多指标综合评分法优选复方降脂缓释片的水提醇沉工艺及活性研究

Optimization of water extraction andethanol precipitation process and activity of compound lipid-lowering sustained-release tablets by multi-index comprehensive scoring method

目的:多指标综合优选复方降脂缓释片的水提醇沉工艺及其降低血脂的活性研究。方法:选择丹酚酸B、荷叶碱、总黄酮提取率为评价指标,采用多指标综合评分的方法,以提取时间、提取次数和溶媒量为影响因素,Box-Behnken响应面法优化水提工艺;以醇沉浓度、醇沉时间和浸膏相对密度为影响因素,正交试验优选醇沉工艺;采用动物高脂血症模型对复方降脂缓释片提取物进行活性研究。结果:最佳水提醇沉工艺为10倍加水量、提取3次,每次1.5 h,提取温度100℃,合并提取液,浓缩至浸膏相对密度1.15 g·mL-1(40℃),加入乙醇使醇量达到70%,放置12 h;通过高脂血症模型实验研究得出复方降脂缓释片提取物能明显降低血脂。结论:优选后的水提醇沉工艺稳定可行;复方降脂缓释片提取物可明显降低血脂。为确保开发出安全有效、适合工业化生产的复方降脂缓释片提供了实验依据与技术支撑。

OBJECTIVE To optimize the water extraction and ethanol precipitation process of compound lipid-lowering sustained-release tablets and to study its lipid-lowering activity.METHODS The extraction rates of salvianolic acid B,nuciferine and total flavonoids were selected as evaluation indexes.The extraction time,number of extraction and solvent amount were used as influencing factors.The extraction process was optimized by Box-Behnken response surface method.Based on the ethanol concentration,the ethanol precipitation time and the relative density of the extract as factors,the orthogonal test was used to optimize ethanol precipitation process;The animal hyperlipidemia model was used to study the activity of compound lipid-lowering sustained-release tablets.RESULTS The optimum water extraction and ethanol precipitation process is 10 times of water addition,3 times of extraction,1.5 h each time.with an extraction temperature of 100℃.The extracts are combined and concentrated to a relative density of 1.15 g·mL-1(40℃),and ethanol is added to allow the content of ethanol to reach 70%,and then been placed for 12 h;Through the experimental study of hyperlipidemia model,it is concluded that the compound lipid-lowering sustained-release tablet extract can significantly reduce blood lipids.CONCLUSION The preferred water extraction and ethanol precipitation process is stable and feasible;Compound lipid-lowering sustained-release tablets extract can significantly reduce blood lipids.The study provides experimental basis and technical support to ensure the development of safe,effective,suitable industrial production of compound lipid-lowering sustained release tablets.