A kind of oral liquid preparation of desloratadine citrate and preparation method and application thereof

A technology of desloratadine and loratadine, which is applied in the field of pharmaceutical preparations to meet clinical needs, improve compliance, and ensure safety

Active Publication Date: 2022-07-29
HEFEI IND PHARMA INST CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there is no anti-allergic drug for children from June to November in China
Domestic children’s antiallergic drugs basically cover the age group of 2 to 11 years, and only a few drugs such as desloratadine and cetirizine are available for patients in the age group of 1 to 2 years, and there is no clear usage and dosage for children under the age of 1. drug

Method used

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  • A kind of oral liquid preparation of desloratadine citrate and preparation method and application thereof
  • A kind of oral liquid preparation of desloratadine citrate and preparation method and application thereof
  • A kind of oral liquid preparation of desloratadine citrate and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Embodiment 1 desloratadine citrate oral solution

[0047] Element concentration desloratadine citrate 0.88kg ethyl paraben 0.25kg sucrose 400kg Disodium Edetate 3kg Sodium citrate 2kg apple essence 1.5kg add water to 1000L

[0048] The preparation method of the present embodiment is:

[0049] (1) take by weighing desloratadine citrate, ethyl paraben, sucrose, disodium edetate, sodium citrate, apple essence of recipe quantity;

[0050] (2) adding the ethyl paraben and sucrose of the recipe quantity into an appropriate amount of purified water, stirring and boiling for about 20 minutes, and cooling to room temperature;

[0051] (3) Add desloratadine citrate, disodium edetate, sodium citrate and apple essence to the above solution, stir for about 30 minutes to dissolve, add purified water to 1000L, and fill to obtain the final product.

Embodiment 2

[0052] Embodiment 2 desloratadine citrate oral solution

[0053]

[0054]

[0055] The preparation method of the present embodiment is:

[0056] (1) take by weighing the desloratadine citrate, sodium benzoate, sucralose, disodium edetate, anhydrous citric acid, sodium citrate, strawberry essence of recipe quantity;

[0057] (2) adding the sodium benzoate of the recipe quantity to an appropriate amount of purified water, stirring and dissolving;

[0058] (3) Add desloratadine citrate, sucralose, disodium edetate, anhydrous citric acid, sodium citrate, strawberry essence to the above solution, stir for about 30 minutes to dissolve, and add purified water to 1000L, fill and get it.

Embodiment 3

[0059] Embodiment 3 desloratadine citrate oral solution

[0060] Element concentration desloratadine citrate 0.88kg methylparaben 0.3kg Propylparaben 0.03kg Sorbitol 10kg Xylitol 15kg Sodium dihydrogen phosphate 0.3kg Disodium phosphate 4.0kg Disodium Edetate 1.5kg orange essence 1.0kg Amaranth 0.1kg add water to 1000L

[0061] The preparation method of the present embodiment is:

[0062] (1) take by weighing the desloratadine citrate, methylparaben, propylparaben, sorbitol, xylitol, sodium dihydrogen phosphate, disodium hydrogen phosphate, disodium edetate, orange essence of recipe quantity , Amaranth;

[0063] (2) methylparaben and propylparaben of recipe quantity are added to an appropriate amount of purified water, stirred and boiled to dissolve in 20 minutes, and cooled to room temperature;

[0064] (3) Add desloratadine citrate, sorbitol, xylitol, sodium dihydrogen phosphate, dis...

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PUM

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Abstract

The present invention provides a desloratadine citrate oral liquid preparation and a preparation method and application thereof. The oral liquid preparation of the present invention comprises desloratadine citrate and pharmaceutically acceptable excipients, the concentration of the desloratadine citrate in the oral liquid preparation is 0.01% to 1.0% (w / v), and the pH ranges The oral liquid preparation of desloratadine citrate includes, but is not limited to, oral solution, syrup or oral drops. The oral liquid preparation of desloratadine citrate of the present invention mainly fills the market gap of antiallergic drugs for children in the age group of June to November, ensures the safety of children's medication, and can also meet the needs of patients of different age groups.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a desloratadine citrate oral liquid preparation and a preparation method and application thereof. Background technique [0002] Desloratadine Citrate was independently developed by Hefei Medical Engineering and Pharmaceutical Co., Ltd. In 2009, it joined Nanjing Haichen Pharmaceutical Co., Ltd. and Yangzijiang Pharmaceutical Group Guangzhou Hairui Pharmaceutical Co., Ltd. to apply for listing. The listed dosage forms are capsules ( Trade name: Ruipukang, approval No. Guoyaozhunzi H20173031), tablets, both specifications are 8.8mg. [0003] Desloratadine citrate is converted into desloratadine in the body to play a role. At present, the approved dosage forms of desloratadine at home and abroad include dry suspension, capsule, syrup, ordinary tablet, dispersible tablet, oral solution, etc. [0004] Patent application CN02128998.0 discloses a complex salt of dilopatadine...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K9/10A61K31/4545A61K47/12A61K47/26A61P11/02A61P17/00A61P37/08
CPCA61K9/0095A61K31/4545A61K47/12A61K47/26A61P37/08A61P11/02A61P17/00
Inventor 何广卫刘为中苏峰王会储昭兴莫佳佳
Owner HEFEI IND PHARMA INST CO LTD
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