Compatibility Stability of Esomeprazole Sodium for Injection

OBJECTIVE To investigate the compatible stability of esomeprazole sodium for injection with 0.9% sodium chloride injection under different conditions. METHODS Under the conditions of room temperature, shading, illumination (4 500 Lx), 40℃ in constant temperature environment, the appearance, pH value, insoluble particles and content of effective components(esomeprazole) in esomeprazole sodium for injection were determined regular after mixed with 0.9% sodium chloride injection. RESULTS Injection of esomeprazole sodium in the placement process had varying degrees of color changes, change degree:40℃ > illumination > room temperature > shading. Under the four conditions, the pH value of the finished product liquid was relatively stable; the pH value was almost unchanged within 12 h, and slightly decreased in the 24 and 48 h, and the constant temperature was decreased more at 40℃. The insoluble particle number of 48 h in the solution of high concentration under the 40℃ constant temperature exceeded the requirement of Chinese Pharmacopoeia, and the insoluble particles of all other solutions met the requirements of Chinese Pharmacopoeia. The content of esomeprazole in 48 h also decreased, and the 40℃ constant temperature condition decreased more. CONCLUSION The injection of esomeprazole sodium is the most unstable under the 40℃ constant temperature, and the solution is most stable under the condition of shading. Therefore, it is recommended that the injection of esomeprazole solution be preserved at room temperature, as far as possible to avoid light, while avoiding the impact of high temperature. The low concentration solution (0.4 mg·mL^-1) is recommended that used after 12 h, and the high concentration solution (1.6 mg·mL^-1) is recommended that dripped in 8 h.