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目的 :在双氯芬酸赖氨酸盐缓释片体外研究的基础上 ,对其初步稳定性进行了考察 ,以确定双氯芬酸赖氨酸盐缓释片有效期。方法 :考察双氯芬酸赖氨酸盐缓释片在高温、光照和高湿条件下的变化 ,进行加速实验3mo ,并进行室温留样观察 ,考察双氯芬酸赖氨酸盐缓释片的各项指标。结果 :双氯芬酸赖氨酸盐缓释片在高温下 ,释放加快 ;在高湿条件下 ,由于为亲水凝胶骨架片 ,易吸湿 ;在强光下 ,d10释放加快。所以 ,双氯芬酸赖氨酸盐缓释片应避免高温、高湿、强光保存。结论 :暂定有效期2y。
OBJECTIVE: To investigate the preliminary stability of diclofenac lysine sustained release tablets in order to determine the validity of diclofenac lysine sustained-release tablets. Methods: The changes of diclofenac lysine sustained-release tablets under high temperature, light and high humidity conditions were investigated. Accelerated experiments were carried out for 3 months. The observed changes at room temperature were observed. The indexes of diclofenac lysine sustained-release tablets were investigated. Results: Diclofenac lysine sustained-release tablets released faster under high temperature. Under high humidity conditions, it was hygroscopic due to the hydrophilic gel matrix tablets. Under high light, d10 release accelerated. Therefore, diclofenac lysine sustained-release tablets should avoid high temperature, high humidity, light preservation. Conclusion: tentative validity of 2y.