摘要
目的制备盐酸吡格列酮分散片并对其进行质量研究。方法以交联聚乙烯吡咯烷酮和微晶纤维素用量为考察因素,以崩解时限,10min的溶出度为考察指标,采用星点设计—效应面法优化处方,对分散片进行崩解时限、分散均匀性、溶出度及稳定性考察和含量测定。结果盐酸吡格列酮分散片工艺简单,稳定性良好,崩解时间小于1min,符合分散片的各项质量指标。结论本品达到分散片要求,制剂质量稳定。
Objective To produce pioglitazone hydrochloride dispersible tablets and investigate the quality. Methods The central composite design - response surface methodology was used to optimize the formulation. The amounts of PPVP and MCC were used as independent variables, and the disintegration time and dissolution at 10 rain were used as dependent variables. The disintegration time, dissolution, dispersible uniformity, stability test and assay were studied. Results The production of the tablets was simple and the dispersible tablets could disintegrate within one minute and the quality conformed to the standard. Conclusions The products reach the standard of the dispersible tablets, and the quality is stable.
出处
《辽宁医学院学报》
CAS
2008年第3期214-216,290,共4页
Journal of Liaoning Medical University (LNMU) Bimonthly
关键词
盐酸吡格列酮
分散片
星点设计
效应面法
pioglitazone hydrochloride
dispersible tablets
central composite design
response surface methodology
