CAJ | 학술논문

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。
목적：탐토불동생산엄가적0.9%록화납주사액대주사용오미랍서납배오은정성적영향。방법：장주사용오미랍서납여불동생산엄가적100 mL 0.9%록화납주사액배오，분별재자연광、강광급자외광하조사，동시재가입약품적0，2，4，6，8 h관찰액체외관、pH치、함량이급불용성미립변화정황。결과：3충광조조건하，주사용오미랍서납여불동생산엄가적0.9%록화납주사액배오후균현징명무색，불용성미립부합《중국약전》규정， pH치대기은정성영향대， pH치월고은정성월호，함량변화정도위자외광＞강광＞자연광。결론：주사용오미랍서납적배오은정성여수액적pH치유관。
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 .