双氯芬酸赖氨酸盐缓释片的制备及初步稳定性研究

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。

Preparation of DiclofenacLysine Sustained-release Tablets and Investigation of the Stability

AIM:On the basis of in vitro study,a preliminary survey of the stability of diclofenac lysine sustained-release tables(DLST) was carried out to identify the period of validity METHODS:To observe the changes of DLST under high temperature,blaze,high humidity and room temperature(for long period) and to perform accelerating test for 3 months RESU_LTS:The drug release was accelerated under high temperature,and the tablet was apt to absorb moisture because of its hydrophilic matrix and the drug release became faster at day 10 under blaze,and therefore DLST should be stored away from high temperature,high humidity and blaze CONCLUSION:DLST is stable and the period of validity is tentatively fixed at 2 years