护肝利湿膏的稳定性研究

Stability Study of Huganlishi Paste

目的通过考察护肝利湿膏的稳定性,为中药膏方的有效期制订提供依据。方法采用影响因素试验、加速试验和长期试验,考察护肝利湿膏的性状、相对密度、微生物限度、芍药苷及小檗碱含量等项目的变化情况。结果影响因素试验结果显示,膏体在高温条件下质地变硬,相对密度无法测得,在高湿、强光条件下各项指标无明显变化;经加速试验观察,供试品检测项无明显变化;经长期考察,供试品在6个月内各项指标稳定,但放置至第9个月时,芍药苷含量明显下降。结论护肝利湿膏在室温、密闭情况下的稳定性较好,有效期建议为6个月。

Objective This article investigated the stability of huganlishi paste,in order to provide the basics for the establishment of its expiration date.Methods Influence factor test,accelerated test and long-term test was carried out studying the change of huganlishi paste's description,relative density,microbial limit,content of paeoniflorin and berberine.Results After high temperature of the influence factor test,the paste changed hard,and relative density was unable to test.After high humidity and high light test,each index shown not obvious change.After accelerated test and 6 months of long-term test,the ointment didn't have obvious change.But after 9 months of the long-term test,the content of paeoniflorin was decreased.Conclusion Huganlishi paste is stable in room temperature and airtight conditions,and its period of validity was suggested set at 6 months.