摘要
目的通过开展相关处方前研究,考察原料药理化性质及原辅料配伍稳定性等,为制备复方分散片提供参考。方法通过恒温平衡法,测定溶解度及稳定性;通过溶出度测定法,考察粒度与替格瑞洛溶解速率的相关性;通过影响因素试验,考察原辅料配伍稳定性及晶型稳定性。结果替格瑞洛几乎不溶于水,磷酸川芎嗪易溶于水;粒度与替格瑞洛溶解速率相关;原辅料样品与原料药的有关物质变化趋势相似;原辅料样品在高温、光照、受压条件下的替格瑞洛晶型较稳定,在高湿条件下晶型略有变化。结论两种药物及原辅料的相容性良好,替格瑞洛川芎嗪分散片小试样品稳定性良好。
OBJECTIVE To examine the physicochemical properties of the raw materials and the compatibility stability of raw materials and excipients by carrying out relevant pre⁃prescription research,to provide a reference for the preparation of compound dispersible tablets.METHODS Solubility and stability were determined by constant temperature equilibrium method.The correlation between particle size and ticagrelor dissolution rate was determined by dissolution assay.Through the influence factor test,the compatibility stability and crystal form stability of raw materials and auxiliary materials were investigated.RESULTS Ticagrelor was almost insoluble in water,ligustrazine phosphate is soluble in water.Ticagrelor dissolution rate was correlated with the particle size.The change trend of the related substances of the raw and excipient samples was similar.The crystal form of ticagrelor was relatively stable under the conditions of high temperature,light and pressure,and the crystal form changed slightly under high humidity conditions.CONCLUSION The compatibility of the two drugs and excipients are good.Small samples of ticagrelor ligustrazine dispersible tablets have good stability.
作者
罗炳华
LUO Binghua(Fujian Tianquan Pharmaceutical Co.,Ltd.,Longyan,Fujian 364000,China)
出处
《今日药学》
CAS
2022年第7期524-528,共5页
Pharmacy Today
关键词
替格瑞洛
磷酸川芎嗪
分散片
处方前研究
ticagrelor
ligustrazine phosphate
dispersible tablets
pre⁃prescription research
