论文部分内容阅读
目的:优化六味地黄生物制剂总多糖的精制工艺,为该制剂的开发提供参考。方法:以粗多糖质量为指标,采用正交试验考察醇沉浓度、醇沉时间、药液相对密度对总多糖醇沉工艺的影响。在单因素试验基础上,以蛋白质清除率和总多糖保存率的综合评分为指标,采用正交试验优化三氯乙酸(TCA)-正丁醇法脱蛋白工艺。以色素清除率和总多糖保存率的综合评分为指标,利用正交试验优化活性炭除色素工艺。结果:最佳醇沉工艺为醇沉浓度85%,醇沉时间6 h,药液相对密度1.05;粗多糖质量8.92 mg。最佳脱蛋白工艺为粗多糖溶液与TCA-正丁醇体积比1∶2,TCA-正丁醇(1∶15),振荡时间20 min,静置时间0.5 h;蛋白质清除率80.23%,总多糖保存率85.45%。最佳除色素工艺为脱色温度40℃,活性炭加入量6%,脱色时间40 min;色素清除率74.84%,总多糖保存率78.69%。结论:优选的精制工艺稳定可行,适用于六味地黄生物制剂总多糖保健产品的开发。
Objective: To optimize the purification process of total polysaccharide of Liuwei Rehmanniae Preparata, and provide reference for the development of the preparation. Methods: The crude polysaccharides quality as an indicator, using orthogonal test alcohol sediment concentration, alcohol precipitation time, the relative density of the liquid polysaccharide alcohol precipitation process. On the basis of single factor experiment, orthogonal test was used to optimize the TCA-n-butanol deproteinization process based on the comprehensive score of protein clearance and total polysaccharide preservation rate. Taking the comprehensive score of pigment removal rate and total polysaccharide preservation rate as indexes, orthogonal test was used to optimize the technology of removing carbon pigment. Results: The optimal alcohol precipitation process was alcohol concentration 85%, alcohol precipitation time 6 h, liquid relative density 1.05; crude polysaccharide mass 8.92 mg. The best deproteinization process was the volume ratio of crude polysaccharide solution to TCA-n-butanol was 1:2, TCA-n-butanol 1:15, shaking time 20 min, standing time 0.5 h, protein clearance 80.23% Polysaccharide preservation rate of 85.45%. The optimal process of removing pigment was decolorization temperature 40 ℃, active carbon 6%, decolorization time 40 min; pigment removal 74.84%, total polysaccharide 78.69%. Conclusion: The optimal purification process is stable and feasible, which is suitable for the development of total polysaccharide health products of Liuwei Rehmanniae Preparata.