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Ambroxol hydrochloride dispersible tablet and preparation method thereof

A technology of ambroxol hydrochloride and dispersible tablets, applied in the field of medicine, can solve the problems of low industrialization efficiency, difficulty in ensuring repeatability and reproducibility, cumbersome crystal preparation process, etc., achieve excellent expectorant effect, and avoid crystal repeatability and the effect of poor reproducibility and simple preparation process

Active Publication Date: 2018-01-12
ZHUHAI TONGYUAN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Adopting ambroxol hydrochloride with different crystal forms to prepare dispersible tablets, although the properties such as the dissolution rate of the drug have been improved to a certain extent, it needs to go through a relatively cumbersome crystal preparation process, and the preparation of crystals with a certain specific crystal form requires strict procedures. Control conditions, repeatability and reproducibility are difficult to guarantee, and industrialization efficiency is not high

Method used

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  • Ambroxol hydrochloride dispersible tablet and preparation method thereof
  • Ambroxol hydrochloride dispersible tablet and preparation method thereof
  • Ambroxol hydrochloride dispersible tablet and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0042] A kind of ambroxol hydrochloride dispersible tablet, the component that it comprises and content are as follows:

[0043]

[0044]

[0045] Preparation:

[0046] (1) Ambroxol hydrochloride raw material is sieved, micronized, and its particle diameter is 100nm, subsequent use;

[0047] (2) Mix and dissolve povidone K30 with ethanol and add purified water to mix to obtain a binder solution, wherein the weight ratio of ethanol to water is 3:2, and the total weight of ethanol and water is 99% of that of povidone K30. times;

[0048] (3) Weigh micronized ambroxol hydrochloride, hesperidin, microcrystalline cellulose, pregelatinized starch, silicon dioxide, sucrose, aspartame according to the prescription ratio, stir and mix it, and then put it into wet In the French granulator, pour the prepared binder solution into the mixed raw and auxiliary materials to make soft materials, stir and make granules;

[0049] (4) The granules in the step (3) are dried, and the granu...

Embodiment 2

[0053] A kind of ambroxol hydrochloride dispersible tablet, the component that it comprises and content are as follows:

[0054]

[0055]

[0056] Preparation:

[0057] (1) Ambroxol hydrochloride raw material is sieved, micronized, and its particle diameter is 150nm, subsequent use;

[0058] (2) Mix Povidone K30 with ethanol, stir and dissolve, add purified water and mix to obtain a binder solution, wherein the weight ratio of ethanol to water is 5:3, and the total weight of ethanol and water is 90% of that of Povidone K30. times;

[0059] (3) Weigh micronized ambroxol hydrochloride, hesperidin, microcrystalline cellulose, pregelatinized starch, silicon dioxide, sucrose, aspartame according to the prescription ratio, stir and mix it, and then put it into wet In the French granulator, pour the prepared binder solution into the mixed raw and auxiliary materials to make soft materials, stir and make granules;

[0060] (4) The granules in step (3) are dried until the mois...

Embodiment 3

[0064]A kind of ambroxol hydrochloride dispersible tablet, the component that it comprises and content are as follows:

[0065]

[0066]

[0067] Preparation:

[0068] (1) Ambroxol hydrochloride raw material is sieved, micronized, and its particle diameter is 150nm, subsequent use;

[0069] (2) Mix and dissolve povidone K30 and ethanol, add purified water and mix to obtain a binder solution, wherein the weight ratio of ethanol to water is 8:5, and the total weight of ethanol and water is 80% of povidone K30 times;

[0070] (3) Weigh micronized ambroxol hydrochloride, hesperidin, microcrystalline cellulose, pregelatinized starch, silicon dioxide, sucrose, aspartame according to the prescription ratio, stir and mix it, and then put it into wet In the French granulator, pour the prepared binder solution into the mixed raw and auxiliary materials to make soft materials, stir and make granules;

[0071] (4) The granules in step (3) are dried until the moisture content is l...

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Abstract

The invention belongs to the technical field of medicine, and specifically relates to an ambroxol hydrochloride dispersible tablet and a preparation method thereof. The ambroxol hydrochloride dispersible tablet comprises the following components in parts by weight: 8 to 12 parts of ambroxol hydrochloride, 0.5 to 1.5 parts of hesperidin, 55 to 65 parts of microcrystalline cellulose, 10 to 15 partsof pregelatinized starch, 1 to 5 parts of silicon dioxide, 5 to 8 parts of cane sugar, 1 to 4 parts of aspartame, 0.5 to 2 parts of polyvinylpyrrolidone K, 0.5 to 1.2 parts of strawberry essence, 1 to5 parts of sodium carboxymethyl starch, and 1 to 5 parts of magnesium stearate. The particle size of the dispersible tablet is 100 to 300 nm. The provided dispersible tablet has the advantages of good dissolution rate, good stability, simple preparation technology, good repeatability, and suitability for popularization.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to a dispersible ambroxol hydrochloride tablet and a preparation method thereof. Background technique [0002] Ambroxol Hydrochloride (Ambroxol Hydrochloride), also known as Mucosolvan, the chemical name is trans-4-[(2-amino-3,5-dibromobenzyl)amino]cyclohexanol hydrochloride, white to slightly yellow Crystalline powder; Ambroxol hydrochloride has the characteristics of promoting mucus elimination and dissolving secretions. It can promote the elimination of viscous secretions in the respiratory tract and reduce the retention of mucus, thus significantly promoting expectoration and improving respiratory conditions. It can also promote the secretion of pulmonary surfactant, the secretion of airway fluid and the movement of cilia. Ambroxol hydrochloride is widely used clinically for thick sputum and difficulty expectoration caused by various acute and chronic respiratory diseases. ...

Claims

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Application Information

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IPC IPC(8): A61K31/7048A61K31/137A61K9/20A61P11/10
Inventor 陈敏李旭丰曾炎科陈丽袁剑
Owner ZHUHAI TONGYUAN PHARMA CO LTD
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