注射用艾司奥美拉唑钠配伍稳定性考察

Compatibility Stability of Esomeprazole Sodium for Injection

关键词:  艾司奥美拉唑  配伍稳定性  pH值  不溶性微粒  高效液相色谱法

Key words:  esomeprazole  compatibility stability  pH  insoluble particles  HPLC

摘要:

目的 考察注射用艾司奥美拉唑钠与0.9%氯化钠注射液在不同条件下的配伍稳定性。方法 将不同浓度注射用艾司奥美拉唑钠与0.9%氯化钠注射液配伍，然后将配置好的溶液放置于室温、遮光、光照（4 500 Lx）、40℃恒温环境下，定时考察注射用艾司奥美拉唑钠的性状、pH值、不溶性微粒数和艾司奥美拉唑的含量。结果 注射用艾司奥美拉唑钠在放置过程中出现不同程度的颜色变化，变化程度：40℃恒温 > 光照 > 室温 > 遮光。在4种条件下成品液pH值均相对稳定，pH值12 h内几乎无变化，24，48 h内略微下降，40℃恒温下降较多。高浓度溶液在40℃恒温条件下于48 h不溶性微粒数超出药典规定，其他所有溶液的不溶性微粒均符合药典要求。48 h内艾司奥美拉唑的含量也有所下降，40℃恒温条件下降较多。结论 注射用艾司奥美拉唑钠在40℃恒温条件下最不稳定，遮光条件下溶液最稳定。因此建议注射用艾司奥美拉唑成品溶液保存在室温条件下，尽量避光，同时避免高温影响，低浓度溶液（0.4 mg·mL^-1）在配置后12 h内使用，高浓度溶液（1.6 mg·mL^-1）8 h内滴完。

Abstract:

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.