双室袋丙氨酰谷氨酰胺氨基酸(18)注射液与市售产品的质量对比研究

Quality comparison of double-compartment bag of alanyl glutamine and amino acid( 18) injection and commercial products

目的:对3批双室袋丙氨酰谷氨酰胺氨基酸(18)注射液混合前各腔室与1批市售原研单瓶的丙氨酰谷氨酰胺注射液、单瓶的复方氨基酸注射液(18AA)进行质量比较,并对3批双室袋混合液与1批原研单瓶按比例配制混合液进行质量比较。方法:参考《中华人民共和国药典》2015年版及企业自拟标准,对混合前丙氨酰谷氨酰胺注射液的性状、pH值、吸光度、氨、有关物质、含量及对复方氨基酸注射液(18AA)的性状、p H值、透光率、亚硫酸氢钠、有关物质、含量等指标进行比较,并对混合后液体的性状、pH值、渗透压摩尔浓度等进行比较。结果:双室袋混合前各腔室与原研单瓶关键指标质量基本一致,但双室袋产品提高了复方氨基酸注射液(18AA)质量标准,增订了有关物质检测项目。同时,双室袋填补了市售产品空白,建立了混合后溶液质量标准,可更好确保临床用药安全。结论:通过质量研究证明,双室袋内在质量与原研产品一致,但双室袋产品提高了复方氨基酸注射液(18AA)质量标准,且填补市售产品空白,建立了混合后溶液质量标准,可更好确保临床用药安全,值得临床推广使用。

Objective:To compare the quality of three batches of double-compartment bag of Alanyl Glutamine and Amino Acid(18)injection before mixing with a batch of original single-bottle alanyl-glutamine injection and a single-bottle compound amino acid injection(18 AA),To compare 3 batches of double-compartment bag mixture with 1 batch of Proportionate mixture of single bottle.Methods:According to the 2015 edition of the Chinese Pharmacopoeia and the enterprise’s own standards,Before mixing,the properties,pH value,absorbance,ammonia,related substances,content of alanyl glutamine injection were compared,and the properties,pH value,transmittance,sodium bisulfite,related substances and content of compound amino acid injection(18 AA)were compared.After mixing,The properties,pH value and osmotic pressure molar concentration were compared.Results:Before mixing,the quality of each compartment was basically the same as that of the original single bottle,but the quality standard of compound amino acid injection(18 AA)of double-compartment bag was improved andthe related substance detection items were updated.At the same time,the double-compartment bag fills the gap of market products and establishes the quality standard of mixed solution,which can better ensure the safety of clinical medication.Conclusion:The quality study in this paper proves that the internal quality of the double-compartment bag is the same as that of the original product,but the double-compartment bag product improves the quality standard of compound amino acid injection(18 AA),fills in the blank of the market products,and establishes the quality standard of mixed solution,which can better ensure the safety of clinical medication and is worth popularizing in clinic.