奥硝唑氯化钠注射液处方筛选及初步稳定性研究

Ornidazole and Sodium Chloride Injection Prescription Screening and Preliminary Stability Study

目的:筛选奥硝唑氯化钠注射液的制备工艺并进行初步稳定性研究。方法:对影响制备工艺的关键控制点活性炭用量、pH值及灭菌参数及稳定性进行研究,并以药物成分含量、有关物质等项目为评价指标对制备工艺进行评价。结果:通过科学合理评价筛选出了奥硝唑氯化钠注射液的制备工艺。结论:所筛选出的制备工艺能够制备出质量完全符合标准的产品。

Objective： Through the scientific method, screening of Ornidazole sodium chloride injection preparation technology and carries on the preliminary stability study. Methods ： We had studied the influence of preparation technology key control point activated carbon dosage, pH value and the sterilization parameters and stability are studied, and the ingredient content and related substances such as project as evaluation index to evaluate preparation technology. Results： The evaluation of scientific and rational screening Ornidazole sodium chloride injection preparation technology. Conclusion ： the preparation process can be screened out were completely conform to the standards of product quality.