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

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
Comparison scheme
Effect test

Example Embodiment

[0041] Example 1,

[0042] An ambroxol hydrochloride dispersible tablet, which contains the following components and contents:

[0043]

[0044]

[0045] Preparation:

[0046] (1) Sieving the raw material of ambroxol hydrochloride and micronizing it to make the particle size 100nm for use;

[0047] (2) Mix povidone K30 with ethanol, stir to dissolve, add purified water and 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 povidone K30. Times

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

[0049] (4) The granules in step (3) are dried, dried to a moisture...

Example Embodiment

[0052] Example 2,

[0053] An ambroxol hydrochloride dispersible tablet, which contains the following components and contents:

[0054]

[0055]

[0056] Preparation:

[0057] (1) Sieving the raw material of ambroxol hydrochloride and micronizing it to make its particle size 150nm for use;

[0058] (2) Mix povidone K30 with ethanol, stir to dissolve, add purified water and mix to obtain a binder solution, where the weight ratio of ethanol to water is 5:3, and the total weight of ethanol and water is 90 of povidone K30. Times

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

[0060] (4) The particles in step (3) are dried to a moisture content ...

Example Embodiment

[0063] Example 3.

[0064] An ambroxol hydrochloride dispersible tablet, which contains the following components and contents:

[0065]

[0066]

[0067] Preparation:

[0068] (1) Sieving the raw material of ambroxol hydrochloride and micronizing it to make its particle size 150nm for use;

[0069] (2) Mix povidone K30 with ethanol, stir to dissolve, 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, and aspartame according to the prescription ratio, stir and mix them, and then put them in the wet In the method 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 to a moisture content of 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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