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目的:制备西罗莫司-羟丙基-β-环糊精(西罗莫司-HP-β-CD)分散片并考察体外溶出度。方法:以崩解时限为考察指标,采用星点设计方法对处方进行优选,比较西罗莫司-HP-β-CD分散片与普通片的溶出度。结果:分散片的性质符合规定,最佳工艺条件的崩解时限为134 s,分散片的溶出速度明显快于普通片。结论:西罗莫司-HP-β-CD分散片的处方组成合理,体外溶出度优于普通片。
Objective: To prepare sirolimus-hydroxypropyl-β-cyclodextrin (sirolimus-HP-β-CD) dispersible tablets and investigate the in vitro dissolution. Methods: Taking the disintegration time as the index, the prescription was optimized by the star design method, and the dissolution of sirolimus-HP-β-CD dispersible tablets and common tablets were compared. Results: The properties of the dispersible tablets were in accordance with the regulations. The disintegration time of the best conditions was 134 s. The dissolution speed of the dispersible tablets was obviously faster than that of the ordinary tablets. Conclusion: The formulations of sirolimus-HP-β-CD dispersible tablets are reasonable in composition and dissolution rate in vitro is better than that of ordinary tablets.