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目的:优选南五味子总木脂素软胶囊的制备工艺。方法:采用紫外分光光度法测定总木脂素含量。选择玉米油和聚乙二醇600(PEG600)为分散剂,氢化植物油和羧甲基纤维素钠(CMC-Na)为稳定剂,聚山梨酯80(Tween80)为助溶剂,筛选内容物最佳处方。以胶囊收率和轧囊现象为综合评价指标,通过正交试验考察进料口温度、胶囊出口温度和转篮干燥时间对制备工艺的影响。结果:内容物最佳处方为主药-玉米油-PEG600-1,2-丙二醇-CMC-Na-氢化植物油-Tween80-水(44∶10∶15∶1∶8∶9∶3∶10),最佳制备工艺为进料口温度50℃,胶囊出口温度20℃,转篮干燥时间24 h。结论:优选的制备工艺稳定可行。
Objective: To optimize the preparation process of total lignans soft capsule of schisandra chinensis. Methods: The total lignin content was determined by ultraviolet spectrophotometry. Corn oil and polyethylene glycol 600 (PEG600) as dispersing agent, hydrogenated vegetable oil and sodium carboxymethylcellulose (CMC-Na) as stabilizers and Tween 80 as cosolvent were selected to select the best content prescription. Taking the capsule yield and the capsule phenomenon as the comprehensive evaluation indexes, the influences of the inlet temperature, the outlet temperature of the capsule and the drying time on the preparation process were investigated by orthogonal test. Results: The best prescription was corn oil-PEG600-1,2-propanediol-CMC-Na-hydrogenated vegetable oil-Tween80-water (44:10:15:1:8:9:3:10) The best preparation process for the inlet temperature of 50 ℃, the capsule outlet temperature of 20 ℃, basket drying time 24 h. Conclusion: The preferred preparation process is stable and feasible.