Intravenous injection of nelarabine and preparation method thereof

A technology for osmotic pressure regulators and injections, which is applied in the field of nelarabine infusion preparations and injections, can solve the problems of reducing the dosage of the main drug, and achieve the effect of reducing adsorption and removing pyrogens

Inactive Publication Date: 2010-12-29
BEIJING D VENTUREPHARM TECH DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The invention provides a nelarabine injection, which solves the above-mentioned problem of nelarabine degradation under high-temperature oxidation conditions, and provides a nelarabine that can be sterilized by an overkill method and has a higher level of sterility assurance and safety At the same time, it can greatly reduce the adsorption of activated carbon on the drug during the preparation process, reduce the dosage of the main drug, and produce products with uniform quality

Method used

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  • Intravenous injection of nelarabine and preparation method thereof
  • Intravenous injection of nelarabine and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Prescription composition:

[0026] Nalarabine 250g

[0027] Sodium chloride 150g

[0028] Propylene glycol 50.0g

[0029] Add water for injection to 50L

[0030]

[0031] Made 1000 pieces

[0032] Mix propylene glycol for injection with 80% water for injection, add nelarabine and stir to dissolve; add hydrochloric acid / sodium hydroxide to adjust the pH value to 5.0-7.0, add an appropriate amount of activated carbon for needles, stir, filter and decarbonize, add water for injection to The whole amount is finely filtered through a microporous membrane, potted, and autoclaved at 121°C for 15 minutes to obtain the finished product.

Embodiment 2

[0034] Prescription composition:

[0035] Nalarabine 250g

[0036] Sodium chloride 225g

[0037] Propylene glycol 25.0g

[0038] Add water for injection to 50L

[0039]

[0040] Made 1000 pieces

[0041] Mix propylene glycol for injection with 80% water for injection, add nelarabine and stir to dissolve; add hydrochloric acid / sodium hydroxide to adjust the pH value to 5.0-7.0, add an appropriate amount of activated carbon for needles, stir, filter and decarbonize, add water for injection to The whole amount is finely filtered through a microporous membrane, potted, and autoclaved at 121°C for 15 minutes to obtain the finished product.

Embodiment 3

[0043] Prescription composition:

[0044] Nalarabine 250g

[0045] Sodium chloride 225g

[0046] Propylene glycol 2.50g

[0047] Add water for injection to 50L

[0048]

[0049] Made 1000 pieces

[0050] Mix propylene glycol for injection with 80% water for injection, add nelarabine and stir to dissolve; add hydrochloric acid / sodium hydroxide to adjust the pH value to 5.0-7.0, add an appropriate amount of activated carbon for needles, stir, filter and decarbonize, add water for injection to The whole amount is finely filtered through a microporous membrane, potted, and autoclaved at 121°C for 15 minutes to obtain the finished product.

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Abstract

The invention provides an intravenous injection of nelarabine and a preparation method thereof. The injection of the invention contains propanediol, has high thermal stability and is used for treating refractory or recurrent acute lymphoblastic leukemia.

Description

technical field [0001] The invention relates to an intravenous administration preparation of nelarabine and a preparation method thereof, in particular to a nelarabine transfusion preparation and an injection. Background technique [0002] Nelarabine is a purine nucleoside analogue developed by GlaxoSmithKline. It is a water-soluble prodrug of ara-G, which can cause cell death by inhibiting DNA synthesis. Its trade name is ARRANON, which is clinically used to treat T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma that have failed or relapsed after at least two treatment regimens. The chemical structural formula of nelarabine is: [0003] [0004] The chemical name is (2-amino-9-β-D-arabinofuranosyl-6-methoxy-9H-purine), nelarabine is slightly soluble in water. Nelarabine Injection is a colorless, clear, sterile liquid. [0005] CN1020107C discloses the core patent of nelarabine compounds, including pharmaceutical formulations and preparation method...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/7076A61K47/10A61K9/08A61K47/02A61P35/02
Inventor 尚丽霞
Owner BEIJING D VENTUREPHARM TECH DEV
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