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Allopurinol sodium sterilzed powder for injection and preparing method

A technology of injection powder and allopurinol sodium, which is applied in the field of allopurinol sodium injection sterile powder and its preparation, and can solve problems such as life-threatening, pain and the like

Inactive Publication Date: 2007-08-29
CHONGQING PHARMA RES INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Drug hemolysis will cause irritation reactions such as pain, redness and swelling at the injection site, which will threaten human life in severe cases

Method used

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  • Allopurinol sodium sterilzed powder for injection and preparing method

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Weigh 25g of allopurinol, add about 50ml of water for injection to disperse it evenly, then add 400ml (0.5M) of NaOH solution, stir until allopurinol is completely dissolved, then dilute to 500ml with water for injection, add 1.5g of needle Stir with activated carbon for 30 minutes, remove the activated carbon by primary filtration, and then filter with a 0.22μ microporous membrane, fill 10ml of the above-prepared sodium allopurinate solution into a 30ml freeze-drying bottle, and freeze-dry to obtain the product.

[0027] One bottle of allopurinate sodium injection sterile powder of this embodiment was used, and after reconstitution with 25 ml of water for injection, the milliosmolality was determined to be 255 mOsm / kg, and the pH was 11.10. Then dilute it to a concentration of 6 mg / ml with normal saline, carry out the hemolytic test with human red blood cells according to the above-mentioned hemolytic test method, and compare it with the negative group and the positive ...

Embodiment 2

[0029] Adopt the method for embodiment 1, prepare sodium allopurinate solution with the NaOH solution of 402ml (0.5M), get bottle this product after freeze-drying, measure milliosmolality after reconstitution with 25ml water for injection and be 261 mOsm / kg, The pH is 11.15. After diluting this solution with 5% glucose injection to a concentration of 6 mg / ml, the hemolytic test was carried out with human red blood cells, and compared with the negative group control and positive group control, as a result, no hemolysis phenomenon occurred in the sample of this embodiment.

Embodiment 3

[0031] Adopt the method of embodiment 1, prepare sodium allopurinate solution with the NaOH solution of 403ml (0.5M), get a bottle of this product after freeze-drying, measure and measure milliosmol concentration with 25ml water for injection after reconstitution is 262mOsm / kg , pH 11.25. After diluting this solution with physiological saline to a concentration of 6 mg / ml, the hemolytic test was carried out with human red blood cells, and compared with the negative and positive groups. As a result, no hemolysis occurred in the samples of this embodiment.

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Abstract

The present invention relates to an allopurinol sodium injection sterile powder and its preparation method. Said allopurinol sodium injection sterile powder contains allopurinol sodium and sodium hydroxide. Said invention also provides their mole ratio range, and provides the concrete steps of its preparation method.

Description

Technical field: [0001] The invention relates to a sterile powder for injection containing sodium allopurinate and a preparation method thereof. The sterile powder for injection contains sodium allopurinate and sodium hydroxide, and when it is formulated into a 20 mg / ml sodium allopurinate solution, the The osmolarity is 250-262mOsm / kg. Background technique: [0002] The chemical structural formula of allopurinol sodium is: [0003] [0004] The chemical name is: 1,5-dihydro-4H-pyrazol[3,4-d]pyrimidine-4-monosodium salt [0005] Sodium Allopurinate is white or off-white powder, soluble in water and ethanol. [0006] Sodium allopurinate solution is a colorless or almost colorless clear solution. [0007] Sodium Allopurinate for Injection was approved by the FDA on May 17, 1996 and was listed in the United States. The listed company is: Nabi Corporation of the United States; trade name: Aloprim TM ; The listed dosage form is: sterile powder for injection; the listed spe...

Claims

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Application Information

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IPC IPC(8): A61K31/519A61K9/14A61K9/19A61K47/02A61P35/00
Inventor 宗太丽牟才华张涛
Owner CHONGQING PHARMA RES INST