Ambroxol hydrochloride sustained-release pellet and preparation method

A technology of ambroxol hydrochloride and sustained-release pellets, which is applied in the direction of pharmaceutical formulas, medical preparations containing no active ingredients, and medical preparations containing active ingredients. Difficult to achieve uniform release and other issues

Active Publication Date: 2010-10-20
AVENTIS PHARMA HAINAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Patent CN100370977C protects a sustained-release tablet containing the active ingredient of ambroxol hydrochloride. Although it can achieve a sustained-release effect, it cannot achieve a near-zero release effect, and due to the environment in the human stomach, it is difficult for the sustained-release tablet to achieve uniformity. release, the difference in release is relatively large; patent CN1546008A protects a liquid ambroxol hydrochloride sustained-release preparation and its preparation method, although it can achieve uniform release in the stomach, but the packaging cost is high and transportation is inconvenient; patent CN1415287A discloses a kind of ambroxol hydrochloride osmotic pump type controlled-release preparation and preparation method thereof, although it can achieve uniform release in the stomach, and convenient transportation, but special equipment is needed in the preparation process, the production cost is high, and it is difficult to test industrialization

Method used

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  • Ambroxol hydrochloride sustained-release pellet and preparation method
  • Ambroxol hydrochloride sustained-release pellet and preparation method
  • Ambroxol hydrochloride sustained-release pellet and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Preparation of Pill Hearts

[0021]

[0022] Preparation Process:

[0023] Mix ambroxol hydrochloride with lactose, cross-linked sodium carboxymethyl starch, and microcrystalline cellulose, use 10% povidone aqueous solution as a binder to make a soft material, use an extrusion spheronizer to prepare pellets, and dry overnight , and sieve out pellets with a diameter of about 1 mm as the pellet core.

[0024] Isolation gown

[0025]

[0026] The hypromellose, polyethylene glycol and talcum powder of the prescribed amount are placed in 50% alcohol water, stirred to make it fully dissolved or dispersed, coated, and the weight increased to 2%.

[0027] slow release coating

[0028]

[0029]

[0030] Place Eudragit, triethyl citrate and talcum powder in 95% ethanol in the prescribed amount, stir to make it fully dissolve or disperse, coat, and increase the weight to 8%;

[0031] The coated micropills are filled into capsules to obtain.

Embodiment 2

[0033] Preparation of Pill Hearts

[0034]

[0035] Preparation Process:

[0036] Mix ambroxol hydrochloride with mannitol, croscarmellose sodium, and microcrystalline cellulose, use 8% hypromellose aqueous solution as a binder to make soft materials, and use an extrusion spheronizer to prepare pellets , dried overnight, and sieve out pellets with a diameter of about 1 mm as pellet cores.

[0037] Isolation gown

[0038]

[0039]

[0040] The hypromellose, polyethylene glycol and talcum powder of the prescribed amount are placed in 50% alcohol water, stirred to make it fully dissolved or dispersed, coated, and the weight increased to 4%.

[0041] slow release coating

[0042]

[0043] Put Eudragit, dibutyl phthalate and talcum powder in the prescription amount in 95% ethanol, stir to make it fully dissolve or disperse, coat, and increase the weight to 15%;

[0044] The coated micropills are filled into capsules to obtain.

Embodiment 3

[0046] Preparation of Pill Hearts

[0047]

[0048] Preparation Process:

[0049] Mix ambroxol hydrochloride with starch, crospovidone, and microcrystalline cellulose, use 10% starch slurry as a binder to make a soft material, use an extrusion spheronizer to prepare pellets, dry overnight, and sieve out Pellets with a diameter of about 1mm are used as pellet cores;

[0050] Isolation gown

[0051]

[0052] The hypromellose, polyethylene glycol and talcum powder of the prescribed amount are placed in 50% alcohol water, stirred to make it fully dissolved or dispersed, coated, and the weight increased to 6%.

[0053] slow release coating

[0054]

[0055] Put Eudragit, dioctyl phthalate and talcum powder in the prescription amount in 95% ethanol, stir to make it fully dissolve or disperse, coat, and increase the weight to 15%;

[0056] The coated micropills are filled into capsules to obtain.

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Abstract

The invention relates to the composition of an ambroxol HCl-containing sustained-release pellet and a preparation method. The sustained-release pellet consists of two parts which are a quick-release pellet core and a sustained-release coating film respectively, can achieve the effect of long-term release approaching to zero-order release, is mainly used for treating acute and chronic respiratory diseases, and is a medicament of first choice for dispelling phlegm.

Description

technical field [0001] The invention relates to a composition and preparation method of sustained-release pellets containing ambroxol hydrochloride. The sustained-release pellets are composed of two parts, an immediate-release pellet core and a sustained-release coating layer, and can achieve long-term release close to zero-order release It is mainly used for the treatment of acute and chronic respiratory diseases, and is the first choice for expectorant. Background technique [0002] Ambroxol hydrochloride Ambroxol HCl has been proved in clinical trials that this product can regulate the secretion of serous fluid and mucus, promote the synthesis of pulmonary surfactant, strengthen the vibration of cilia, and increase the clearance capacity of the mucociliary transport system. This product can also increase the fluid volume of the respiratory tract, reduce mucus secretion, promote the secretion of pulmonary surfactant and the movement of bronchial cilia, and make sputum easy...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/137A61K47/38A61K47/36A61K47/34A61P11/10A61K47/10
Inventor 孟凡静
Owner AVENTIS PHARMA HAINAN
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