注射用头孢哌酮钠-舒巴坦钠与四种输液的配伍稳定性

Stability of Cefoperazone Sodium and Sulbactam Sodium for Injection in four Infusion solutions

关键词:  注射用头孢哌酮钠-舒巴坦钠  稳定性  微粒  细菌内毒素  含量测定

Key words:  Cefoperazone Sodium and Sulbactam Sodium for Injection  stability  particle  bacterial endotoxin  content measure

摘要:

［目的］考察注射用头孢哌酮钠-舒巴坦钠在0.9%氯化钠注射液、5%葡萄糖注射液、5%葡萄糖氯化钠注射液、乳酸钠林格注射液四种输液中的配伍稳定性。［方法］将注射用头孢哌酮钠-舒巴坦钠分别与上述4种输液进行配伍，在0~6 h内测定pH值、微粒变化、细菌内毒素含量及含量变化。［结果］分别与上述四种输液配伍后，每毫升中粒径分别≥10 μｍ和≥25 μｍ以上的微粒数均符合中国药典（2005年版）规定，小粒径的微粒数有明显增加；细菌内毒素含量：0 h及6 h均＜ 3.0 EU·mL-1，且随放置时间的增长有明显增加；注射用头孢哌酮钠-舒巴坦钠与5%葡萄糖氯化钠注射液配伍后含量下降约10%，而与其他3种输液配伍后含量下降不超过5%。［结论］注射用头孢哌酮钠-舒巴坦钠可与0.9%氯化钠注射液、5%葡萄糖注射液、乳酸钠林格注射液配伍使用，但不能与5%葡萄糖氯化钠注射液配伍使用；低浓度（5 mg·mL-1L）在0~6 h内含量没有明显变化，稳定性较好。

Abstract:

［Objective］To observe the stability of Cefoperazone Sodium and Sulbactam Sodium for Injection in 0.9%Sodium Chloride Injection, 5%Glucose Injection, 5%Glucose and Sodium Chloride Injection, Sodium Lactate Ringer’s Injection.［Methods］The pH value，particles，content of bacterial endotoxin，content of injection were measured for 0~6 h.［Results］The numbers of the particle (≥25 μm and ≥10 μm) measured up to standard, but there was significantly increased level in mini-particle (<10 μm). The content of bacterial endotoxin was less than 3.0 EU·mL-1for 0 h，6 h and remarkable increased along with the time of placement.The content of Cefoperazone Sodium and Sulbactam Sodium for Injection decreased 10% in 5% Glucose and Sodium Chloride Injection, but with other three injections, the content decreased no more than 5%.［Conclusions］Cefoperazone Sodium and Sulbactam Sodium for Injection was unstable in 5% Glucose and Sodium Chloride Injection, but should be used in 0.9% Sodium Chloride Injection, 5% Glucose Injection, Sodium Lactate Ringer's Injection.