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目的:进行戊己胃漂浮缓释片有效期研究。方法:采用HPLC法同时测定戊己胃漂浮缓释片中盐酸小檗碱、吴茱萸碱、吴茱萸次碱及芍药苷的含量,并以多个有效成分为指标,运用经典恒温法预测其有效期。结果:盐酸小檗碱、吴茱萸碱、吴茱萸次碱及芍药苷的量随时间变化属一级降解反应,在25℃时的分解速度常数K分别为:4.22×10-6、3.13×10-6、4.80×10-6、4.14×10-6,以有效期时间最短的吴茱萸次碱为指标,制剂有效期为2.50年。结论:戊己胃漂浮缓释片的有效期暂定为2.50年。
Objective: To study the expiration date of pentosidine floating tablets. Methods: Simultaneous determination of berberine hydrochloride, evodiamine, rutaecarpine hydrochloride and paeoniflorin in pentosidine floating sustained release tablets by HPLC was carried out. The effective components were used as indexes to predict the expiration date of the tablets. Results: The amount of berberine hydrochloride, evodiamine, rutaecarpine and paeoniflorin changed with the time. The decomposition rate constant at 25 ℃ was 4.22 × 10-6 and 3.13 × 10-6, respectively , 4.80 × 10-6, 4.14 × 10-6, with the shortest duration of the rutaecarpine as an indicator, the preparation is valid for 2.50 years. Conclusion: The effective period of pentosidine floating tablets is tentatively planned to be 2.5 years.