碳酸氢钠林格注射液制备工艺及包装系统研究  

Study on the Preparation Process and Packaging System of Sodium Bicarbonate Ringer's Injection

作　　者：魏春燕 徐凡 张雯雯 刘任 WEI Chun-yan;XU Fan;ZHANG Wen-wen;LIU Ren(Jiangsu Chia Tai Fenghai Pharmaceutical Co.,Ltd.,Yancheng 224100,China)

机构地区：[1]江苏正大丰海制药有限公司,江苏盐城224100

出　　处：《海峡药学》2024年第8期3-6,共4页Strait Pharmaceutical Journal

摘　　要：目的通过试验确定碳酸氢钠林格注射液的处方、工艺参数和包装系统。方法对枸橼酸用量、工艺中的pH条件、灭菌条件、包装系统等进行筛选。结果按照筛选出的处方、工艺参数、包装系统,可生产出符合质量标准的产品。结论按确定的处方工艺生产碳酸氢钠林格注射液,工艺稳定,便于操作,产品质量安全、可控。OBJECTIVE To determine the prescription,process parameters and packaging system of sodium bicasbonate Ringer's injection through experiments.METHODS The dosage of citric acid,pH conditions in the process,sterilization conditions and packaging system were screened.RESULTS According to the selected prescription,process parameters and packaging system,the products meeting the quality standards can be produced.CONCLUSION The production of sodium bicarbonate Ringer's injection according to the determined prescription process is stable,easy to operate,and the product quality is safe and controllable.

关 键 词：碳酸氢钠 林格 注射液 处方 工艺 

分 类 号：R94[医药卫生—药剂学]