多指标正交试验优选三奇复萎软索丸的制丸工艺  

Multi-index Ortogonal Test to Optimize the Mini-pill Preparation Technology of Sanqi Fuwei Ruansuo Mini-pills

作　　者：刘静 LIU Jing(Department of Pharmacy,Nantong Haimen Hospital of Traditional Chinese Medicine,Jiangsu Province,Nantong 226100,China)

机构地区：[1]南通市海门区中医院药剂科,江苏南通226100

出　　处：《中国中医药现代远程教育》2022年第15期138-140,共3页Chinese Medicine Modern Distance Education of China

摘　　要：目的优选确定三奇复萎软索丸最佳制丸工艺。方法采用正交试验L9(34)法,以丸剂的溶散时限、水分含量作为等价权重评价指标,对影响蜜丸成型的3个关键因素:炼蜜程度、原料药与炼蜜的配比、干燥灭菌时间进行多水平考察,并对实验结果进行方差分析。结果三奇复萎软索丸制备的最佳工艺条件为:采用老蜜,最细药粉与老蜜的配比为1∶1;控制蜜温在90℃合坨;制成丸剂低温烘干间歇灭菌33h,放冷分装即得。结论本工艺在传统制丸基础上进行改良并增加了参数依据,工艺稳定、重现性好,制得的丸剂质量可控。该方法提升了院内制剂三奇复萎软索丸的工艺标准,保障了该制剂的质量稳定性和临床应用效果。Objective To optimize and determine the best mini-pill preparation technology of Sanqi Fuwei Ruansuo mini-pills.Methods Using orthogonal test L9(34)method,dissolution time limit of pills,moisture content was used as an equivalent weight evaluation index,three key factors that affect the forming of honey pill:degree of condensing honey,the ratio of raw materials and refined honey,multi-level inspection of drying and sterilization time,and perform analysis of variance on the experimental results.Results The best technological conditions for the preparation of Sanqi Fuwei Ruansuo mini-pills are:adopt old honey,the ratio of the finest medicinal powder to the old honey is 1∶1,control the honey temperature at 90℃,made into pills,low-temperature drying and intermittent sterilization for 33 hours,keeping it cold and pack it.Conclusion This process is improved on the basis of traditional pill making and added parameter basis,process stability,reproducibility,the quality of the prepared pills is controllable.The method has improved the technical standard of the hospital preparation Sanqi Fuwei Ruansuo mini-pills,and ensure the quality stability and clinical application effect of the preparation.

关 键 词：三奇复萎软索丸 制丸工艺 正交试验 溶散时限 含水量 

分 类 号：R283.6[医药卫生—中药学]