Dextromethorphan hydrobromide lyophilized powder and preparation method thereof

A technology of dextromethorphan hydrobromide and freeze-dried powder injection, which can be applied in freeze-dried delivery, powder delivery, pharmaceutical formulation and other directions, can solve the problems of high product safety risk, increase product cost, etc., and achieve high safety for clinical use, The effect of less excipients and high 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 hydrobromide injections, but the use of more excipients increases the cost of the product and makes the product have a higher safety risk

Method used

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  • Dextromethorphan hydrobromide lyophilized powder and preparation method thereof
  • Dextromethorphan hydrobromide lyophilized powder and preparation method thereof
  • Dextromethorphan hydrobromide lyophilized powder and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Dextromethorphan hydrobromide: 16g

[0021] Lactic acid and sorbic acid: 11g lactic acid + 8g sorbic acid

[0022] Polyethylene glycol 2000: 45g

[0023] PH regulator: appropriate amount

[0024] Water for injection: 2000ml

[0025] Process:

[0026] 1. Take prescription amount of lactic acid and sorbic acid, add 50% water for injection, heat to 50~55℃, stir to dissolve, add prescription amount of dextromethorphan hydrobromide to the solution, stir to dissolve and continue stirring for 15 minutes .

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

[0028] 3. Combine 1 and 2 solutions, adjust the pH to 3.3-3.6 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 and decarburize, intermediate After passing the inspection, filter and sterilize with a 0.22μm fi...

Embodiment 1

[0030] Dextromethorphan hydrobromide: 16g

[0031] Lactic acid and sorbic acid: 11g lactic acid + 8g sorbic acid

[0032] PH regulator: appropriate amount

[0033] Water for injection: 2000ml

[0034] Process:

[0035] 1. Take prescription amount of lactic acid and sorbic acid, add 80% water for injection, heat to 50~55℃, stir to dissolve, add prescription amount of dextromethorphan hydrobromide to the solution, stir to dissolve and continue stirring for 15 minutes .

[0036] 2. Adjust the pH to 3.3~3.6 with 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 and decarburize, check the intermediate, use 0.22μm after passing Sterilize through filtration membrane, pour the filtrate into a vial and freeze-dry to obtain a freeze-dried powder injection, which is packaged after passing the inspection.

Embodiment 2

[0038] Dextromethorphan hydrobromide: 16g

[0039] Polyethylene glycol 2000: 45g

[0040] pH regulator: appropriate amount

[0041] Water for injection: 2000ml

[0042] Process:

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

[0044] 2. Adjust the pH to 3.3~3.6 with 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 and decarburize, check the intermediate, use 0.22μm after passing Sterilize through filtration membrane, pour the filtrate into a vial and freeze-dry to obtain a freeze-dried powder injection, which is packaged after passing the inspection.

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Abstract

The invention relates to dextromethorphan hydrobromide lyophilized powder. The dextromethorphan hydrobromide lyophilized powder is prepared from the following raw materials: 16g of dextromethorphan hydrobromide, 11g of lactic acid, 8g of sorbic acid, 45g of polyethylene glycol 2000 and 2000ml of water for injection; and the pH of adjusted to 3.3-3.6.

Description

technical field [0001] The invention relates to dextromethorphan hydrobromide freeze-dried powder 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...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/485A61K47/12A61K47/34A61P11/14
Inventor 金春来
Owner 南通丝乡丝绸有限公司
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