3种注射用盐酸表柔比星溶液的稳定性考察

 目的 考察3种盐酸表柔比星制剂（一种水针剂，两种粉针剂）配制成临床常用溶液后的稳定性。方法 采用0.9%生理盐水，将3种盐酸表柔比星制剂配制成0.4 mg·mL^-1的溶液，分别放置在不同温度，不同避光条件下，定时取样，考察各受试溶液的稳定性，包括样品外观，pH值，样品含量等。结果 3种制剂配制成溶液后在2~8 ℃条件下避光保存40 d，平均含量保留在93.76%以上。室温避光及不避光条件下，仅水针剂配制成溶液后平均含量保持在92.57%以上，另外两种粉针剂在配制成溶液后放置2~7 d，平均含量保留即下降为90%以下。结论 3种盐酸表柔比星制剂配制成溶液后在2~8 ℃条件下保存40 d以及在室温条件下放置1 d均保持稳定，水针剂在室温条件下长期保存（40 d）的稳定性明显优于两种粉针剂。

Stability Study of Epirubicin Hydrochloride Solutions for Injection Prepared From Three Different Formulations

OBJECTIVE To evaluate the stability of epirubicin hydrochloride solutions for clinical use prepared from three different formulations (one concentrated solution and two powders for injection). METHODS Epirubicin hydrochloride in three formulations was dissolved or diluted in 0.9% sodium chloride to prepare the test solutions with concentration of 0.4 mg·mL^-1. These solutions were stored at different temperatures and under different shading circumstances， and samples were collected periodically during the storage to evaluate the stability， including visual inspection， pH value and content of epirubicin. RESULTS All epirubicin solutions were stable when stored at 2-8 ℃ under dark condition for 40 d with average content of greater than 93.76%. When stored at room temperature with or without light exposure for 40 d， only the solution diluted from the concentrated water solution for injection was stable， as the average content remained above 92.57%. While the solutions prepared from the other two powders for injection were not stable， as the average content fell below 90% at room temperature after 2-7 d. CONCLUSION Epirubicin solutions prepared from three different formulations are stable when stored either at 2-8 ℃ under dark condition for 40 d or at room temperature for 24 h. The solution prepared from the concentrated water solution for injection is more stable than the solutions prepared from the two powders for injections when stored at room temperature for a long period (40 d).