注射用腺苷钴胺与维生素B_(1)注射液的配伍稳定性考察

Investigation on compatible stability of cobamamide for injection and vitamin B_(1) injection

目的:考察在室温不同光照条件下注射用腺苷钴胺与维生素B_(1)注射液配伍稳定性,并与临床常用溶媒进行比较。方法:将注射用腺苷钴胺分别与维生素B_(1)注射液、灭菌注射用水及0.9%氯化钠注射液配伍。2 h内在室温避光、红光、部分见光及完全见光条件下,分别观察和检测各配伍液外观、不溶性微粒数及pH值变化,采用高效液相色谱法测定配伍液中腺苷钴胺及维生素B_(1)的含量。结果:在避光和红光条件下,注射用腺苷钴胺与维生素B_(1)注射液配伍2 h内外观、pH值、不溶性微粒数及含量均未发生明显变化;在部分见光及完全见光条件下,配伍液2 h内不溶性微粒数、pH值及维生素B_(1)含量保持稳定,但腺苷钴胺的含量明显下降。相同光照条件下,注射用腺苷钴胺分别与灭菌注射用水、0.9%氯化钠注射液配伍2 h内,pH值均随时间呈上升趋势,腺苷钴胺含量均呈明显下降趋势,且下降速度较维生素B_(1)配伍组更快。结论:注射用腺苷钴胺与维生素B_(1)注射液配伍2 h内,在避光和红光条件下稳定性良好,在部分及完全见光条件下的稳定性均优于其与灭菌注射用水或0.9%氯化钠注射液。

OBJECTIVE To investigate the compatible stability of cobamamide for injection and vitamin B_(1)injection under different light conditions at room temperature, and compare it with the compatible stability in common clinical solvents.METHODS Cobamamide for injection was dissolved in vitamin B_(1)injection, sterile water for injection and sodium chloride injection respectively. The changes of appearance, insoluble particles number and pH values under different light conditions were observed within 2 hours. The changes of the contents of cobamamide and vitamin B_(1)were analyzed respectively by HPLC.RESULTS No significant change was demonstrated in the outward appearance, the insoluble particles number, the pH value and contents for the mixed solution within 2 hours under dark or red light condition. The insoluble particles number, the pH value and the content of vitamin B_(1)remains stable, while the content of cobamamide decreases significantly within 2 hours under partial light or complete light condition. Under the same light conditions, the pH values shows an upward trend in the cobamamide solution mixed with sterile water for injection or sodium chloride injection within 2 hours. Meanwhile, the content of cobamamide shows a significant downward trend. And the solutions had higher decline rates of cobamamide than cobamamide for injection dissolved in vitamin B_(1).CONCLUSION Cobamamide for injection combined with vitamin B_(1)injection is stable within 2 hours under red light or dark condition at room temperature. And the solution is more stable than cobamamide for injection dissolved in sterile water for injection or sodium chloride injection within 2 hours under low or strong light exposure at room temperature.