盐酸雷莫司琼注射液与地塞米松磷酸钠注射液配伍稳定性考察

目的:考察盐酸雷莫司琼注射液与地塞米松磷酸钠注射液配伍后的稳定性。方法:建立高效液相色谱法测定在4、25、37℃避光和光照条件下该配伍液(0.9%氯化钠注射液为溶媒)中雷莫司琼的含量;另对该配伍液的pH值、不溶性微粒进行考察,并做外观检查。结果:盐酸雷莫司琼注射液与地塞米松磷酸钠注射液配伍后,避光条件下48 h内配伍液的pH值、主药百分含量相对0 h均无明显变化,所有条件下外观检查均合格,不溶性微粒均符合《中国药典》(2010年版)规定;而在光照条件下,随着温度的升高,放置时间的延长,配伍液的pH值、主药含量均有所下降,不溶性微粒则无变化。结论:盐酸雷莫司琼注射液与地塞米松磷酸钠注射液在0.9%氯化钠注射液中配伍,于避光条件下可稳定共存,且光照是影响其稳定性的主要因素。

Compatibility Stability of Ramosetron Hydrochloride Injection with Dexamethasone Sodium Phosphate Injection

OBJECTIVE： To investigate the stability of Ramosetron hydrochloride injection mixed with Dexamethasone sodium phosphate injection. METHODS： HPLC method was adopted to determine the content of ramosetron hydrochloride in mixture （in 0.9% Sodium chloride injection） at 4℃, 25℃, 37℃ under dark and light, pH value, insoluble particles and visual inspection were detected. RESULTS： After Ramosetron hydrochloride injection mixed with Dexamethasone sodium phosphate injection, the pH and the relative percentages of the main drug didn＇t changed significantly under dark conditions within 48 h, compared with 0 h. Visual inspection were satisfactory under all conditions, insoluble particles were in line with Chinese Pharmacopoeia （2010 edition）. In the light conditions, as the temperature raised, the extension of storage time, the pH and the content of main drug had declined, while insoluble particles did not change. CONCLUSIONS： Ramosetron hydrochloride injection and Dexamethasone sodium phosphate injection in 0.9% Sodium chloride injection are stable under dark conditions. The light is the main influential factor of the stability.