复方氨基酸(19)注射液配制的全静脉营养液稳定性研究及临床应用

Stability and clinical application of total nutrient admixture mixed with compound amino acids(19) injection

目的考察由新型复方氨基酸(19)丙谷二肽注射液(创伤用)[以下简称复方氨基酸(19)注射液]配制的全静脉营养液的稳定性及应用于人体的安全性。方法复方氨基酸(19)注射液配制的全静脉营养液在4、25、40℃条件下存放48h,按中国药典2010年版二部附录要求,观察其外观、不溶性微粒、脂肪乳粒粒径大小和分布、pH值、渗透压的变化,并检查细菌内毒素。通过伦理委员会批准该营养液用于6例健康受试者,考察其应用于人体的安全性、耐受性。结果观察期内,复方氨基酸(19)注射液配制的全静脉营养液在4、25、40℃条件下不溶性微粒、脂肪乳粒粒径大小和分布、pH值、渗透压均在药典规定的范围内,40℃时外观略有变化。无菌试验和细茵内毒素检查的结果显示,该全静脉营养液无菌、无细菌内毒素。6例健康受试者可安全耐受该全静脉营养液。结论复方氨基酸(19)注射液配制的全静脉营养液在4、25、40℃条件下存放24h符合中国药典静脉用注射乳状液的质量要求,应用于人体是安全可耐受的。

Objective To investigate the stability and safety of total nutrient admixture with new type compound amino acids（19） and N（2）-L-alany-L-glutamine injection（for wounds）.Methods Total nutrient admixture with compound amino acids（19） injection was stored at 4,25,and 40 ℃ for 48 h to observe the appearance,insoluble particle,particle size/distribution,pH value,and osmotic pressure.According to the methods in Chinese pharmacopoeia（Edition 2010） appendix,bacterial endotoxin test and sterility test were used.Through the approval of the ethics committee,6 healthy volunteers were selected to investigate the safety and tolerance of total nutrient admixture.Results In the observation period,the insoluble particle,particle size/distribution,pH value,and osmotic pressure of the total nutrient admixture with compound amino acids（19）injection at 4,25,and 40 ℃ conformed to the rules of Chinese Pharmacopoeia except for the appearance.There was no bacterial endotoxin and microorganism.It was safe for the 6 healthy volunteers.Conclusion At 4,25,and 40 ℃,total nutrient admixture with compound amino acids（19） injection is stable,which accords with all requirements for intravenous infusion.