不同生产厂家的0.9%氯化钠注射液对奥美拉唑钠配伍稳定性的影响

The Impact on Compatible Stability of Omeprazole Sodium by 0.9% Sodium Chloride Injection Produced by Different Manufacturers

目的 :探讨不同生产厂家的0.9%氯化钠注射液对注射用奥美拉唑钠配伍稳定性的影响。方法:将注射用奥美拉唑钠与不同生产厂家的100 mL 0.9%氯化钠注射液配伍,分别在自然光、强光及紫外光下照射,同时在加入药品的0,2,4,6,8 h观察液体外观、pH值、含量以及不溶性微粒变化情况。结果:3种光照条件下,注射用奥美拉唑钠与不同生产厂家的0.9%氯化钠注射液配伍后均显澄明无色,不溶性微粒符合《中国药典》规定,pH值对其稳定性影响大,pH值越高稳定性越好,含量变化程度为紫外光>强光>自然光。结论:注射用奥美拉唑钠的配伍稳定性与输液的pH值有关。

Objective： To study the impact on the compatible stability of omeprazole sodium for injection by 0 . 9%sodium chloride injection produced by different manufacturers . Methods： Omeprazole sodium for injection was added into 100 ml of 0 . 9% sodium chloride injection produced by different manufacturers and the mixture was exposed under natural light , hard light and UV respectively . The changes of appearance , pH , content and insoluble particles were observed at 0 , 2 , 4 , 6 , 8 h after the addition . Results： Under three kinds of illumination conditions , the mixture of omeprazole sodium for injection and 0 . 9% sodium chloride injection produced by different manufacturers was all clear and colorless . The insoluble particles met with the requirements set forth in the Chinese Pharmacopoeia . PH showed much impact on the stability , the higher pH the better the stability was . The degree of content changes under three illuminations was UV〉hard light〉natural light . Conclusion： The compatible stability of omeprazole sodium for injection is related to the pH of infusion .