Umberg Zipser LLP
Preparation method of azacitidine for injection
Disclosed is a preparation method for an azacitidine for injection, wherein each injection vial of azacitidine for injection contains 100 mg of azacitidine and 100 mg of mannitol. The preparation method comprises the steps of measuring 80% of the total volume of water for injection at a temperature of 2-6° C.; adding mannitol, and stirring to completely dissolved at a temperature of 2-6° C.; adding azacitidine, stirring to completely dissolved at a temperature of 2-6° C. to obtain an azacitidine solution for injection; filling each injection vial with 23 ml azacitidine solution for injection after filtration; freeze-drying at a preset temperature; and stoppering, capping and packaging after nitrogen filling. The preparation method has the advantages of a simple process, low energy consumption, high production efficiency and stable product quality.
Zhejiang Huahai Pharmaceutical Co., Ltd.
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A61K A61K A61P F26B A61K A61K A61P A61K A61P
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Zhiyun Libin Jiening Xinshi Hao Xiangjie
Wang Hu Liu Wang Chen Shi