川参方直接压片工艺量化控制研究  

Quantification control of direct compression tableting of Chuanshenfang

作　　者：阮克萍[1,2] 冯怡[1,2] 刘国平 赵立杰[1,2] 杜若飞[1,2] 朱蕾[1,4] 

机构地区：[1]上海中医药大学中药现代制剂技术教育部工程研究中心,上海201203 [2]上海张江中药现代制剂技术工程研究中心,上海201203 [3]上海丽珠制药有限公司,上海201206 [4]克瑞配料贸易上海有限公司,上海200233

出　　处：《中草药》2014年第9期1262-1264,共3页Chinese Traditional and Herbal Drugs

基　　金：国家科技重大专项(2009ZX09502-009);上海市教委重点学科(J50302)

摘　　要：目的研究中药粉体物理特性和工艺因素对片剂质量的影响,优化中药直接压片工艺处方。方法以中药川参方提取物为模型药物,应用U9(95)均匀设计优化直接压片工艺处方。结果在研究范围内片剂的质量主要受压片压力、粉体粒径、粉体含水量影响,川参方的最佳压片工艺为压片压力1 300 kg,粉体粒径125μm,粉体含水量4.5%。结论根据制剂原料的物理性质变化,既可以预先对处方进行有针对性的定量调节和预测,确保产品质量的稳定性和均一性。Objective To study theeffects of physical properties and technological factors of Chinese matiria medica powder on tbe quality of the tablet, and to optimize the direct compression tableting technology. Methods Using Chuanshenfang extract as a model drug, uniform design was applied to optimizing the direct compression tableting process. Results Tablet quality was affected by pressure, particle size, and water content. The optimal process parameters were pressure of 1 300 kg, particle size of 125 μm, and water content of 4.5%. Conclusion The direct compression tableting process could be predicted and adjusted according to the physical properties of powders so that the quality stability and homogeneity of tablet are ensured.

关 键 词：川参方 直接压片 均匀设计 量化控制 物理性质 

分 类 号：R286.2[医药卫生—中药学]