Pharmaceutical composition containing oxaliplatin and fluorouracil

A technology of oxaliplatin and fluorouracil, which is applied in the field of medicine and can solve problems such as toxicity and side effects that have not been clearly overcome

Inactive Publication Date: 2013-11-20
HAINAN LINGKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] In the prior art, there are technical revelations about the combined use of the two, but the toxicity and side effects of the two have not been clearly overcome. The gist of the present invention is to prepare the injection combination by using specific excipients. By selecting specific excipients agent, which not only maintains its own stability and formability, but also unexpectedly solves the defects of the other party’s active ingredients

Method used

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  • Pharmaceutical composition containing oxaliplatin and fluorouracil
  • Pharmaceutical composition containing oxaliplatin and fluorouracil
  • Pharmaceutical composition containing oxaliplatin and fluorouracil

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Example 1 Preparation of oxaliplatin freeze-dried powder for injection

[0043] prescription:

[0044]

[0045] Preparation Process:

[0046] (1) First add 12L water for injection into the container;

[0047] (2) Add 600g dextran and stir to dissolve completely;

[0048] (3) Add 150g of oxaliplatin, stir to dissolve completely, and adjust the pH to 5.9 with 1mol / L sodium hydroxide solution or 1mol / L hydrochloric acid solution;

[0049] (4) Add 7.5g of activated carbon for injection, add the remaining water for injection, constant volume, stir and absorb for 30 minutes;

[0050] (5) The solution is decarbonized by coarse filtration, coarsely filtered through a 0.45 μm cartridge filter, and then sterilized and filtered with a 0.22 μm microporous membrane until the visible foreign matter is qualified;

[0051] (6) Filling, 5ml / bottle or 10ml / bottle;

[0052] (7) Freeze drying

[0053] ① During the pre-freezing period, lower the shelf temperature to -40°C±2°C, and w...

Embodiment 2

[0056] Example 2 Preparation of Oxaliplatin Injection

[0057] prescription:

[0058]

[0059] Preparation Process:

[0060] (1) First add 96L water for injection into the liquid mixing tank;

[0061] (2) Add 140g oxaliplatin and 140g dextran, stir to dissolve completely, and adjust the pH to 6.1 with 1mol / L sodium hydroxide solution or 1mol / L hydrochloric acid solution;

[0062] (4) Add 60g of activated carbon for injection, add the remaining water for injection, constant volume, stir and absorb for 30 minutes;

[0063] (5) The solution is decarbonized by coarse filtration, coarsely filtered through a 0.45 μm cartridge filter, and then sterilized and filtered with a 0.22 μm microporous membrane until the visible foreign matter is qualified;

[0064] (6) Filling, 20ml / bottle or 100ml / bottle, sealing, and sterilizing to obtain Oxaliplatin Injection.

Embodiment 3

[0065] Example 3 Preparation of Fluorouracil Injection

[0066] prescription:

[0067]

[0068] Preparation Process:

[0069] (1) First add 8000ml of water for injection into the container;

[0070] (2) Add 250g of fluorouracil, stir to dissolve completely, and adjust the pH to 8.8 with 1mol / L sodium hydroxide solution;

[0071] (3) Add 5g of activated carbon for injection, add the remaining water for injection, constant volume, stir and absorb for 30 minutes;

[0072] (4) The solution is decarbonized by coarse filtration, coarsely filtered through a 0.45 μm cartridge filter, and then sterilized and filtered with a 0.22 μm microporous membrane until the visible foreign matter is qualified;

[0073] (5) Filling, 10ml / bottle, sealing, and sterilizing to obtain fluorouracil injection.

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Abstract

The invention relates to a pharmaceutical composition containing oxaliplatin and fluorouracil, and especially relates to an application product of the pharmaceutical composition, wherein the application product comprises an oxaliplatin injection and an injection containing fluorouracil. Administration comprises following steps, the oxaliplatin injection is dissolved and diluted for independent intravenous drop infusion, and then the fluorouracil injection is dissolved and diluted for intravenous drop infusion, wherein the oxaliplatin injection must be applied to drop infusion before the fluorouracil injection.

Description

technical field [0001] The invention relates to a pharmaceutical composition of oxaliplatin and fluorouracil, in particular to a combined application package of an oxaliplatin injection and an injection containing fluorouracil, and belongs to the technical field of medicine. Background technique [0002] Oxaliplatin belongs to new platinum derivatives. Its central platinum atom is surrounded by oxalic acid and 1.2-diaminocyclohexane, which is in trans conformation and is a stereoisomer. Like other platinum derivatives, oxaliplatin acts on DNA by generating alkylated conjugates to form intra-strand and inter-strand crosslinks, thereby inhibiting DNA synthesis and replication. Oxaliplatin binds DNA rapidly, taking up to 15 minutes, whereas cisplatin binds DNA in two phases, including a delayed phase after 48 hours. Its presence can be shown by measuring the adduct in leukocytes one hour after administration in humans. DNA synthesis during replication, subsequent DNA separati...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/513A61P35/00A61K31/282
Inventor 陶灵刚
Owner HAINAN LINGKANG PHARMA CO LTD
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