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Preparing method of freeze-dried antibiotic formulation

A drying, said technology, applied in the field of preparation of antibiotic freeze-dried dosage forms, can solve problems such as heat sensitivity and instability

Inactive Publication Date: 2005-01-26
济南久创化学有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Since imipenem and cilastatin sodium contain sulfur, they are easily combined with oxygen in the air to form form of impurity, while sensitive to heat, unstable in solution

Method used

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  • Preparing method of freeze-dried antibiotic formulation

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Effect test

Embodiment 1

[0025] Under the condition of nitrogen, 50g of sodium bicarbonate was added to 325g of water for injection, and 125g of imipenem was added, while stirring to obtain a clear solution with a pH value of 6.5-8.5. The solution was filtered with a 0.2 μm filter membrane, filled into a glass bottle, and placed in a freeze dryer (ChristAlpha1-2) to freeze-dry. -0.5 mbar) dry. After the main drying, the temperature was raised to 15° C., the vacuum degree was adjusted to 0.02 mbar, and the drying was continued for 2 hours to obtain an off-white freeze-dried product.

Embodiment 2

[0027] Under the condition of flowing nitrogen, 100 g of sodium bicarbonate was added to 500 g of water for injection, 250 g of cilastatin sodium was added, and stirred at the same time to obtain a clear solution with a pH value of 6.5-8.0. The solution was filtered with a 0.2 μm filter membrane, filled into a glass bottle, and placed in a freeze dryer (ChristAlpha1-2) to freeze-dry. The vial was cooled to -40°C, then raised to -20°C--5°C, vacuum (0.1 -0.5 mbar) dry. After the main drying, the temperature was raised to 20° C., the vacuum degree was adjusted to 0.02 mbar, and the drying was continued for 3 hours to obtain an off-white freeze-dried product.

Embodiment 3

[0029] Under nitrogen, 50g of sodium bicarbonate was added to 500g of water for injection, 125g of imipenem was added, and 125g of cilastatin sodium was added, while stirring to obtain a clear solution with a pH value of 6.5-8.5. The solution was filtered with a 0.2 μm filter membrane, filled into a glass bottle, and placed in a freeze dryer (Christ Alpha1-2) to freeze-dry. The vial was cooled to -45°C, then raised to -20°C--5°C, vacuum ( 0.1-0.5 mbar) dry. After the main drying, the temperature was raised to 15° C., the vacuum degree was adjusted to 0.02 mbar, and the drying was continued for 3 hours to obtain an off-white freeze-dried product.

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PUM

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Abstract

The invention dislcloses the process for preparing Imipenem / Cilastatin Sodiun cryodesiccation powder preparation, which is prepared from imipenem, Cilastatin Sodium or the mixture of imipenem and Cilastatin Sodium.

Description

(1) Technical field [0001] The invention belongs to a preparation method of imipenem / cilastatin sodium [Imipenem / Cilastatin Sodiun] freeze-dried powder dosage form. [0002] Imipenem (Imipenem) is a derivative of thiamycin with the molecular formula C 12 h 17 N 3 o 4 S·H 2 O, the molecular weight is 317.36. The molecular formula of cilastatin sodium is C 16 h 25 N 2 NaO 5 S, the molecular weight is 380.44. (2) Background technology [0003] Imipenem / Cilastatin Sodiun is a broad-spectrum carbapenem antibiotic. Imipenem is the first stable derivative of thiamycin and is characterized by a broader bactericidal spectrum than any other antibiotic studied. Cilastatin sodium is a specific enzyme inhibitor, which blocks the metabolism of imipenem in the kidney and makes it play a bactericidal effect. [0004] Imipenem / cilastatin sodium is currently available in powder form for intravenous infusion in China. It is mainly obtained by mixing imipenem sterile powder, cilast...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/195A61K31/407A61P31/04
Inventor 傅伟
Owner 济南久创化学有限责任公司
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