Method for preparing clindamycin hydrochloride powder for injection

A technology of clindamycin hydrochloride and powder injection is applied in the field of preparation of pharmaceutical preparations, and can solve the problems of unclear structure and pharmacological properties of degradation products, poor stability of clindamycin hydrochloride, and increased degradation of clindamycin hydrochloride, etc. To meet clinical needs, the powder has good fluidity and less impurities.

Inactive Publication Date: 2006-08-09
王冕
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Clindamycin hydrochloride has poor stability in aqueous solution, and the structure and pharmacological properties of many degradation products are not clear, which may affect the safety of medication. Its injection needs to be stored in a cool place, causing inconvenience to transportation and storage
In the preparation process of clindamycin hydrochloride aqueous injection, a certain amount of additives such as isotonic agent, pH regulator and antioxidant are added. The security is reduced, which affects the stability of the product
Freeze-dried preparations are more stable than injections, easy to store and transport, and are beneficial to ensuring the quality of medicines, but the cost is high. Therefore, there is an urgent need to develop cheap and stable clindamycin hydrochloride preparations clinically.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Embodiment 1: Preparation of clindamycin hydrochloride powder injection (specification: 600mg / support)

[0024] Take the prescribed amount of clindamycin hydrochloride, add 800ml of water for injection at 70°C, stir to dissolve, add 3% active carbon for needles, stir and absorb for 30 minutes, coarsely filter with a diatomaceous earth filter and a titanium filter, and put it in a sterile Under the environment (local grade 100), fine filter with a 0.45μm filter, add 3500ml of acetone to the filtrate and heat it up to 55°C to dissolve, add 100g of activated carbon, filter it with a funnel while it is hot, add 8000ml of acetone under stirring, and put it in a clean room for 5- Place the crystals at 10°C, filter with a vertical melting funnel, dry at 80°C, pulverize, subpackage in a sterile environment (partially grade 100), make 600mg / bottle, crimp the cap, and pack.

Embodiment 2

[0025] Embodiment 2: Preparation of clindamycin hydrochloride powder injection (specification: 600mg / support)

[0026] Take the prescribed amount of clindamycin hydrochloride, add 900ml of ethanol at 60°C, stir to dissolve, add 3% activated carbon for needles, stir and absorb for 25 minutes, use a diatomaceous earth filter and a titanium filter to coarsely filter, and place in a sterile environment (partial 100 grade), use 0.45μm microporous filter membrane for fine filtration, add 4000ml of acetone to the filtrate and heat up to 50°C to dissolve, add 150g of activated carbon, filter it with a vertical dissolution funnel while it is hot, and add 8000ml of acetone under stirring in the clean room for 5 Place the crystals at -10°C, filter with a vertical melting funnel, dry at 83°C, pulverize, subpackage in a sterile environment (partially grade 100), make 600mg / bottle, crimp the cap, and pack.

Embodiment 3

[0027] Embodiment 3: Preparation of clindamycin hydrochloride powder injection (specification: 600mg / support)

[0028] Take the prescribed amount of clindamycin hydrochloride, add 750ml of water for injection at 75°C, stir to dissolve, add 3.5% active carbon for needles, stir and absorb for 25 minutes, and use a diatomite filter and a titanium filter to coarsely filter it, and put it in a sterile Under the environment (local grade 100), fine filter with a 0.45μm filter, add 3500ml of acetone to the filtrate and heat it up to 55°C to dissolve, add 100g of activated carbon, filter it with a funnel while it is hot, add 8000ml of acetone under stirring, and put it in a clean room for 5- Place the crystals at 10°C, filter with a vertical melting funnel, dry at 80°C, pulverize, subpackage in a sterile environment (partially grade 100), make 600mg / bottle, crimp the cap, and pack.

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PUM

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Abstract

The present invention discloses a preparation method of clindamycin hydrochloride powder injection. Said preparation method includes the following steps: (1) adding solvent to dissolve clindamycin hydrochloride; (2), decoloring the dissolved solution and filtering; (3), fine filtering the above-mentioned filtrate under the condition of sterile environment to obtain fine filtrate; (4), adding acetone into the fine filtrate, heating, dissolving, adding active carbon and filtering; (5), standing still to obtain clindamycin crystal; and (6), drying, pulverizing and filling so as to obtain the invented product.

Description

technical field [0001] The invention belongs to a preparation method of a pharmaceutical preparation, in particular 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 hydrochloride is a derivative obtained by replacing the hydroxyl group at the 7-position of lincomycin with chlorine. It was first synthesized by Magerlein et al. in 1966. This product is a lincomycin antibiotic, and its antibacterial activity is higher than Mycin is 4-8 times stronger. Clindamycin inhibits bacterial protein synthesis by binding to the ribosomal 50S subunit, preventing peptide chain elongation. It has excellent curative effect on Gram-positive bacteria such as Staphylococcus spp. (including penicillin-resistant strains), Streptococcus spp., Escherichia coli, Bacillus tetani, pneumococcus, Clostridium welchii, and a few actinomycetes, and is als...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/7056A61K9/14A61P31/04
Inventor 王冕魏锐
Owner 王冕
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