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Azacitidine freeze-drying powder injection and preparation method thereof

A technology of azacitidine and freeze-dried powder injection, applied in the field of azacitidine, can solve the problems of the influence of clinical medication safety and effectiveness, poor stability of azacitidine, increase of impurities during storage period, etc. Conducive to storage and ensure the effect of medication safety

Inactive Publication Date: 2010-01-27
HANGZHOU XIANDA MEDICINE TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The U.S. FDA approved the drug Vidaza in May 2004. Due to the poor stability of the active ingredient azacitidine (rapidly hydrolyzed in water), the preparation on the market is a powder injection preparation
However, it is found through research that the powder preparation will form different crystal forms during the rapid freeze-drying process, resulting in changes in stability and increased impurities during storage, thus potentially affecting the safety and effectiveness of clinical medication.

Method used

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  • Azacitidine freeze-drying powder injection and preparation method thereof
  • Azacitidine freeze-drying powder injection and preparation method thereof
  • Azacitidine freeze-drying powder injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Preparation of azacitidine freeze-dried powder preparation

[0030] 1.1 Formation:

[0031] Azacitidine 100g

[0032] Mannitol 100g

[0033] Vitamin C 10g

[0034] Add water for injection to 3000ml

[0035] A total of 1000 pieces were made.

[0036] 1.2 Take the following steps to prepare:

[0037] a. According to the above preparation prescription, take 100g of azacitidine raw material, 100g of mannitol, and 10g of vitamin C, and dissolve them with 2400ml of water for injection;

[0038] b. Add activated carbon with 1% volume of the dissolved medicinal solution, decolorize, and filter to remove carbon;

[0039] c. Dilute to the prepared amount with the above-mentioned water for injection, measure the concentration of the medicinal solution, and the pH value of the medicinal solution ranges from 3.5 to 6.0;

[0040] d. Filter and sterilize through a filter membrane to a liquid storage tank, sub-package, freeze-dry according to a preset temperature, crimp the cap,...

Embodiment 2

[0050] Preparation of azacitidine freeze-dried powder preparation

[0051] 2.1 Formation:

[0052] Azacitidine 100g

[0053] Mannitol 100g

[0054] Vitamin C 15g

[0055] Add water for injection to 2500ml

[0056] A total of 1000 pieces were made.

[0057] 2.2 Take the following steps to prepare:

[0058] a. According to the above preparation prescription, take 100g of azacitidine raw material, 100g of mannitol, and 15g of vitamin C, and dissolve them with 2000ml of water for injection;

[0059] b. Add 0.8% active carbon of the volume of the dissolved medicinal solution for decolorization, and filter to remove carbon;

[0060] c. Dilute to the prepared amount with the above-mentioned water for injection, measure the concentration of the medicinal solution, and the pH value of the medicinal solution ranges from 3.5 to 6.0;

[0061] d. Filter and sterilize through a filter membrane to a liquid storage tank, sub-package, freeze-dry according to a preset temperature, crimp ...

Embodiment 3

[0071] Preparation of azacitidine freeze-dried powder preparation

[0072] 3.1 Formation:

[0073] Azacitidine 100g

[0074] Mannitol 100g

[0075] Vitamin C 28g

[0076] Add water for injection to 4000ml

[0077] A total of 1000 pieces were made.

[0078] 3.2 Take the following steps to prepare:

[0079] a. According to the above prescription, take 100g of azacitidine raw material, 100g of mannitol, and 28g of vitamin C, and dissolve them with 3200ml of water for injection;

[0080] b. add 1.5% activated carbon of water for injection for decolorization, and filter to remove carbon;

[0081] c. Dilute to the prepared amount with the above-mentioned water for injection, measure the concentration of the medicinal solution, and the pH value of the medicinal solution ranges from 3.5 to 6.0;

[0082] d. Filter and sterilize through a filter membrane to a liquid storage tank, sub-package, freeze-dry according to a preset temperature, crimp the cap, and pack.

[0083] In this e...

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Abstract

The invention discloses a medicinal azacitidine freeze-drying powder injection for treating myelodysplastic syndrome and a preparation method thereof. The prescription of the azacitidine freeze-drying powder injection comprises azacitidine, mannitol and vitamin C. The invention solves the problem of rapid impurity increase caused by different crystal forms formed in the processes of rapidly freezing and drying the prior powder injection by optimizing the prescription and improving the preparation method.

Description

Technical field [0001] The present invention relates to a drug azacitidine (Azacitidine) for treating myelodysplastic syndrome (MDS), specifically azacitidine freeze-dried powder injection preparation and its preparation method. Background technique [0002] Azacitidine is a cytosine nucleoside analog mainly used to treat myelodysplastic syndrome (MDS). The US FDA approved the drug Vidaza for marketing in May 2004. Due to the poor stability of the active ingredient azacitidine (rapidly hydrolyzed in water), the preparation on the market is a powder injection preparation. However, research has found that the powder injection preparation will form different crystal forms during the rapid freeze-drying process, resulting in changes in stability and an increase in impurities during storage, thus potentially affecting the safety and effectiveness of clinical medication. Contents of the invention [0003] The object of the present invention is to provide a stable azacitidine fr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/706A61K47/22A61P19/08
Inventor 樊华
Owner HANGZHOU XIANDA MEDICINE TECH
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