壳聚糖絮凝法用于天贝止咳口服液纯化工艺研究

Study on Clarification Process of Tianbei Zhike Oral Liquid by Chitosan

目的优选天贝止咳口服液的纯化工艺。方法采用壳聚糖絮凝法,通过L9(34)正交试验,以盐酸麻黄碱、盐酸伪麻黄碱含量及固形物去除率为指标,建立综合评分标准,对药液浓度、絮凝温度、壳聚糖加入量3个因素进行考察,优选出最佳纯化工艺条件,并与醇沉法进行对比。结果优选出的最佳纯化工艺条件为:A3B1C1,即药液浓度为1∶3,絮凝温度为30℃,壳聚糖加入量为0.3 g/mL。壳聚糖絮凝法与醇沉法均能使药液澄清,但前者在低成本和工艺简单的基础上,能最大程度避免有效成分遗失。结论壳聚糖絮凝法能够代替醇沉法用于天贝止咳口服液的澄清工艺。

Objective To optimize the purification process of Tianbei Zhike Oral Liquid.Methods By using chitosan flocculation method,through L9(34)orthogonal test,the comprehensive scoring standard was established by taking the content of ephedrine hydrochloric acid,pseudoephedrine hydrochloride and the removal rate of solids as indexes.The concentration of drug solution,the amount of chitosan and flocculation temperature were investigated.Investigate and screen out the optimal purification conditions and compared with the alcohol precipitation method.Results The optimal purification process conditions was A3B1C1,that was,the concentration of the drug solution was 1∶3 and the flocculation temperature was 30℃,the amount of chitosan was 0.3 g/mL.Both chitosan flocculation method and alcohol precipitation method could clarify the liquid,the former could retain the effective components to the maximum extent,the cost was low,and the process was simple.Conclusion The chitosan flocculation method can replace the alcohol precipitation method for the clarification process of Tianbei Zhike Oral Liquid.