注射用炎琥宁冻干粉针剂生产质量评估探索

Production Quality Evaluation Exploration for Potassium Sodium Dehydroandroan Drographolide Succinate Booster Injection

目的:针对近三年内注射用炎琥宁(规格200 mg)冻干粉针剂型生产质量情况分析,探讨影响制品冻干剂生产的相关影响因素。方法:通过对回顾期限内生产注射用炎琥宁质量情况进行统计和趋势的全面分析。结论:确认在现行的生产工艺及控制条件下产品的安全性、有效性、稳定性及质量符合标准的水平,为持续改进产品质量和降低质量风险提供依据。

Objective： Qualities analysis was performed for Potassium Sodium De-hydroandroan Drographolide Succinate （PSDDS, specifications 200 mg） producing needle dosage form production in view of the last three years. Methods： PSDDS quality statistics and trends of comprehensive analysis were explored on the review related influence factors affecting products freeze-dried agent within the time limit. Conclusion： The current condition of the production process was confirmed, and product safety, efficacy, stability and quality standard level were control. The quality risk was reduced and product quality was improved continuously by this process.