3种中药注射剂与2种代糖溶媒配伍稳定性研究

Stability Study on Compatibility of Three Traditional Chinese Medicine Injections and Two Kinds of Sugar Substitute Solvents

目的:考察3种中药注射剂(参麦注射液、生脉注射液、丹参注射液)与2种代糖溶媒(果糖注射液、木糖醇注射液)配伍溶液的稳定性,为糖尿病患者合理应用中药注射剂提供参考。方法:依据中药注射剂说明书建议最大剂量与代糖溶媒最小量分别配制试验溶液,考察外观、pH、紫外光谱和最大吸收波长、不溶性微粒、热源、渗透压等,测定指标成分含量。结果:3种中药注射剂(参麦注射液、生脉注射液、丹参注射液)与2种代糖溶媒(果糖注射液、木糖醇注射液)配伍后0~6 h内,溶液无沉降现象,颜色、pH值、紫外吸收波长、不溶性微粒、指标成分含量等无显著变化,热原和渗透压符合要求。结论:果糖和木糖醇注射液可以作为参麦注射液、生脉注射液、丹参注射液的代糖溶媒。

Objective:The stability of the compatible solutions of three kinds of TCM injections(Shenmai injection,Shengmai injection,Danshen injection)and two kinds of saccharides(Fructose injection,Xylitol injection)was investigated to provide reference for the rational use of TCM injections in diabetics.Methods:The test solution was prepared according to the maximum dose and the minimum amount of saccharide solvent suggested in the instruction of TCM injection,and the appearance,pH,UV spectrum,maximum absorption wavelength,insoluble particles,heat source,osmotic pressure,etc.,were investigated to determine the content of indicator components.Results:The solution has no settlement phenomenon,and the color,pH value,UV absorption wavelength,insoluble particles and index component content have no significant change within 0 to 6 h after mixing three kinds of traditional Chinese medicine injection with two kinds of saccharides.Conclusion:Fructose and Xylitol injection can be used as sugar substitute solvent for Shenmai injection,Shengmai injection and Danshen injection.