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Loratadine syrup and preparation method thereof

A technology of loratadine and syrup, applied in the field of loratadine syrup and its preparation, loratadine syrup, can solve the problems of poor water solubility and instability, achieve stable content, be easy to accept, improve The effect of solubility

Active Publication Date: 2015-08-26
GUANGDONG SHUNFENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] But, from the water solubility of loratadine, its water solubility is very poor, and is all unstable under alkali, heat condition, so when loratadine syrup is prepared, the dissolution stability of loratadine is a key factor. very critical question

Method used

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  • Loratadine syrup and preparation method thereof
  • Loratadine syrup and preparation method thereof
  • Loratadine syrup and preparation method thereof

Examples

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Effect test

Embodiment 1

[0029] No. 1 loratadine syrup includes the following components per 1000ml: 1.0g loratadine, 10.0g β-cyclodextrin, 2.5g sodium benzoate, 3.95g 95% ethanol, 2.0g citric acid, Grapefruit essence 1.0g, sucrose 650g, and the balance is purified water.

[0030] The preparation method of above-mentioned No. 1 loratadine syrup comprises the following steps:

[0031] S1. Take sucrose and add 250ml of purified water, heat to dissolve into syrup, and cool to below 60°C;

[0032] S2. Take β-cyclodextrin and add 120ml of purified water, heat and stir to dissolve, set aside;

[0033] S3. Take the main drug loratadine and add it to 95% ethanol. After stirring and dissolving, add it into the clathrate solution in step S2 in a thin stream, and stir until it is completely dissolved, then set aside;

[0034] S4. Add the solution in step S3 into the syrup in step S1, then add sodium benzoate, citric acid, and grapefruit essence in sequence, add purified water to the full amount, stir evenly, a...

Embodiment 2

[0036] No. 2 loratadine syrup includes the following components per 1000ml by weight: 1.0g of loratadine, 11.0g of β-cyclodextrin, 2.5g of sodium benzoate, 3.95g of 95% ethanol, 2.5g of citric acid, Orange essence 1.0g, sucrose 650g, and the balance is purified water.

[0037] The preparation method of above-mentioned No. 2 loratadine syrup comprises the following steps:

[0038] S1. Take sucrose and add 250ml of purified water, heat to dissolve into syrup, and cool to below 60°C;

[0039] S2. Take β-cyclodextrin and add 140ml of purified water, heat and stir to dissolve, set aside;

[0040] S3. Take the main drug loratadine and add it to 95% ethanol. After stirring and dissolving, add it into the clathrate solution in step S2 in a thin stream, and stir until it is completely dissolved, then set aside;

[0041] S4. Add the solution in step S3 into the syrup in step S1, then sequentially add sodium benzoate, citric acid, and orange essence, add purified water to the full amou...

Embodiment 3

[0043] No. 3 loratadine syrup contains the following components per 1000ml: 1.0g loratadine, 10.0g gamma-cyclodextrin, 2.5g sodium benzoate, 3.95g 95% ethanol, 2.0g sodium citrate , grapefruit essence 1.0g, sucrose 650g, and the balance is purified water.

[0044] The preparation method of above-mentioned No. 3 loratadine syrup comprises the following steps:

[0045] S1. Take sucrose and add 250ml of purified water, heat to dissolve into syrup, and cool to below 60°C;

[0046] S2. Take γ-cyclodextrin and add 120ml of purified water, heat and stir to dissolve, set aside;

[0047] S3. Take the main drug loratadine and add it to 95% ethanol. After stirring and dissolving, add it into the clathrate solution in step S2 in a thin stream, and stir until it is completely dissolved, then set aside;

[0048] S4. Add the solution in step S3 into the syrup in step S1, then add sodium benzoate, sodium citrate, and grapefruit essence in sequence, add purified water to the full amount, sti...

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Abstract

The invention discloses loratadine syrup and a preparation method thereof. According to the syrup, with loratadine as a main medicine, beta-cyclodextrin or gamma-cyclodextrin as an inclusion agent, citrate or sodium citrate as a pH regulator, and a grapefruit essence or an orange essence as a corrective agent, on the basis of the parts by weight, each 100 parts of the main medicine is matched with 800-1200 parts of the inclusion agent, 150-250 parts of the pH regulator and 90-100 parts of the corrective agent. Through adjusting rational proportions of the components, the problem of the solubility of loratadine in a liquid preparation is solved; the stability of the physical property and the chemical property is ensured; the loratadine syrup is especially suitable for inpatient children and patients with dysphagia; the medication compliance and the bioavailability are improved.

Description

technical field [0001] The invention relates to a loratadine syrup, which belongs to the technical field of medicine, in particular to a loratadine syrup and a preparation method thereof. Background technique [0002] Loratadine belongs to a long-acting tricyclic antihistamine, competitively inhibits histamine H1 receptors, inhibits allergic symptoms caused by histamine, has low affinity for central nervous system H1 receptors and is difficult to pass through the blood-brain Barrier, no central inhibitory effect, almost no anticholinergic effect, no effect on gastric acid secretion and cardiac function. Loratadine is clinically used to treat allergic rhinitis, acute and chronic urticaria and other allergic skin diseases, and has the characteristics of quick onset, high curative effect, less frequent medication, good safety and good tolerance of patients. [0003] At present, there are loratadine tablets, capsules, granules, syrups and the like for clinical use. Among them,...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/4545A61K47/12A61K47/48A61P37/08
Inventor 梁勇坤余良钟冯韵华王北明廖志刚
Owner GUANGDONG SHUNFENG PHARMA
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