复方醋酸钠林格注射液制备工艺研究  

Study on the Preparation Process of Compound Sodium Acetate Ringer’s Injection

作　　者：李恩澳 丁极武 陆荣政 刘荣华[1] LI Enao;DING Jiwu;LU Rongzheng;LIU Ronghua(College of Pharmacy,Jiangxi University of Chinese Medicine,Nanchang 330004,China;Nanjing Zenkom Pharmaceutical CO.,Ltd.,Nanjing 210000,China)

机构地区：[1]江西中医药大学药学院,江西南昌330004 [2]南京正科医药股份有限公司,江苏南京210000

出　　处：《山东化工》2024年第20期40-42,47,共4页Shandong Chemical Industry

摘　　要：目的:优选复方醋酸钠林格注射液的制备工艺。方法:以注射液的性状、pH值、5-羟甲基糠醛、葡萄糖含量等作为指标,采用单因素考察法对pH值、溶解温度、滤膜材质、灭菌工艺以及包装形式进行考察。结果:最佳工艺条件为80℃溶解葡萄糖酸钙,注射液pH值调节至6.1,在非PVC三层共挤膜软袋基础上,加装外阻隔袋121℃热压灭菌15 min,即得复方醋酸钠林格注射液。结论:优选的制备工艺可行,制得的产品质量稳定,可为复方醋酸钠林格注射液的工业化开发提供基础。Objective:To optimize the preparation technology of Compound Sodium Acetate Ringer’s Injection.Methods:The character,pH,5-hydroxymethyl furfural and glucose content of the injection were used as indexes,the pH value,solution temperature,membrane material,sterilization process and packaging form were investigated by single factor method.Results:The optimal process was 80℃dissolved calcium gluconate,pH of injection was adjusted to 6.1,and an external barrier bag of 121℃was added to the non-PVC three-layer co-extruded film soft bag to sterilize the injection for 15 min,the Compound Sodium Acetate Ringer’s Injection is obtained.Conclusion:The optimized preparation technology is feasible and the product quality is stable,which can provide a basis for the industrial development of Compound Sodium Acetate Ringer’s Injection.

关 键 词：复方醋酸钠林格注射液 制备工艺 单因素试验 

分 类 号：TQ469[化学工程—制药化工] R944.1[医药卫生—药剂学]