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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 cream and lay the foundation for the quality standard research of the preparation. Methods: The contents of catechin and epicatechin in the preparation were determined by HPLC. The effects of temperature, humidity and light on the effective substances were investigated. The classical thermostatic accelerated method Stability at room temperature. Results: Under the conditions of 60 ℃, high humidity and high light, the active ingredient content of the preparation changed obviously. When the storage temperature was 25 ℃, the catechin was used as the index, t0.9 was 1.27 years, epicatechin As an indicator, t0.9 for 1.1 years. Conclusion: The degradation rate of compound catechin anti-diarrheal cream is affected by temperature, humidity and light, and should be stored under dark, dry and cool conditions.