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Dextromethorphan hydrobromide film-controlled slow-release pellet capsule

A technology of dextromethorphan hydrobromide and sustained-release pellets, which can be used in medical preparations with non-active ingredients, respiratory diseases, organic active ingredients, etc., and can solve problems such as decreased film release.

Active Publication Date: 2013-07-24
北京天衡药物研究院有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In order to solve the problem of release decline caused by film aging of dextromethorphan hydrobromide film-controlled sustained-release pellets prepared by water dispersion coating, the present invention provides a kind of dextromethorphan hydrobromide that can maintain stable release performance all the time during the validity period. Membrane-controlled dextromethorphan hydrobromide sustained-release pellet capsules are characterized in that the core of the pellets contains sodium carboxymethyl starch with high water-swellability, and the sustained-release coating film is deformed by water swelling, thereby Counteracts membrane aging

Method used

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  • Dextromethorphan hydrobromide film-controlled slow-release pellet capsule
  • Dextromethorphan hydrobromide film-controlled slow-release pellet capsule
  • Dextromethorphan hydrobromide film-controlled slow-release pellet capsule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] The dextromethorphan hydrobromide sustained-release pellet capsule of embodiment 1 common ball core

[0028] 1. Prescription

[0029] 1. Pill core prescription (1000 capsules)

[0030]

[0031] 2. Prescription of sustained-release film coating solution

[0032]

[0033]

[0034] 3. No. 0 stomach-soluble gelatin capsule shell 1000 capsules

[0035] Second, the preparation process:

[0036] 1. Ball core preparation process:

[0037] (1) Take dextromethorphan hydrobromide, microcrystalline cellulose PH101, lactose of prescription quantity, put in wet granulator and mix homogeneously;

[0038] (2) 2% carboxymethylcellulose sodium 10% ethanol solution to make soft material;

[0039] (3) Extrude on the extruder, the screen aperture is 1.0mm, and the extrusion speed is 20-30rpm;

[0040] (4) spheronization, the spheronization speed is 900~1000rpm, drying in the fluidized bed;

[0041] (5) Sieve, and take ball cores between 16 and 30 mesh.

[0042] 2. Preparati...

Embodiment 2

[0065] Dextromethorphan Hydrobromide Sustained-release Pellet Capsules Containing 5% Carboxymethyl Starch Sodium of Embodiment 2

[0066] 1. Prescription

[0067] 1. Pill core prescription (1000 capsules)

[0068]

[0069] 2. Prescription of sustained-release film coating solution: same as in Example 1.

[0070] 3. No. 0 stomach-dissolving gelatin capsule shells, 1,000 capsules.

[0071] Second, the preparation process:

[0072] 1. Ball core preparation process:

[0073] (1) Take dextromethorphan hydrobromide, microcrystalline cellulose PH101, lactose, carboxymethyl starch sodium of recipe quantity, put in the wet granulator and mix uniformly;

[0074] (2) 2% carboxymethylcellulose sodium 10% ethanol solution to make soft material;

[0075] (3) Extrude on the extruder, the screen aperture is 1.0mm, and the extrusion speed is 20-30rpm;

[0076] (4) spheronization, the spheronization speed is 900~1000rpm, drying in the fluidized bed;

[0077] (5) Sieve, and take ball c...

Embodiment 3

[0093] Example 3 Dextromethorphan Hydrobromide Sustained-release Pellet Capsules Containing 10% Carboxymethyl Starch Sodium

[0094] 1. Prescription

[0095] 1. Pill core prescription (1000 capsules)

[0096]

[0097] 2. Prescription of sustained-release film coating solution: same as in Example 1.

[0098] 3. No. 0 stomach-dissolving gelatin capsule shells, 1,000 capsules.

[0099] Second, the preparation process:

[0100] 1. Ball core preparation process: with embodiment 2.

[0101] 2. The preparation process of the slow-release film coating solution: the same as in Example 1.

[0102] 3. Coating (sustained release film):

[0103] The ball core is placed in a fluidized bed for coating, and the weight gain of the coating film is controlled, and the weight gain of the coating is 21.5% and 26.7%.

[0104] 4, heat treatment: with embodiment 1.

[0105] 5. Capsule filling: the coated pellets are filled into capsules.

[0106] 3. Release, content determination and resul...

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Abstract

The invention relates to a dextromethorphan hydrobromide film-controlled slow-release pellet capsule. A slow-release film of the dextromethorphan hydrobromide film-controlled slow-release pellet utilizes Eurdragit RS 30D as a film-formation material. A pellet core of the dextromethorphan hydrobromide film-controlled slow-release pellet contains sodium carboxymethyl starch having high expansibility, and also contains pharmaceutically-acceptable common excipients for the slow-release pellet, wherein preferably, the excipients comprise microcrystalline cellulose and lactose, and the pellet core comprises 5 to 20wt% of sodium carboxymethyl starch. The slow-release film comprises Eurdragit RS 30D, triethyl citrate as a plasticizer, and talcum powder as an antiplastering aid, wherein preferably, a ratio of Eurdragit RS 30D to triethyl citrate to talcum powder is 30: 1: 4 and coating weight gain is in a range of 16 to 35%. The dextromethorphan hydrobromide film-controlled slow-release pellet comprises the pellet core containing sodium carboxymethyl starch having high water expansibility and thus after absorbing water, the dextromethorphan hydrobromide film-controlled slow-release pellet obviously expands so that the slow-release film is stretched; the thickness of the slow-release film is reduced; the water-permeable micropore diameter is increased; and permeability is improved and the permeability reduction caused by film aging is compensated. Therefore, in middle and later stages, the dextromethorphan hydrobromide film-controlled slow-release pellet release rate is basically constant; in the last stage, residues are less; and stable release performances can be kept prior to expiration date.

Description

technical field [0001] The invention relates to a dextromethorphan hydrobromide film-controlled sustained-release pellet capsule, specifically, a dextromethorphan hydrobromide film-controlled sustained-release pellet capsule with a core containing sodium carboxymethyl starch, belonging to field of pharmaceutical preparations. Background technique [0002] Dextromethorphan hydrobromide is a non-addictive central antitussive, which acts by inhibiting the medullary cough center. It is used for upper respiratory tract infection, acute or chronic bronchitis, bronchial asthma, bronchiectasis, pneumonia, tuberculosis, etc. It can also be used to treat cough caused by thoracentesis, bronchography and bronchoscopy, especially for dry cough and cough patients who cannot eat after surgery. The basic clinical requirement for this type of drug is that it can control symptoms for a long time. [0003] Dextromethorphan hydrobromide is slightly soluble in water. The earliest common prepar...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K31/485A61K47/32A61K47/36A61K47/38A61P11/14
Inventor 姜庆伟狄媛吕玉珠唐亚坤刘俊轶
Owner 北京天衡药物研究院有限公司
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