茅莓分散片的制备及溶出度测定  

Preparation of Rubus parvifolius L.dispersible tablets and determination of its dissolution rate

作　　者：梅明 林世和[1] 周进[1] 杨明 胡松[1] Ming MEI;Shi-He LIN;Jin ZHOU;Ming YANG;Song HU(Department of Pharmacy,Wuhan No.1 Hospital,Wuhan 430030,China;Key Laboratory of Modern Preparation of TCM,Ministry of Education,Jiangxi University of Traditional Chinese Medicine,Nanchang 330004,China)

机构地区：[1]武汉市第一医院药学部,武汉430030 [2]江西中医药大学现代中药制剂教育部重点实验室,南昌330004

出　　处：《中国药师》2023年第11期197-203,共7页China Pharmacist

基　　金：国家自然科学基金面上项目(30973952)。

摘　　要：目的 优选茅梅分散片的制备工艺,并测定其溶出度。方法 在单因素试验的基础上,以微晶纤维素(MCC)、交联聚乙烯吡咯烷酮(PVPP)、低取代羟丙基纤维素(L-HPC)为影响因素,崩解时间为评价指标,采用中心复合设计-效应面法优化茅莓分散片的处方工艺。再以茅莓总皂苷为指标,参考中国药典方法测定溶出度。结果最优处方工艺为茅莓总皂苷浸膏粉用量为36.9%,MCC用量为42%,PVPP用量为13%,L-HPC用量为8%,微粉硅胶用量为0.1%,模型相关系数较高。所制分散片崩解时间小于3 min,在50 min时,累积溶出度达到88%以上。结论 优选工艺稳定可靠,可用于茅莓分散片的制备。Objective To optimize the preparation process of Rubus parvifolius L.dispersible tablets and determine its dissolution.Methods On the basis of single factor test,the formulation process of dispersible tablets was optimized by central composite design-response surface method with microcrystalline cellulose(MCC),polyvinyl polypyrrolidone(PVPP) and low substituted hydroxypropyl cellulose(L-HPC) as the influencing factors and disintegration time as the evaluation index.The total saponins of Rubus parvifolius L.was used as an indicator to determine the dissolution rate with reference to the method of Chinese Pharmacopoeia.Results The optimal prescription was 36.9% total saponin extract powder,42% MCC,13% PVPP,8% L-HPC and 0.1% microsilica gel,which showed a high correlation coefficient of the model.The disintegration time of the prepared dispersive tablets was less than 3 min,and the cumulative dissolution rate reached more than 88% at 50 min.Conclusion The optimized process is stable and reliable,and can be used for the preparation of Rubus parvifolius L.dispersible tablets.

关 键 词：茅莓 分散片 中心复合设计-效应面法 溶出度 

分 类 号：R283.6[医药卫生—中药学]