正交试验优选左金滴丸的成型工艺

目的:优选左金滴丸的成型工艺。方法:采用正交试验,以基质种类、药物与基质的比例、药液温度、冷却剂种类为考察因素,以混合状况、成型情况、溶散时间为指标选取基质和冷却剂;以冷却剂温度、滴头的内外径大小、滴距、滴速为考察因素,以丸重差异变异系数为指标选取滴制条件。结果:最佳成型工艺为以聚乙二醇4000为基质,液体石蜡为冷却剂,冷却温度为12℃,滴头的内外径大小为3.5/4.9mm,滴距为10cm,滴速为25滴.min-1。结论:该工艺稳定、重现性好,所得制剂成型好,可为左金滴丸的生产提供参考依据。

Optimization of the Forming Technology of Zuojin Dropping Pill by Orthogonal Experiment

OBJECTIVE： To optimize the forming technology for Zuojin dropping pill.METHODS：The base material and cooling agent were optimized by orthogonal experiment with the type of base material, the ratio of drug to base material, the temperature of physic liquor, the type of the cooling agent as factors taking the mixing state, forming condition and dissolution time as indexes;the dripping condition was optimized with the temperature of the cooling agent, the caliber of the dripping mouth, the dripping distance and dripping speed as factors taking the variation coefficient of the pill weight difference as index. RESULTS：The optimal forming technology was as follows： with polyglycol 4000 as base and paraffin oil as cooling agent; the cooling temperature was 12℃;the caliber of the dripping mouth was 3.5/4.9mm;the dripping distance was 10 cm and the dripping speed was 25 drop·min^-1.CONCLUSION： The forming technology is stable, reproducible and the preparation was well - shaped, and the forming technology serves as a reference for the production of Zuojin dropping pill.