丹参注射液与3种代糖溶媒配伍的稳定性研究

Stability study on compatibility of Danshen injection and three kinds of sugar substitute solvents

目的：考察丹参注射液与3种代糖溶媒（果糖注射液、转化糖注射液和转化糖电解质注射液）配伍的稳定性,旨在为糖尿病患者的临床用药提供参考。方法：按临床用药的最大使用量（20 m L·次-1）,制备丹参注射液与3种代糖溶媒（果糖注射液、转化糖注射液和转化糖电解质注射液）的配伍溶液,考察配伍溶液的外观、p H、不溶性微粒、含量测定、紫外光谱及最大吸收波长。结果：在5 h内,溶液性状、不溶性微粒、含量、紫外光谱及最大吸收波长均无显著变化,p H在正常范围（3.5~5.5）内略有变化,且1~2 h内各项数据变化最小,最为稳定。结论：丹参注射液与3种代糖溶媒配伍后,溶液在5 h内基本稳定,建议配伍静置1 h后再输注,以提高输液的安全性。

Objective：To investigate the compatibility stability of Danshen injection and three sugar substitute solvents （fructose injection, invert sugar injection and invert sugar electrolyte injection）to guide rational drug use in diabetic patients. Methods： The compatible solutions of Danshen injection and three kinds of sugar substitute solvents （fructose injection ,invert sugar injection and invert sugar and electrolytes injection）were prepared at the maximum medication amount of 20 mL to investigate the appearance, pH, insoluble particles, content, ultraviolet spectrum and the maximum absorbance wavelength of the compatible solution. Results：Within 5 hours, there were no significant changes within the appearance character, insoluble particles, content, ultraviolent spectrum or the maximum wave- length. The value of pH showed a slight change in the normal range （ 3.5 - 5.5 ）. Each index had no significant changes in 1 -2 hours, indicating the prepared solvent was stable. Conclusion：The solution was basically stable within 5 hours after compatibility of Dashen injection and three sugar substitute solvents. It is suggested to stand the compatible solution for 1 hour before infusion to improve transfusion safety.