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目的:优选参芪复方颗粒的水提工艺条件,并考察不同因素下提取液中皂苷类成分含量的变化。方法:采用HPLC-ELSD测定人参皂苷Rg1,Re,Rb1和黄芪甲苷的含量,流动相水-乙腈梯度洗脱,流速0.8 m L·min-1,气体流量2.6 L·min-1,漂移管温度102℃。以皂苷类含量及干膏得率的综合评分为指标,在单因素试验基础上,通过正交试验考察料液比、提取时间、提取次数对参芪复方颗粒水提工艺的影响;通过测定不同影响因素下参芪复方颗粒水提液及浓缩液中皂苷类含量的变化,考察该制剂的热稳定性。结果:最佳提取工艺为加10倍量水提取3次,每次40 min;人参皂苷Rg1,Re,Rb1和黄芪甲苷提取量分别为1.556,2.155,2.168,0.718 mg·g-1。参芪复方颗粒制剂工艺过程中受热温度和时间是影响其皂苷类成分含量变化的主要因素之一。结论:参芪复方颗粒在制备工艺过程中应避免高温及长时间受热,在浓缩中应采用减压浓缩法,以降低人参皂苷类成分的降解。优选的水提工艺合理可行、重复性好,适用于该制剂的工业化生产。
OBJECTIVE: To optimize the conditions of water extraction of Shenqi Compound Granules and investigate the changes of the content of saponins in the extract under different factors. Methods: The contents of ginsenoside Rg1, Re, Rb1 and astragaloside were determined by HPLC-ELSD. The mobile phase consisted of water and acetonitrile gradient, the flow rate was 0.8 m L · min-1 and the gas flow rate was 2.6 L · min- Temperature of 102 ℃. Based on the single factor test and the comprehensive score of the saponin content and the dry extract yield, the effects of the ratio of solid to liquid, extraction time and the number of extraction on the water extraction process of Shenqi Compound Granules were investigated by orthogonal test. Under the influence factors, the changes of the content of saponins in Shenqi Compound Granule Water Extract and Concentrate, and the thermal stability of the preparation were investigated. Results: The optimum extraction process was extraction of 10 times the amount of water three times, each time 40 min; extraction of ginsenosides Rg1, Re, Rb1 and Astragaloside were 1.556,2.155,2.168,0.718 mg · g-1. Shenqi Compound Granules in the process of heating temperature and time are one of the main factors that affect the content of saponins. Conclusion: Shenqi compound granule should avoid high temperature and prolonged heat in the process of preparation. Concentration should be concentrated by vacuum concentration to reduce the degradation of ginsenosides. The preferred water extraction process is reasonable and feasible, good repeatability, suitable for the industrial production of the preparation.