注射用硝普钠溶液稳定性的考察

目的：研究注射用硝普钠配制成溶液后的稳定性，并比较药品说明书规定不同的厂家生产的药品其溶液稳定性是否有差异。方法：将注射用硝普钠按临床应用条件配制成溶液，考察在不同温度、不同避光条件下，不同放置时间硝普钠溶液的稳定性，包括溶液外观性状、pH、紫外-可见吸收光谱、硝普钠含量等。结果：在临床应用该药所用的避光条件下，在20℃或35℃时，不同厂家生产的注射用硝普钠配制成溶液后28h内是稳定的；在不用避光套且阳光直射条件下，硝普钠溶液极其不稳定，在5min内便发生变化；在应用避光套但仍有阳光直射条件下，溶液仍不稳定，硝普钠含量等90min内发生明显变化。结论：药品说明书规定不同的厂家生产的注射用硝普钠配制成溶液后，在28h内均稳定，其稳定性没有差异。临床配制硝普钠溶液时应注意严格避光，且患者在用该药静脉滴注过程中即使使用了避光套也应避免阳光直射，确保用药安全。

Study on Stability of Sodium Nitroprusside Solution for Injection

Objective： To study the stability of sodium nitroprusside （SNP） solution for injection, and make sure whether there was difference between the stability of SNP of different instructions. Method： SNP for injection was prepared into solution according to clinical use. The stability of SNP solution was studied in different temperatures and shading circumstances at different time, including appearance, pH value, ultraviolet-visible absorption spectrum and SNP content. Result： SNP solutions of different instructions were stable for 28 hours after preparation in shading circumstances at 25℃ or 35℃ . Under the direct sunshine without lightproof covering, the solution was very unstable and changed in 5 minutes. The solution was also unstable and changed in 90 minutes under direct sunshine with lightproof covering. Conclusion： There were no differences between SNP solutions from different instructions, the solutions were stable for 28 hours under the condition of clinical use. Furthermore, attention must be paid to protect from sunshine when SNP solution is prepared, and avoid direct sunshine during the process of patients＇ intervenous drop infusion even if lightproof covering is used, in order to make sure the safety of the drug use.