正交试验法优选生脉分散片的提取纯化工艺

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。

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

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 chitosan,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.