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Desloratadine grain and preparation method thereof

A technology of desloratadine and loratadine, which is applied in the field of medicine, can solve problems such as trachea stuck in the throat, children's trachea blockage, children's physical injuries, etc., and achieve the effects of long shelf life, convenient taking, and convenient storage and carrying

Active Publication Date: 2011-05-04
HAINAN PULIN PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Due to the incomplete development of various body organs of young children, when taking tablet medicines, due to the poor swallowing ability of children, it is very easy for the accidents that the tablets block the trachea or get stuck in the throat.
Most parents use the method of pressing the pills into powder and then adding water to take them. However, since most medicines have obvious bitter taste, it is rare for children to take them voluntarily. Most parents use the method of forced feeding. This method is very likely to cause the child's tracheal blockage and cause danger.
Although the syrup solves the problem of taking compliance, the preservatives in it also cause harm to children's bodies

Method used

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  • Desloratadine grain and preparation method thereof
  • Desloratadine grain and preparation method thereof
  • Desloratadine grain and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Embodiment 1: This embodiment prepares 100 bags of desloratadine granules, adopting the following prescription:

[0032]

[0033]

[0034] Preparation Process:

[0035] (1) Pass the raw material through a 100-mesh sieve, and pass through an 80-mesh sieve for other materials for subsequent use;

[0036] (2) Mix desloratadine with the prescription amount of polyethylene glycol 4000, sodium citrate and 50g mannitol according to the method of increasing the same amount, and prepare the soft material by using 2% hypromellose and an appropriate amount of yellow ferric oxide aqueous solution, Prepare granules by passing through a 30 mesh sieve;

[0037] (3) Dry the granules at 30-35°C until the water content is lower than 2.0%;

[0038] (4) Coat the dried granules with Opadry water-soluble coating material and yellow ferric oxide aqueous solution and dry until the water content is lower than 2.0%, to obtain Granule 1;

[0039] (5) Mix the prescription amount of sucros...

Embodiment 2

[0042] Embodiment 2: This embodiment prepares 100 bags of desloratadine granules, adopting the following prescription:

[0043]

[0044]

[0045] Preparation Process:

[0046] (1) Pass the raw material through a 100-mesh sieve, and pass through an 80-mesh sieve for other materials for subsequent use;

[0047] (2) Mix desloratadine with the prescribed amount of polyethylene glycol 4000, malic acid, sodium bicarbonate and 50g mannitol according to the method of equal increase, and mix glycerin into the above mixed powder, and use 2% hypromellose Cellulose and an appropriate amount of red iron oxide aqueous solution are used to prepare soft materials, and granules are prepared by passing through a 30-mesh sieve;

[0048] (3) Dry the granules at 30-35°C until the water content is lower than 2.0%;

[0049] (4) Coating the dried granules with a mixed solution of hypromellose aqueous solution added with red iron oxide and titanium dioxide, and drying until the water content i...

Embodiment 3

[0052] Embodiment 3: the present embodiment adopts following prescription:

[0053]

[0054] Preparation Process:

[0055] (1) Pass the raw material through a 100-mesh sieve, and pass through an 80-mesh sieve for other materials for subsequent use;

[0056] (2) Mix desloratadine and 3g povidone, prescription amount of polyethylene glycol 4000, tartaric acid, sodium hydroxide and 50g mannitol according to the method of equal increase, and use 3% povidone and appropriate amount of red iron oxide Prepare soft materials from aqueous solution, and pass through a 30-mesh sieve to prepare granules;

[0057] (3) Dry the granules at 30-35°C until the water content is lower than 2.0%;

[0058] (4) Coat the dried granules with a mixed solution of povidone aqueous solution and red iron oxide and titanium dioxide, and dry until the water content is lower than 2.0%, to obtain granules 1;

[0059] (5) Mix the prescription amount of sucrose, maltose, and banana essence according to the ...

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Abstract

The invention relates to a desloratadine grain and a preparation method thereof. The preparation method comprises the steps: fully coating a medicine and proper auxiliary materials (such as a stabilizing agent, a cosolvent, a PH adjusting agent, a filling agent and the like) into a water-soluble high molecular material; and adding a proper opacifier into a coating material, so that the medicine can be isolated from the light and the external moist air when the medicine is stored, and the stability of the medicine can be adequately guaranteed when the medicine is stored under the room temperature; mixing the coated grain with a proper flavoring agent and soluble auxiliary materials to obtain the desloratadine granular formulation; and properly adding a small quantity of edible coloring agent and fruity essence to increase the novelty to the children, and improve the taking compliance.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a desloratadine granule and a preparation method thereof. Background technique [0002] Desloratadine is a non-sedating long-acting tricyclic antihistamine, which is the active metabolite of loratadine, and can inhibit various allergic inflammatory processes by selectively blocking peripheral H1 receptors. Chemical release. The main scope of treatment includes relief of symptoms of allergic rhinitis or chronic idiopathic urticaria. [0003] The dosage forms available for clinical selection mainly include tablets, dispersible tablets, and syrups. The absorption of tablets in the body must go through processes such as disintegration and dissolution before reaching the blood circulation through the gastrointestinal tract. However, during the production process of tablets, it is often difficult to disintegrate due to reasons such as dressings and processes, and the drug release is not compl...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/4545A61K47/38A61K47/36A61K47/32A61K47/34A61P37/08A61P11/02A61P17/00A61K47/10
Inventor 范敏华刘华赵德芳
Owner HAINAN PULIN PHARMA
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