Preparation method for Bumetanide freeze-dried powder preparation for injection

A technology of bumetanide and freeze-dried powder injection, which is applied in the field of medicine, can solve problems such as complicated process, increased impurities, and uncontrollable quality, and achieve the effects of good resolubility, reduced solvent usage, and increased solubility

Active Publication Date: 2015-06-17
HAINAN GENERAL & KANGLI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Because bumetanide is insoluble in water, in order to make it soluble in water, in the prior art, an alkaline solution is usually used to dissolve the bumetanide powder, and then an acidic solution is added to adjust the pH value to make the solution return to neutrality. However, the stability of bumetanide in the alkaline solution will decrease, the dissolution process will lead to an increase of impurities, and the preparation process needs to be adjusted by adding an acidic solution, the process is complicated, and there are defects in uncontrollable quality.

Method used

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  • Preparation method for Bumetanide freeze-dried powder preparation for injection
  • Preparation method for Bumetanide freeze-dried powder preparation for injection
  • Preparation method for Bumetanide freeze-dried powder preparation for injection

Examples

Experimental program
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Effect test

Embodiment 1

[0014] Prepare one thousand bottles of bumetanide freeze-dried powder preparation for injection with a total amount of 2000ml:

[0015] 1. Measure 2ml of glycerin and add it to 8ml of water for injection, stir to obtain a latent solvent;

[0016] 2. Weigh 0.5g of bumetanide, add it to the latent solvent, and stir in the dark to completely dissolve the bumetanide, add activated carbon whose mass is 0.03% of the latent solvent volume, stir at room temperature for 30 minutes, filter until clarity, and obtain Solution 1, standby;

[0017] 3. Take 200g of mannitol, add about 80% of the total amount of water for injection, stir to dissolve, add activated carbon with a mass of 0.03% of the volume of the mixed solution, stir at room temperature for 30 minutes, filter until clear, and obtain solution 2 for later use;

[0018] 4. Mix solution 1 and solution 2, add the remaining water for injection to a total of 2000ml, filter the solution until it is clear, check the content of bumetan...

Embodiment 2

[0024] Prepare one thousand bottles of bumetanide freeze-dried powder preparation for injection with a total amount of 2000ml:

[0025] 1. Measure 3ml of glycerin and add it to 7ml of water for injection, stir to obtain a latent solvent;

[0026] 2. Weigh 0.5g of bumetanide, add it to the latent solvent, and stir in the dark to dissolve the bumetanide completely. Add activated carbon whose mass is 0.03% of the latent solvent volume, stir at room temperature for 30 minutes, and filter until clear. Get solution 1, set aside;

[0027] 3. Take 200g of mannitol, add about 80% of the total amount of water for injection, stir to dissolve, add activated carbon whose mass is 0.03% of the volume of latent solvent, stir at room temperature for 30 minutes, filter until clear, and obtain solution 2 for later use;

[0028] 4. Mix solution 1 and solution 2, add the remaining water for injection to a total of 2000ml, filter the solution until it is clear, check the content of bumetanide, ste...

Embodiment 3

[0034] Prepare one thousand bottles of bumetanide freeze-dried powder preparation for injection with a total amount of 2000ml:

[0035] 1. Measure 4ml of glycerin and add it to 6ml of water for injection, stir to obtain a latent solvent;

[0036] 2. Weigh 0.5g of bumetanide, add it to the latent solvent, and stir in the dark to dissolve the bumetanide completely. Add activated carbon whose mass is 0.03% of the latent solvent volume, stir at room temperature for 30 minutes, and filter until clear. Get solution 1, set aside;

[0037] 3. Take 200g of mannitol, add about 80% of the total amount of water for injection, stir to dissolve, add activated carbon whose mass is 0.03% of the volume of latent solvent, stir at room temperature for 30 minutes, filter until clear, and obtain solution 2 for later use;

[0038] 4. Mix solution 1 and solution 2, add the remaining water for injection to a total of 2000ml, filter the solution until it is clear, check the content of bumetanide, ste...

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Abstract

The invention provides a bumetanide freeze-dried powder preparation for injection and a preparation method thereof. The method consists of: weighing 10ml of glycerol and water for injection in a volume ratio of 1:4-2:3, and stirring them to obtain a latent solvent; weighing 0.5g of bumetanide and dissolving it in the latent solvent, conducting filtering to clarity, thus obtaining a solution A; weighing 200g of mannitol, adding water for injection accounting for 80% of the total amount, carrying out stirring and filtering to clarity, thus obtaining a solution B; mixing the solution A and the solution B evenly, then adding the remaining water for injection to a total amount of 2000ml, performing degerming filtering, then subjecting the product to filling into 1000 10ml tube-type bottles respectively according to a dosage of 2.0ml / bottle; subjecting the tube-type bottles to heat preservation for 4h under -45DEG C; conducting vacuum pumping to a vacuum degree of not greater than 20pa, raising the slab temperature to -5DEG C at a rate of 2DEG C / h, and carrying out heat preservation for 18h; raising the slab temperature to 30DEG C at a rate of 7DEG C / h, and carrying out heat preservation for 2h, thus obtaining the bumetanide freeze-dried powder preparation for injection. According to the invention, the product stability is effectively ensured, the content of impurities is reduced, and the re-dissolubility of the product is good.

Description

technical field [0001] The invention belongs to the technical field of medicine and relates to a freeze-dried preparation, in particular to a bumetanide freeze-dried powder preparation and a preparation method thereof. Background technique [0002] Bumetanide is a diuretic, used for edematous diseases, hypertension, prevention of acute renal failure, hyperkalemia and hypercalcemia, dilutional hyponatremia, hypersecretion of antidiuretic hormone, acute drug The treatment of poisoning, etc. may still be effective for some cases where furosemide is ineffective. [0003] Bumetanide is currently available in dosage forms such as tablets and injections. Compared with water injection, powder injection adopts freeze-drying production process, and the drug is dried in a closed container at low temperature under vacuum, so that the drug is not easy to oxidize and avoid decomposition due to high heat; the freeze-dried powder preparation made by freeze-drying, the finished product Low...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K47/10A61K31/196A61P7/10
Inventor 王志涛林密林小雪
Owner HAINAN GENERAL & KANGLI PHARMA
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