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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 Shengmai dispersible tablets extraction and purification process. Methods: The ginsenoside Rg1, Re content and extract yield of the composite score as an indicator, the use of orthogonal test ethanol volume fraction, the amount of solvent, extraction time on the extraction process; using chitosan flocculation sedimentation The effects of concentration of extract, amount of chitosan and standing time on the purification process were investigated by orthogonal test. Results: The optimal extraction process was extraction and extraction of 8 times amount of 85% ethanol three times for 2 hours each time. The contents of ginsenoside Rg1 and Re were 0.251% and 0.074%, respectively. The optimal purification process was 1 g · mL-1 of crude drug, 10% of chitosan and 12 h of standing time. The mass fractions of ginsenoside Rg1 and Re were 0.394% and 0.116%, respectively. Conclusion: The optimized extraction and purification process is stable and reasonable, which provides a reference for the formulation reform of Shengmai Dispersible Tablets.