板蓝根滴丸制备工艺优化研究

Study on the Optimization of the Preparation Technology of Radix isatidis Dropping Pills

[目的]研究影响板蓝根滴丸制备的各种因素,确立最佳制备工艺。[方法]以外观质量、溶散时限和丸重差异为评价指标,采用正交设计试验对各影响因素进行考察。[结果]以聚乙二醇6000+聚乙二醇4000(9:1)为基质,药物与基质比例为1:3,药液温度为80℃,二甲基硅油为冷凝剂,冷却液温度为5℃,滴速为50d/min,滴距为7cm,制得的滴丸外观质量好、溶散时限短、丸重差异小,与颗粒剂比较吸湿性小。[结论]该滴丸质量稳定,重现性好,设备简单,适于工业化生产。

[Objective] The research aimed to study the effects of various influencing factors of Radix isatidis dropping pills and establish the best preparation technology.[Method] Using appearance quality,disintegration time limit and weight difference of pills as evaluation indices,various influencing factors were investigated by using orthogonal test.[Result] PEG6000：PEG4000 of 9：1 was used as substrate,the ratio of drug to matrix was 1：3,temperature of mixture was 80 ℃,dimethylsilicone oil was used as condensing agent,the temperature of coolant was 5 ℃,dropping speed was 50 drop/min and drop distance was 7 cm.The prepared dropping pills had good appearance quality,short disintegration time limit and small weight difference of pills.The hygroscopicity was smaller than that of granules.[Conclusion] The prepared dropping pills had stable quality,good reproducibility and simple device.And they were suitable for the industrialization production.