帕瑞昔布钠冻干制剂的质量源于设计工艺开发及验证研究

Development and Validation of the Production Process of Parecoxib Sodium Freeze-dried Preparation Based on Quality by Design

目的制备帕瑞昔布钠冻干制剂,并评估验证其工艺可行性和质量可靠性。方法基于质量源于设计(QbD)方法对帕瑞昔布钠冻干制剂的制备工艺进行风险评估,确定关键步骤及关键工艺参数,明确中间体和终产品的关键质量属性(CQAs),并依此确定验证项目和可接受标准,对其进行生产工艺验证研究。结果帕瑞昔布钠冻干制剂的生产工艺符合药品生产质量管理规范(GMP)要求,中间体和终产品的检验结果符合产品质量标准。结论帕瑞昔布钠冻干制剂的生产工艺可行,产品质量可控。

OBJECTIVE To prepare parecoxib sodium freeze-dried preparation, evaluate and validate the feasibility of the pro- duction process and quality reliability of the preparation. METHODS Risk assessment of the production process of parecoxib sodium freeze-dried preparation was performed based on the method of quality by design （QbD）. The key steps and key process parameters were identified. The critical quality attributes （CQAs）of the intermediates and final product were clarified, the validation protocol and acceptable standard were accordingly developed, and the production process was validated. RESULTS The production process of parecoxib sodium freeze-dried preparation met the GMP requirements, and the intermediate and final products met the quality stand- ards. CONCLUSION The established production proeess of pareeoxib sodium freeze-dried preparation is feasible and the product quality is controllable.