正交试验法优选生脉分散片的提取纯化工艺

Optimization of Extraction and Purification Processes for Shengmai Dispersible Tablets by Orthogonal Test

目的:优选生脉分散片的提取纯化工艺。方法:以提取物中人参皂苷Rg1,Re含量及浸膏得率的综合评分为指标,采用正交试验考察乙醇体积分数、溶剂用量、提取时间对提取工艺的影响;采用壳聚糖絮凝沉降法,通过正交试验考察提取液浓缩程度、壳聚糖用量、静置时间对纯化工艺的影响。结果:最佳提取工艺为加8倍量85%乙醇回流提取3次,每次2 h;人参皂苷Rg1,Re质量分数分别为0.251%,0.074%。最佳纯化工艺为提取液生药质量浓度1 g·mL-1,壳聚糖用量10%,静置时间12 h;人参皂苷Rg1,Re质量分数分别为0.394%,0.116%。结论:优选的提取纯化工艺稳定合理,为生脉分散片的剂型改革提供参考。

Objective： To optimize extraction and purification processes of Shengmai dispersible tablets. Method： Taking composite score of contents of ginsenoside Rg1 , Re and yield of extract as index, orthogonal design was adopted to investigate effects of ethanol concentration, solid-liquid ratio, extracting time on extraction process; Chitosan flocculation sedimentation method was employed, orthogonal test was adopted to optimize purification technology with concentration degree of extracting solution, dosage of ehitosan, standing time as factors. Result： The best extraction process was as follows： extracted thrice with eight times the amount of 85 % ethanol for 2 h each time; contents of ginsenoside Rg1 and Re were 0. 251% and 0. 074%. Optimum purification process was as following： the concentration of extracting solution 1 g ·mL^-1 , dosage of chitosan 10% , standing time for 12 h; contents of ginsenoside Rg1 and Re were 0. 394% and 0. 116%. Conclusion： This optimized process was stable and feasible for providing a reference to dosage-form reformation of Shengmai dispersible tablets.