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

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.