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Fludarabine phosphate composition for injection and preparation method thereof

A technology of fludarabine phosphate and composition, which is applied in the field of fludarabine phosphate composition for injection and its preparation, can solve problems such as no improvement, and achieve relatively high production cost, uniform and accurate content, and simple preparation process Effect

Active Publication Date: 2011-01-19
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] None of the existing known technologies propose improvements to the above defects

Method used

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  • Fludarabine phosphate composition for injection and preparation method thereof
  • Fludarabine phosphate composition for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] prescription:

[0044] Fludarabine Phosphate 500g

[0045] Mannitol 500g

[0046] Add water for injection to 20Kg

[0047] Preparation:

[0048] Put fludarabine phosphate and mannitol in the preparation tank, add water for injection to 20Kg, stir, adjust the pH to 7.7 with 0.1mol / L phosphoric acid solution and 0.1mol / L sodium hydroxide solution to completely dissolve them, and continue stirring make the mix even;

[0049] Sterile filtration, packing:

[0050] Filter the fludarabine phosphate solution through a microporous membrane into a sterile room, dispense it into cillin bottles at a volume of 2ml / bottle, and half-stopper;

[0051] Vacuum Freeze Drying:

[0052] a. Pre-freezing: Put the subpackaged fludarabine phosphate liquid in a freeze dryer, lower the temperature of the front box to below -40°C, and keep warm until the fludarabine phosphate liquid is completely frozen;

[0053] b. Rear box refrigeration: use the compressor to cool the rear box...

Embodiment 2

[0056] prescription:

[0057] Fludarabine Phosphate 500g

[0058] Mannitol 500g

[0059] Add water for injection to 40Kg

[0060] Preparation:

[0061] Put fludarabine phosphate and mannitol in the preparation tank, add water for injection to 40Kg, stir, adjust the pH to 7.7 with 0.1mol / L phosphoric acid solution and 0.1mol / L sodium hydroxide solution to completely dissolve them, and continue stirring make the mix even;

[0062] Sterile filtration, packing:

[0063] Filter the fludarabine phosphate solution through a microporous membrane into a sterile room, pack it into cillin bottles at a volume of 4ml / bottle, and half-stopper;

[0064] Vacuum Freeze Drying:

[0065] a. Pre-freezing: Put the subpackaged fludarabine phosphate liquid in a freeze dryer, lower the temperature of the front box to below -40°C, and keep warm until the fludarabine phosphate liquid is completely frozen;

[0066] b. Rear box refrigeration: use the compressor to cool the rear box col...

Embodiment 3

[0069] prescription:

[0070] Fludarabine Phosphate 500g

[0071] Mannitol 1Kg

[0072] Add water for injection to 20Kg

[0073] Preparation:

[0074] Put fludarabine phosphate and mannitol in the preparation tank, add water for injection to 20Kg, stir, adjust the pH to 7.7 with 0.1mol / L phosphoric acid solution and 0.1mol / L sodium hydroxide solution to completely dissolve them, and continue stirring make the mix even;

[0075] Sterile filtration, packing:

[0076] Filter the fludarabine phosphate solution through a microporous membrane into a sterile room, dispense it into cillin bottles at a volume of 2ml / bottle, and half-stopper;

[0077] Vacuum Freeze Drying:

[0078] a. Pre-freezing: Put the subpackaged fludarabine phosphate liquid in a freeze dryer, lower the temperature of the front box to below -40°C, and keep warm until the fludarabine phosphate liquid is completely frozen;

[0079] b. Rear box refrigeration: use the compressor to cool the rear box ...

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Abstract

The invention relates to a fludarabine phosphate composition for injection, which contains fludarabine phosphate and mannitol. A preparation method for the fludarabine phosphate composition comprises the following steps of: 1) preparation: putting the fludarabine phosphate and the mannitol in a preparation tank in a weight ratio of 1:1, adding water for injection into the tank, stirring the mixture, adjusting the pH to 7.7 by using 0.1mol / L phosphoric acid solution and 0.1mol / L sodium hydroxide solution to fully dissolve the mixture, and continuously stirring the solution for uniform mixing; 2) sterile filtration, packing and half plugging; and 3) vacuum freezing drying. The fludarabine phosphate composition has the advantages of simple formula, advanced process, good appearance formation, uniform and stable quality, uniform and accurate content, thorough moisture drying and better stability.

Description

technical field [0001] The present invention relates to a fludarabine phosphate composition for injection and a preparation method thereof, and the fludarabine phosphate composition prepared by the method can be used for B-cell chronic lymphocytic leukemia (CLL) patients treat. Background technique [0002] The chemical name of fludarabine phosphate is chemical name: 9-β-D-arabinofuranyl-2-fluoroadenine-5'-phosphate. [0003] Chemical Structure: [0004] [0005] Molecular formula: C 10 h 13 FN 5 o 7 P [0006] Molecular weight: 365.21. [0007] Chronic lymphocytic leukemia (CLL) is the most common leukemia in adults. 95% of CLL patients originate from B cells (B-CLL), and only a very small number belong to malignant transformation of T cells. B-CLL is classified as non-Hodgkin Lymphoma. In the past, chronic lymphocytic leukemia (CLL) was regarded as an incurable disease, and palliative and symptomatic treatment was adopted clinically. The nucleotide congener fl...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/7076A61P35/02
Inventor 赵俊叶东蔡继兰
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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