Preparation of Stemoninine Orally Disintegrating Tablets / 中国药房

ABSTRACT

OBJECTIVE:To prepare Stemoninine orally disintegrating tablets,and to optimize its formulation and preparation technology. METHODS:Direct powder compression method was used to prepare Stemoninine orally disintegrating tablets. Using material angle of repose,disintegration time and taste evaluation as index,single factor test was used to screen several factors as bulking agent,disintegrating agent,glidant and flavoring agent;using disintegration time as index,L9(34) orthogonal test was used to optimize the formulation with ratio of MCC+mannitol,PVPP,silica powder and aspartame+stevia as factors. Validation test was also conducted. RESULTS:Optimized formulation was that MCC+mannitol(1∶1)was 50%,PVPP was 20%,silica powder was 2% and aspartame+stevia(10∶1)was 7%. 3 batches of prepared Stemoninine orally disintegrating tablets were smooth in sur-face and good in taste;their disintegrating time was(22.6±2.1)s,and weight variation,hardness,contents were within the speci-fied range (all RSD≤0.97%,n=3). CONCLUSIONS:The formulation and technology of Stemoninine orally disintegrating tab-lets are reasonable,and the quality indexes are all in line with the requirements of orally disintegrating tablets.