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A kind of ambroxol hydrochloride sustained-release capsule and preparation method thereof

A technology of ambroxol hydrochloride and sustained-release capsules, which is applied in the field of medicine, can solve the problems of organic toxic solvent residues, expensive sustained-release materials, and high production costs of medicines, and achieve stable release, low production costs, and few types.

Active Publication Date: 2021-01-19
南京易亨制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Patent CN101862305A protects a kind of ambroxol hydrochloride sustained-release pellets and its preparation method. The sustained-release material used is Eudragit (polymethacrylate). The sustained-release material is expensive and the cost of drug production is high
Patent CN 1415287A discloses ambroxol hydrochloride osmotic pump-type controlled-release preparation and its preparation method. Acetone and chloroform mixed solvents are used in the coating process, which is likely to cause residues of organic toxic solvents

Method used

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  • A kind of ambroxol hydrochloride sustained-release capsule and preparation method thereof
  • A kind of ambroxol hydrochloride sustained-release capsule and preparation method thereof
  • A kind of ambroxol hydrochloride sustained-release capsule and preparation method thereof

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Embodiment 1

[0017]

[0018] Preparation process: Ambroxol hydrochloride, carbomer resin, hydroxypropylmethylcellulose phthalate, D-mannitol, calcium carbonate, crospovidone, carboxymethylcellulose are weighed in the recipe quantity Calcium and poloxamer are mixed, granulated with 70% ethanol as a binder, dried at a temperature of 50-60 degrees, prepared into granules, magnesium stearate is added, and the capsule shell is filled as the content to obtain ambroxol hydrochloride sustained-release capsules .

Embodiment 2

[0020]

[0021] Preparation process: Ambroxol hydrochloride, carbomer resin, hydroxypropylmethylcellulose phthalate, D-mannitol, calcium carbonate, crospovidone, carboxymethylcellulose are weighed in the recipe quantity Calcium and poloxamer are mixed, granulated with 70% ethanol as a binder, dried at a temperature of 50-60 degrees, prepared into granules, magnesium stearate is added, and the capsule shell is filled as the content to obtain ambroxol hydrochloride sustained-release capsules .

Embodiment 3

[0023]

[0024] Preparation process: Ambroxol hydrochloride, carbomer resin, hydroxypropylmethylcellulose phthalate, D-mannitol, calcium carbonate, crospovidone, carboxymethylcellulose are weighed in the recipe quantity Calcium and poloxamer are mixed, granulated with 70% ethanol as a binder, dried at a temperature of 50-60 degrees, prepared into granules, magnesium stearate is added, and the capsule shell is filled as the content to obtain ambroxol hydrochloride sustained-release capsules .

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Abstract

The invention discloses an ambroxol hydrochloride sustained release capsule. The ambroxol hydrochloride sustained release capsule comprises a capsule shell and content, wherein the content comprises asustained release material, a diluent, a disintegrating agent, a surfactant and a lubricant; and the sustained release material is prepared from carbomer resin and hydroxypropyl methyl cellulose phthalate; and a weight ratio of ambroxol hydrochloride to carbomer resin to the hydroxypropyl methyl cellulose phthalate is 1 to (0.5-2) to (0.04-0.6). The invention further discloses a preparation method. The preparation is free of solvent residues; and the process is simple.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an ambroxol hydrochloride sustained-release capsule and a preparation method thereof. Background technique [0002] Ambroxol hydrochloride, the molecular formula is C 13 h 18 Br 2 N 2 O·HCl, white to light yellow crystalline powder; almost odorless. It promotes the removal of viscous secretions and reduces mucus retention in the respiratory tract, thereby significantly promoting expectoration. It has a good effect of dissolving mucus and phlegm and lubricating the respiratory tract, and can promote the secretion of pulmonary surfactant, the secretion of respiratory fluid and the movement of cilia. It is suitable for acute and chronic respiratory diseases accompanied by abnormal sputum secretion and poor expectoration function. Ambroxol (Ambroxol, bromide) is white or off-white powder, slightly soluble in ethanol, almost insoluble in water. Its hydrochloride is...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/52A61K47/32A61K47/38A61K31/137A61P11/10
Inventor 朱学东顾伟伟封思阳周礼明严晓星
Owner 南京易亨制药有限公司