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目的:制备苯磺贝他斯汀片,以高效液相色谱法测定其溶出度,并对自制片与原研片的溶出曲线相似性进行评价.方法:以微晶纤维素、羟丙甲纤维素、甘露醇、阿斯巴甜及硬脂酸镁为辅料压制苯磺贝他斯汀素片,以欧巴代胃溶型薄膜包衣预混剂喷雾包衣制备成片.以休止角、崩解时限、含量均匀度及溶出度为指标筛选素片处方和包衣材料用量.结果: 经试验选择素片最优处方:苯磺贝他斯汀5 mg、甘露醇43 mg、微晶纤维素21. 5 mg、阿斯巴甜0. 5 mg、硬脂酸镁0. 5 mg及羟丙甲纤维素15 mg,包衣增厚选择5%左右.自制片与原研片在水、盐酸(pH 1. 2)、乙酸盐缓冲液(pH 4. 5)、和磷酸盐缓冲液(pH 6. 8)4种介质中具有相似的溶出行为.结论:自制片与原研片具有相似的体外溶出行为,质量相近.“,”Objective: To prepare bepotastine besilate film-coated tablets, determine the dissolution rate by HPLC, and evaluate the similarity of dissolution curves for self-made tablets and the original tablets. Methods: Bepotastine besilate tablets were prepared by using microcrystalline cellulose, hydroxypropyl cellulose, mannitol, aspartame and magnesium stearate as the accessories. Bepotas-tine besilate film-coated tablets were prepared by using OpadryⅡpremixed spray-coating liquid. The formulation was screened with the angle of repose, disintegration time, content uniformity and dissolution rate as the indices. The coating material amount was screened with the dissolution rate as the index. Results: The optimal formulation of bepotastine besilate film-coated tablet contained bepotastine besilate 5 mg,mannitol 43 mg,microcrystalline cellulose 21. 5mg,aspartame 0. 5 mg,magnesium stearate 0. 5 mg and hydroxypropyl cellulose 15 mg. The optimal weight of coating material was 5% . The self-made tablets and the original tablets had similar dissolution behavior in 4 media including water, hydrochloric acid(pH 1. 2), acetate buffer solution(pH 4. 5) and phosphate buffer solution(pH 6. 8). Conclusion:The self-made tablets have similar dissolution behavior in vitro with the original tablets, and their quality is similar.