复方茵柏合剂壳聚糖澄清工艺研究

目的研究壳聚糖澄清法用于复方茵柏合剂的除杂效果以及制备工艺的可行性。方法以绿原酸为评价指标，通过正交设计优选澄清条件，与原制备工艺比较，并进行稳定性试验。结果壳聚糖澄清法所制备样品中绿原酸含量、薄层色谱鉴别与原工艺比较均无显著差异，且澄清度和稳定性均优于原工艺。结论壳聚糖澄清法具有简化工艺、缩短生产周期、提高制剂稳定性等优点，可用于复方茵柏合剂的制备。

Study on Clarification Process of Compound Yinbai Mixture by Chitosan

Objective To study the clarification effect of removing impurity by chitosan and the feasibility of the preparation technology for Compound Yinbai Mixture. Methods Taking the content of chlorogenic acid as marker, the orthogonal design was used to optimize the best clarify condition. The two preparation technologies and stability tests were compared. Results There was no significant difference in content of chlorogenic acid, TLC between the clarification method and the original preparation technology. The clarity and stability surpassed the original preparation technology. Conclusion The chitosan clarification method possesses the advantages of simplifying technology, increasing stability and shortening production cycle. It can be used to prepare Compound Yinbai Mixture.