复方儿茶止泻霜剂稳定性研究  

Experimental Study on Stability of Compound Catechu anti-diarrhea Ointment

作　　者：杨智超[1] 李强[2] 高明[1] 

机构地区：[1]大连大学医学院,辽宁大连116622 [2]上海中医药大学药学院,上海201203

出　　处：《中华中医药学刊》2013年第8期1613-1615,共3页Chinese Archives of Traditional Chinese Medicine

基　　金：国家自然科学基金资助项目(81073011)

摘　　要：目的:考察复方儿茶止泻霜剂的稳定性,为该制剂的质量标准研究奠定基础。方法:建立高效液相色谱法测定该制剂的药效成分儿茶素和表儿茶素含量,考察主要影响因素温度、湿度和光照对其有效物质的影响;采用经典恒温加速法预测该制剂在室温下的稳定性。结果:在60℃、高湿、强光条件下,该制剂的有效成分含量变化明显,当储存温度为25℃时,以儿茶素为指标,t0.9为1.27年;以表儿茶素为指标,t0.9为1.11年。结论:复方儿茶止泻霜剂降解反应速率受温度、湿度和光照的影响,应在避光、干燥和阴凉条件下贮藏。Objective ： To investigate the stability of Compound Catechu anti - diarrhea ointment and provide the basis for the researches on quality standard preparations. Methods：HPLC method was adopted to simultaneously determine cate chin and epicatechin and investigate the mainly substance under different conditions such as temperature, humidity and light irradiation. Meanwhile, the constant temperature method was applied to evaluate the stability at room temperature. Results ： Under the conditions of 60 ℃, high humidity, strong light, the content of active ingredients changed dramatical- ly. When catechin as index, to at room temperature was 1.27 years and when epicatechin as index, t0.9 at room temper- ature was 1.11 years. Conclusion ： Compound Catechu anti - diarrhea ointment degradation depends on temperature, humidity and light. Therefore it should be stored in the environment with a low temperature, avoiding humidity and light.

关 键 词：复方儿茶止泻霜剂 稳定性 HPLC 

分 类 号：R927.1[医药卫生—药学]