Preparation of Pantoprazole Sodium Freeze-dried Injection
- VernacularTitle:泮托拉唑钠冻干注射剂的研制
- Author:
Xiaohui WANG
;
Botao YU
;
Yunping JIANG
;
Weihua JIN
;
Hua CHEN
- Publication Type:Journal Article
- Keywords:
Pantoprazole sodium;
HPLC;
Freeze-dried injection;
Preparation
- From:
China Pharmacy
1991;0(02):-
- CountryChina
- Language:Chinese
-
Abstract:
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 within12.0～60.0?g/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.
