黑种草子总皂苷滴丸的制备工艺研究

Optimization of preparation for semen nigellae total saponins Dropping Pill

目的:优选黑种草子总皂苷滴丸的制备工艺。方法:以滴丸的外观质量评分、丸重量差异变异系数和溶散时限的综合评分作为考核指标,通过单因素和正交试验对影响滴丸成型的因素进行考察,优选最佳制备工艺。结果:优选的最佳制备工艺为:以PEG4000∶PEG6000(5∶1)为基质,总皂苷提取物与基质配比1∶3,滴制温度80℃,冷却剂为二甲基硅油(运动黏度350 m Pa·s),冷却温度5℃,滴距10 cm,滴制速度30滴/min。结论:优选出的制备工艺稳定可行。

Objective To optimize the preparation for semen nigellae total saponins Dropping Pill.Methods The comprehensive score including appearance quality,weight variation of pills and dissolution time was used as criteria for evaluation.Single factor exper-iment and orthogonal design were used to optimize the preparation of the dropping pill.Results The optimized conditions were as fol-lows.The radio of PEG4000 to PEG6000 was 5∶1.The radio of total saponins to matrix was l∶3.The temperature of drug solution was 80℃.The coolant was dimethicone which viscosity was 350 mPa·s.The cooling temperature was 5℃.The dropping distance was 10 cm.The dropping speed was 30 drops per minute.Conclusion The optimized preparation is stable and feasible.