辐照环境中盐酸氨溴索注射液的稳定性研究

Study on the stability of ambroxol hydrochloride injection under irradiation environment

为考察盐酸氨溴索注射液在辐照环境中的稳定性,将注射液分别经60Coγ射线(吸收剂量2、4、8、16、26、34 k Gy)辐照、光照(4 500±500)lx、紫外线(UV)辐照、高温(40、60℃)处理10 d,以颜色、澄明度、盐酸氨溴索浓度、有关物质为指标,考察其稳定性。结果表明:注射液在γ射线辐照、光照、UV、60℃高温环境中盐酸氨溴索浓度显著下降(p<0.01);且注射液经γ射线辐照、UV辐照后降解生成多种极性较大的未知物质,颜色变为红棕色;盐酸氨溴索浓度在各种处理后的储存过程中仍会持续下降。研究结果表明,盐酸氨溴索注射液在γ射线辐照、UV环境中极不稳定,且在两种环境中产生的效应相近。

Ambroxol hydrochloride injections were irradiated with 60 Co γ-rays at different absorbed doses（2, 4, 8, 16, 26, and 34 k Gy）, exposed to light（4 500±500） lx, and ultraviolet, and stored under high temperature（40, 60 ℃） for 10 d. The color, clarity, drug concentration, and related substances of injection were inspected. It was found that injection drug concentration significantly decreased under γ-irradiation, light exposure, UV radiation, and high temperature（60 ℃）（p0.01）. The injection solution color changed to red brown due to the generation of unknown polarization-related substances under irradiation and UV environment, and drug content continued to decrease upon storage. It is shown that ambroxol hydrochloride injection is extremely unstable and is similarly affected under irradiation and UV environment.