吐温-80对固体分散体中盐酸胺碘酮溶出度及稳定性的影响

EFFECT OF TWEEN-80 ON THE DISSOLUTION AND STABILITY OF AMIODARONE HYDROCHLORIDE OF SOLID DISPERSIONS

目的观察吐温-80对固体分散体中盐酸胺碘酮溶出度及稳定性的影响。方法溶剂法制备固体分散体,紫外分光光度法测定药物含量,溶出仪考察药物溶出度,加速试验考察稳定性。结果以聚乙烯吡咯烷酮K30为载体制备得到的盐酸胺碘酮固体分散体,其体外溶出度明显快于聚乙二醇6000制备的固体分散体;随着固体分散体中吐温-80用量的增加,盐酸胺碘酮的溶出速率明显加快。加速实验放置3个月,药物溶出度未发生明显变化,但制剂吸水率增加。结论吐温-80能增加固体分散体的药物溶出,但贮存时必须注意防潮。

Objective To investigate the effect of Tween80 on the dissolution and stability of amiodarone hydrochloride in solid dispersions.Methods The solid dispersions were prepared by using solvent evaporation.The drug content was determined by the method of UV.The dissolution was determined by using dissolution apparatus.The stability was evaluated by using accelerating test.Results The solid dispersions of amiodarone hydrochloride by using PVP as a carrier had quicker dissolution than those using PEG6000 as a carrier.With the increase of the dosage of Tween-80 in solid dispersions,the dissolution of amiodarone hydrochloride was significantly faster.The drug dissolution had not been changed significantly while water uptake of the preparations increased after three months of accelerating test.Conclusion Tween-80 can enhance the drug dissolution of solid dispersions,but efficient dampproof measures are needed in the storage of the preparations.