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目的:研究不同光照、温度条件下盐酸美沙酮口服液的稳定性。方法:采用高效液相色谱法测定盐酸美沙酮口服液中盐酸美沙酮的含量,考察光照、温度,加速实验和长期留样实验对其稳定性的影响。结果:盐酸美沙酮口服液对强光照射敏感,对高温稳定性较好。结论:盐酸美沙酮口服液在生产和贮藏过程在室温条件下稳定,注意避光保存。
Objective: To study the stability of methadone hydrochloride oral solution under different light and temperature conditions. Methods: The contents of methadone hydrochloride in oral solution of methadone hydrochloride were determined by high performance liquid chromatography (HPLC). The effects of light, temperature, accelerated and long-term sample retention on the stability were investigated. Results: Methadone hydrochloride oral solution was sensitive to strong light irradiation and had good stability to high temperature. Conclusion: The methadone hydrochloride oral solution is stable at room temperature during production and storage, and should be kept out of the light.