盐酸氨溴索注射液与全肠外营养液的配伍稳定性考察

Study on compatible stability of ambroxol hydrochloride injection mixed with total parenteral nutrition

目的:考察盐酸氨溴索注射液与全肠外营养液的配伍稳定性。方法:按照无菌操作规程配制盐酸氨溴索注射液与全肠外营养液的配伍液后,考察其在室温下放置0、2、4、6、8、10、24 h后的微生物限度、外观,同时采用高效液相色谱法测定各时间点盐酸氨溴索的含量。结果:24 h内配伍液无菌落发育,外观无显著性变化,且盐酸氨溴索在全肠外营养液中的含量也未发生变化。结论:24 h内室温条件下盐酸氨溴索注射液在全肠外营养液中稳定。

Objective:To investigate the compatible stability of ambroxol hydrochloride injection mixed with total parenteral nutrition(TPN).Methods:Ambroxol hydrochloride injection was mixed with TPN according to sterile operation procedure.The microbial limit and appearance at room temperature were investigated at 0,2,4,6,8,10 and 24 h.The content of ambroxol hydrochloride was determined by HPLC.Results:Within 24 h,no bacterial colony was found in the mixture.There was no significant change in the appearance.No change was observed in the content of ambroxol hydrochloride in TPN.Conclusion:At room temperature,ambroxol hydrochloride in TPN is stable within 24 h.