Injection calcium folinate composite and preparation method thereof

A technology of calcium folinate and composition, applied in the field of calcium folinate composition for injection and preparation thereof, can solve the problems of clarity, unqualified foreign body and the like, and achieve relatively high production cost, uniform and stable quality, and uniform content. accurate effect

Inactive Publication Date: 2011-09-14
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] 200910001262.9 discloses a composition of calcium folinate and phenylalanine, a freeze-dried powder injection and a preparation method thereof, although the composition of calcium folinate and phenylalanine solves the problem of water solubility during preparation, but It is difficult to solve the problems of visible foreign matter and unqualified clarity during reconstitution

Method used

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  • Injection calcium folinate composite and preparation method thereof
  • Injection calcium folinate composite and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] prescription:

[0042] Calcium folinate 54g

[0043] Mannitol 5g

[0044] Add water for injection to 1250Kg

[0045] Preparation:

[0046] Put calcium folinate and mannitol in a preparation tank, add water for injection, stir to dissolve completely and mix evenly, and adjust the pH value to 6.8 with 0.1mol / L sodium hydroxide solution;

[0047] Sterile filtration, packing:

[0048] Filter the prepared calcium folinate solution through a microporous membrane into a sterile room, divide it into vials, and half stopper it;

[0049] Vacuum Freeze Drying:

[0050] a. Pre-freezing: Put the subpackaged calcium folinate liquid in a freeze dryer, lower the temperature of the product to -40°C, and keep warm until the liquid calcium folinate is completely frozen;

[0051] b. Refrigeration of the rear box: use the compressor to cool the cold trap of the rear box, and keep the temperature of the cold trap of the rear box at –45~–55°C;

[0052] c. Drying: Turn on the vacuum pum...

Embodiment 2

[0054] prescription:

[0055] Calcium folinate 54g

[0056] Mannitol 10g

[0057] Add water for injection to 1250Kg

[0058] Preparation:

[0059] Put calcium folinate and mannitol in a preparation tank, add water for injection, stir to dissolve completely and mix evenly, and adjust the pH value to 7.5 with 0.1mol / L sodium hydroxide solution;

[0060] Sterile filtration, packing:

[0061] Filter the prepared calcium folinate solution through a microporous membrane into a sterile room, divide it into vials, and half stopper it;

[0062] Vacuum Freeze Drying:

[0063] a. Pre-freezing: Put the subpackaged calcium folinate liquid in a freeze dryer, lower the temperature of the product to -40°C, and keep warm until the liquid calcium folinate is completely frozen;

[0064] b. Refrigeration of the rear box: use the compressor to cool the cold trap of the rear box, and keep the temperature of the cold trap of the rear box at –45~–55°C;

[0065] c. Drying: Turn on the vacuum pu...

Embodiment 3

[0067] prescription:

[0068] Calcium folinate 54g

[0069] Mannitol 15g

[0070] Add water for injection to 1250Kg

[0071] Preparation:

[0072] Put calcium folinate and mannitol in a preparation tank, add water for injection, stir to dissolve completely and mix evenly, and adjust the pH value to 7.8 with 0.1mol / L sodium hydroxide solution;

[0073] Sterile filtration, packing:

[0074] Filter the prepared calcium folinate solution through a microporous membrane into a sterile room, divide it into vials, and half stopper it;

[0075] Vacuum Freeze Drying:

[0076] a. Pre-freezing: Put the subpackaged calcium folinate liquid in a freeze dryer, lower the temperature of the product to -40°C, and keep warm until the liquid calcium folinate is completely frozen;

[0077] b. Refrigeration of the rear box: use the compressor to cool the cold trap of the rear box, and keep the temperature of the cold trap of the rear box at –45~–55°C;

[0078] c. Drying: Turn on the vacuum pu...

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Abstract

The invention relates to an injection calcium folinate composite and a preparation method thereof. The calcium folinate composite prepared through the method is mainly used as detoxicant of a folic acid antagonist (such as methotrexate, pyrimethamine or trimethoprim and the like). The injection calcium folinate composite is clinically used for preventing serious toxic actions caused by excessive methotrexate or large dose treatment. The injection calcium folinate composite comprises calcium folinate and mannitol. The preparation method comprises the steps of: 1, preparing: placing the calciumfolinate and the mannitol in a preparing tank according to the weight ratio of 1:(0.1-0.5), adding injection water, adding active carbon for boiling for 20min; 2, aseptically filtering, packaging, half-plugging; and 3, freeze-drying in vacuum to obtain the injection calcium folinate composite. The injection calcium folinate composite has the advantages of simple formula, advanced process, uniformand stable quality, thorough moisture drying and better dissolvability.

Description

technical field [0001] The present invention relates to a calcium folinate composition for injection and a preparation method thereof. The calcium folinate composition prepared by the method is mainly used as a folic acid antagonist (such as methotrexate, pyrimethamine or methoxy benzidine, etc.) antidote. This product is often used clinically to prevent severe toxic effects caused by methotrexate overdose or high-dose treatment. Background technique [0002] The chemical name of calcium folinate is 5-methyl-5,6,7,8-tetrahydropteroyl-L-monoglutamic acid calcium salt. [0003] Its structural formula is: [0004] [0005] Molecular formula: C 20 h 21 CaN 7 o 7 ·5H 2 o [0006] Molecular weight: 601.61 [0007] Calcium folinate has a detoxifying effect on methotrexate (MTX). MTX is a folic acid antagonist. The anti-tumor mechanism of MTX is that its structure is similar to folic acid, which can inhibit the activity of dihydrofolate reductase, resulting in the lack ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/519A61K31/047A61K9/19A61P39/02
Inventor 戴建国曹嘉成张启杰
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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