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Acetaminophen taste-masking granules and preparation method thereof

A technology of acetaminophen and taste-masking granules, which is applied in the directions of pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc. Reduce the convenience of taking and other problems, achieve good medication compliance, improve medication convenience, and increase the effect of adapting to the population

Pending Publication Date: 2021-08-03
北京科信聚润医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparation method is as follows: micronize acetaminophen, add diluent, disintegrant, suspending agent, sweetener, bitterness blocker, flavor and binder solution and stir to prepare soft material, and then use a sieve to The granules were obtained by sieving, and then dried to obtain dry suspension granules. The inventors found that the acetaminophen dry suspension granules prepared by this technology, because the acetaminophen was not taste-masked coating, still The original odor of the drug remains, and the patient's compliance with the drug is reduced. Before taking it, it must be made into a syrup, which greatly reduces the convenience of taking it.
[0005] Oral acetaminophen taste-masking granules in the prior art requires water to help the drug to obey when taking it, which is not conducive to or limits the inconvenient use of water for obedience patients, and because of the bitter smell of acetaminophen, it greatly affects patients, especially children. Patient Medication Adherence

Method used

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  • Acetaminophen taste-masking granules and preparation method thereof
  • Acetaminophen taste-masking granules and preparation method thereof
  • Acetaminophen taste-masking granules and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Example 1: Acetaminophen taste-masking granules

[0048] The paracetamol taste-masking granules of the unit preparation, its prescription composition is as follows:

[0049]

[0050] Preparation process description:

[0051] The acetaminophen is coated by a fluidized bed, and a taste-masking layer and an isolation layer are coated respectively, and then the flavoring auxiliary material composition is mixed. details as follows:

[0052] (1) Preparation of taste-masking layer solution and packaging of taste-masking layer

[0053] First, dissolve sodium lauryl sulfate in 200.0 mg of purified water, add stearic acid in a high-speed dispersion state, disperse to a dissolved state, add Eudragit EPO in a dispersed state, and disperse until no solid matter floats in the On the surface, add titanium dioxide, talcum powder, and simethicone oil to disperse for 30 minutes to form a uniform dispersion. Before coating, use a 0.5mm sieve to filter and use it as a coating solutio...

Embodiment 2

[0065] Example 2: Acetaminophen Taste Masking Granules

[0066] 1. Prescription composition and preparation

[0067]

[0068]

[0069] 2. Preparation of taste-masking layer solution

[0070] First, dissolve sodium lauryl sulfate in purified water, add stearic acid in a high-speed dispersion state, disperse to a dissolved state, add Eudragit EPO in a dispersed state, and disperse until no solid matter floats on the surface, Then add titanium dioxide, talcum powder, and simethicone oil to disperse for 30 minutes to form a uniform dispersion, and filter it with a 0.5mm sieve before coating.

[0071] 3. Preparation of isolation layer solution:

[0072] In the state of stirring the purified water, add hypromellose 603 and polyethylene glycol 6000, stir until dissolved, and then add talcum powder to form the final solution.

[0073] 4. List of coating parameters for taste-masking layer:

[0074] craft item parameter batch number 20141002 batch 500g ...

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Abstract

The invention relates to an acetaminophen preparation, and particularly provides novel acetaminophen taste-masking granules which are water-free swallowing granules and are prepared by coating acetaminophen with a taste-masking layer and an isolating layer and then mixing with a taste-modifying auxiliary material composition. Compared with the prior art, the acetaminophen taste-masking granules have the prominent technical effects that the acetaminophen taste-masking granules can effectively cover the bitter peculiar smell of acetaminophen and have good taste and medication compliance; and surprisingly, the acetaminophen taste-masking granules have the technical effect of anhydrous oral administration, the situation that conventional granules need to be taken with water is broken, the medication convenience and the medication compliance of patients are improved, the adaptive population of the patients is increased, and the medication compliance of the patients, especially children, is favorably improved.

Description

[0001] This application is a divisional application of a Chinese invention patent application with an application date of January 29, 2015, an application number of 201510045401.3, and an invention title of "A paracetamol taste-masking granule and its preparation method". technical field [0002] The invention relates to a new paracetamol preparation, in particular, it provides a novel paracetamol taste-masking granule, which is an anhydrous swallowable granule. It belongs to the field of pharmaceutical preparations. Background technique [0003] The chemical name of acetaminophen is N-(4-hydroxyphenyl)acetamide, and its molecular formula is C 8 h 9 NO 2 , structural formula It is usually a white crystalline powder with antipyretic and analgesic effects. It is used for cold and fever, joint pain, neuralgia, migraine, cancer pain and post-operative pain relief. Oral administration is easy to absorb, and the blood concentration reaches the peak within 0.5-1 hour. In the b...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/50A61K31/167A61K47/32A61K47/38A61P29/00
Inventor 王锦刚蒋海松朱德志朱广辉
Owner 北京科信聚润医药科技有限公司