注射用泮托拉唑钠制备工艺的研究

Study on the Preparation of Pantoprazole Sodium for Injection

目的:建立冻干工艺技术制备注射用泮托拉唑钠的工艺方法。方法:以冻干粉针制剂的性状、p H值、澄明度、含量和有关物质等为考察指标,采用单因素实验法,对处方中金属离子络合剂、支架剂、支架剂用量、p H范围、活性炭用量及冻干过程关键工艺参数进行筛选和优化,并最终根据实验结果确定最优处方和冻干工艺。结果:经过优选的处方和合理筛选的冻干工艺可以准确稳定的对泮托拉唑钠的含量、成型性、溶解性等质量指标进行测定。结论:以上处方设计合理,工艺路线可行,本文的研究为注射用泮托拉唑钠的处方及工艺筛选提供了依据。

Objective: A method for preparing pantoprazole sodium for injection by freeze-drying process was established. Methods: In this paper, the traits, pH value, clarity, content, and related substances of freeze-dried powder preparations were used as indicators. Single-factor experiments, and metal ion complexing agents and stents in prescriptions were used. The dosage, the amount of the stent, the pH range, the amount of activated carbon, and the key process parameters of the lyophilization process were selected and optimized. Finally, the optimal formulation and lyophilization process were determined based on the experimental results. Results: The optimum prescription and reasonable selection of freeze-drying process can accurately and steadily determine the content, formability and solubility of pantoprazole sodium. Conclusion: The above prescription is reasonable in design and feasible in process. This study provides a basis for the prescription and process screening of pantoprazole sodium for injection.