妇科千金分散片制备工艺研究

目的:制备出符合要求的妇科千金分散片制剂,进行制备工艺的研究.方法:以分散均匀性、粉末流动性、片的硬度、片重差异、主要成分含量为指标,比较不同处方的不同辅料比例的片剂压制情况、粉末流动性、崩解时限、分散均匀性、片重差异和含量情况.结果:辅料选择为微晶纤维素10%、低取代羟丙基纤维素12%、交联聚乙烯吡咯烷酮24%、微粉硅胶3.5%、硬脂酸镁0.5%,采用粉末直接压片的工艺路线进行制备.结论:该工艺中试生产出来的产品各项指标均符合规定,可操作性强,重现性好,适合工业大生产的要求.

Preperation Process of Fukeqianjin Dispersible Tablets

To make the qualified Fekeqianjin Dispersible Tablets,we carried out a detailed research.Methods:with the indicators such as disperal uniformity,rigidity etc.diffirent ingrents were compared.Result:we chose PPVP 24%,MC 10%,HPMC 12%,KSG 3.5%,Magnesium Stearate 0.5%,pressed powder to tablets.Conclusion:the mass trail products made accord to the best preparation meet to the legal regulations.The process is operatable,repeatable and suitale to the batch manufatury.