首页|复方醋酸钠林格注射液制备工艺研究

复方醋酸钠林格注射液制备工艺研究

扫码查看
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。
Study on the Preparation Process of Compound Sodium Acetate Ringer's Injection
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-P VC 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.

compound sodium acetate ringer's injectionpreparation processsingle factor test

李恩澳、丁极武、陆荣政、刘荣华

展开 >

江西中医药大学药学院,江西南昌 330004

南京正科医药股份有限公司,江苏南京 210000

复方醋酸钠林格注射液 制备工艺 单因素试验

2024

山东化工
山东省化工研究院 山东省化工信息中心

山东化工

影响因子:0.249
ISSN:1008-021X
年,卷(期):2024.53(20)