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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

Inactive Publication Date: 2017-02-08
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in actual operation, we found that such a process is prone to the problem of drug agglomeration, resulting in too long drug dissolution time, incomplete dissolution of the drug, and easy precipitation of tiny crystals, resulting in unqualified clarity and insoluble particles, increasing oxidative degradation impurities, clinically dangerous

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] prescription:

[0059] Plerixafor 24g Sodium chloride 5.9g hydrochloric acid Appropriate amount Water for Injection Add to 1200ml Co-made 1000 bottles

[0060] Take 80% of the amount of water for injection and put it in a stainless steel bucket, add the prescribed amount of sodium chloride, add about 50ml of 3mol / L hydrochloric acid after dissolving, weigh the prescribed amount of plerixafor and add it to the water for injection, stir to dissolve, measure the pH value, and then According to the pH value, add 1 mol / L hydrochloric acid and 1 mol / L sodium hydroxide solution to adjust the pH value to 6 to 8. Add 0.02% activated carbon for needles, stir for 30 minutes, and decarburize while hot to obtain the first filtrate. Let the filtrate cool to room temperature, measure the solution content and pH; replenish water for injection to the full amount according to the measurement results, and pass through a 0.22 micron filter membrane...

Embodiment 2

[0062] prescription:

[0063] Plerixafor 24g Sodium chloride 4.1g hydrochloric acid Appropriate amount Water for Injection Add to 1000ml Co-made 1000 bottles

[0064] Take 50% of the water for injection and put it in a stainless steel bucket, add the prescribed amount of sodium chloride, add about 30ml of 5mol / L hydrochloric acid, weigh the prescribed amount of Plerixafor, add it to the water for injection, stir and dissolve, measure the pH value, and then according to the pH Add 0.5mol / L hydrochloric acid and 1mol / L sodium hydroxide solution to adjust the pH value to 6-8. Add 0.02% activated carbon for needles, stir for 30 minutes, and decarburize while hot to obtain the first filtrate. Let the filtrate cool to room temperature, measure the solution content and pH; add water for injection to the full amount according to the measurement results, and pass through a 0.22 micron filter membrane to obtain the bulk solution of the preparati...

Embodiment 3

[0066] prescription:

[0067] Plerixafor 24g Sodium chloride 6.3g hydrochloric acid Appropriate amount Water for Injection Add to 1500ml Co-made 1000 bottles

[0068] Take 70% of the water for injection and put it in a stainless steel bucket, add the prescribed amount of sodium chloride, add about 90ml of 2mol / L hydrochloric acid, stir and dissolve, weigh the prescribed amount of plerixafor, add it to the water for injection, stir and dissolve, measure the pH value, Then add 1 mol / L hydrochloric acid and 1 mol / L sodium hydroxide solution to adjust the pH value to 6 to 8 according to the pH value. Add 0.02% activated carbon for injection, stir for 30 minutes, filter and decarbonize while hot to obtain the first filtrate, let the filtrate cool to room temperature, measure the solution content and pH; add water for injection to the full amount according to the measurement results, and pass through a 0.22 micron filter membrane to obtain th...

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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.

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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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/395A61K47/02A61P7/00A61P35/00
Inventor 赵俊刘留成李晓昕朱磊
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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