Freeze drying method of azithromycin for injection

The invention provides a freeze-drying method of azithromycin for injection, which comprises the following steps: (1) mixing azithromycin with a citric acid solution and a citric acid-sodium hydroxide mixed solution in sequence, stirring for clarification, and adjusting the pH value to obtain an azi...

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Bibliographic Details
Main Authors LIU JINGPING, JI ZIZHEN, LIU QUANGUO, MAI FAREN, WU WEIZHEN, HAN YUYAN, CHEN KELING, CHEN YUZHU, WU YUHAN
Format Patent
LanguageChinese
English
Published 01.06.2021
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Summary:The invention provides a freeze-drying method of azithromycin for injection, which comprises the following steps: (1) mixing azithromycin with a citric acid solution and a citric acid-sodium hydroxide mixed solution in sequence, stirring for clarification, and adjusting the pH value to obtain an azithromycin solution before freeze-drying; (2) after low-temperature water is sprayed outside the filled liquid medicine, pre-freezing; (3) heating the temperature to -10 DEG C from -45 DEG C within 110-130 min at the vacuum degree of 18-22 Pa, keeping the temperature, increasing the vacuum degree to 28-30 Pa, keeping the temperature, recovering the vacuum degree to 20-25 Pa, and continously keeping the temperature; gradually raising the temperature from -10 DEG C to 0 DEG C within 50-70 minutes, and keeping the temperature; and (4) analyzing and drying to obtain the azithromycin freeze-dried powder injection for injection. According to the method, the high-stability azithromycin solution before freeze-drying is comb
Bibliography:Application Number: CN202011633287