摘要
目的基于质量源于设计(QbD)的理念,对胞磷胆碱钠注射液的生产工艺进行优化,确保产品安全、有效和质量可控。方法基于QbD理念,确定胞磷胆碱钠注射液的质量概况(QTPP)、关键质量属性(CQA),结合对处方工艺变量的风险评估,对胞磷胆碱钠注射液进行配液、灭菌工艺研究,筛选并确定最佳工艺条件。结果通过控制配液投料前注射用水温度40℃以下,调节pH值在6.2~8.0之间,采用终端灭菌工艺121℃/12 min,控制灭菌升温时间小于15 min,降温时间小于10 min,制备的产品质量符合要求。结论优化后工艺参数,可实现胞磷胆碱钠注射液终端灭菌,提高产品无菌水平,提高临床用药安全性。
Objective To optimize the production process of Citicoline Sodium Injection based on quality by design(QbD),and ensure product safety,effectiveness and quality control.Methods Based on the concept of QbD,the quality target product profile(QTPP)and the critical quality attributes(CQA)of Citicoline Sodium Injection were determined,and combined with the risk assessment of the process variables,the liquid dispensing and sterilization process of Citicoline Sodium Injection were studied,and the optimal process conditions were screened and determined.Results By controlling the temperature of water for injection below 40℃,adjusting the pH value between 6.2 and 8.0,using the terminal sterilization process 121℃/12 min,controlling the sterilization heating time less than 15 min,cooling time less than 10 min,the quality of the prepared products met the requirements.Conclusion Using the optimized process parameters,the terminal sterilization of Citicoline Sodium Injection can be realized,the sterility level of the product can be improved,and the clinical drug safety can be improved.
作者
黄翠苹
王玉青
张娜
HUANG Cuiping;WANG Yuqing;ZHANG Na(China Resources Double-Crane Limin Pharmaceutical<Jinan>Co.,Ltd.,Jinan 250200,China)
出处
《药学研究》
CAS
2024年第5期444-448,486,共6页
Journal of Pharmaceutical Research
