Dextromethorphan hydrobromide injection and preparation method thereof

A technology of dextromethorphan hydrobromide and injection, which is applied in directions such as pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, can solve problems such as increased product cost, high product safety risks, and the like, To achieve the effect of less excipients, high clinical safety and good stability

Active Publication Date: 2014-01-29
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

Commercially available dextromethorphan hydrobromide injections often add a large number of excipients to obtain stable dextromethorphan

Method used

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  • Dextromethorphan hydrobromide injection and preparation method thereof
  • Dextromethorphan hydrobromide injection and preparation method thereof
  • Dextromethorphan hydrobromide injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Dextromethorphan hydrobromide: 15g

[0021] Lactic acid and sorbic acid: 13g lactic acid + 7g sorbic acid

[0022] Polyethylene glycol 2000: 42g

[0023] PH regulator: appropriate amount

[0024] Water for injection: 2000ml

[0025] Process:

[0026] 1. Take the prescribed amount of lactic acid and sorbic acid, add 50% water for injection, heat to 50-55°C, stir to dissolve, take the prescribed amount of dextromethorphan hydrobromide into the solution, stir to dissolve and continue to stir for 15 minutes .

[0027] 2. Take the prescribed amount of polyethylene glycol 2000, add 40% water for injection, stir for 15 minutes, and adjust the pH to 3.0-3.5 with hydrochloric acid.

[0028] 3. Combine solutions 1 and 2, adjust the pH to 3.4-3.5 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 After inspection, filter and steriliz...

Embodiment 1

[0030] Dextromethorphan hydrobromide: 15g

[0031] Lactic acid and sorbic acid: 13g lactic acid + 7g sorbic acid

[0032] PH regulator: appropriate amount

[0033] Water for injection: 2000ml

[0034] Process:

[0035] 1. Take the prescribed amount of lactic acid and sorbic acid, add 80% water for injection, heat to 50-55°C, stir to dissolve, take the prescribed amount of dextromethorphan hydrobromide into the solution, stir to dissolve and continue to stir for 15 minutes .

[0036] 2. Use a pH regulator (sodium hydroxide solution) to adjust the pH to 3.4-3.5, 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 Sterilize by filter membrane, pour into 2ml ampoules according to specifications, fill with nitrogen gas, melt seal, sterilize with damp heat at 121°C for 15 minutes, pack after passing the inspection.

Embodiment 2

[0038] Dextromethorphan hydrobromide: 15g

[0039] Polyethylene glycol 2000: 42g

[0040] pH regulator: appropriate amount

[0041] Water for injection: 2000ml

[0042] Process:

[0043] 1. Take the prescribed amount of polyethylene glycol 2000, add 80% water for injection, stir for 15 minutes, and adjust the pH to 3.0-3.5 with hydrochloric acid. Get the prescribed amount of dextromethorphan hydrobromide and add it into the solution, stir and dissolve and continue to stir for 15 minutes.

[0044] 2. Use a pH regulator (sodium hydroxide solution) to adjust the pH to 3.4-3.5, 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 Sterilize by filter membrane, pour into 2ml ampoules according to specifications, fill with nitrogen gas, melt seal, sterilize with damp heat at 121°C for 15 minutes, pack after passing the inspection.

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Abstract

The invention relates to a dextromethorphan hydrobromide injection prepared from the following raw materials: 15g of dextromethorphan hydrobromide, 13g of lactic acid, 7g of sorbic acid, 42g of polyethylene glycol 2000 and 2000ml of water for injection through adjusting the pH value to 3.4-3.5.

Description

technical field [0001] The invention relates to dextromethorphan hydrobromide injection and a preparation method thereof. Background technique [0002] Dextromethorphan hydrobromide is a derivative of dextromorphinan artificially synthesized by Hoffman Roche Company in Switzerland in 1950 by modifying the structure of morphine. Fen has no analgesic effect but has obvious antitussive effect. Animal and clinical studies have shown that dextromethorphan is an effective central antitussive, which mainly acts on the medulla oblongata cough center. It is excreted as dextromethorphan as its original form or demethyl metabolite. It has low toxicity and few adverse reactions, so it is widely used for coughs caused by various reasons. Commercially available dextromethorphan hydrobromide injections often add a large amount of auxiliary materials to obtain stable dextromethorphan hydrobromide injections, but the use of more auxiliary materials increases the cost of the product and mak...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/485A61K47/12A61K47/34A61P11/14
Inventor 金春来
Owner 南通丝乡丝绸有限公司
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