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Clindamycin Phosphate Injection Pharmaceutical Composition and Preparation Method

A technology of clindamycin phosphate and clindamycin, which is applied in the field of medicine and can solve the problems of unfavorable complete sterilization and the reduction of clindamycin phosphate content

Active Publication Date: 2016-08-03
CHENGDU TIANTAISHAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it has been found that as the number of filtrations increases, the content of clindamycin phosphate in the liquid medicine decreases exponentially, which is unfavorable for the complete sterilization of the liquid medicine

Method used

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  • Clindamycin Phosphate Injection Pharmaceutical Composition and Preparation Method
  • Clindamycin Phosphate Injection Pharmaceutical Composition and Preparation Method
  • Clindamycin Phosphate Injection Pharmaceutical Composition and Preparation Method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0103] Embodiment 1: Clindamycin Phosphate Injection Pharmaceutical Composition

[0104] formula:

[0105]

[0106] Preparation method:

[0107] (1) Active ingredient, complexing agent, bacteriostat and 2-amino-2-hydroxymethyl-1,3-propanediol are added to the water for injection accounting for 65% of the prescription volume, stirred and dissolved, and acid-base regulator is added Adjust the pH value of the liquid medicine to the specified value;

[0108] (2) Add 0.5% activated carbon for needles of the volume of the liquid medicine, stir and absorb for 10 minutes, filter and decarbonize with filter paper, add water for injection to the full amount, check the pH value of the liquid medicine, and adjust the medicine with an acid-base regulator again if necessary The pH value of the liquid reaches the specified value;

[0109] (3) Filter the drug solution through microporous membranes (cellulose acetate membranes) of 0.8 μm, 0.45 μm, and 0.22 μm for the production of aqu...

Embodiment 2

[0137] Embodiment 2: Clindamycin Phosphate Injection Pharmaceutical Composition

[0138] formula:

[0139]

[0140] Preparation method:

[0141] (1) Active ingredient, complexing agent, bacteriostat and 2-amino-2-hydroxymethyl-1,3-propanediol are added to water for injection accounting for 50% of the prescription volume, stirred and dissolved, and acid-base regulator is added Adjust the pH value of the liquid medicine to the specified value;

[0142] (2) Add 0.5% activated carbon for needles of the volume of the liquid medicine, stir and absorb for 10 minutes, filter and decarbonize with filter paper, add water for injection to the full amount, check the pH value of the liquid medicine, and adjust the medicine with an acid-base regulator again if necessary The pH value of the liquid reaches the specified value;

[0143] (3) Filter the liquid medicine with microporous membranes (polytetrafluoroethylene membrane material) of 0.8 μm, 0.45 μm, and 0.22 μm pore sizes for ...

Embodiment 3

[0146] Embodiment 3: clindamycin phosphate injection pharmaceutical composition

[0147] formula:

[0148]

[0149] Preparation method:

[0150] (1) Active ingredient, complexing agent, bacteriostat and 2-amino-2-hydroxymethyl-1,3-propanediol are added to water for injection accounting for 80% of the prescription volume, stirred and dissolved, and acid-base regulator is added Adjust the pH value of the liquid medicine to the specified value;

[0151] (2) Add 0.5% activated carbon for needles of the volume of the liquid medicine, stir and absorb for 10 minutes, filter and decarbonize with filter paper, add water for injection to the full amount, check the pH value of the liquid medicine, and adjust the medicine with an acid-base regulator again if necessary The pH value of the liquid reaches the specified value;

[0152] (3) Filter the liquid medicine with microporous membranes (nitrocellulose membrane material) with pore sizes of 0.8 μm, 0.45 μm, and 0.22 μm for the ...

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Abstract

The invention relates to a pharmaceutical composition and a preparation method of clindamycin phosphate injection. Specifically, the present invention belongs to the field of medical technology, and relates to a pharmaceutical composition for injection and a preparation process thereof, in particular to a pharmaceutical composition for clindamycin injection and a preparation method thereof, more particularly to a Clindamycin phosphate injection pharmaceutical composition and its preparation method. In one embodiment, the pharmaceutical composition of clindamycin phosphate injection of the present invention comprises clindamycin phosphate, complexing agent, bacteriostat, acid-base regulator and water for injection. The pharmaceutical composition of clindamycin phosphate injection for injection of the present invention has remarkable and excellent pharmaceutical properties.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a pharmaceutical composition for injection and a preparation process thereof, in particular to a pharmaceutical composition for clindamycin injection and a preparation method thereof, more particularly to a clindamycin Phosphate ester injection pharmaceutical composition and its preparation method. The pharmaceutical composition of clindamycin phosphate injection for injection of the present invention has remarkable and excellent pharmaceutical properties. Background technique [0002] Clindamycin, also known as clindamycin, was first synthesized by Magerlein et al. in 1966. Upjohn Corporation of the United States first successfully developed it and obtained a patent right in the United States in 1969. In 1975, it was jointly developed by North China Pharmaceutical Factory and Beijing Pharmaceutical Industry Research Institute in China. [0003] Clinically commonly used clindamy...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/18A61K31/7056A61P31/04
Inventor 江威王敬伍隆霞左伟方专赵东明
Owner CHENGDU TIANTAISHAN PHARMA
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