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目的:筛选布洛芬盐酸苯海拉明分散片的最优处方并对其质量进行评价,为申报三类新药提供核心数据.方法:以崩解时限、分散均匀性、硬度和口感为指标,单因素试验筛选崩解剂和矫味剂,正交试验优化处方,湿法制粒制备分散片,HPLC测定其片剂的含量和溶出度.结果:崩解剂为6%PVPP(内外加比例2∶1),填充剂为24%MCC,粘合剂为2%的PVPk30溶液适量,矫味剂占2%且阿司帕坦/甜菊素为1∶9,所制备的分散片口感良好,崩解时限为64.63±3.58s,5min分散片中布洛芬和盐酸苯海拉明的溶出度均达到了80%以上,含量和分散均匀性均在规定范围内.结论:该分散片处方合理,工艺简单,质量指标符合分散片要求.
OBJECTIVE: To screen the optimal formulation of ibuprofen diphenhydramine hydrochloride dispersible tablets and evaluate its quality, and to provide the core data for the declaration of three new drugs.METHODS: According to the disintegration time, dispersion uniformity, hardness and mouthfeel, Disintegration agent and flavoring agent were screened by single factor experiment, the prescription was optimized by orthogonal test, the dispersible tablet was prepared by wet granulation method, and the tablet content and dissolution rate were determined by HPLC.RESULTS: The disintegration agent was 6% PVPP : 1), 24% MCC filler, 2% PVPk30 binder, 2% flavoring agent and aspartame / stevia at 1: 9. Solution time limit was 64.63 ± 3.58s, the dissolution rate of ibuprofen and diphenhydramine hydrochloride reached more than 80% in 5min dispersible tablets, and the content and dispersion uniformity were within the prescribed limits.Conclusion: The dispersible tablets prescription is reasonable, Process is simple, quality indicators meet the requirements of dispersible tablets.