三七总皂苷滴丸制备工艺研究

Study on Preparation Process of Panax Notoginseng Saponins Droping Pills by Orthogonal Design

目的:确立三七总皂苷滴丸的最佳成型工艺。方法:先采用单因素实验以溶散时限、圆整度、沉降情况、硬度、拖尾情况并结合工业生产实际优选滴丸成型工艺条件;再采用L(934)正交试验法,以重量差异变异作为评价指标,优选出滴丸的滴制条件,从而得出最佳成型工艺。结果:最佳制备工艺为:聚乙二醇-6000为基质,药物与基质配比为1∶6,药液温度(70±1)℃,液体二甲硅油为冷却剂,滴头内外径(mm)比2.5∶3.5,滴速65滴/min,滴距6cm,冷却剂温度(8±1)℃。结论:该成型工艺稳定、重现性好,所得制剂成型性好,质量指标符合2005年版《中国药典》滴丸剂质量标准。

Objective： To obtain the optimal forming technology of panax notoginseng saponins droping pills.Methods： The optimum conditions of preparation process of total saponins from panax notoginseng droping pills were selected by single-factor with dissolution,integrality,subside,hardness,trail condition and were in connection with industrial production practice;then L9（34） orthogonal design was adopted and weight variation was used as evaluation indicator to select good dropping conditions for obtaining the optimal forming technology.Results： The optimized preparation conditions were as follows： PEG6000 was used as matrix;the ratio of drugs and matrix was 1∶6;temperature of liquid was（70±1）℃;liquid dimethicone was used as condensate;the internal and external diameter of burette was 2.5mm and 3.5mm respectively;dropping speed was 65 drop/min;the temperature of refrigerant was（8± 1）℃;dropping distance was 6cm.Conclusion： The preparation process is stable,reproducible and the preparation is well-shaped,of which quality index can meet the standards set by Chinese Pharmacopoeia（2005 edition）.