疏肝颗粒工艺设计和稳定性研究

Study on the Process Design and Stability of the Shugan Granule

目的研究赣州市皮肤病医院制剂疏肝颗粒工艺设计和稳定性。方法将疏肝颗粒作为研究对象,分析其工艺设计,并进行水煎煮提取工艺考察。以口感、溶化性、成型难易程度和颗粒的得率作为考察指标,评价颗粒剂的成型工艺,确定辅料的种类及制粒方法。结果提取次数(A)对得膏量影响显著,提取时间(B)和加水量(C)影响不明显,且各因素影响作用的大小顺序为A>B>C>D。综合考虑颗粒口感、溶化性、成型难易程度以及颗粒的得率等,可得出最佳制备工艺条件为药粉∶蔗糖粉∶甜菊素=0.8∶1.18∶0.02,确定成型工艺定辅料为蔗糖粉、甜菊素,润湿剂为95%乙醇。结论院内制剂“疏肝颗粒”的工艺设计方案行之有效,且稳定性较佳。

Objective To study the process design and stability of Shugan granules.Methods Shugan granule was selected as the research object,the process design was analyzed,and the water extraction process was investigated.Taking the taste,solubility,molding difficulty and the yield of granules as the indexes,the molding process of granules was evaluated,and the types of excipients and granulation methods were determined.Results The extraction times(A)had a significant effect on the amount of the extract,but the extraction time(B)and the amount of water(C)had no obvious effects.The order of the effects of each factor was A>B>C>D.Considering the taste,solubility,molding difficulty and yield of the granules,the optimal preparation conditions were obtained as follows:powder:sucrose powder:steviol=0.8:1.18:0.02.The excipients of the molding process were cane sugar powder and stevioidin,and the wetting agent was 95%ethanol.Conclusion The process design of Shugan granule is effective and stable.