苍耳丸制丸工艺优化及工艺验证  

Preparation Process Optimization and Process Validation of CangEr Pills

作　　者：杨琳 王春泰 张囡[1] 黄涛[1] 佟若菲[1] 孙燕燕[1] YANG Lin;WANG Chun-tai;ZHANG Nan;HUANG Tao;TONG Ruo-fei;SUN Yan-yan(Department of pharmacy,Children′s Hospital of Tianjin,Tianjin 300134,China)

机构地区：[1]天津市儿童医院药剂科,天津300134

出　　处：《海峡药学》2022年第9期1-4,共4页Strait Pharmaceutical Journal

摘　　要：目的优化苍耳丸(大蜜丸)药粉混合时间,并针对苍耳丸制丸后硬度较大的问题,优化苍耳丸制丸的工艺参数。方法通过批量小试和正交试验的方法,确定并优化苍耳丸粉碎、混合、和坨工序的工艺参数,并通过210403、210404、210405三批次工艺验证,证实其工艺的可靠性和稳定性。结果优化后的苍耳丸制丸工艺参数为:七味中药饮片粉碎成细粉,过80目筛后混合30 min,和坨时采用嫩蜜,加热至55℃后,按照100 g药粉加炼蜜110 g的比例进行和坨操作。结论优化后的苍耳丸制丸工艺简单可行,制得的产品各项检验合格,稳定性良好。OBJECTIVE Optimize the mixing time of CangEr pills(big-honeyed pills)powder,and aiming at the hardness of CangEr pills,optimize the process parameters of CangEr pills.METHODS Through batch tests and orthogonal tests,the process parameters of crushing,mixing and lump of CangEr pills were determined and optimized,and by 210403,210404,210405 three batches of process validation,confirmed the reliability and stability of the process.RESULTS The optimal process parameters of CangEr pills were as follows:seven Chinese herbs were crushed into fine powder,sieved with 80 mesh and mixed for 30 min,tender honey was used for mixing,after heating to 55℃,the mixing operation was carried out according to the proportion of 100 g powder and 110 g refined honey.CONCLUSION The optimized preparation process of CangEr pills is simple and feasible,and the products are qualified and stable.

关 键 词：苍耳丸 大蜜丸 硬度 工艺参数 工艺验证 

分 类 号：R94[医药卫生—药剂学]