目的研究盐酸乌拉地尔注射液的稳定性及有效期。方法采用不同条件下的加速试验和室温留样观察法进行试验。结果活化能估算法得出,在不同温度下加速试验后,主药含量仍在标示量的90%以上。温度40℃,湿度75%条件下放置3个月后,含量无明显变化,有关物质等指标均符合规定。室温留样观察试验2年,含量不变,其他各项指标均无明显变化。结论盐酸乌拉地尔注射液稳定性较好,有效期可暂定为2年。 Objective To study the stability and expiration date of urapidil hydrochloride injection. Methods The accelerated test under different conditions and observing method at room temperature were used to carry out the experiment. Results Activation energy estimation method obtained, at different temperatures accelerated test, the main drug content is still marked amount of more than 90%. Temperature 40 ℃, humidity 75% under the conditions placed 3 months, no significant changes in the content of the relevant substances and other indicators are in line with the provisions. Observed at room temperature for 2 years, the same content, the other indicators did not change significantly. Conclusion The stability of urapidil hydrochloride injection is good, the validity period can be tentatively scheduled for 2 years.