A kind of doripenem for injection and preparation method thereof

A technology for doripenem and injection, applied in the field of medicine, can solve the problems of unstable preparation, difficulty in reconstitution of doripenem and the like

Active Publication Date: 2022-07-01
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] Aiming at the technical problems existing in the above-mentioned commercially available products, the present invention provides a kind of doripenem for injection and its preparation method, which has the advantage of solving the problem of difficult reconstitution of doripenem for injection, and also solves the problem of doripenem for injection When penem is stored for a long time, the preparation is unstable, and the ring-opening substances, related substances, and polymers in the preparation gradually increase, which improves the stability of the product and the safety of the drug

Method used

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  • A kind of doripenem for injection and preparation method thereof
  • A kind of doripenem for injection and preparation method thereof
  • A kind of doripenem for injection and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0024] (1) Doripenem of 500g and sodium bicarbonate of 50g are dissolved in the mixed solvent of 50L of water and methanol (the volume ratio of water: methanol is 1:7), and the obtained solution is filtered with a 0.22um microporous membrane Sterilized and filtered, ready for use.

[0025] (2) Autoclave the spray-dried cabinet body with pure steam, the sterilization temperature is 121°C, and the sterilization time is 15 minutes.

[0026] (3) The feed liquid in (1) was heated to 45°C, fed into a spray dryer, and spray-dried at 45°C under nitrogen purging, and the drying time was 8h.

[0027] (4) Under the protection of nitrogen, the obtained granules are divided into clean vials, each bottle contains 0.25g, the bottle is filled with nitrogen, and then the rubber stopper is pressed tightly, and the aluminum cap is rolled outside.

Embodiment 2

[0029] (1) Doripenem of 500g and sodium bicarbonate of 25g are dissolved in the mixed solvent (water: the volume ratio of isopropanol is 1:27) of the water of 50L, isopropanol, gained solution is used 0.22um Microporous membrane sterilization filtration, spare.

[0030] (2) Sterilize the spray-dried cabinet body with pure steam autoclave, the sterilization temperature is 121°C, and the sterilization time is 30 minutes.

[0031] (3) The feed liquid in (1) was heated to 65°C, fed into a spray dryer, and spray-dried at 65°C under nitrogen purging, and the drying time was 10h.

[0032] (4) Under the protection of nitrogen, the obtained granules are divided into clean vials, each bottle contains 0.25g, the bottle is filled with nitrogen, and then the rubber stopper is pressed tightly, and the aluminum cap is rolled outside.

Embodiment 3

[0034] (1) Dissolve 500 g of doripenem and 37.5 g of sodium bicarbonate in a mixed solvent of 50 L of water: methanol: isopropanol (the volume ratio of water: methanol: isopropanol is 1:15:15) , the obtained solution was sterilized and filtered with a 0.22um microporous membrane for use.

[0035] (2) Sterilize the spray-dried cabinet with pure steam by autoclaving, the sterilization temperature is 121°C, and the sterilization time is 20 minutes. (3) The feed liquid in (1) was heated to 55°C, fed into a spray dryer, and spray-dried at 55°C under nitrogen purging, and the drying time was 9h.

[0036] (4) Under the protection of nitrogen, the obtained granules are divided into clean vials, each bottle contains 0.25g, the bottle is filled with nitrogen, and then the rubber stopper is pressed tightly, and the aluminum cap is rolled outside.

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Abstract

The invention provides doripenem for injection, which specifically contains any one of doripenem and stabilizer sodium bicarbonate or sodium citrate. The present invention obtains drug particles with uniform particle size, regular shape and excellent fluidity through measures such as spray drying, nitrogen filling, etc., which is convenient for industrialized large-scale production, and obviously reduces the production of doripenem polymer and related substances; Reconstituted quickly, which is beneficial for medical staff to dispense medicines.

Description

technical field [0001] The invention relates to a doripenem for injection and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Doripenem Chemical Name: (+)-(4R,5S,6S)-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-3-[[ (3S,5S)-5-[(Aminosulfonamido)-methyl]-3-pyrrolidinyl]thio]-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid monohydrate The chemical structure is as follows: [0003] [0004] The antibacterial mechanism of doripenem is the same as that of other β-lactam antibiotics, and it inhibits bacterial cell wall synthesis by binding to bacterial penicillin binding proteins (PBPs). This product has a very high affinity with S.aureus, E.coli, P.aeruginosa and other sensitive bacteria PBPs. Doripenem is stable to most beta-lactamases, including penicillinase, cephalosporinase, and extended-spectrum beta-lactamases (ESBLs). Doripenem is stable to human dehydropeptidase (DHP-1) and is not hydrolyzed by DHP-1 in vivo, so ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K31/407A61K47/02A61K47/12A61P31/04
CPCA61K9/0019A61K9/1611A61K9/1617A61K31/407
Inventor 张贵民孙宗彬于龙环朱鹏
Owner SHANDONG NEWTIME PHARMA
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