Title:
MULTIPLE ELECTROLYTES INJECTION AND PREPARATION METHOD THEREFOR
Document Type and Number:
WIPO Patent Application WO/2022/222630
Kind Code:
A1
Abstract:
A multiple electrolytes injection and a preparation method therefor. The preparation method therefor comprises: sequentially adding a prescription amount of L-malic acid, magnesium chloride, sodium chloride, potassium chloride, calcium chloride, sodium acetate and sodium hydroxide to 70-80% of a total formulation volume of water for injection; stirring and dissolving same, heating same to boiling, and maintaining heating for 10-20 min; replenishing the water for injection to the total formulation volume; and filtering same by passing same through a multistage polyether sulfone filter element having sequentially reduced pore diameters, and filling and sterilizing same to obtain the multiple electrolytes injection. According to the present application, a multiple electrolytes injection (II), the impurity types and content of which are both significantly reduced, is prepared by means of a one-step preparation method, and the storage stability of the injection is significantly improved. In a stability investigation test, the impurity content of the multiple electrolytes injection (II) is not significantly increased.
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Inventors:
LIU XIAOJUAN (CN)
ZHANG ZEHUI (CN)
WANG BO (CN)
JIN JIAXIN (CN)
ZHANG JINBAO (CN)
YANG XUEJIE (CN)
SU YAN (CN)
ZHANG ZEHUI (CN)
WANG BO (CN)
JIN JIAXIN (CN)
ZHANG JINBAO (CN)
YANG XUEJIE (CN)
SU YAN (CN)
Application Number:
PCT/CN2022/079881
Publication Date:
October 27, 2022
Filing Date:
March 09, 2022
Export Citation:
Assignee:
SHIJIAZHUANG NO 4 PHARM CO LTD (CN)
International Classes:
A61K9/08; A61J3/00; A61K33/14; A61P3/12
Foreign References:
CN113274350A | 2021-08-20 | |||
CN109432123A | 2019-03-08 | |||
CN110174474A | 2019-08-27 | |||
CN103989704A | 2014-08-20 | |||
CN110522763A | 2019-12-03 |
Other References:
CHEN YOUQING: "Study on Preparation Processand Stability of Multiple Electrolytes Injection (Ⅱ)", CHINESE MASTER'S THESES FULL-TEXT DATABASE, 24 November 2018 (2018-11-24), pages 1 - 134, XP055977927
Attorney, Agent or Firm:
SHIJIAZHUANG GOWELL INTELLECTUAL PROPERTY LAW FIRM (CN)
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