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Ambroxol hydrochloride film-controlled slow-release pellet capsule

A technology of ambroxol hydrochloride film and sustained-release pellets, which can be used in medical preparations of non-active ingredients, respiratory diseases, organic active ingredients, etc., and can solve the problems of film aging and release decline

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 membrane aging of ambroxol hydrochloride film-controlled sustained-release pellets prepared by aqueous dispersion coating, the present invention provides a film-controlled ambroxol hydrochloride that can maintain stable release performance throughout the validity period. Ambroxol hydrochloride sustained-release pellet capsules are characterized in that the core of the pellets contains low-substituted hydroxypropyl cellulose with high water-swellability, and the sustained-release coating film is deformed by water-absorbing swelling, thereby offsetting the film aging

Method used

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  • Ambroxol hydrochloride film-controlled slow-release pellet capsule
  • Ambroxol hydrochloride film-controlled slow-release pellet capsule
  • Ambroxol hydrochloride film-controlled slow-release pellet capsule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] The ambroxol hydrochloride sustained-release pellet capsule of embodiment 1 common ball core

[0029] 1. Prescription

[0030] 1. Pill core prescription (1000 capsules)

[0031]

[0032] 2. Prescription of sustained-release film coating solution

[0033]

[0034]

[0035] 3. No. 0 stomach-soluble gelatin capsule shell 1000 capsules

[0036] Second, the preparation process:

[0037] 1. Ball core preparation process:

[0038] (1) ambroxol hydrochloride is crossed 60 mesh sieves;

[0039] (2) Ambroxol hydrochloride and microcrystalline cellulose PH101 of recipe quantity are taken by weighing, put in the wet granulator and mix homogeneously;

[0040] (3) 2% carboxymethylcellulose sodium 10% ethanol solution to make soft material;

[0041] (4) Extrude on the extruder, the screen aperture is 1.0mm, and the extrusion speed is 20-30rpm;

[0042] (5) spheronization, the spheronization speed is 900~1000rpm, drying in the fluidized bed;

[0043] (6) Sieve, and tak...

Embodiment 2

[0067] Embodiment 2 Ambroxol hydrochloride sustained-release pellet capsule containing 10% low-substituted hydroxypropyl cellulose

[0068] 1. Prescription

[0069] 1. Pill core prescription (1000 capsules)

[0070]

[0071] 2. Prescription of sustained-release film coating solution: same as in Example 1

[0072] 3. No. 0 stomach-soluble gelatin capsule shell 1000 capsules

[0073] Second, the preparation process:

[0074] 1. Ball core preparation process:

[0075] (1) ambroxol hydrochloride is crossed 60 mesh sieves;

[0076] (2) Ambroxol hydrochloride, microcrystalline cellulose PH101, low-substituted hydroxypropyl cellulose, lactose are taken by weighing recipe quantity, put in wet granulator and mix homogeneously;

[0077] (3) 2% carboxymethylcellulose sodium 10% ethanol solution to make soft materials;

[0078] (4) Extrude on the extruder, the screen aperture is 1.0mm, and the extrusion speed is 20-30rpm;

[0079] (5) spheronization, the spheronization speed is ...

Embodiment 3

[0098] Embodiment 3 Ambroxol hydrochloride sustained-release pellet capsule containing 20% ​​low-substituted hydroxypropyl cellulose

[0099] 1. Prescription

[0100] 1. Pill core prescription (1000 capsules)

[0101]

[0102] 2. Prescription of sustained-release film coating solution: same as in Example 1

[0103] 3. No. 0 stomach-soluble gelatin capsule shell 1000 capsules

[0104] Second, the preparation process:

[0105] 1. Ball core preparation process: the same as in Example 2

[0106] 2. Preparation process of sustained-release film coating solution:

[0107] Same as Example 1

[0108] 3. Coating (sustained release film):

[0109] 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 26.4% and 30.1%.

[0110] 4, heat treatment: with embodiment 1

[0111] 5. Fill capsules

[0112]Fill the coated pellets into capsules to obtain the product.

[0113] 3. Release, cont...

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PUM

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Abstract

The invention relates to an ambroxol hydrochloride film-controlled slow-release pellet capsule. A slow-release film of the ambroxol hydrochloride film-controlled slow-release pellet utilizes Kollicoat SR 30D as a film-formation material. A pellet core of the ambroxol hydrochloride film-controlled slow-release pellet contains low-substituted hydroxyprepyl cellulose 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 10 to 40wt% of low-substituted hydroxyprepyl cellulose. The slow-release film comprises Kollicoat SR 30D, triethyl citrate as a plasticizer, and talcum powder as an antiplastering aid, wherein preferably, a ratio of Kollicoat SR 30D to triethyl citrate to talcum powder is 30: 1.5: 4 and a film weight increasing ratio is in a range of 20 to 36%. The ambroxol hydrochloride film-controlled slow-release pellet comprises the pellet core containing low-substituted hydroxyprepyl cellulose having high water expansibility and thus after absorbing water, the ambroxol hydrochloride 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 size is increased; and permeability is improved and the permeability reduction caused by film aging is counteracted. Therefore, in middle and later stages, the ambroxol hydrochloride film-controlled slow-release pellet release rate is basically constant; in the last stage, residues are less; and stable release performances can be kept in the period of validity.

Description

technical field [0001] The invention relates to an ambroxol hydrochloride membrane-controlled sustained-release pellet capsule, in particular to an ambroxol hydrochloride membrane-controlled sustained-release pellet capsule with a pellet core containing low-substituted hydroxypropyl cellulose, belonging to the field of pharmaceutical preparations . Background technique [0002] Ambroxol hydrochloride is a mucolytic agent, which can increase the secretion of serous glands of the respiratory mucosa and reduce the secretion of mucus glands, thereby reducing the viscosity of sputum, promoting the secretion of pulmonary surfactant, increasing the movement of bronchial cilia, and making sputum easy to cough up. It is used for the treatment of thick sputum and difficulty expectoration caused by acute and chronic bronchitis, bronchial asthma, bronchiectasis, tuberculosis, etc. [0003] Ambroxol hydrochloride is slightly soluble in water, and the earliest common preparations listed ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K9/16A61K31/137A61K47/38A61P11/10
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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