清热解毒分散片辅料处方优选

Optimization of the Prescription of Excipients for Qingre Jiedu Dispersible Tablets

目的优选清热解毒分散片的辅料处方。方法采用单因素试验法,以崩解剂类型、加入方法及填充剂和黏合剂的类型为考察因素,以崩解时限、可压性、硬度等为考察指标,优选清热解毒分散片的辅料处方。结果以低取代羟丙纤维素为崩解剂,以微晶纤维素和二氧化硅为填充剂,以60%乙醇溶液作为黏合剂制备的分散片,可在3 min内全部崩解,可压性较好,硬度为3.5 kg/mm2,且分散均匀性良好。结论优选的处方辅料类型及比例适宜,崩解时限符合要求,可为清热解毒分散片的工业化生产提供参考。

Objective To optimize the prescription of excipients for Qingre Jiedu Dispersible Tablets.Methods The single factor test was used to optimize the prescription of excipients for Qingre Jiedu Dispersible Tablets with the type of disintegrating agent,adding method,the type of filler and adhesive as the factors,and with the disintegrating time,compressibility and hardness as the inspection indexes.Results The dispersible tablets were prepared with low-substituted hydroxypropyl cellulose(LS-HPC)as the disintegrating agent,microcrystalline cellulose(MCC)and silica as filling agent and 60%ethanol solution as adhesive.The dispersible tablets with good compressibility,hardness of 3.5 kg/mm2 and good dispersing uniformity could disintegrate completely in 3 min.Conclusion The optimal type and proportion of excipients are suitable,and the disintegration time can meet the requirements,which can provide reference for the industrial production of Qingre Jiedu Dispersible Tablets.