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Clindamycin hydrochloride injection and preparation method thereof

A technology of clindamycin hydrochloride and clindamycin, which can be applied to pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc., can solve the risk of increasing drug safety and increase the cost of drug production , poor process reproducibility and other problems, to achieve the effect of reducing drug safety, reducing the risk of adverse reactions, and stable product quality

Active Publication Date: 2010-06-30
HAINAN LEVTEC PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] Existing technology or adding stabilizers, special excipients and other auxiliary materials in the prescription; or adopting ultrafiltration and nano preparations in the process that require high equipment, which increases the production cost of the drug, and the process reproducibility is poor. The rate is low, which greatly increases the risk of drug safety in clinical use

Method used

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  • Clindamycin hydrochloride injection and preparation method thereof
  • Clindamycin hydrochloride injection and preparation method thereof
  • Clindamycin hydrochloride injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Embodiment 1: Clindamycin hydrochloride freeze-dried powder injection

[0044] Clindamycin hydrochloride 300g (calculated as clindamycin)

[0045] Acetic acid-sodium acetate buffer

[0046] Add water for injection to 1500ml

[0047]

[0048] Made 1000 pieces

[0049] Preparation process: In the clean area, first prepare the acetic acid-sodium acetate buffer solution, weigh the prescribed amount of clindamycin hydrochloride and dissolve it in an appropriate amount of water for injection, stir to dissolve, and adjust with the prepared acetic acid-sodium acetate buffer solution The pH value of the solution is 4.5, add 0.2% activated carbon to the total weight of the solution, add water for injection to the full amount, stir at room temperature for 20 minutes, and circulate for 10 minutes. The filtrate is tested for content, density, endotoxin, acidity, clarity, etc., and filled after passing the test; freeze-dried, plugged out of th...

Embodiment 2

[0050] Embodiment 2 Clindamycin hydrochloride freeze-dried powder injection

[0051] Clindamycin hydrochloride 300g (calculated as clindamycin)

[0052] Sodium acetate 7.2g

[0053] Acetic acid 4.0ml

[0054] Add water for injection to 1500ml

[0055]

[0056] Made 1000 pieces

[0057] Preparation process: In a clean area, first take an appropriate amount of water for injection and put it into a concentrated preparation tank, add the prescribed amount of clindamycin hydrochloride, and stir until completely dissolved. Dissolve the prescribed amount of acetic acid and sodium acetate in an appropriate amount of water for injection, stir to dissolve, add to the concentrated preparation tank, and stir evenly; add water for injection to the full amount, weigh 0.2% (W / V) of liquid amount of activated carbon and add to the concentrated Prepare the tank, stir and decolorize at room temperature for 25 minutes, then recirculate and stir for 15 ...

Embodiment 3

[0058] Embodiment 3 Clindamycin hydrochloride freeze-dried powder injection

[0059] Clindamycin hydrochloride 450g (calculated as clindamycin)

[0060] Acetic acid-sodium acetate buffer

[0061] Add water for injection to 2250ml

[0062]

[0063] Made 1000 pieces

[0064] Preparation process: In the clean area, first prepare the acetic acid-sodium acetate buffer solution, weigh the prescribed amount of clindamycin hydrochloride and dissolve it in an appropriate amount of water for injection, stir to dissolve, and adjust with the prepared acetic acid-sodium acetate buffer solution The pH value of the solution is 4.0, add 0.2% activated carbon, add water for injection to the full amount, stir and decolorize at room temperature for 20 minutes, recirculate and stir for 10 minutes, first coarse filter to remove carbon, and then fine filter with a 0.22 μm filter membrane; take the fine filtrate for assay , density, endotoxin, acidity, c...

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Abstract

The invention discloses a clindamycin hydrochloride injection and a preparation method thereof. The preferred preparation formulation is injection and lyophilized powder. The clindamycin hydrochloride injection composition consists of clindamycin hydrochloride as an active ingredient and moderate buffer salt. The solvent of the invention is only water for injection and has no any other organic solvents, and the lyophilized powder does not contain excipients. The clindamycin hydrochloride injection has the advantages that: firstly, the formula is simple, the species of excipients are few, and the excipients belong to the medicinal injection grade, are commonly used medicinal excipients, meet the requirements of intravenous injection medication of human bodies, and greatly reduce the risk of potential adverse reaction in clinical use; secondly, the product quality is very stable, the long-term 2-year experiment shows that the product quality has a little change, so that the product can meet the needs of industrialized mass production.

Description

technical field [0001] The invention relates to a clindamycin hydrochloride injection and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] The chemical name of clindamycin hydrochloride is: 6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-7(S)-chloro-6, 7,8-trideoxy-L-threo-α-D-galactopyranoside hydrochloride, its chemical structural formula: [0003] [0004] Clindamycin hydrochloride is a kind of lincomycin antibiotic, its antibacterial spectrum is similar to lincomycin, but its antibacterial effect is more than 4 times stronger than lincomycin. In particular, it has special effects on Staphylococcus aureus, Pneumococcus and Streptococcus, and also has a good effect on anaerobic cocci. Effective against strains resistant to lincomycin, penicillin, and erythromycin. Clinically applicable to moderate and severe infections caused by Streptococcus, Staphylococcus and anaerobic bacter...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K9/19A61K31/7056A61K47/12A61P31/04A61P11/00A61P19/08A61P15/00
Inventor 龙娇邢贞凯张必耀张志宏
Owner HAINAN LEVTEC PHARMA
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