苦连康肤洗剂的稳定性研究

Study on the stability of Kulian Kangfu Lotion

目的探讨苦连康肤洗剂的初步稳定性。方法重点以药品的性状、鉴别、pH值、盐酸小檗碱含量为指标,考察苦连康肤洗剂在严峻条件及普通条件下的稳定性。结果苦连康肤洗剂对强光、高湿及高温等影响因素均稳定;苦连康肤洗剂样品经加速试验6个月及长期试验12个月的试验考察,药品的性状无明显变化;苦连康肤洗剂中的黄连、冰片、苦参特征斑点清晰可见;苦连康肤洗剂样品的pH值稳定,样品的含量无明显减损。结论苦连康肤洗剂的稳定性较佳,进一步验证了其制备工艺的合理性。

Objective To discuss the stability of Kulian Kangfu Lotion.Methods The stability of Kulian Kangfu Lotion under severe and ordinary conditions was investigated with the characteristics,identification,pH value and content of berberine hydrochloride as the indexes.Results Kulian Kangfu Lotion has stable effect on strong light,high humidity and high temperature.After 6 months of accelerated test and 12 months of long-term test,Kulian Kangfu Lotion sample showed no obvious change in its properties.The characteristic spots of Coptidis Rhizoma,Borneol and Sophora flavestifolia in Kulian Kangfu Lotion were clearly visible.The pH value of Kulian Kangfu Lotion sample was stable,and the content of the sample had no obvious loss.Conclusion Kulian Kangfu Lotion has good stability and the rationality of the preparation process was further verified.