奥硝唑注射液接瓶头孢噻肟钠注射液的稳定性研究

Stability of compatibility of ornidazole injection instilled after cefotaxime sodium for injection

目的考察奥硝唑注射液接瓶头孢噻肟钠注射液的稳定性。方法采用头孢噻肟钠与奥硝唑按照不同质量比配伍，观察配伍液在25℃4h内外观的变化。药品与药品、对照品与对照品以1：2质量比配伍，观察配伍液在25℃75min内外观的变化，并每15min测量配伍液的pH值。结果头孢噻肟钠与奥硝唑以2：1—1：100质量比配伍，在25℃4h内配伍液颜色由微淡黄色澄清液变成淡粉色澄清液；以1：2—1：10质量比配伍在25℃1h内颜色由微淡黄色澄清液变成淡粉色澄清液；以1：2质量比配伍，药品的配伍液在40min由微淡黄色澄清液变成淡粉色澄清液，对照品的配伍液在75rain内无改变，二者pH值变化不明显。结论奥硝唑氯化钠注射液接瓶头孢噻肟钠注射液发生的变色反应由辅料产生。临床使用时应避免奥硝唑注射液直接与头孢噻肟钠注射液接瓶，如果需要接瓶，建议接瓶前用注射用0．9％氯化钠注射液20ml冲管。

Objective To investigate stability of compatibility of ornidazole injection instilled after cefotaxime sodium for injection. Methods Cefotaxime sodium for injection mixed ornidazole injection with different quality proportion. The appearance of mixtures were observed at 25℃ for 4h. Drugs mixed drugs, and control articles mixed control articles. Cefotaxime sodium for injection mix ornidazole injection with the quality proportion of 1 to 2.The appearance and pH value of mixtures were observed at 25 ℃ for 75min. Results The mixtures with cefotaxime sodium for injection and ornidazole injection with the quality proportion of 2 to 1- 1 to 100 were change from light yellow clear liquid to light pink clear liquid at 25℃ for 4h. The mixtures of drugs with the quality proportion of 1 to 2 changed from light yellow clear liquid to light pink clear liquid at 25℃ in 40min, but the colour of the contrail articles were same in 75min.There were no significiant changes in pH value. Conclusion Avoid ornidazole injection instilled after cefotaxime sodium for injection. Instill 0,9% sodium chloride for injection 20ml before omidazole injection.