达非尼分散片的稳定性考察

Stability of Modafinil Dispersible Tablets

目的考察莫达非尼分散片的稳定性。方法根据《中国药典》要求,对莫达非尼分散片进行影响因素试验、加速试验和长期稳定性试验,考察各条件下药物的外观性状、含量、有关物质、溶出度和分散均匀性等指标的变化情况。结果在影响因素试验中,药品除在高湿条件下略有吸湿增重和含量有所下降外,在强光和高温条件下均比较稳定;经加速试验和长期稳定性试验,3批样品的各项指标均未发生明显变化,符合质量标准的规定。结论莫达非尼分散片在市售包装条件下的有效期内质量稳定。

Objective To investigate the stability of Modafinil dispersible tablets. Methods According to the requirement of Chinese Pharmacopoeia, the changes of various indexes including appearance, content, related substances, dissolution and scattered uniformity of Modafinil dispersible tablets were tested in influencing factor test, accelerated test and long-term test. Results In influencing factor test, medicines stood stably in high light test and high temperature test and their weight and content varied slightly in high humidity test. All the indexes of 3 batches samples in accelerated test and long-term test didn＇t change clearly and were in line with the quality standard requirements. Conclusion The quality of Modafinil dispersible tablets under sold packaging is stable and reliable in period of validity.