Ambroxol hydrochloride oral cavity disintegrating tablet and method of producing the same

A technology of ambroxol hydrochloride and orally disintegrating tablets, which is applied in the field of ambroxol hydrochloride orally disintegrating tablets and its preparation, can solve the problems of high energy consumption, low yield, and unsuitability for industrialized mass production, and achieve energy consumption Low power, low power, and shortened disintegration time

Active Publication Date: 2008-02-27
CHONGQING CONQUER PHARML
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the existing preparation technology, there are β-cyclodextrin inclusion method, microencapsulation method and polyethylene glycol melting method, etc. for the taste-masking treatment of active ingredients, but these methods all have the following limitations or shortcomings: ① Yield Low; ② not suitable for industrial mass production; ③ high energy consumption

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Embodiment 1: a kind of ambroxol hydrochloride orally disintegrating tablet, wherein the distribution ratio of each component is calculated as: ambroxol hydrochloride 25%, titanium dioxide 10%, sodium lauryl sulfate 2.5%, 40% dilute Proper amount of ethanol, 28.5% of sorbitol, 24% of microcrystalline cellulose, 8% of low-substituted hydroxypropyl cellulose, 2% of aspartame, appropriate amount of water, magnesium stearate accounts for 0.8% of dry granule weight.

[0023] The preparation method of above-mentioned ambroxol hydrochloride orally disintegrating tablet, its step is as follows:

[0024] 1. Taste-masking treatment first: mix ambroxol hydrochloride, titanium dioxide, and sodium lauryl sulfate evenly according to the above ratio, then add 260ml of dilute ethanol with a concentration of 40% by volume, and stir well to form a uniform suspension Liquid with certain fluidity at room temperature. Put it in an emulsification homogenizer (gap adjustment: +10~+20) and gr...

Embodiment 2

[0027] Embodiment 2: a kind of ambroxol hydrochloride orally disintegrating tablet, wherein the distribution ratio of each component is calculated as: ambroxol hydrochloride 25%, micronized silica gel 12.5%, mannitol 14.5%, lactose 12%, microcrystalline fiber 26% cellulose, 8% low-substituted hypromellose, 2% mixture of aspartame and sodium saccharin, an appropriate amount of hypromellose aqueous solution with a concentration of 1% by volume, and magnesium stearate in dry granule weight 0.8%.

[0028] The preparation method of above-mentioned ambroxol hydrochloride orally disintegrating tablet, its step is as follows:

[0029] 1. Firstly, taste-masking treatment: mix ambroxol hydrochloride and micro-powder silica gel according to the above ratio, then place them in a ball mill for grinding, control the speed at 45 rpm, and grind for 60 minutes, pour out, and pass through a 120-mesh sieve. Weigh and reserve.

[0030]2. Mix mannitol, lactose, microcrystalline cellulose (MCC), ...

Embodiment 3

[0032] Embodiment 3: a kind of ambroxol hydrochloride orally disintegrating tablet, wherein the distribution ratio of each component is calculated as: ambroxol hydrochloride 25%, magnesium stearate 8%, sodium lauryl sulfate 4.5%, manna 32.5% of alcohol, 20% of microcrystalline cellulose, 8% of sodium carboxymethyl cellulose, 2% of sodium saccharin, an appropriate amount of water, and 0.8% of dry granule weight of talcum powder.

[0033] The preparation method of above-mentioned ambroxol hydrochloride orally disintegrating tablet, its step is as follows:

[0034] 1. Firstly, taste-masking treatment: that is, after preliminary mixing of ambroxol hydrochloride, magnesium stearate and sodium lauryl sulfate according to the above ratio, put them in a ball mill and grind them at a controlled speed of 60 rpm. After 60 minutes, pour it out through a 120-mesh sieve, weigh it, and set aside.

[0035] 2. Mannitol, microcrystalline cellulose (MCC), sodium carboxymethyl cellulose (CMC-Na)...

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Abstract

The invention discloses an oral disintegration tablet of alcaine aminobromisuo, which contains alcaine aminobromisuo with effective dosage and pharmacological findings, wherein the alcaine aminobromisuo is processed by metarchon with rate of aminobromisuo and metarchon at 1: 0. 1-1. 5, which is blended with pharmacologically acceptable findings; the metarchon can be medically inorganic oxide or / and medicinal organic acid and salt; the acceptable findings is filler, corrigent, disintegration agent, adhesive and lubricant; the oral disintegration tablet of alcaine aminobromisuo hasn't bitterness and numb sense to disintegrate within one minute with stripping degree not less than 90%. The invention is convenient and simple to control with high yield and low energy consumption, which widens the resource of metarchon to save cost.

Description

technical field [0001] The invention relates to an ambroxol hydrochloride orally disintegrating tablet and a preparation method thereof. Background technique [0002] Ambroxol hydrochloride has properties that promote mucus drainage and dissolve secretions. It can increase the secretion of serous glands in 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. Ambroxol hydrochloride is characterized by its clear pharmacological action, definite curative effect, low side effects and adverse reactions. Its oral preparation has been included in the scope of OTC Class A drugs and has been widely used clinically. Existing dosage forms include tablets, capsules, oral liquids, injections and powder injections. In recent years, a new dosage form - orally disintegrating tablets, is being developed and ap...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/137A61K9/20A61P11/10
Inventor 江桂清
Owner CHONGQING CONQUER PHARML
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