蜂地麻涂剂的稳定性研究

目的：考察蜂地麻涂剂的稳定性,为临床合理贮存、使用该药品提供参考。方法：采用多梯度HPLC法同时测定盐酸丁卡因和盐酸麻黄碱的含量,按《中国药典》（2010年版）药物制剂稳定性试验指导原则进行影响因素试验和长期试验,考察蜂地麻涂剂在不同试验条件下的外观性状、pH以及主成分（盐酸丁卡因和盐酸麻黄碱）含量变化。结果：影响因素试验结果显示,样品在60℃及高湿条件下含量有所下降;长期试验考察结果显示各项质量指标未见明显变化。结论：蜂地麻涂剂的稳定性较好,可将其有效期暂定为1年。

The stability study on pigmentum Fengdima

Objective： To investigate the stability of pigmentum Fengdima and provide reference for its storage and utilization. Methods：A multiple gradient HPLC method was used to simultaneously determine the content of tetracaine hydrochloride and ephedrine hydrochloride. The appearance, pH and contents of tetracaine hydrochloride and ephedrine hydrochloride were investigated by inlfuence factors test and long-term test, according to the guidance for stability test of preparation stated in Chinese Pharmacopeia （2010 edition）. Results：The results of inlfuence factors test showed that the contents of tetracaine hydrochloride and ephedrine hydrochloride decreased under 60℃and high humidity conditions. Long-term test results showed that no obvious change was observed in quality indexes. Conclusion：Pigmentum Fengdima was a relatively stable preparation, and its shelf-life was tentatively set up as one year.