注射用硝普钠在不同浓度及避光条件下稳定性研究

目的考察注射用硝普钠在不同浓度梯度,2种不同避光条件下稳定性,为临床合理用药提供依据。方法将注射用硝普钠按临床应用浓度配成6组溶液,考察在不同避光条件,不同放置时间硝普钠的稳定性,包括溶液澄明度、可见异物、颜色、pH、含量变化。结果在避光条件下,6组不同浓度硝普钠溶液28h内澄明度均符合规定,没发现可见异物,颜色无可见变化,高浓度溶液(1500μg·mL^-1)含量下降速度最慢;在没有避光条件下,硝普钠溶液8h颜色可见变化,低浓度溶液(50μg·mL^-1)10h含量下降速度快。结论浓度为1000μg·mL^-1的注射用硝普钠在铝箔包裹的白色注射器中放置28h稳定,适合重症医学科临床实际应用。

Compatible Stability of Sodium Nitroprusside for Injection(SNP)in differ-ent Concentration Gradient and Environment

OBJECTIVE To evaluate the compatible stability of sodium nitroprusside for injection(SNP)in different concentration gradient and in two kinds of environment.METHODS Six groups of SNP was respectively prepared according to the concentration of clinical use.The stability of SNP solution was studied in different environment with different storing time,and the assessment indices included the appearance,insoluble particles,pH value and SNP content.RESULTS Six groups SNP of clarity all meet the requirements,no visible foreign body was found,no change in colour,the rate of decline was slowest in photophobic condition.SNP of without lightproof,the solutions of color were changed in 8h,the content was falling fast in 10h.CONCLUSION High concentration of SNP(1000μg·mL^-1)were stable within 28h in photophobic condition.