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Oral disintegrating tablet containing tramadol hydrochloride and acetaminopher, and its preparation method

A technology of paracetamol and tramadol hydrochloride is applied in the field of oral disintegrating tablets containing tramadol hydrochloride and paracetamol hydrochloride and their preparation fields, and can solve the problem of not being able to take them in time, having large side effects, and being unable to take tramadol hydrochloride and paracetamol hydrochloride. Problems such as the composition of orally disintegrating tablets of acetaminophen

Active Publication Date: 2006-07-19
SHANGHAI SINE PHARMA LAB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] However, the tramadol hydrochloride / acetaminophen compound tablets currently on the market are ordinary tablets, which need to be swallowed with water when taking them. Once pain occurs, they cannot be taken in time, and the pain cannot be relieved in time. It needs to be excreted through the gastrointestinal tract. Absorption, low bioavailability, large side effects;
[0007] At the same time, it is impossible to form orally disintegrating tablets with tramadol hydrochloride and acetaminophen by conventional methods, because tramadol hydrochloride and / or acetaminophen are extremely bitter drugs, and generally do not make orally disintegrating tablets

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Preparation Process:

[0034] (1) Mix 10 mg of flavoring agent aspartame and 70 mg of filler mannitol, add 0.5 mg (0.6% of the total mass of flavoring agent and filler) of polyvinylpyrrolidone, and pass through a 20-mesh sieve to make wet The granules were dried at 70°C to obtain granules (I);

[0035] Said binder is polyvinylpyrrolidone;

[0036] (2) 325mg paracetamol and 3mg lubricant silicon dioxide are mixed, cross 70 mesh sieves, use 37.5mg mass concentration as the aqueous solution of coating taste-masking agent acrylic resin of 40% as coating agent coating, obtain particles (II);

[0037] (3) Mix 37.5mg tramadol hydrochloride with 180mg saturated ethanol solution of coating taste-masking agent β-cyclodextrin, add tramadol hydrochloride and β-cyclodextrin respectively in the ethanol solution, and use a high-speed mixer to Stir for 2-5 hours, then spread the stirred solution on a glass dish, put it in a 50-70 oven for drying, take it out, and crush the dr...

Embodiment 2

[0043] 325mg / 37.5mg paracetamol tramadol / tablet, the formula is shown in Table 2.

[0044] component name

components

Amount added

active ingredient

Acetaminophen

325mg

[0045] active ingredient

tramadol hydrochloride

37.5mg

Coating Taste Masking Agent

Acrylic

8mg

Coating Taste Masking Agent

β-cyclodextrin

110mg

Coating Taste Masking Agent

Ethyl cellulose

15mg

flavoring agent

aspartame

5mg

flavoring agent

ethyl maltol

4mg

essence

lemon zest

13mg

disintegrant

Crospovidone

46mg

Disintegrant

Sodium dodecyl sulfate

10mg

filler

Mannitol

60mg

lubricant

silica

6.1mg

Adhesive

Polyvinylpyrrolidone

0.4mg

[0046] The preparation process is as follows:

[0047] (1) Mix 5 mg of aspartame as the flavoring agent and 60 mg of the filler mannitol, add 0.4 mg (0.6...

Embodiment 3

0.5mg

[0058] Preparation process is with embodiment 1

[0059] The test results are shown in Table 4.

[0060]

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PUM

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Abstract

The invention provides an orally disintegrating tablet containing tramadol hydrochloride and paracetamol, and the preparing process, wherein tramadol hydrochloride and paracetamol are dressed for mouth cavity use. During the dressing process, right amount of medicinal auxiliary materials are charged.

Description

technical field [0001] The invention relates to a preparation containing tramadol hydrochloride and acetaminophen and a preparation method thereof, in particular to an orally disintegrating tablet containing tramadol hydrochloride and acetaminophen and a preparation method thereof. technical background [0002] Tramadol hydrochloride is a synthetic opioid central analgesic, its spatial structure is similar to the partial structure of endorphin, it can also specifically bind to opioid receptors, stimulate receptors, and produce morphine-like analgesic effects, but without morphine The same serious adverse reactions, under the therapeutic dose, the tolerance is better, the dependence is low, because there is no adrenergic and serotonergic effects, respiratory depression, constipation, dysuria will not occur, and the blood vessels, liver and kidney functions will not be affected. , smooth muscle and striated muscle, etc. There is no adverse effect, the onset is fast and the dur...

Claims

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Application Information

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IPC IPC(8): A61K31/167A61K9/20A61P29/00A61P25/04A61K31/135
Inventor 余伟民钱建张冬梅
Owner SHANGHAI SINE PHARMA LAB
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