中药半浸膏薄膜衣片的成型工艺考察  

Investigation of Molding Technology for Semi-Extract Film-Coated Tablet of Traditional Chinese Medicine

作　　者：张源[1] 周琴妹[1] 高洁[2] 

机构地区：[1]江苏省中医院制剂部,南京210029 [2]南京中医药大学,南京210046

出　　处：《中国实验方剂学杂志》2013年第2期24-28,共5页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：江苏省中医药管理局课题(LZ09055)

摘　　要：目的:以冠心平片为模型,研究中药半浸膏薄膜衣片的成型工艺。方法:单因素考察冠心平片的处方设计及制粒、压片的工艺条件;以包衣操作时间和包衣外观合格率为综合评价指标,采用正交试验优选冠心平片的薄膜包衣工艺参数,并对半成品、成品进行吸湿性研究。结果:冠心平片的流化床制粒处方为干膏粉加1.5%～2%微粉硅胶混匀,以1.9～2.0倍量60%乙醇为湿润剂;工艺条件为雾化压力0.10～0.12 MPa,物料温度51～53℃,进风温度85～90℃,风机流量120～140M3.h-1,供液泵转速10～15～20～26 r.min-1。薄膜包衣最佳工艺参数为包衣液质量浓度16%,主机转速6～8 r.min-1,片床温度45～50℃。冠心平颗粒最佳含水量7.0%～9.0%,压片机压力0.4～0.6 MPa。吸湿率随相对湿度变化的数学方程为逻辑斯蒂模型,操作环境的相对湿度应控制<62%。结论:优选的成型工艺稳定可行,可推广于冠心平片的大生产应用,为中药半浸膏薄膜衣片的大生产提供试验依据。Objective： To study on molding film-coated tablet by taking Guanxinping tablet as process of traditional Chinese medicine （TCM） semi-extract model. Method： Prescription design and granulating of Guanxinping tablet was investigated by single factor test; With coating operation time and qualification rate of coating appearance as comprehensive evaluation index, orthogonal test was used to optimize film coating process parameters of Guanxinping tablet, and hygroscopicity study of semi-finished and finished products was used. Result： Fluidized bed granulation prescription of Guanxinping tablet was： dry extract powder mixed with 1.5%- 2% tiny powder silica gel, with 1.9 times the amount of 60% ethanol as wetting agent; technology conditions were as follows： atomizing pressure 0. 10-0. 12 MPa, materials temperature 51-53%, inlet air temperature 85-90 ℃ , fan flow 120-140 M3 h-1 , speed of feed liquid pump 10-15-20-26 r·min-1 Optimum film coating technology parameters were： the concentration of coating solution 16%, main engine speed 6-8 r· min-1, chip bed temperature 45-50 ℃. Optimal moisture content was 7.0% -9.0% , pressure of tableting machine 0.4-0.6 MPa. Mathematical equation of moisture rate with change of relative humidity was fitted Logistic model, relative humidity of operating environment should be controlled to 〈 62%. Conclusion： Optimized molding technology was stable and feasible, it could be extended to large-scale production of Guanxinping tablet, this study could provide experimental basis for industrial production of TCM semi-extract film-coated tablet.

关 键 词：中药半浸膏薄膜衣片 处方设计 成型工艺 正交试验 吸湿性 

分 类 号：R283.6[医药卫生—中药学]