银黄口服液制备过程中绿原酸含量稳定性考察

目的 考察银黄口服液制备过程中绿原酸含量的稳定性.方法 在2015年版《中国药典(一部)》制剂制备工艺基础上,以药液pH、煎煮时间、灭菌方式为自变量,考察绿原酸的含量变化,并比较法定工艺与优选工艺制备的样品中绿原酸的含量;于温度(40±2)℃、相对湿度为(75±5)％环境下进行6个月加速试验,考察不同灭菌条件下制剂中绿...

Stability of Chlorogenic Acid Content in the Preparation Process of Yinhuang Oral Liquid

Objective To investigate the stability of chlorogenic acid content in the preparation process of Yinhuang Oral Liquid.Methods Based on the preparation process of Yinhuang Oral Liquid in the Chinese Pharmacopoeia(2015 Edition,Volume I),the content changes of chlorogenic acid were investigated with the pH of drug liquid,decocting time and sterilization method as the independent variables,and the content of chlorogenic acid in the samples prepared by the statutory process and optimal process was compared.The accelerated test was carried out for six months with temperature of(40±2)℃ and relative humidity of(75±5)%to investigate the content change and microbial limit of chlorogenic acid in the preparation under different sterilization conditions.Results The pH of the drug liquid was adjusted to 6.0 before decocting.The content of chlorogenic acid in the preparation was the highest after decocting for 30 min and sterilizing in 80℃ water bath for 60 min.Compared with that in the preparation prepared by the statutory process,the transfer rate of chlorogenic acid in the preparation prepared by the optimal process was increased by 24.95%.After sterilization in 80℃ water bath for 60 min,the microbial limit test of the preparation was qualified.Conclusion The process is reasonable and feasible,which can effectively improve the content of chlorogenic acid in Yinhuang Oral Liquid.