A kind of injection composition containing plerixafor and its preparation method and application

A composition and technology for injection, which is applied in the field of injection composition containing plerixafor and its preparation, can solve the problems of unqualified insoluble particles in clarity, incomplete dissolution of drugs, increased oxidative degradation impurities, etc., and achieves reduction The hidden dangers of medication, reducing the time of dosing, and the effect of reducing the time of dosing
CN104069061BInactive Publication Date: 2017-02-08JIANGSU AOSAIKANG PHARMA CO LTD

Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
JIANGSU AOSAIKANG PHARMA CO LTD
Publication Date
2017-02-08
Estimated Expiration
Not applicable · inactive patent

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Abstract

The invention belongs to the technical field of medicine, especially the field of chemical pharmacy, and relates to a plerixafor-containing composition for injection and a preparation method and application thereof. The plerixafor-containing composition for injection has a pH value of 6 to 8 and is in the form of a stable aseptic aqueous solution of water-soluble plerixafor. According to the invention, solubility of plerixafor in an aqueous solution during dosing is substantially improved, dosing time is reduced, stability of a finished product is improved, and potential safety hazards to patients caused by clarity of the product in clinical medication are avoided.
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Description

technical field

[0001] The invention belongs to the technical field of medicine, in particular to the field of chemical pharmacy, and relates to a plerixafor-containing composition for injection, a preparation method and application thereof. Background technique

[0002] The chemical name of plerixafor is 1,1'-[1,4-phenylenebis(methylene)]-bis-1,4,8,11-tetraazacyclotetradecane; Plerixafor is an off-white crystalline solid; it is hygroscopic; the melting point of anhydrous substance is 131.5°C; Plerixafor is a strong base, and the 8 Ns on the macrocycle can quickly bind protons; the two macrocycles can be chelated Divalent metal ions, especially zinc, copper, nickel, cobalt and rhodium, are biologically active in their zinc complexes; the partition coefficient of plerixafor in n-octanol and pH=7 buffer is less than 0.1. Its structural formula is:

[0003]

[0004] On December 15, 2008, the U.S. FDA approved its preparation products (trade name Mozobil TM ), which was de...

Claims

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