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Desloratadine syrup preparation and preparation method thereof

The technology of desloratadine and loratadine is applied in the field of syrup medicament and its preparation, which can solve the problems of unsolved taste problem, undisclosed sucrose-containing, large sucrose, etc. The effect of improving and inhibiting degradation of degraded impurities

Inactive Publication Date: 2015-07-22
ZHEJIANG KAIRUN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Chinese patent CN102697711A discloses desloratadine oral liquid preparation and its preparation method. The patented technology clearly adds a coloring agent in its formula, but it does not solve the problem that the desloratadine liquid preparation will become desloratadine during storage. Pink
At the same time, there is no good solution to the problem of the taste of children's medication in special populations.
[0006] Chinese patent CN104095807A discloses a desloratadine syrup preparation and a preparation method thereof. This Chinese patent contains coloring agents such as carmine in its specific embodiment, but it does not solve the problem of desloratadine solution well. The preparation will turn pink in storage
[0007] Chinese patent CN101505750 discloses a sugar-free, storage-stable antihistamine syrup, claiming to solve the problem that the desloratadine liquid preparation will turn pink during storage, but it is not disclosed in the specific implementation Contains sucrose
Although the content of reducing sugar in sucrose is low, the amount of sucrose in the syrup is very large, and the sucrose solution will be degraded under the influence of temperature, light, pH and other factors during long-term storage, and the resulting fructose and glucose will also be accelerated. Degradation of radadine, at the same time the sucrose solution will also appear pale yellow in long-term storage

Method used

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  • Desloratadine syrup preparation and preparation method thereof
  • Desloratadine syrup preparation and preparation method thereof
  • Desloratadine syrup preparation and preparation method thereof

Examples

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preparation example Construction

[0054] A preparation method of a syrup preparation of desloratadine as described above, said preparation method comprising the steps of:

[0055] (1) Hypromellose is dissolved with an appropriate amount of water to make a certain concentration;

[0056] (2) Desloratadine is dissolved in propylene glycol;

[0057] (3) Dissolve the pH regulator, stabilizer, and preservative with an appropriate amount of water, and then add sucrose to dissolve;

[0058] (4) Slowly add step (2) to step (3) while stirring to make the solution clear, then add the solution of step (1) and flavoring agent, stir evenly, filter and add water to the full amount, and sterilize at 60°C 6 hours.

[0059] The preferred scheme of the present invention is: in the described step:

[0060] In step (1), hypromellose is added with hot water at 70-80°C under stirring, and stirred for several minutes until it is uniformly dispersed, then an appropriate amount of water is added, and stirred to dissolve it;

[006...

Embodiment

[0074] Embodiment: The multiple combinations of stabilizers described in the present invention include mixtures of antioxidants, hypromellose, propylene glycol, glycerin, and water-soluble beta-cyclodextrin.

[0075] The preparation method of desloratadine sucrose of the present invention is:

[0076] (1) Hypromellose is dissolved with an appropriate amount of water to make a certain concentration;

[0077] (2) Desloratadine is dissolved in propylene glycol;

[0078] (3) Dissolve the pH regulator, stabilizer, and preservative with an appropriate amount of water, and then add sucrose to dissolve;

[0079] (4) Slowly add step (2) to step (3) while stirring to make the solution clear, then add the solution of step (1) and flavoring agent, stir evenly, filter and add water to the full amount, and sterilize at 60°C 6 hours.

Embodiment 1

[0103] prescription composition

[0104]

[0105] Preparation method:

[0106] (1) Add hypromellose with hot water at 70-80°C under stirring, stir for a few minutes to disperse evenly, then add appropriate amount of water, stir to dissolve;

[0107] (2) Desloratadine is dissolved in propylene glycol;

[0108] (3) Add citric acid, sodium citrate, EDTA-2Na, sodium benzoate, and hydroxypropyl-β-cyclodextrin into an appropriate amount of water, stir to dissolve, add sucrose and stir to dissolve;

[0109] (4) Slowly add steps (1) and (2) to step (3) while stirring to clarify the solution, then add menthol and cooling agent 3, stir evenly, filter and add water to the full amount. Sterilize at 60°C for 6 hours.

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PUM

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Abstract

A desloratadine syrup preparation mainly comprises desloratadine, sucrose, a pH adjusting agent, a stabilizer, and a flavoring or antiseptic, wherein desloratadine exists in a hydrochloride form. The pH value of the syrup preparation is 4.0-7.0. The desloratadine syrup preparation has the advantages of fast effectiveness, strong effect, no toxicity to the heart, less drug interaction, and no food taboo.

Description

technical field [0001] The invention relates to a desloratadine syrup preparation and a preparation method thereof, belonging to syrup medicaments and a preparation method thereof. Background technique [0002] Desloratadine is a non-sedating long-acting histamine antagonist with potent and selective antagonism on peripheral H1 receptors. Literature reports have confirmed that desloratadine has the advantages of anti-allergic, antihistamine, and anti-inflammatory three-in-one; after oral administration, desloratadine is effectively excluded from the central nervous system (CNS), so it can be selected Sexually blocks peripheral histamine H1 receptors. A large number of in vitro (mainly human tissue cells) and in vivo studies have shown that this product has the advantages of rapid onset of action, strong potency, no cardiotoxicity, few drug interactions, and no food contraindications. [0003] The dosage forms of desloratadine clinical selection include tablet, dispersible ...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/4545A61K47/26A61K47/10A61K47/38A61K47/40A61K47/12A61P37/08A61P29/00
Inventor 莫荣喜沈阳邱兵
Owner ZHEJIANG KAIRUN PHARMA
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