摘要
目的制备注射用左泮托拉唑钠，并制定其质量控制方法和相关标准。方法结合制剂的外观和稳定性，筛选冻干支持剂的种类和用量及依地酸二钠的用量，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2％（W／V）甘露醇作为冻干支持剂，0．1％（W／V）依地酸二钠作为金属络合剂，左泮托拉唑钠在36～84μg·mL^-1浓度范围内线性关系良好，平均回收率为99．54％，RSD=1．48％（n=9）。结论该制备工艺合理，质量控制方法简便、易行，制备的注射用冻干灭菌粉末能够满足制剂学及临床需要。
Objective To prepare and control the quality of （L）-pantoprazole sodium for injection. Methods The kinds and quantity of frozen-dried supporting agent were screened based on the external apperance and stability, and the quantity of disodium edetate was screened according to the stability. The content of （L）-pantoprazole sodium and related substances were determined by HPLC. Results Mannitol 2% （W/V） and 0.1% （W/V） disodium edetate were used as frozen-dried supporting agent and metal ion chelation agent respectively. A good linear relationship was obtained in the range of 36 - 84 μg·mL^-1, the average recovery of sample was 99.54%, and RSD was 1.48% （n = 9）. Conclusion The preparation technics is appropriate and the quality control method is simple and feasible. The prepared frozen-dried injection is able to meet both the pharmaceutical and clinical requirements.
出处
《医药导报》
CAS
2006年第3期236-238,共3页
Herald of Medicine
