CAJ | 학술논문

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。
목적：고찰봉지마도제적은정성，위림상합리저존、사용해약품제공삼고。방법：채용다제도HPLC법동시측정염산정잡인화염산마황감적함량，안《중국약전》（2010년판）약물제제은정성시험지도원칙진행영향인소시험화장기시험，고찰봉지마도제재불동시험조건하적외관성상、pH이급주성분（염산정잡인화염산마황감）함량변화。결과：영향인소시험결과현시，양품재60℃급고습조건하함량유소하강；장기시험고찰결과현시각항질량지표미견명현변화。결론：봉지마도제적은정성교호，가장기유효기잠정위1년。
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.