Title:
PREPARATION METHOD FOR VIDARABINE MONOPHOSPHATE FREEZE-DRIED POWDER INJECTION
Document Type and Number:
WIPO Patent Application WO/2022/213447
Kind Code:
A1
Abstract:
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 smoother. The preparation method provided by the present invention can effectively improve the drug stability, appearance shape and looseness of the finished product.
Inventors:
WANG SHOU CHUN (CN)
WANG JIN YU (CN)
PAN SHU HUA (CN)
WANG JIN YU (CN)
PAN SHU HUA (CN)
Application Number:
PCT/CN2021/093203
Publication Date:
October 13, 2022
Filing Date:
May 12, 2021
Export Citation:
Assignee:
HAINAN JIN RUI PHARMACEUTICAL CO LTD (CN)
International Classes:
A61K9/19; A61K31/7076; A61K47/02; A61K47/12; A61P31/20; F26B5/06
Foreign References:
| CN102379853A | 2012-03-21 | |||
| CN103054817A | 2013-04-24 | |||
| CN107890459A | 2018-04-10 | |||
| CN102908320A | 2013-02-06 | |||
| EP2428201A1 | 2012-03-14 |
Other References:
CHEN WEI-BO,YANG LI,YANG HUA: "Study on the Drying Technology in Manufacturing Vidarabine Monophosphate for Injection", CHINA TROPICAL MEDICINE, vol. 7, no. 4, 30 April 2007 (2007-04-30), pages 654 - 655, XP055976099
Attorney, Agent or Firm:
BEIJING HC-IP AGENCY CO., LTD. (GENERALPARTNERSHIP) (CN)
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