摘要
目的考察膦甲酸钠和苦参素注射液在不同条件下体外配伍的稳定性。方法按照临床剂量配伍膦甲酸钠和苦参素注射液,分别保存于4℃,(23±2)℃及45℃环境下,分别于0,8,12,24,48,72,96,120,168,240,360 h时观察配伍液有无浑浊、沉淀、云状物、气泡、变色等现象,并取样测定p H变化;分别于0,2,4,8,24,48,72,96,120,168,240,360 h时取配伍液,建立高效液相色谱法并检查样品含量的变化。结果在15 d的检测过程中,4℃,(23±2)℃及45℃条件下膦甲酸钠和苦参素配伍液液体澄清,未出现浑浊、沉淀等现象,pH稳定,含量较稳定。结论膦甲酸钠氯化钠注射液和苦参素注射液体外配伍稳定性较好,配伍液至少在15 d内可保持稳定。
Objective To investigate the compatible stability of Foscarnet Sodium Chloride Injection and Oxymatrine Injection in vitro under different conditions. Methods The initial solutions were prepared according to the clinical dose of Foscarnet Sodium Chloride Injection and Oxymatrine Injection,and stored at 4 ℃ ,（23±2） ℃ and 45 ℃. The solutions were inspected for changes in pH and the visual inspection such as the turbidity,precipitation,cloudiness, bubble and discoloration at each sampling interval（0,8,12,24,48,72,96, 120,168,240,360 h）.The samples were taken at 0,2,4,8,24,48,72,96,120,168,240,360 h to check the sample content changes by HPLC method. Results During the 15- day detection process, the compatibility solution of Foscarnet Sodium Chloride Injection and Oxymatrine Injection was clarified under the conditions of 4 ℃, （23 ± 2） ℃ and 45 ℃ without turbidity and precipitation. The pH and the content were stable. Conclusion The stability of the compatibility solution of Foscarnet Sodium Chloride Injection and Oxymatrine Injection in vitro is good,and the compatibility solution is stable for at least 15 d.
作者
温海燕
宋金春
Wen Haiyan;Song Jinchun(Department of Pharmacy,Renmin Hospital of Wuhan University,Wuhan,Hubei,China 43006)
出处
《中国药业》
CAS
2018年第22期14-17,共4页
China Pharmaceuticals
关键词
膦甲酸钠
苦参素
体外配伍
稳定性考察
foscarnet sodium
oxymatrine
compatibility in vitro
stability testing
