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Preparation method of furosemide freeze-dried powder injection

A technology of freeze-dried powder injection and furosemide, which is applied in the field of preparation of furosemide freeze-dried powder injection, can solve the problems of long sealed storage period, small loss of active ingredients, and inability to control the uniformity of furosemide, so as to reduce Effect of reconstitution time

Inactive Publication Date: 2015-11-11
HUNAN KELUN PHARMA
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  • Summary
  • Abstract
  • Description
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  • Application Information

AI Technical Summary

Problems solved by technology

During the freeze-drying process, the water directly sublimes without going through the liquid state, so that the physical and chemical properties and shape of the dried material are basically unchanged, the loss of active ingredients is small, and the sealed storage period is long
[0004] However, the existing preparation method cannot control the uniformity of furosemide in the product, so that the product is agglomerated or incompletely dissolved during use, so that the obtained product has the problem of long reconstitution time, which is not conducive to the clinical application of the product

Method used

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Examples

Experimental program
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Effect test

preparation example Construction

[0029] The invention provides a preparation method of furosemide freeze-dried powder injection, which comprises the following steps:

[0030] a) Mix furosemide, alkaline solution and first water for injection, adjust the pH value and mix with excipients to obtain mixed solution A;

[0031] b) Mixing the mixed solution A with the second water for injection, followed by filtering, freezing and drying to obtain furosemide lyophilized powder injection;

[0032] The mass ratio of the first water for injection to the second water for injection is 5: (4-6).

[0033] In the present invention, furosemide, alkaline solution and first water for injection are mixed, pH is adjusted and then mixed with excipients to obtain mixed solution A. The present invention first mixes furosemide, alkaline solution and first water for injection. In the present invention, the furosemide is the main drug. The source of the furosemide is not particularly limited in the present invention, and commercially availab...

Embodiment 1

[0052] To prepare 1,000 furosemide freeze-dried powder injections with a specification of 20 mg / bottle:

[0053] (1) First, add 20g furosemide and 10g sodium hydroxide solution with a mass concentration of 0.4% to 1000g water for injection, stir at 40°C to obtain a mixed solution of furosemide and sodium hydroxide; then use 1mol / The pH of L hydrochloric acid was adjusted to 9; then 80g of mannitol was added to stir the solvent; 1.5g of activated carbon was added and stirred for 15min, after which the titanium rod was decarbonized to obtain a mixed solution A.

[0054] (2) Mix the above-mentioned mixed solution A with 1000g of water for injection, then pass through 0.45μm microporous filter element and 0.22μm microporous filter element, then fill and semi-press stopper; then put the product in the freeze dryer, Frozen at -43°C for 1.5h, then controlled the heating rate to 7°C / h and heated to 35°C, then dried for 3h to obtain furosemide freeze-dried powder injection. Observe that th...

Embodiment 2

[0057] To prepare 1,000 furosemide freeze-dried powder injections with a specification of 20 mg / bottle:

[0058] (1) First, add 20g furosemide and 10g sodium hydroxide solution with a mass concentration of 0.4% to 1000g water for injection, stir at 40°C to obtain a mixed solution of furosemide and sodium hydroxide; then use 1mol / The pH of L hydrochloric acid was adjusted to 8.5; then 50g of mannitol was added to stir the solvent; 1.5g of activated carbon was added and stirred for 15min, after which the titanium rod was decarbonized to obtain a mixed solution A.

[0059] (2) Mix the above-mentioned mixed solution A with 1000g of water for injection, then pass through 0.45μm microporous filter element and 0.22μm microporous filter element, then fill and semi-press stopper; then put the product in the freeze dryer, Frozen at -40°C for 2h, then controlled the heating rate to 7°C / h and heated to 30°C, then dried for 5h to obtain furosemide freeze-dried powder injection. Observe that th...

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Abstract

The invention provides a preparation method of furosemide freeze-dried powder injection. The method comprises the following steps: a, mixing furosemide, an alkaline solution and first water for injection, and then mixing with an excipient after performing pH value adjustment, so as to obtain a mixed solution A; b, mixing the mixed solution A with second water for injection, and sequentially filtering, freezing and drying, so as to obtain the furosemide freeze-dried powder injection; the mass ratio of the first water for injection and the second water for injection is 5:(4 to 6). Compared with the prior art, the preparation method provided by the invention can effectively control the uniformity of the furosemide in the furosemide freeze-dried powder injection, and the redissolving time of products can be reduced. Experimental results show that, the redissolving time of furosemide freeze-dried powder injection obtained by adopting the preparation method provided by the invention is within 3 seconds.

Description

Technical field [0001] The invention relates to the technical field of pharmaceutical preparations, and more specifically, to a preparation method of furosemide freeze-dried powder injection. Background technique [0002] Furosemide is a diuretic, which mainly inhibits the effect of the ascending branch of the medullary loop of the kidney and the cortex on Cl - And Na + Reabsorption, promote Cl - , Na + , K + Diuretic due to the excretion of large amounts of water. It is clinically used to treat cardiac edema, renal edema, cirrhotic ascites, and peripheral edema caused by pulmonary edema, cerebral edema, acute renal failure or vascular wall disorders. [0003] At present, furosemide has been made into various pharmaceutical dosage forms for clinical treatment. Among them, furosemide for injection is the most commonly used and has a large market demand. Its indications include: (1) Edema diseases, including congestive heart failure Liver cirrhosis and kidney disease (nephritis and ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/341A61P7/10
Inventor 李全学余泽勇廖孝曙逯佩荣刘志军彭朝晖寻中华陈杨柳刘思川程志鹏万阳浴葛均友
Owner HUNAN KELUN PHARMA
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