Desloratadine citrate disodium oral liquid preparation as well as preparation method and application thereof

A technology of desloratadine and loratadine is applied in the field of pharmaceutical preparations to achieve the effects of high quality taste, improved compliance and guaranteed safety

Active Publication Date: 2020-06-30
HEFEI IND PHARMA INST
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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

Method used

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  • Desloratadine citrate disodium oral liquid preparation as well as preparation method and application thereof
  • Desloratadine citrate disodium oral liquid preparation as well as preparation method and application thereof
  • Desloratadine citrate disodium oral liquid preparation as well as 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 Ethylparaben 0.25kg sucrose 400kg Edetate Disodium 3kg sodium citrate 2kg apple flavor 1.5kg Add water to 1000L

[0048] The preparation method of this embodiment is:

[0049] (1) Desloratadine citrate, ethylparaben, sucrose, edetate disodium, sodium citrate, apple flavor are taken by weighing prescription quantity;

[0050] (2) Add the prescribed amount of ethylparaben and sucrose into an appropriate amount of purified water, stir and boil for about 20 minutes, and cool to room temperature;

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

Embodiment 2

[0052] Embodiment 2 desloratadine citrate oral solution

[0053]

[0054]

[0055] The preparation method of this embodiment is:

[0056] (1) Desloratadine citrate, sodium benzoate, sucralose, edetate disodium, anhydrous citric acid, sodium citrate, and strawberry essence are weighed in prescription quantities;

[0057] (2) adding the sodium benzoate of prescription quantity into appropriate purified water, stirring and dissolving;

[0058] (3) Add desloratadine citrate, sucralose, edetate disodium, anhydrous citric acid, sodium citrate, strawberry essence to the above solution, stir for about 30 minutes until dissolved, add purified water to 1000L, filled and ready to serve.

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 Edetate Disodium 1.5kg orange essence 1.0kg Amaranth 0.1kg Add water to 1000L

[0061] The preparation method of this embodiment is:

[0062] (1) Weigh desloratadine citrate, methylparaben, propylparaben, sorbitol, xylitol, sodium dihydrogen phosphate, disodium hydrogen phosphate, disodium edetate, orange essence in the prescribed amount , amaranth;

[0063] (2) Add the prescribed amount of methylparaben and propylparaben to an appropriate amount of purified water, stir and boil for 20 minutes to dissolve, and cool to room temperature;

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

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Abstract

The invention provides a desloratadine citrate disodium oral liquid preparation as well as a preparation method and an application thereof. The oral liquid preparation of the invention comprises desloratadine citrate disodium and pharmaceutically acceptable auxiliary materials, wherein the concentration of the desloratadine citrate disodium in the oral liquid preparation is 0.01-1.0% (w/v), and the pH is 2.0-8.0; and the desloratadine citrate disodium oral liquid preparation comprises an oral solution, a syrup or an oral drip. The desloratadine citrate disodium oral liquid preparation mainly fills the market blank of children antiallergic drugs in the age of six to eleventh months, guarantees the safety of the children medication, and can also meet the requirements of patients with 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 researched and developed by Hefei Medical Engineering and Pharmaceutical Co., Ltd. In 2009, it jointly applied for listing with Nanjing Haichen Pharmaceutical Co., Ltd. and Yangzijiang Pharmaceutical Group Guangzhou Hairui Pharmaceutical Co., Ltd. The listed dosage forms are capsules ( Product name: Ruipukang, approval number H20173031), tablets, specifications are 8.8mg. [0003] Desloratadine citrate is converted into desloratadine in the body to play its role. At present, the dosage forms of desloratadine that have been approved for marketing at home and abroad include dry suspension, capsule, syrup, ordinary tablet, dispersible tablet, oral solution, etc. [0004] Patent application CN02128998.0 dis...

Claims

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Application Information

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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
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