Oral liquid preparation of rupatadine fumarate and preparation method of oral liquid preparation

A technology for rupatadine fumarate and liquid preparations, which is applied in the field of rupatadine fumarate oral liquid preparations and its preparation, and can solve problems such as poor stability

Inactive Publication Date: 2020-05-08
扬子江药业集团江苏紫龙药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The purpose of the present invention is to overcome the disadvantages of poor stability of rupatadine fumarate preparations

Method used

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  • Oral liquid preparation of rupatadine fumarate and preparation method of oral liquid preparation
  • Oral liquid preparation of rupatadine fumarate and preparation method of oral liquid preparation
  • Oral liquid preparation of rupatadine fumarate and preparation method of oral liquid preparation

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Embodiment 1-preparation of oral liquid preparation of the present invention

[0020] prescription:

[0021]

[0022]

[0023] Preparation method:

[0024] 1. Weigh the prescribed amount of rupatadine fumarate, polyethylene glycol 600, xylitol, sodium saccharin dihydrate, quinoline yellow;

[0025] 2. Add the above raw and auxiliary materials into about 80ml of purified water, and stir until it dissolves;

[0026] 3. Prepare citric acid-sodium citrate buffer solution with pH 5.0;

[0027] 4. Adjust with pH 5.0 citric acid-sodium citrate buffer solution to adjust the pH value of the raw material solution to 5.0;

[0028] 5. Dilute to 100ml with purified water;

Embodiment 2

[0029] Embodiment 2-preparation of oral liquid preparation of the present invention

[0030] prescription:

[0031]

[0032] Preparation method:

[0033] 1. Weigh the prescribed amount of rupatadine fumarate, povidone K25, xylitol, sodium saccharin dihydrate, quinoline yellow, sodium bisulfite, methylparaben;

[0034] 2. Add the above raw and auxiliary materials into about 80ml of purified water, and stir until it dissolves;

[0035] 3. Prepare a citric acid-sodium citrate buffer solution with a pH of 4.8;

[0036] 4. Adjust with pH 4.8 citric acid-sodium citrate buffer solution to adjust the pH value of the raw material solution to 4.8;

[0037] 5. Dilute to 100ml with purified water;

Embodiment 3

[0038] Embodiment 3-preparation of oral liquid preparation of the present invention

[0039] prescription:

[0040]

[0041]

[0042] Preparation method:

[0043] 1. Weigh the prescribed amount of rupatadine fumarate, povidone K25, xylitol, sodium saccharin dihydrate, orange flavor, quinoline yellow, sodium bisulfite, methylparaben;

[0044] 2. Add the above raw and auxiliary materials into about 80ml of purified water, and stir until it dissolves;

[0045] 3. Prepare citric acid-sodium citrate buffer solution with pH 5.0;

[0046] 4. Adjust with pH 5.0 citric acid-sodium citrate buffer solution to adjust the pH value of the raw material solution to 5.0;

[0047] 5. Dilute to 100ml with purified water;

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PUM

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Abstract

The invention relates to the fields of medicine and dosage forms of medicine, in particular to an oral liquid preparation of rupatadine fumarate and a preparation method of the oral liquid preparation, and discloses an oral liquid preparation of rupatadine fumarate. The oral liquid preparation per 100 mL contains 0.128 g of rupatadine fumarate, 1-20 g of a solubilizer, 1-30 g of a sweetening agent, 0-0.2 g of a flavoring agent, 0-0.01 g of a coloring agent, 0-0.20 g of a preservative and a pH regulator for adjusting the pH value to 4.6-5.6. The oral liquid preparation of rupatadine fumarate has good stability in the study of accelerated stability.

Description

technical field [0001] The invention relates to the field of medicines and dosage forms thereof, in particular to a rupatadine fumarate oral liquid preparation and a preparation method thereof. Background technique [0002] Allergic diseases, it is a common disease and frequently-occurring disease, can be divided into two kinds of seasonal and perennial, including allergic rhinitis, urticaria, asthma, eczema and so on. With the progress of industrialization, the drastic changes of modern lifestyle and human ecological environment, the incidence of allergic diseases has a global increasing trend, and its incidence accounts for about 5-50% of the population. [0003] At present, antihistamines are the main clinical drugs for the treatment of allergic rhinitis and allergic urticaria in my country. At present, the first-generation antihistamines represented by diphenhydramine, chlorpheniramine, and promethazine are gradually replaced by second-generation antihistamines with no ...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K31/4545A61K47/26A61K47/32A61P11/02A61P37/08A61P11/06A61P17/00
CPCA61K9/0053A61K31/4545A61K47/26A61K47/32A61P11/02A61P11/06A61P17/00A61P37/08
Inventor 褚岩凤赫侠平蒋佳文朱顺
Owner 扬子江药业集团江苏紫龙药业有限公司
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