DOE法优化肺表面活性物质混悬剂的工艺参数  

Optimization of Process Parameters for Pulmonary Surfactant Suspension by the DOE Method

作　　者：许俊博 赵海英 陆文超 寇同欣 刘宁 XU Junbo;ZHAO Haiying;LU Wenchao;KOU Tongxin;LIU Ning(China Resources Double-Crane Pharmaceutical Co.,Ltd.,Beijing 100120)

机构地区：[1]华润双鹤药业股份有限公司,北京100120

出　　处：《中国医药工业杂志》2025年第3期360-364,共5页Chinese Journal of Pharmaceuticals

摘　　要：为了制备符合质量标准的合成肺表面活性物质混悬剂,该研究采用实验设计(DOE)方法对工艺参数进行优化。以产品关键质量属性中的粒度和表面活性作为主要考察指标,运用响应面法优化配制温度、搅拌转速、分散时间等工艺参数。最终确定的优化工艺参数为:分散温度40~42℃、搅拌转速500~600 r/min、搅拌时间3~5 min。照优化工艺参数制备的样品均符合质量要求,表明该优化工艺稳定、可靠,为合成肺表面活性物质制剂的生产提供了技术支持。In order to prepare a synthetic pulmonary surfactant suspension that meets quality standards,this study employed Design of Experiment(DOE)to optimize process parameters.The particle size and surface activity,which are key quality attributes of the product,were used as the main evaluation indicators.The response surface methodology was adopted to optimize process parameters such as dispersion temperature,stirring speed,and dispersion time.The optimized process parameters were determined as follows:dissolution temperature of 40–42℃,stirring speed of 500–600 r/min,and stirring time of 3–5 min.The samples prepared with the optimized process all met the quality requirements.It indicated that the optimized process were stable and reliable,providing a technical support for the production of synthetic pulmonary surfactant preparations.

关 键 词：合成肺表面活性物质 混悬剂 工艺优化 呼吸窘迫综合征 

分 类 号：R974[医药卫生—药品] R944.16[医药卫生—药学]