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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1.1NTU。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。
OBJECTIVE To explore the efficient flocculation and impurity removal process of pediatric Cough Chuan Ling Yuan extract to better remove impurities, retain the active ingredients and improve the clarity and stability of liquid medicine. Methods Chitosan was used to flocculate the original extract of Kerelingling Oral Liquid. Taking the retention of chlorogenic acid, the removal rate of tannin and protein and the turbidity of liquid as the main indexes, the effects of flocculant dosage , Flocculation temperature, stirring speed and stirring time on the flocculation effect, in order to get the appropriate flocculation process conditions. The results showed that the optimum flocculation process of chitosan flocculation Kereling oral liquid extract was liquid temperature 30 ℃, chitosan 0.75 g / L, the first at the top of impeller blade linear velocity of 1.31 m / s under the conditions of rapid stirring 120 s, and then stirred at 0.26 m / s speed 15 min, the flocculation of the liquid after centrifugation at a separation factor of 1 430 for 20 min, then the retention rate of chlorogenic acid of 94.6% , The removal rates of tannin and protein were 44.7% and 51.6% respectively, and the turbidity of liquid was 1.1NTU. After 90 days of storage, the turbidity of liquid was only 3.5 NTU after standing for 90 days, and its stability was outstanding. Compared with the alcohol precipitation method, the chitosan has a good flocculation and impurity removal effect on pediatric Cough Chuan Ling crude drug extract, the retention rates of the active ingredient chlorogenic acid and polysaccharide increased by 6.3% and 25.8%, respectively, and the tannin removal rate increased by 21.6 %, Liquid turbidity is only 1/4 alcohol sediment, placed 3 months, the increase of liquid turbidity is only alcohol precipitation method 1/5. Conclusion The flocculation method can be used for the purification and impurity removal of Xiaoerkechuanling Oral Liquid.