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Dextromethorphan hydrobromide oral dispersible film agent and preparation method thereof

A technology of dextromethorphan hydrobromide and dispersion film, which can be applied in the directions of non-active ingredients medical preparations, active ingredients-containing medical preparations, pharmaceutical formulas, etc., and can solve problems such as bad taste

Active Publication Date: 2014-11-12
山西皇城相府药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The dextromethorphan hydrobromide oral dispersible film well solves the problem of the bitter and numb taste of dextromethorphan hydrobromide, and through the preferred preparation method, the surface of the film is smooth and smooth

Method used

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  • Dextromethorphan hydrobromide oral dispersible film agent and preparation method thereof
  • Dextromethorphan hydrobromide oral dispersible film agent and preparation method thereof
  • Dextromethorphan hydrobromide oral dispersible film agent and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0366] Example 1 A kind of dextromethorphan hydrobromide oral dispersible film

[0367] See Tables 21 and 22 for prescriptions.

[0368] Prepared by:

[0369] 1. Dilute 25ml of 1mol / L sodium hydroxide solution to 175ml with purified water, and after mixing evenly, add the prescribed amount of polycridine, the weight / molar ratio of polycridine to sodium hydroxide is 1g : 0.0025mol, stirred for 6 hours;

[0370] 2. Add 8.75ml of ethanol and 2.5g of dextromethorphan hydrobromide to the above suspended solution, stir at room temperature, and react for 12 hours; filter with suction, discard the filtrate, and keep the filter cake;

[0371] 3. Dissolve 2.5 g of dextromethorphan hydrobromide in 175 ml of purified water and stir to dissolve. After dextromethorphan hydrobromide is completely dissolved, add the above filter cake for reaction, stir at room temperature, and react for 10 hours; filter with suction, discard the filtrate, and keep the filter cake;

[0372] 4. Dissolve 2....

Embodiment 2

[0385] Example 2 A kind of dextromethorphan hydrobromide oral dispersible film

[0386] See Tables 21 and 22 for prescriptions.

[0387] Prepared by steps similar to Example 1, the difference is:

[0388] 1. Dilute 50ml of 1mol / L sodium hydroxide solution to 175ml with purified water, the weight / molar ratio of polycridine to sodium hydroxide is 1g:0.005mol, and stir for 4 hours;

[0389] 2. Stir for 6 hours;

[0390] 3. Stir for 8 hours;

[0391] 5. Wash with 32.5ml ethanol and 30ml water in turn;

[0392] 10. Stir to dissolve 4.5 g of Hypromellose E3.

Embodiment 3

[0393] Example 3 A kind of dextromethorphan hydrobromide oral dispersible film

[0394] See Tables 21 and 22 for prescriptions.

[0395] Prepared by:

[0396] 1. Dilute 35ml of 1mol / L sodium hydroxide solution to 175ml with purified water, and after mixing evenly, add the prescribed amount of polycridine, the weight / molar ratio of polycridine to sodium hydroxide is 1g : 0.0025mol, stirred for 10 hours;

[0397] 2. Add 8.75ml of ethanol and 2.5g of dextromethorphan hydrobromide to the above suspended solution, stir at room temperature, and react for 10 hours; filter with suction, discard the filtrate, and keep the filter cake;

[0398] 3. Dissolve 2.5 g of dextromethorphan hydrobromide in 175 ml of purified water and stir to dissolve. After dextromethorphan hydrobromide is completely dissolved, add the above filter cake for reaction, stir at room temperature, and react for 8 hours; filter with suction, discard the filtrate, and keep the filter cake;

[0399] 4. Dissolve 2...

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Abstract

The invention provides a dextromethorphan hydrobromide oral dispersible film agent. The film agent comprises dextromethorphan hydrobromide, polacrilin or polacrilin potassium with grain diameter of 50-150mu m, a film forming agent, a plasticizer, a disintegrating agent, a wetting agent and water, wherein dextromethorphan hydrobromide and polacrilin or polacrilin potassium form a dextromethorphan hydrobromide compound, and the weight ratio of dextromethorphan hydrobromide to polacrilin or polacrilin potassium is 1:1-1:2, and preferably 1:1.3-1:1.5; the film forming agent comprises hydroxypropyl methylcellulose E3 and hydroxypropyl methylcellulose E50. The invention also provides a preparation method of the dextromethorphan hydrobromide oral dispersible film agent. The dextromethorphan hydrobromide oral dispersible film agent can well solve the problem of poor taste of dextromethorphan hydrobromide, is particularly suitable for children and old patients, and can remarkably improve the compliance of patients. An oral film tablet is nicer by an optimal preparation method.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a dextromethorphan hydrobromide oral dispersible film and a preparation method thereof. Background technique [0002] Dextromethorphan hydrobromide, also known as dextromethorphan, is a central antitussive drug. The antitussive effect is equal to or slightly stronger than codeine. It has no analgesic and hypnotic effects. Long-term use has no drug resistance and addiction It is suitable for coughs caused by colds, asthma and tuberculosis. Clinical application shows that it has high safety and few adverse reactions. Dextromethorphan hydrobromide preparations sold in the market are mainly injections and various swallowable oral preparations, such as syrup, soft capsules, oral liquids, tablets, granules, chewable tablets, capsules, sustained-release tablets, dispersible tablets, drop pills , oral solution. However, the elderly, children and some patients wit...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/70A61K31/485A61K47/38A61K47/32A61P11/14
Inventor 张建国赵荷英
Owner 山西皇城相府药业股份有限公司
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