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Clarithromycin freeze-dried injection and preparation method thereof

A technology for clarithromycin and freeze-dried powder injection, which is applied in the field of clarithromycin freeze-dried powder for injection and its preparation, can solve the problems of poor stability, poor water solubility, limitation and the like of injection liquid, and achieves good stability and low content of related substances. , the effect of less excipients

Active Publication Date: 2015-04-29
南通丝乡丝绸有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The drug effect of clarithromycin can be better exerted by administration by injection route, but due to its poor water solubility, the solubility of clarithromycin in water is 1:1000, which limits it to be made into an injection form
At present, in addition to solid preparations, various dosage forms including injections have also been developed at home and abroad, but most of the injections have poor stability

Method used

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  • Clarithromycin freeze-dried injection and preparation method thereof
  • Clarithromycin freeze-dried injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Clarithromycin: 28g

[0024] Ascorbic acid and lactic acid: 20g ascorbic acid + 10g lactic acid

[0025] Macrogol 4000: 63g

[0026] PH regulator: appropriate amount

[0027] Water for injection: 2000ml

[0028] Process:

[0029] 1. Take the prescribed amount of ascorbic acid and lactic acid, add 50% water for injection, heat to 50-55°C, stir to dissolve, take the prescribed amount of clarithromycin and add it to the solution, stir to dissolve and continue to stir for 15 minutes.

[0030] 2. Take the prescribed amount of polyethylene glycol 4000, add 40% water for injection, stir for 15 minutes, and adjust the pH to 3.0-3.5 with hydrochloric acid.

[0031] 3. Combine solutions 1 and 2, adjust the pH to 4.3-4.5 with a pH regulator (sodium hydroxide solution), add water for injection to the full amount, add 0.15% activated carbon for needles, stir for 25 minutes, filter for decarburization, intermediate Inspection, after passing the test, use a 0.22 μm filter membran...

Embodiment 1

[0033] Clarithromycin: 28g

[0034] Ascorbic acid and lactic acid: 20g ascorbic acid + 10g lactic acid

[0035] PH regulator: appropriate amount

[0036] Water for injection: 2000ml

[0037] Process:

[0038] 1. Take the prescribed amount of ascorbic acid and lactic acid, add 80% water for injection, heat to 50-55°C, stir to dissolve, take the prescribed amount of clarithromycin, add it to the solution, stir to dissolve and continue to stir for 15 minutes.

[0039] 2. Use a pH regulator (sodium hydroxide solution) to adjust the pH to 4.3-4.5, add water for injection to the full amount, add 0.15% activated carbon for needles, stir for 25 minutes, filter for decarburization, check the intermediate, and use 0.22 μm after passing the test Membrane filter to sterilize, pour the filtrate into vials, and freeze-dry to obtain freeze-dried powder injections, which are packaged after passing the inspection.

Embodiment 2

[0041] Clarithromycin: 28g

[0042] Macrogol 4000: 63g

[0043] pH regulator: appropriate amount

[0044] Water for injection: 2000ml

[0045] Process:

[0046] 1. Take the prescribed amount of polyethylene glycol 4000, add 80% water for injection, stir for 15 minutes, and adjust the pH to 3.0-3.5 with hydrochloric acid. Add the prescribed amount of clarithromycin into the solution, stir to dissolve and continue to stir for 15 minutes.

[0047] 2. Use a pH regulator (sodium hydroxide solution) to adjust the pH to 4.3-4.5, add water for injection to the full amount, add 0.15% activated carbon for needles, stir for 25 minutes, filter for decarburization, check the intermediate, and use 0.22 μm after passing the test Membrane filter to sterilize, pour the filtrate into vials, and freeze-dry to obtain freeze-dried powder injections, which are packaged after passing the inspection.

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Abstract

The invention relates to clarithromycin freeze-dried powder injection, which is prepared from the following raw materials: 28g clarithromycin, 20g ascorbic acid, 10g lactic acid, 63g polyethylene glycol 4000, 2000ml water for injection; the pH is adjusted to 4.3-4.5.

Description

technical field [0001] The invention relates to a clarithromycin freeze-dried powder injection and a preparation method thereof. Background technique [0002] Clarithromycin is a fourteen-membered ring semisynthetic erythromycin derivative with a chemical name of 6-O-methylerythromycin. Its antibacterial spectrum is similar to that of erythromycin, including most Gram-positive bacteria and Many Gram-negative bacteria. Compared with erythromycin, clarithromycin is more stable to acid, has enhanced antibacterial activity, improved oral bioavailability, increased blood concentration, and better gastrointestinal compatibility. It is a commonly used antibacterial drug in clinical practice. [0003] The traditional dosage forms of clarithromycin are ordinary tablets, sustained-release tablets, capsules, granules, dry suspensions and intravenous injections. The drug effect of clarithromycin can be better exerted by administration by injection route, but due to its poor water solu...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/7048A61K47/22A61K47/12A61K47/34A61P31/04
Inventor 金春来
Owner 南通丝乡丝绸有限公司