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 bad mouthfeel duration, long mouthfeel duration, severe taste and so on, and achieve bad taste Short duration, good disintegration effect and high dissolution rate

Active Publication Date: 2012-01-25
HANGZHOU CONBA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The object of the present invention is to provide a kind of ambroxol hydrochloride orally disintegrating tablet, aiming at the problem that ambroxol hydrochloride orally disintegrating tablet produces severe taste and numbness to the oral cavity during taking, and the bad taste persists for a long time. Good disintegration effect, high dissolution rate, good taste, short duration of bad taste

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

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Comparison scheme
Effect test

example 1

[0042] Example 1: Preparation of Ambroxol Hydrochloride Orally Disintegrating Tablets

[0043](1) Ambroxol hydrochloride orally disintegrating tablet quality formula:

[0044]

[0045] (2) Preparation method

[0046] 1) With hydroxypropyl methylcellulose and taste-masking essence-TP5004 as coating materials, take 6.3g of hydroxypropylmethylcellulose (HPMC) from the above formula, add 80ml of 50% ethanol aqueous solution until it is completely dissolved, and prepare as 8% HPMC aqueous ethanol solution, add 0.63g taste-masking essence-TP5004, fully stir and dissolve, make taste-masking coating solution; 2) get 30g ambroxol hydrochloride powder and put in the fluidized bed, put the prepared The coating solution is evenly sprayed on the surface of the ambroxol hydrochloride powder with a bottom spray gun, the air intake is controlled at 40°C±5°C, the atomization pressure is 1.8-2pa, and the coated granules containing ambroxol hydrochloride are prepared through a fluidized bed ...

example 2

[0048] Example 2: Preparation of Ambroxol Hydrochloride Orally Disintegrating Tablets

[0049] (1) Ambroxol hydrochloride orally disintegrating tablet quality formula:

[0050]

[0051] (2) Preparation method:

[0052] Experimental operation is the same as embodiment 1, prepares 1000 tablets of ambroxol hydrochloride cavity disintegrating tablets, the effective content of ambroxol hydrochloride in each tablet is 30mg, the tablet weighs 132.5mg, the time limit for disintegrating in vitro is 35 seconds, and the dissolution rate is 98.5%.

[0053] At the same time, a taste survey was conducted on 8 healthy volunteers. Based on the feedback from the 8 subjects, there was no gritty, sweet taste, and a little numbness, which lasted for an average of 37 seconds and disappeared. It was accompanied by a cooling sensation when taken, and disintegrated in the mouth on average. The time limit is 32 seconds, and the results are shown in Tables 1 to 8.

example 3

[0054] Example 3: Preparation of Ambroxol Hydrochloride Orally Disintegrating Tablets

[0055] (1) Quality formula of ambroxol hydrochloride orally disintegrating tablets

[0056]

[0057] (2) Preparation method

[0058] Experimental operation is the same as in Example 1, prepare 100 ambroxol hydrochloride orally disintegrating tablets, the effective content of ambroxol hydrochloride in each tablet is 30 mg, the tablet weighs 120.72 mg, the disintegration time limit is 30 seconds, and the dissolution rate is 97.9%.

[0059] At the same time, 8 healthy volunteers conducted a taste survey. The comprehensive feedback from the 8 subjects was that there was no gritty, sweet taste, and a little numbness, which lasted for an average of 39 seconds and disappeared. The solution time limit is 27 seconds, and the results are shown in Tables 1 to 8.

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Abstract

The invention discloses an ambroxol hydrochloride orally disintegrating tablet. The orally disintegrating tablet comprises ambroxol hydrochloride and is prepared by proportioning the following raw auxiliary materials in part by weight: ambroxol hydrochloride flavor masking particles are prepared by coating and contain 1 part of ambroxol hydrochloride agents, 1-2 parts of filling agents, 0.1-0.25 part of disintegrating agents, 0.5-1 part of flavoring agents, 0.01-0.05 part of mouth cooling agents, 0.029-0.05 part of lubricating agents and 0.03-0.05 part of flow agents. The ambroxol hydrochloride orally disintegrating tablet has a good disintegrating effect and good dissolution rate. As a certain proportion of mouth cooling agents are added in the auxiliary materials, the discomfort generated to an oral cavity and a throat part is effectively alleviated after drug taking. The ambroxol hydrochloride orally disintegrating tablet has good mouthfeel and short duration of bad mouthfeel, can bring good drug taking process to a patient after being taken and is suitable for industrialization production.

Description

(1) Technical field [0001] The invention relates to an oral chemical medicine quick-release preparation, in particular to an ambroxol hydrochloride orally disintegrating tablet and a preparation method thereof. (2) Background technology [0002] Ambroxol hydrochloride is a unique new expectorant drug, and its expectorant effect is stronger than that of bromhexine. This product has the functions of dissolving mucus, promoting the synthesis of pulmonary surfactant and activating the purification function of mucus and cilia. It also has the effect of reducing the adhesion between sputum and cilia and making sputum easy to cough up. [0003] Because ambroxol hydrochloride has definite curative effect and few adverse reactions, it is currently the most widely used expectorant in clinical practice, and it is also suitable for the elderly and children. Therefore, it is necessary to develop new preparations suitable for different populations to meet the needs of clinical medication...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/137A61K47/38A61P11/10
Inventor 徐春玲徐秀卉金朱明陆振宇黄海波傅美景徐慧娟
Owner HANGZHOU CONBA PHARMA
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