桃核承气缓释片的稳定性研究

Study on the Stability of Taohe Chengqi Sustained-release Tablets

目的:考察桃核承气缓释片的稳定性,预测其有效期;了解影响其稳定性的因素,为加速试验和长期试验提供依据。方法:通过经典恒温加速试验和影响因素试验法考察稳定性,采用高效液相色谱法测定制剂中大黄酸和大黄素的含量。结果:大黄酸的有效期为2.42年,大黄素的有效期为2.40年;强光照射对桃核承气缓释片的稳定性有一定影响,高温和高湿度对其稳定性影响很小。结论:桃核承气缓释片室温下的有效期为2年。为了有利于制剂的质量、安全性和有效性,生产和贮藏过程中应采用适当的避光措施。

OBJECTIVE： To investigate the stability of Taohe chengqi sustained-release tablets, predict period of validity; to in- vestigate the influential factors of the stability, and to provide reference for accelerated test and long-term test. METHODS： The sta- bility of it was investigated with classical constant temperature accelerated experiment and influential factor test, and the contents of rhein and emodin were determined by HPLC. RESULTS： The validity of rhein was 2.42 years, and that of emodin was 2.40 years; strong light exposure could affect the stability of Taohe chengqi sustained-release tablets, and high temperature and humidity had lit- tle influence. CONCLUSION： At room temperature, the period of validity of Taohe chengqi sustained-release tablets is 2 years. In order to ensure the quality, safety and validity, lucifuge measures should be adopted during the production and stroage.