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Preparation method of imipenem-cilastatin sodium sterile powder

The technology of cilastatin sodium and imipenem is applied in the field of preparing imipenem and cilastatin sodium aseptic powder, which can solve the problems of easy oxidative decomposition of active ingredients and the like, and achieves the advantages of being favorable for dispensing, having good fluidity, The effect of increasing the specific surface area

Active Publication Date: 2015-11-18
LUNAN BETTER PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0011] The invention provides a method for preparing imipenem and cilastatin sodium aseptic powder, which has the advantage of solving the problem of uniform mixing of imipenem and cilastatin sodium, and also solving the problem that the active ingredient is easily mixed during long-term storage. The problem of oxidative decomposition

Method used

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  • Preparation method of imipenem-cilastatin sodium sterile powder
  • Preparation method of imipenem-cilastatin sodium sterile powder
  • Preparation method of imipenem-cilastatin sodium sterile powder

Examples

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Embodiment 1

[0025] (1) Imipenem and cilastatin sodium are dissolved in the solvent in a weight ratio of 1:1, and the solution is sterilized and filtered with a 0.22um microporous membrane for subsequent use; the solvent used is water: acetone=1 :10. (2) Sterilize the cabinet of the spray dryer with pure steam hot-pressing at a sterilization temperature of 121° C. and a sterilization time of 20 minutes. After sterilization, dry it with nitrogen gas and cool it down for use. (3) Heat the feed liquid in (1) to 50°C, feed it into a spray dryer, and spray dry it under the condition of 50°C and nitrogen purging, and the pressure in the drying box is 350kPa. After the uniform granules were obtained, the moisture content, organic solvent residue, imipenem and cilastatin sodium in the granules were determined. (4) Pack the above-mentioned qualified particles into clean vials under the protection of nitrogen gas, fill the bottles with nitrogen gas, press the rubber stopper tightly, and roll the al...

Embodiment 2

[0027] (1) Dissolve imipenem and cilastatin sodium in a solvent in a weight ratio of 1:1, and filter the solution with a 0.22um microporous membrane for sterilization; for subsequent use; the solvent used is water: tert-butanol =1:30. (2) Sterilize the cabinet of the spray dryer with pure steam hot-pressing at a sterilization temperature of 121° C. and a sterilization time of 20 minutes. After sterilization, dry it with nitrogen gas and cool it down for use. (3) Heat the feed liquid in (1) to 55°C, feed it into a spray dryer, and spray dry it under the condition of 55°C and nitrogen purging, and the pressure in the drying box is 450kPa. After the uniform granules were obtained, the moisture content, organic solvent residue, imipenem and cilastatin sodium in the granules were determined. (4) Pack the above-mentioned qualified particles into clean vials under the protection of nitrogen gas, fill the bottles with nitrogen gas, press the rubber stopper tightly, and roll the alumi...

Embodiment 3

[0029] (1) Dissolve imipenem and cilastatin sodium in a solvent in a weight ratio of 1:1, and filter the solution with a 0.22um microporous membrane for sterilization; the solvent used is water: acetone: t Butanol=1:10:10. (2) Sterilize the cabinet of the spray dryer with pure steam hot-pressing at a sterilization temperature of 121° C. and a sterilization time of 20 minutes. After sterilization, dry it with nitrogen gas and cool it down for use. (3) Heat the feed liquid in (1) to 60°C, feed it into a spray dryer, and carry out spray drying under the condition of 60°C and nitrogen purging, and the pressure in the drying oven is 500kPa. After the uniform granules were obtained, the moisture content, organic solvent residue, imipenem and cilastatin sodium in the granules were determined. (4) Pack the above-mentioned qualified particles into clean vials under the protection of nitrogen gas, fill the bottles with nitrogen gas, press the rubber stopper tightly, and roll the alumin...

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Abstract

The invention provides a preparation method of imipenem-cilastatin sodium sterile powder. With the adoption of the preparation method provided by the present invention, the problem of difficulty in uniform mixing due to big grain diameter difference between imipenem and cilastatin sodium as well as the problem of proneness to oxidation due to sulfur contained in the components in existing preparation technology are solved through the measures of solvent adjusting, spray drying, nitrogen filling, etc.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a method for preparing imipenem cilastatin sodium sterile powder. Background technique [0002] Imipenem is a carbapenem antibiotic that has antibacterial effects on Gram-positive and negative aerobic and anaerobic bacteria, and is especially suitable for mixed infections caused by various pathogens and aerobic / anaerobic bacteria, and Early treatment before the pathogen is not identified. Cilastatin sodium has no antibacterial effect, and its main function is to inhibit the dehydrogenase secreted by kidney cells, block the metabolism of imipenem in the kidney, protect imipenem from hydrolysis, and then increase the urinary tract without Change the concentration of imipenem. The combination of the two at a ratio of 1:1 has played an important role in the control of drug-resistant bacteria, enzyme-producing bacteria infections and the treatment of infections in immun...

Claims

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Application Information

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IPC IPC(8): A61J3/02A61K31/407A61K9/14A61P31/04A61K31/198
Inventor 张贵民赵震震
Owner LUNAN BETTER PHARMA
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