Ambroxol hydrochloride oally disintegrating tablet and preparation method thereof

A technology for ambroxol hydrochloride and orally disintegrating tablets, applied in the field of ambroxol hydrochloride orally disintegrating tablets and preparation thereof, can solve the problems of incapability of production, difficult to mix evenly, poor content uniformity and the like, and achieve shortened disintegration The time limit, the method is easy and controllable, and the effect is convenient to take

Inactive Publication Date: 2017-09-08
CHONGQING CONQUER PHARML
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparation of orally disintegrating tablets by direct powder compression method has certain limitations. For raw materials with poor fluidity and strong viscosity, the stickiness is obvious during tablet compression, which is not feasible for production. The ratio is low, it is difficult to mix uniformly by direct powder compression method, and the content uniformity is poor; the preparation of orally disintegrating tablets by freeze-drying method takes a long time, high technical difficulty, high equipment cost, and small batches, etc.
[0005] Obviously, the preparation method of orally disintegrating tablets in the prior art has problems such as difficult mixing of ingredients, poor content uniformity, long time-consuming and high technical difficulty.

Method used

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

Examples

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Effect test

Embodiment 1

[0028] Embodiment 1: a kind of ambroxol hydrochloride orally disintegrating tablet, disintegrant is polyvinylpolypyrrolidone and low-substituted hydroxypropyl cellulose, wherein each component distribution ratio is counted as: ambroxol hydrochloride 25%, Titanium dioxide 8%, sodium lauryl sulfate 4.5%, mannitol 32.5%, microcrystalline cellulose 15%, crospovidone 8%, low-substituted hydroxypropyl cellulose 4%, sodium saccharin 2%, stearin Magnesium acid 1%, appropriate amount of water.

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

[0030] S1, first carry out taste-masking treatment with ambroxol hydrochloride and taste-masking agent titanium dioxide, sodium lauryl sulfate, weigh ambroxol hydrochloride, titanium dioxide and sodium lauryl sulfate in proportion, after preliminary mixing , placed in a ball mill to grind, control the speed at 60 rpm, and grind for 60 minutes, pour it out through a 120-mesh sieve, we...

Embodiment 2

[0035]Embodiment 2: a kind of ambroxol hydrochloride orally disintegrating tablet, disintegrating agent is low-substituted hydroxypropyl cellulose, wherein each component distribution ratio is counted as: ambroxol hydrochloride 25%, talcum powder 8%, ten 4.5% sodium dialkyl sulfate, 32.5% mannitol, 15% microcrystalline cellulose, 12% low-substituted hydroxypropyl cellulose, 2% sodium saccharin, 1% magnesium stearate, appropriate amount of water.

[0036] A preparation method of ambroxol hydrochloride orally disintegrating tablet, the steps are as follows:

[0037] S1, at first ambroxol hydrochloride and taste-masking agent talcum powder, sodium lauryl sulfate are carried out taste-masking treatment, take ambroxol hydrochloride, talc powder and sodium lauryl sulfate in proportion, after preliminary mixing , placed in a ball mill to grind, control the speed at 60 rpm, and grind for 60 minutes, pour it out through a 120-mesh sieve, weigh it, and set aside;

[0038] S2. Weigh the...

Embodiment 3

[0042] Embodiment 3: a kind of ambroxol hydrochloride orally disintegrating tablet, disintegrating agent is polyvinylpolypyrrolidone, and wherein each component distribution ratio is counted as by weight percentage: ambroxol hydrochloride 25%, talcum powder 8%, twelve Sodium alkyl sulfate 4.5%, mannitol 32.5%, microcrystalline cellulose 15%, crospovidone 12%, sodium saccharin 2%, magnesium stearate 1%, appropriate amount of water.

[0043] A preparation method of ambroxol hydrochloride orally disintegrating tablet, the steps are as follows:

[0044] S1, at first ambroxol hydrochloride and taste-masking agent talcum powder, sodium lauryl sulfate are carried out taste-masking treatment, take ambroxol hydrochloride, talc powder and sodium lauryl sulfate in proportion, after preliminary mixing , placed in a ball mill to grind, control the speed at 60 rpm, and grind for 60 minutes, pour it out through a 120-mesh sieve, weigh it, and set aside;

[0045] S2. Weigh the filling agent ...

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Abstract

The invention discloses an ambroxol hydrochloride oally disintegrating tablet and a preparation method thereof. The orally disintegrating tablet consists of effective dose of ambroxol hydrochloride and pharmaceutical adjuvants, wherein the pharmaceutical adjuvants include a taste masking agent, a filler, a flavoring agent, a disintegrant, an adhesive and a lubricant; and the disintegrant is a combination of cross-linked povidone and other disintegrants. The ambroxol hydrochloride oally disintegrating tablet prepared by the invention has the characteristics of being convenient to take without the use of water, rapid in disintegrating, rapid in absorption, high in bioavailability and the like. The preparation method of the finished product (the ambroxol hydrochloride oally disintegrating tablet) provided by the invention is low in cost, simple in processing equipment, easy and controllable in implementation, low in operating cost, economic and convenient, and applicable to large-scale production.

Description

technical field [0001] The invention relates to an oral tablet, in particular to an ambroxol hydrochloride orally disintegrating tablet and a preparation method thereof. Background technique [0002] Ambroxol hydrochloride is a new generation of mucus-dissolving agent, which is mainly used clinically to treat acute and chronic respiratory diseases. Secretion, thereby reducing sputum viscosity; at the same time, it can promote the secretion of pulmonary surfactant, increase bronchial ciliary movement, make sputum easy to cough up, achieve significant expectoration, and improve respiratory conditions. Ambroxol hydrochloride was first listed in Germany in the early 1980s, and later in France, Italy, Japan, Spain and many other countries. It is in the forefront of the drug rankings of key hospitals in major cities in my country. [0003] At present, the dosage forms of ambroxol hydrochloride in the domestic market mainly include oral preparations and injections. Among them, the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/137A61K47/32A61K47/38A61K47/36A61P11/10
CPCA61K9/2027A61K9/0056A61K9/2054A61K9/2059A61K9/2095A61K31/137
Inventor 陈用芳胡瀚赵伟淑李湖川田建
Owner CHONGQING CONQUER PHARML
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