天舒滴丸成型工艺及体外溶出度  

Molding Process and Dissolution in vitro of Tianshu Dripping Pills

作　　者：张爱丽[1] 毕宇安[2,3] 

机构地区：[1]江苏联合职业技术学院连云港中医药分院,江苏连云港222006 [2]江苏康缘药业股份有限公司,江苏连云港222001 [3]中药制药过程新技术国家重点实验室,江苏连云港222001

出　　处：《中国实验方剂学杂志》2011年第20期11-13,共3页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家科技重大新药创制专项(2009ZX09313-032)

摘　　要：目的:优化天舒滴丸的制备成型工艺,并建立体外溶出度的测定方法。方法:以滴丸光滑圆整率、丸重差异、溶散时限为指标,采用正交设计试验对影响因素进行考察;以阿魏酸为溶出指标,采用小杯法和高效液相色谱法进行溶出度测定。结果:滴丸成型最佳工艺-药物基质1∶2,PEG6000-S40 3∶1,冷却剂管口温度(25～30)℃,滴速60～65 d.min-1;滴丸在10 min内阿魏酸累积溶出率超过85%,15 min内基本溶出完全。结论:制备工艺合理,对工业化生产有帮助,所得滴丸溶出度好。Objective：To optimize preparation technology of Tianshu dropping pills and to establish determination method of its dissolution in vitro.Method：Spherical degree,pill weight and time of dissolution as indexes,influential factors were investigated by orthogonal design.Small vessel and HPLC method were applied to determine dissolution of ferulic acid.Result：The optimal conditions were as follows： drug-matrix1∶2,PEG6000-S40 3∶1,coolant nozzle temperature was 25-30 ℃,dripping rate was 60-65 d·min-1;Accumulated dissolution percentage of ferulic acid reached over 85% in 10 min,and dissolved completely within 15 min.Conclusion：This process is reasonable and favorable for industrial production,dissiolution of Tianshu dropping pills was good.

关 键 词：天舒滴丸 制备工艺 正交试验 体外溶出度 

分 类 号：R283.6[医药卫生—中药学]