头孢匹胺钠与甲硝唑的配伍稳定性研究

Study on the Compatibility of Cefpiramide Sodium and Metronidazole Injection

关键词:  注射用头孢匹胺钠  甲硝唑注射液  配伍稳定性  HPLC  有关物质

Key words:  cefpiramide sodium for injection  metronidazole injection  compatibility stability  HPLC  related substances

摘要:

目的 研究注射用头孢匹胺钠与甲硝唑注射液的配伍稳定性。方法 考察配伍前后溶液外观、不溶性微粒和pH值的变化情况；采用HPLC考察注射用头孢匹胺钠与甲硝唑注射液配伍后，在5，25，35℃，避光、室内光照、紫外线照射条件下，8 h内配伍液中头孢匹胺钠与甲硝唑的含量变化，并考察头孢匹胺钠与甲硝唑在配伍液中有关物质的限度。结果 在混合4 h内，头孢匹胺钠与甲硝唑含量没有明显变化，紫外线对配伍液的稳定性有一定的影响。结论 注射用头孢匹胺钠与甲硝唑注射液在4 h内可配伍使用，应尽量避免日光照射。

Abstract:

OBJECTIVE To investigate the compatibility of cefpiramide sodium for injection and metronidazole injection. METHODS The changes in pH value, appearance and insoluble particles were observed, and the relative contents of cefpiramide sodium and metronidazole were determined by HPLC in 8 h after mix at 5, 25, 35℃ under the condition of dark, indoor illumination and ultraviolet light. The limits of the related substances of cefpiramide sodium and metronidazole in the compatibility solution were investigated also. RESULTS In 4 h, cefpiramide sodium and metronidazole concentration didn't change significantly. The ultraviolet radiation had a certain effect on the stability of the mixture. CONCLUSION Cefpiramide sodium for injection can be combined with metronidazole injection in 4 h, but should avoid sunlight.