[关键词]
[摘要]
目的 探索小儿咳喘灵原药提取液高效絮凝除杂工艺,更好地去除杂质,保留有效成分,提高药液的澄清度及其稳定性。方法 采用壳聚糖对小儿咳喘灵口服液原药提取液进行絮凝处理,以有效成分绿原酸保留率、鞣质和蛋白质的去除率及药液浊度作为主要衡量指标,考察絮凝剂用量、絮凝温度、搅拌速度及搅拌时间对絮凝效果的影响,以期得到适宜的絮凝工艺条件。结果 确定了壳聚糖絮凝小儿咳喘灵口服液原药提取液的最佳絮凝工艺为药液温度30 ℃,加入壳聚糖0.75 g/L,先在搅拌桨叶片顶端线速度为1.31 m/s的条件下快速搅拌120 s,再在0.26 m/s的速度下搅拌15 min,絮凝后的药液在分离因数为1 430条件下离心20 min,此时绿原酸的保留率为94.6%,鞣质和蛋白质的去除率分别为44.7%和51.6%,药液浊度为1.1 NTU。药液静置存放90 d后浊度仅为3.5 NTU,稳定性突出。与醇沉法相比,壳聚糖对于小儿咳喘灵原药提取液的絮凝除杂效果良好,有效成分绿原酸及多糖的保留率分别提高了6.3%和25.8%,鞣质去除率提高21.6%,药液的浊度仅是醇沉浊度的1/4,放置3个月药液浊度的上升幅度仅为醇沉法的1/5。结论 絮凝法可以用于小儿咳喘灵口服液原药液的净化除杂工艺。
[Key word]
[Abstract]
Abstract: Objective To find out an efficient flocculation process of herbs water-extraction solution of Xiao’er Kechuanling Oral Liquid, remove impurities, reserve more active components of solution, and improve solution clarity and stability. Methods The natural macromolecule flocculant chitosan was applied to purify herbs water-extraction solution of Xiao’er Kechuanling Oral Liquid. The influences of the flocculant dosage, flocculation temperature, mixing speed and time on flocculation effect were investigated, and the optimal process conditions were obtained based on the retention rate of chlorogenic acid, removal rate of tannin and protein, and the turbidity degree of the supernatant solution. Results The optimum flocculation process conditions were as follows: the flocculation temperature was 30 ℃, the chitosan dosage was 0.75 g/L, the tip velocity of propeller was 2.6 m/s and the fast mixing time was 120 s, then the tip velocity of propeller was 0.52 m/s and the slow mixing time was 15 min, and after that the treated solution was centrifuged for 20 min at centrifuging factor 1 430. At the optimal process condition point, the retention rate of chlorogenic acid was 94.6%, the removal rate of tannin and protein was 44.7% and 51.6%, respectively, the turbidity degree was 1.1 NTU and only 3.5 NTU after 90 d of the storage duration of the supernatant solution. Compared with ethanol precipitation, the flocculation effect of water-extraction solution of Xiao’er Kechuanling Oral Liquid with chitosan had distinct advantages that the content of chlorogenic acid and polysaccharide and the removal rate of tannin was improved by 6.3%, 25.8%, and 21.6% respectively, the turbidity degree was only 1/4 of the solution treated by ethanol precipitation, and three months later the rise of turbidity degree was 1/5 of that by ethanol precipitation. Conclusion Flocculation technology could be used in the purification process of the extract of Xiao’er Kechuanling Oral Liquid.
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[基金项目]
国家重大新药创制科技重大专项综合性新药研究开发项目子课题(2009ZX09301-008);国家自然科学基金资助项目(21276195)