Preparation method of clindamycin phosphate powder injection

The technology of phosphate powder injection and clindamycin is applied in the directions of medical preparations containing active ingredients, powder delivery, pharmaceutical formulations, etc., which can solve the problems of intolerance to patients, high local irritation, and reduced product safety, etc. To achieve the effect of reducing hydrolysis and degradation reactions, high bioavailability and good stability

Active Publication Date: 2005-04-06
ZHUHAI EBANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Clindamycin phosphate is a lactone compound, which is easy to degrade in water, and its hydrolyzed products are more toxic than clindamycin phosphate, and the structure and pharmacological properties of many other degradation products are not clear, which may affect medication safety
The aqueous solution of clindamycin phosphate used in reported dosage forms such as clindamycin phosphate aqueous injection and large infusion has many deficiencies: the phosphate group in the chemical structure of clindamycin phosphate has a certain amount in the aqu

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Embodiment 1: Preparation of Clindamycin Phosphate Powder Injection (Specification: 148.5mg / support)

[0024] Use pure water to make absolute ethanol into an ethanol solution with a concentration of 75% for subsequent use, take the prescribed amount of clindamycin phosphate, add 5 times the amount of ethanol solution of the above concentration, stir until dissolved, press clindamycin phosphate The amount of 0.02% g / v of the ethanol solution is added to activated carbon for decolorization for 25 minutes, and after rough filtration with a diatomaceous earth filter or a titanium filter, under a sterile environment (local grade 100), fine filtration with a 0.15 μm filter membrane, Place the crystallization, remove the supernatant, repeat the crystallization once in the same way, filter with a filter cloth, dry at 60°C, crush, subpackage in a sterile environment (partial 100 grade), make 148.5mg / bottle, roll the cap , ready to pack.

Embodiment 2

[0025] Embodiment 2: Preparation of Clindamycin Phosphate Powder Injection (Specification: 1426mg / support)

[0026] Use water for injection to make absolute ethanol into an ethanol solution with a concentration of 85% for later use, take the prescribed amount of clindamycin phosphate, add 8 times the amount of ethanol solution of the above concentration, stir until dissolved, press clindamycin phosphate The amount of 0.08% g / v of the ethanol solution is added to activated carbon for decolorization for 50 minutes, after coarse filtration with a diatomaceous earth filter or a titanium filter, under a sterile environment (local 100 grade), fine filtration with a 0.45 μm filter membrane, Place the crystallization, remove the supernatant, repeat the crystallization once in the same way, filter with a filter cloth, dry at 80°C, crush, subpackage in a sterile environment (partial 100 grade), make 1426mg / bottle, roll the cap, Ready to serve.

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PUM

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Abstract

The invention relates to a method for preparing clindamycin phosphate powder filling agent, including: adding and dissolve clindamycin phosphate in alcohol solution; adding in activated charcoal to make decolorization, then roughly filtering, finely filtering, and placing to crystallize, filtering to eliminate supernatant and obtaining clindamycin phosphate crystal; then making transfer-solution for the second time, recrystallizing once, filtering and obtaining the recrystallized clindamycin phosphate crystal; drying and crushing, making split charging, capping and packaging in aseptic condition and making it. In the preparing course, it needs no high temperature treatment, need not add in additive, and its powder has good fluidity, high purity, few impurities, high bio-capability and good stability. It has no anaphylaxis and hemolysis and has no stimulation to blood vessels by intravenous injection. It adds a new clinic form of clindamycin phosphate, meeting clinic requirement.

Description

technical field [0001] The invention belongs to the technical field of medicine preparation, and particularly relates to a preparation method of a preparation for treating infectious diseases caused by Gram-positive bacteria and infectious diseases caused by anaerobic bacteria. Background technique [0002] Clindamycin Phosphate is a derivative of lincomycin, which is produced by clindamycin through a semi-synthetic method. This product was first successfully developed by Magerlein in 1966. It has no activity in vitro and is rapidly hydrolyzed after being injected into the body. As clindamycin, it exerts pharmacological effects, and its mechanism of action is to inhibit bacterial protein synthesis. This product has the same antibacterial spectrum, antibacterial activity and therapeutic effect as clindamycin. It mainly has antibacterial activity against Gram-positive bacteria such as Staphylococcus aureus, pneumococcus and hemolytic streptococcus and most anaerobic bacteria. ...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K31/7056A61P31/04
Inventor 庄洪波
Owner ZHUHAI EBANG PHARMA
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