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Ambroxol hydrochloride orally disintegrating tablet and preparation method thereof

A technology of ambroxol hydrochloride and orally disintegrating tablets, applied in the field of ambroxol hydrochloride orally disintegrating tablets and its preparation, can solve the problems of high technical difficulty, high equipment cost, poor fluidity, etc. Easy maintenance and low operating costs

Active Publication Date: 2019-12-17
CHONGQING CONQUER PHARML
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Orally disintegrating tablets are usually prepared by direct compression and freeze-drying methods. Among them, due to the poor fluidity and strong viscosity of ambroxol hydrochloride, the stickiness is obvious during tablet compression. The preparation by direct compression method has certain limitations, while the use of freeze-drying The preparation method is time-consuming, high technical difficulty, high equipment cost, and small batch

Method used

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  • Ambroxol hydrochloride orally disintegrating tablet and preparation method thereof
  • Ambroxol hydrochloride orally disintegrating tablet and preparation method thereof
  • Ambroxol hydrochloride orally disintegrating tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Embodiment 1: a kind of ambroxol hydrochloride orally disintegrating tablet, wherein the distribution ratio of each component is calculated by weight (g):

[0027]

[0028]

[0029] A preparation method of ambroxol hydrochloride orally disintegrating tablet, the steps are as follows:

[0030] S1. Mix and grind ambroxol hydrochloride and silicon dioxide for 60 minutes, pour out and pass through an 80-mesh sieve, and it is mixed powder I;

[0031] S2. Mix and pulverize mannitol, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, aspartame, and crospovidone with a total addition amount of 33.33% by weight and pass through an 80-mesh sieve, which is mixed powder II;

[0032] S3, mixing the mixed powder I and mixed powder II prepared in steps S1 and S2 evenly, adding a menthol hot water solution with a concentration of 10% by weight to make a soft material, and the soft material is passed through a 30-mesh sieve to make wet granules;

[0033] S4, dry...

Embodiment 2

[0036] Embodiment 2: a kind of ambroxol hydrochloride orally disintegrating tablet, wherein the distribution ratio of each component is calculated by weight (g):

[0037]

[0038]

[0039] A preparation method of ambroxol hydrochloride orally disintegrating tablet, the steps are as follows:

[0040] S1. Mix and grind ambroxol hydrochloride and silicon dioxide for 60 minutes, pour out and pass through an 80-mesh sieve, and it is mixed powder I;

[0041] S2. Mix and pulverize mannitol, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, aspartame, and crospovidone with a total addition of 50% by weight and pass through an 80-mesh sieve, which is mixed powder II;

[0042] S3, mixing the mixed powder I and mixed powder II prepared in steps S1 and S2 evenly, adding a menthol hot water solution with a concentration of 10% by weight to make a soft material, and the soft material is passed through a 30-mesh sieve to make wet granules;

[0043] S4, drying the we...

Embodiment 3

[0046] Embodiment 3: a kind of ambroxol hydrochloride orally disintegrating tablet, wherein the distribution ratio of each component is calculated by weight (g):

[0047]

[0048] A preparation method of ambroxol hydrochloride orally disintegrating tablet, the steps are as follows:

[0049] S1. Mix and grind ambroxol hydrochloride and silicon dioxide for 60 minutes, pour out and pass through an 80-mesh sieve, and it is mixed powder I;

[0050]S2. Mix and pulverize mannitol, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, aspartame, and crospovidone with a total addition amount of 37.5% by weight and pass through an 80-mesh sieve, which is mixed powder II;

[0051] S3, mixing the mixed powder I and mixed powder II prepared in steps S1 and S2 evenly, adding a menthol hot water solution with a concentration of 10% by weight to make a soft material, and the soft material is passed through a 30-mesh sieve to make wet granules;

[0052] S4, drying the wet gr...

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Abstract

The invention discloses an ambroxol hydrochloride orally disintegrating tablet and a preparation method thereof. The ambroxol hydrochloride orally disintegrating tablet comprises ambroxol hydrochloride and pharmaceutically necessities, wherein the pharmaceutically necessities comprise a taste masking agent, filler, an adhesive, a flavoring agent, a disintegrating agent and a lubricant. The ambroxol hydrochloride orally disintegrating tablet is characterized in that the taste masking agent is silicon dioxide, the filler is mannitol and microcrystalline cellulose, the adhesive is a menthol hydrothermal solution, the flavoring agent is aspartame, the disintegrating agent is polyvinylpolypyrrolidone and low-substituted hydroxypropyl cellulose, and the lubricant is magnesium stearate. The product is not bitter, cannot numb the tongue, is short in disintegrating time, and meets the requirements of the Chinese Pharmacopoeia 2015 for disintegrating time, hardness and friability. The preparation method of the product is simple, easy to operate, controllable, economical, convenient, and applicable to large-scale production.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a kind of ambroxol hydrochloride orally disintegrating tablet and a preparation method thereof. Background technique [0002] Ambroxol hydrochloride is a sputum dissolving agent firstly developed by Germany. It has a good effect of dissolving mucus and lubricating the respiratory tract. It can promote the secretion of pulmonary surfactant and respiratory fluid, and can improve lung function. damage and protect the lungs. Because ambroxol hydrochloride has clear pharmacology, low toxic and side effects and remarkable curative effect, it has become the drug of choice for clinical treatment of acute and chronic respiratory diseases, abnormal bronchial secretion, etc. at present. [0003] Orally disintegrating tablet is a quick-acting oral dosage form developed in recent years. It can be quickly dispersed or dissolved in saliva after being put into the mouth. The drug can be absorb...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K47/38A61K31/137A61P11/00
CPCA61K9/0056A61K9/2054A61K9/2095A61K31/137
Inventor 胡瀚陈用芳赵伟淑杨绪凤李湖川田建
Owner CHONGQING CONQUER PHARML
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