多因素多水平多指标考察注射用硝普钠与溶媒配伍的稳定性.pdf

·临 床 · 多因素多水平多指标考察注射用硝普钠与溶媒配伍的稳定性  林小明，韦宝含，曾毅，韦平原，梁汉钦，谢伟乾，陈明忠(广西贵港市人民医院，广西 贵港 537100) 摘要：目的 研究注射用硝普钠的最佳配伍方案。方法 选择温度、溶媒、溶媒用量、光照、时间 5 个因影响因素，采 用L 3 6 16(4 ×2 ) 因素水平表，用高效液相色谱法对各样品溶液中的硝普钠含量进行测定，用GWF-5J 型微粒分析仪对各样 品溶液中的微粒含量进行测定，用pHS-2C 型精密酸度计对各样品溶液中的pH 值进行测定，并结合综合评分对注射用硝 普钠的最佳配伍方案进行优选研究。结果 最佳配伍方案为硝普钠50 mg ，溶于250 mL 氯化钠注射液中，避光下，在26 h 内用完。结论 该方案为临床用药提供了科学依据。 关键词：硝普钠；高效液相色谱法；配伍 中图分类号：R969.3 文献标志码：B 文章编号：1007-7693(2014)07-0878-04 DOI: 10.13748/ki.issn1007-7693.2014.07.029 Stability of Nitroprusside Sodium for Injection Compatibility with Solvent Multiple Factors and Levels Multicriteria LIN Xiaoming, WEI Baohan, ZENG Yi, WEI Pingyuan, LIANG Hanqin, XIE Weiqian, CHEN Mingzhong (Peoples Hospital of Guigang City, Guigang 537100, China) ABSTRACT: OBJECTIVE To research the best compatibility program of nitroprusside sodium for injection. METHODS 3 6 L16(4 ×2 ) of orthogonal design was used with five factors: temperature, solvent, solvent dosage, illumination and time; the content of sodium nitroprusside was detected by HPLC; the insoluble particles were observed by a GWF-5J type particle analyzer; the pH were observed by a pHS-2C precision acidity meter; the integrated brading method was used in selecting the optinum process. RESULTS The optinized processing was sodium nitroprusside 50 mg, dissolved in 250 mL sodium chloride injection, avoiding light, used in 26 h. CONCLUSION This scheme provides the scientific basis for the clinical medication. KEY WORDS: sodium nitroprusside; HPLC; combination 注射用硝普钠(sodium nitroprusside，SNP)是一 个水平，其余各因素选择 2 个水平，并考察 A ×D 交互作用，因素水平表见表 1。选用 L 3 6 种速效和短时作用的血管扩张药，临床上用于