Dextromethorphan hydrobromide lyophilized powder and preparation method thereof

A technology of dextromethorphan hydrobromide and freeze-dried powder injection, applied in freeze-dried delivery, powder delivery, pharmaceutical formulations and other directions, can solve problems such as increased product cost, high product safety risk, etc., and achieves less excipients and safe clinical use. High performance and good stability

Active Publication Date: 2015-03-25
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 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 3.3-3.6 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 for decarburization, intermediate Inspection, after passing the test, u...

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 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 3.3-3.6, 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

[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 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 3.3-3.6, 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 dextromethorphan hydrobromide freeze-dried powder injection, which is made of the following raw materials: 16g dextromethorphan hydrobromide, 11g? Lactic acid, 8g sorbic acid, 45g polyethylene glycol 2000, 2000ml water for injection; adjust the pH 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 Patents(China)
IPC IPC(8): A61K31/485A61K47/12A61K47/34A61P11/14A61K9/19
Inventor 金春来
Owner 南通丝乡丝绸有限公司
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