泮托拉唑钠冻干注射剂的研制

目的 :制备泮托拉唑钠冻干针剂。方法 :结合制剂的色泽、外观、pH值、澄明度及与输液间配伍变化 ,单因素筛选支架剂的种类 ,采用高效液相色谱法测定主药的含量及有关物质。结果 :选用甘露醇作为支架剂 ,依地酸二钠作为金属螯合剂 ,以NaOH调节 pH值于9 5～11 5之间 ,泮托拉唑钠检测浓度在12 0～60 0μg/ml范围内线性关系良好 (r=0 9998) ,平均回收率为100.26 % ,RSD=1 14 % (n=9) ,标示量为98.6 %。结论 :制备工艺合理 ,质量控制方法简便、易行 ,制备的冻干针剂能满足制剂学及临床需要。

Preparation of Pantoprazole Sodium Freeze-dried Injection

OBJECTIVE:To investigate the preparation technic of pantoprazole sodium freeze-dried injection.METHO_ DS:The kinds of auxiliary were screened based on the color and luster,external appearance,pH value,clarity and the compatible stability of pantoprazole sodium lyphilization injection with other infusion solutions;the content and other associated material of freeze-dried injection were determined by HPLC method.RESULTS:With Mannitol being freeze-dried powder supporting agent and disodium edetate being metal ion chelation agent and pH value at9.5～11.5adjusted by NaOH,the calibration curves of the prepared freeze-dried injection was linear within12.0～60.0μg/ml in concentration(r=0.9998),the average recovery rate of which at100.26%,RSD=1.14%(n=9),the labeled amount at98.6%.CONCLUSION:The preparation technics is appropriate and the quality control method is simple and feasible.And the prepared freeze-dried injection is able to meet both the pharmaceutical and clinical requirements.