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Fludarabine phosphate freeze-dried powder injection

A technology of fludarabine phosphate and freeze-dried powder injection, which is applied in the field of pharmaceutical preparations, can solve the problems of difficulty in ensuring the moisture content of the finished product and long use time, and achieve the effect of safe effect, stable quality and high safety

Active Publication Date: 2015-07-15
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The first drying requires a temperature of -20°C, which takes a long time, and the second drying is at 30°C, and the moisture content of the finished product is difficult to guarantee

Method used

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  • Fludarabine phosphate freeze-dried powder injection
  • Fludarabine phosphate freeze-dried powder injection
  • Fludarabine phosphate freeze-dried powder injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Fludarabine Phosphate 5g

[0025] Water for injection 100ml

[0026] Weigh 5g of the 75-100μm fludarabine phosphate powder obtained by micronization, add 100ml of water for injection, use sodium hydroxide to adjust the pH value to 7.2-8.2, stir to dissolve completely, and fill each 1ml into a 10ml vial middle. The plate layer of the lyophilizer was cooled to -45°C, and after filling, the vials were put into the lyophilizer and kept warm for 2 hours. Raise the temperature of the plate layer to -8°C, keep it warm for 2 hours, then cool the plate layer down to -45°C, and keep it warm for 3 hours. Heat the plate layer to 20°C within 8 to 12 hours; keep warm at 35°C for 8 hours, fill it with a nitrogen pressure plug, take out the crimped cap and pack it.

Embodiment 2

[0028] Fludarabine Phosphate 5g

[0029] Water for injection 100ml

[0030] Weigh 5g of the 75-100μm fludarabine phosphate powder obtained by micronization, add 100ml of water for injection, use sodium hydroxide to adjust the pH value to 7.2-8.2, stir to dissolve completely, and fill each 1ml into a 10ml vial middle. The plate layer of the lyophilizer was cooled to -45°C, and after filling, the vials were put into the lyophilizer and kept warm for 4 hours. Raise the temperature of the plate layer to -8°C, keep the temperature for 2 hours, then cool down the plate layer to -40°C, and keep the heat preservation for 3 hours. Heat the plate layer to 15°C within 8 to 12 hours; keep warm at 40°C for 10 hours, fill in the nitrogen pressure plug, take out the crimped cap and pack it.

Embodiment 3

[0032] Fludarabine Phosphate 5g

[0033] Water for injection 100ml

[0034] Weigh 5g of the 75-100μm fludarabine phosphate powder obtained by micronization, add 100ml of water for injection, use sodium hydroxide to adjust the pH value to 7.2-8.2, stir to dissolve completely, and fill each 1ml into a 10ml vial middle. The plate layer of the lyophilizer is cooled to -50°C, and after filling, the vials are put into the lyophilizer and kept warm for 1 hour. Raise the temperature of the plate layer to -8°C, keep the temperature for 2 hours, then cool down the plate layer to -40°C, and keep the heat preservation for 3 hours. Heat the plate layer to 25°C within 8 to 12 hours; keep warm at 30°C for 10 hours, fill in the nitrogen pressure plug, take out the crimped cap and pack it.

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Abstract

The invention relates to a fludarabine phosphate freeze-dried powder injection, wherein fludarabine phosphate is the only ingredient of the fludarabine phosphate freeze-dried powder injection. According to a preparation method, finished products are preferably prepared by mixing 75 to 100<mu>m of fludarabine phosphate powder with injection water, and an obtained solution with a fludarabine phosphate concentration ranging from 5 to 20% is subjected to freeze drying. The preparation method is simple; operation is convenient; and the preparation method is suitable for industrialized production.

Description

technical field [0001] The invention relates to a fludarabine phosphate freeze-dried powder injection, which belongs to the technical field of pharmaceutical preparations. Background technique [0002] Fludarabine phosphate is an antimetabolite fluorinated purine nucleoside analogue, it is highly selective to lymphocytes, it can inhibit the repair of DNA in quiescent cells and the synthesis of DNA in mitotic cells, and has The effect of promoting the apoptosis of these cells is currently widely used in the treatment of various blood system diseases, especially chronic B lymphocytic leukemia. Fludarabine phosphate improves the remission rate of the disease by promoting tumor cell apoptosis. The way it promotes apoptosis is mainly achieved by regulating the following pathways: death receptor pathway, mitochondrial pathway, P53, ceramide, BCl-2 family and some apoptosis promoters and apoptosis inhibitors. [0003] Fludarabine phosphate (Fludarabine phosphate) is developed by ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/7076A61P35/02
Inventor 赵志全张丽萍冯中张瑜隋华芹
Owner SHANDONG NEWTIME PHARMA
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