Antibacterial clindamycin phosphate powder injection and its preparing process

A technology of clindamycin phosphate and powder injection, which is applied in the direction of antifungal agents, powder delivery, carbohydrate active ingredients, etc., can solve the problems of poor stability and solubility of preparations, and achieve good stability and good curative effect Effect

Inactive Publication Date: 2002-03-06
JIANGSU JIUXU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The technical problem to be solved by the present invention is to provide a safe, stable, fast-dissolving, clear solution of clindamycin

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0015] Example (1) Formula: Clindamycin Phosphate 97.3%

[0016] Poloxamer 0.2%

[0017] Sodium Hydroxide 2.5%

[0018] Preparation method 1: first dissolve 0.2% poloxamer in an appropriate amount of water for injection, then add 97.3% clindamycin phosphate and stir evenly, then add 2.5% sodium hydroxide solution to adjust the pH value to 5.0- 7.0, filtration, sterile filtration, spray drying, or recrystallization from organic solvents, crushing, and sieving to obtain sterile powders, aseptically subpackaged, and sealed with glands to obtain the finished product.

[0019] Preparation method 2: first dissolve 0.2% poloxamer in an appropriate amount of water for injection, then add 97.3% clindamycin phosphate and stir well, then add 2.5% sodium hydroxide solution to adjust the pH value to 5.0-7.0 , filtered, sterile filtered, divided into sterile vials, vacuum freeze-dried, and sealed with a gland to obtain the finished product.

[0020] Em...

Embodiment ( 5

[0035] Embodiment (five) formula: clindamycin phosphate 82%

[0036] Tween 80 10%

[0037] Sodium Hydroxide 8%

[0038] Preparation method 1: first dissolve 10% Tween 80 in an appropriate amount of water for injection, then add 82% clindamycin phosphate and stir evenly, then add 8% sodium hydroxide solution to adjust the pH value to 5.0-7.0 , filtered, aseptically filtered, spray-dried, or recrystallized from an organic solvent, pulverized, sieved to obtain a sterile powder, aseptically packaged, and sealed with a gland to obtain the finished product.

[0039] Preparation method 2: first dissolve 10% Tween 80 in an appropriate amount of water for injection, then add 82% clindamycin phosphate and stir evenly, then add 8% sodium hydroxide solution to adjust the pH value to 5.0-7.0, Filtration, sterile filtration, packaging in sterile vials, vacuum freeze-drying, and sealing with a cap to obtain the finished product.

[0040] Embodiment (6) form...

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PUM

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Abstract

An antibacterial clidamycin phosphate powder injection for treating infective diseases caused by gram-positive bacteria or anaerobic bacteria contains clindamycin phosphate (77-97.3%), the surfactant(Poloxamet 188 or Tween 80) for speeding up dissolving of clindamycin phosphate, and optional sodium hydroxide (25-8%) for regulating pH value. Its advantages are high safety and stability, high dissolving speed and high clearness of its solution.

Description

technical field [0001] The invention relates to an antibacterial clindamycin phosphate powder injection and a preparation method thereof. It can be widely used in the treatment of various infectious diseases caused by Gram-positive bacteria and anaerobic bacteria. Background technique [0002] Clindamycin phosphate is a derivative of clindamycin, which is clinically used to treat various infectious diseases caused by Gram-positive bacteria and anaerobic bacteria. At present, there are aqueous injections, transfusions, sterile subpackaged powder injections, freeze-dried powder injections, etc. on the market. Clindamycin phosphate is less stable, and infusion solutions and water injections need to be heated and sterilized during the preparation process, resulting in drug decomposition and damage, and long-term storage will also hydrolyze, producing some decomposition products, which affect the safety of medication. Moreover, since clindamycin phosphate is also relatively poo...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K31/70A61P31/10
Inventor 李宏
Owner JIANGSU JIUXU PHARMA
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