正交试验法优选心脑欣滴丸的制备工艺研究

目的：优选心脑欣滴丸的最佳成型工艺。方法以滴丸的外观及圆整度、沉降速度、平均丸重、重量差异限度和滴丸合格率等为评价指标，以正交试验法筛选滴丸基质种类、基质比例、冷凝剂、滴速、滴距、药液温度和冷凝温度等因素对滴丸制备过程中成型工艺的影响。结果以聚乙二醇4000：聚乙二醇6000（1：8）为基质，药粉与基质比例为1：2，二甲硅油为冷凝剂，滴速为50滴/ min，滴距为8 cm，药液温度为80℃，冷凝温度为10~12℃为最佳滴制条件。结论以该工艺制成的滴丸符合《中国药典》2015年版要求，可适用于实验室制备和工业化生产。

Study on optimization of preparation technology for Xinnaoxin Dropping Pills by orthogonal test

Objective To establish the best forming preparation process for Xinnaoxin Dropping Pills.Methods Indi-cators for the evaluation of appearance and roundness,subsidence,mean weight,weight difference and qualified rate of drop-ping pills.The impact of the matrix type of drop pill,ratio of base condensing agent,speed,distance,liquid and condensing-temperature,using L9(34 )orthogonal design the best molding process.ResuIts The best preparation condition was PEG-4000 and PEG-6000 with a ratio of 1: 8,powder and matrix with a ratio of 1: 2,condensing agent was dimethicone,drip sys-tem speed of 50 drops per minute,drip distance of 8 cm,liquid temperature of 80 degrees,condensing temperature was 10~12 degrees.ConcIusion Drop pills made by the process fits the standard of CP2015,this preparation method was suitable for the laboratory test and the industrial production.