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

Stability of Nitroprusside Sodium for Injection Compatibility with Solvent Multiple Factors and Levels Multicriteria

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L16(43×26)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。

OBJECTIVE To research the best compatibility program of nitroprusside sodium for injection. METHODS L16（43×26） 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 rag, dissolved in 250 mL sodium chloride injection, avoiding light, used in 26 h. CONCLUSION This scheme provides the scientific basis for the clinical medication.