目的:观察不同温度下,50 ml注射器中盐酸氢吗啡酮注射液、盐酸吗啡注射液的稳定性.方法:分别配置盐酸氢吗啡酮终浓度为0.05 mg/ml、盐酸吗啡终浓度为0.25 mg/ml的混合溶液,所得混合溶液分为两组,再分别储存于25℃、37℃环境下,第0、1、3、5、7、9、11、13、15天分别取样,采用高效液相色谱法测定各容器中盐酸氢吗啡酮和盐酸吗啡浓度.结果:25℃条件下,第7天吗啡浓度明显下降,仅保留初始浓度的91.91%;而盐酸氢吗啡酮浓度保留初始浓度的98.49%.37℃条件下,吗啡浓度在第7天时也出现明显的下降,保留初始浓度的89.35%;而盐酸氢吗啡酮浓度直到第13天时浓度依然占初始浓度的95%以上.结论:应用注射器作为容器时, 25℃、37℃条件下盐酸氢吗啡酮的药物浓度稳定性均较好,药物有效期可达10天以上.%Objective: To evaluate the stability of Hydromorphone and Morphine in the 50 ml syringe under the condition of 25℃ and 37℃. Methods: The mixed solution of hydromorphone (0.05 mg/ml) and morphine (0.25 mg/ml) were prepared, and then both were stored at 25℃ and 37℃,respectively. Samples were collected at 0, 1, 3, 5, 7, 9, 11, 13 and 15 days from the syringes and analyzed by high performance liquid chromatography (HPLC) for concentration of hydromorphone and morphine respectively. Results: The concentration of mor-phine decreased significantly at the seventh day at 25℃, leaving only 91.91% of the initial concentration, while the hydromorphone concentration remained 98.49% of the initial concentration. Under the condition of 37℃, the concentration of morphine also decreased obviously at the seventh day, remained 89.35% of the initial con-centration; while the hydromorphone concentration still accounted for more than 95% of the initial concentration until the thirteenth day. Conclusion: The stability of the hydromorphone at both 25℃ and 37℃ can keep well and be effective more than 10 days when the syringe is used as a container.
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