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目的:探讨壳聚糖絮凝法代替蛋清法用于排铅口服液澄清工艺的可行性,优化生产工艺。方法:以总黄酮、多糖和澄明度为衡量指标,通过单因素考察壳聚糖加入量、体系pH、絮凝温度判断因素水平的适宜范围,并运用正交设计试验综合优选最佳澄清工艺。结果:壳聚糖絮凝最佳工艺条件为:絮凝温度50℃,壳聚糖加入量0.20%,药液pH5.0。结论:壳聚糖絮凝法制备的口服液在有效成分和澄明度等方面均明显优于蛋清沉降法,且可节省生产成本。壳聚糖絮凝法可代替蛋清沉降法用于排铅口服液的澄清工艺。
Objective: To investigate the feasibility of using chitosan flocculation instead of egg white method for the clarification of lead-lead oral solution and optimize the production process. Methods: With the total flavonoids, polysaccharides and clarity as the measurement index, single factor was used to investigate the appropriate range of factors for determining chitosan dosage, system pH and flocculation temperature. The optimal design process was optimized by orthogonal design. Results: The optimal conditions for the flocculation of chitosan were as follows: the flocculation temperature was 50 ℃, the amount of chitosan added was 0.20% and the pH was 5.0. Conclusion: The oral liquid prepared by chitosan flocculation method is obviously superior to egg white sedimentation method in the aspects of effective components and clarity, and the production cost can be saved. Chitosan flocculation method can replace the egg white sedimentation method for the lead-free oral liquid clarification process.