健肾片放大生产过程中关键因素探讨  

Discussion on the critical factors in the scaled-up production of Jianshen tablets

作　　者：顾和亚[1] 张源[1] 戴国友[1] 

机构地区：[1]江苏省中医院,江苏南京210029

出　　处：《中医临床研究》2011年第14期5-6,共2页Clinical Journal Of Chinese Medicine

摘　　要：目的:介绍健肾片放大生产过程中一些关键因素与产品质量的关系。方法:分述制剂过程中浸膏及辅料影响因素、制粒和设备的影响因素。结果:在健肾片放大生产过程中,亲水浸膏与疏水浸膏比例、辅料的投入量,素片芯的硬度和脆碎度、包衣技术等是影响产品质量的关键因素。结论:通过对上述关键因素的控制,可以实现健肾片质量的稳定性与重现性。Objective： To explore the relationship between some critical factors in the scaled-up production of Jiashen tablets and the quality of this product. Method： The influencing factors of extract and adjuvant and the influencing factors of granulation and equipment were state respectively. Result： In the scaled-up production of Jianshen tablets, the proportion of the amount of hydrophilic extract and hydrophobic extract, the input amount of adjuvant, the hardness and crispness of plain films as well as coating technique are the critical factors influencing the quality of the product. Conclusion： By controlling the above critical factors, the stability and reproducibility of the quality of Jianshen tablets can be achieved.

关 键 词：健肾片 生产过程 关键因素 

分 类 号：R322.61[医药卫生—人体解剖和组织胚胎学]