PREPARATION METHOD FOR VIDARABINE MONOPHOSPHATE FREEZE-DRIED POWDER INJECTION

The present invention relates to the technical field of drug preparation, and provides a preparation method of a vidarabine monophosphate freeze-dried powder injection, comprising: taking water for injection, adjusting the pH value thereof to 8.0-8.5, adding vidarabine monophosphate for dissolving,...

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Bibliographische Detailangaben
Hauptverfasser: WANG, Jin Yu, PAN, Shu Hua, WANG, Shou Chun
Format: Patent
Sprache:chi ; eng ; fre
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Zusammenfassung:The present invention relates to the technical field of drug preparation, and provides a preparation method of a vidarabine monophosphate freeze-dried powder injection, comprising: taking water for injection, adjusting the pH value thereof to 8.0-8.5, adding vidarabine monophosphate for dissolving, then performing decolorization, sterile filtration, and subpackaging, and subjecting the obtained feed liquid to pre-freezing, to sublimation drying four times and to desorption drying three times, so as to obtain a vidarabine monophosphate freeze-dried powder injection. According the present invention, by adjusting the pH value, the hydrolysis reaction of vidarabine monophosphate is reduced, and the impurity content of the finished product is reduced; the settings of technological parameters in the sublimation drying process and the desorption drying process avoid solute migration in liquid medicine, and ensure the fullness and looseness of the finished product, so that the surface of the finished product is smoot