香丹注射液与3种代糖溶媒配伍的稳定性研究

Compatible Stability of Xiangdan Injection and 3 Kinds of Sugar Substitute Solvent

关键词:  香丹注射液  代糖溶媒  配伍  稳定性  糖尿病用药安全

Key words:  Xiangdan injection  sugar substitute vehicle  compatibility  stability  diabetes medication safety

摘要:

目的 考察香丹注射液与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，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，制备香丹注射液与3种代糖溶媒的配伍溶液，考察配伍溶液的外观、pH值、不溶性微粒、含量测定、紫外光谱及最大吸收波长。结果 其中一批香丹注射液与转化糖电解质注射液配伍20 min后出现浑浊，其他溶液在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，pH值在正常范围内略有变化。结论 不建议香丹注射液与转化糖电解质注射液临床配伍使用，其他溶液在配伍5 h内基本稳定，建议配伍静置一段时间后再输注，以提高输液的安全性。

Abstract:

OBJECTIVE To explore the compatible stability of Xiangdan injection and 3 kinds of sugar substitute solvent (fructose injection, invert sugar injection and invert sugar electrolytes injection), and to provide reference for clinical medication of patients with diabetes. METHODS According to the maximum amount of clinical application, Xiangdan injection was prepared with 3 kinds of sugar substitute solvent. The appearance of the compatibility of solution, pH value, insoluble particles, content determination, ultraviolet spectrum and maximum absorption wavelength were measured. RESULTS One group of Xiangdan injection and invert sugar electrolyte injection after the compatibility for 20 min turned turbid. The solution properties, particulate matter, content, UV spectrum and maximum absorption wavelength had no change within 5?h after the compatibility of other solutions, and the pH changed slightly in the normal range. CONCLUSION Xiangdan injection and invert sugar electrolyte injection compatibility for clinical is not suggested. The other solutions are basically stable within 5 h after compatibility. It is suggested to stand the solution for some time after compatibility before infusion to improve transfusion safety.