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Loratadine syrup and preparation method thereof

A technology of loratadine and syrup, which is applied in the field of loratadine syrup and its preparation, can solve the problems of safety risk, difficult to master trickle operation, and high requirement of inclusion process, and achieve uniform quality, no alcohol residue, good clinical safety

Inactive Publication Date: 2019-03-22
HUBEI KANGYUAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method has higher requirements on the inclusion process: the syrup must be cooled to below 60°C before the inclusion process; the inclusion process must add the ethanol solution containing the main drug in a trickle manner, and the trickle operation may be difficult to master; the inclusion process A large amount of ethanol must be used to dissolve the main drug first, and the residue of ethanol also brings safety risks to the drug

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

Experimental program
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Effect test

Embodiment 1

[0018] A kind of loratadine syrup, each component formula is: loratadine 1.0g, sucrose 680g, propylene glycol 100ml, glycerin 50ml, citric acid 20g, sodium benzoate 3g, disodium edetate 1g, add water to 1000ml.

[0019] A preparation method for loratadine syrup, comprising the steps of:

[0020] (1) Take sucrose by weighing, add water, heat to dissolve, filter with filter cloth while hot, make simple syrup;

[0021] (2) Add disodium edetate and loratadine to glycerin and propylene glycol, stir to dissolve them, and then add them to the simple syrup made in step (1);

[0022] (3) Continue to add citric acid, sodium benzoate and appropriate amount of water to the syrup, stir well, boil, cool, and fill to obtain the loratadine syrup.

Embodiment 2

[0024] A kind of loratadine syrup, each component formula is: loratadine 1.05g, sucrose 750g, propylene glycol 100ml, glycerin 50ml, citric acid 18g, sodium benzoate 2.5g, edetate disodium 1g, add water to 1000ml.

[0025] A preparation method for loratadine syrup, comprising the steps of:

[0026] (1) Take sucrose by weighing, add water, heat to dissolve, filter with filter cloth while hot, make simple syrup;

[0027] (2) Add disodium edetate and loratadine to glycerin and propylene glycol, stir to dissolve them, and then add them to the simple syrup made in step (1);

[0028] (3) Continue to add citric acid, sodium benzoate and appropriate amount of water to the syrup, stir well, boil, cool, and fill to obtain the loratadine syrup.

Embodiment 3

[0030] A kind of loratadine syrup, each component formula is: loratadine 0.95g, sucrose 650g, propylene glycol 100ml, glycerin 50ml, citric acid 25g, sodium benzoate 3.5g, edetate disodium 1g, add water to 1000ml.

[0031] A preparation method for loratadine syrup, comprising the steps of:

[0032] (1) Take sucrose by weighing, add water, heat to dissolve, filter with filter cloth while hot, make simple syrup;

[0033] (2) Add disodium edetate and loratadine to glycerin and propylene glycol, stir to dissolve them, and then add them to the simple syrup made in step (1);

[0034] (3) Continue to add citric acid, sodium benzoate and appropriate amount of water to the syrup, stir well, boil, cool, and fill to obtain the loratadine syrup.

[0035] Carry out influencing factor test, acceleration and long-term stability investigation comparison with commercially available loratadine syrup and the obtained loratadine syrup prepared by the embodiment of the present invention 1, the r...

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a loratadine syrup and a preparation method thereof. The loratadine syrup, in terms of 1000ml,comprises the following components: 0.9-1.1g of loratadine, 650-750g of a sweetener, 80-120ml of propylene glycol, 40-60ml of glycerol, 0.9-1.1g of ethylenediaminetetraacetic acid disodium salt, 15-25g of an acidity regulator, 2-4g of a preservative, and water added until the total amount is 1000ml. The loratadine syrup prepared by the method provided by the invention can meet a requirement of uniform dispersion of bulk drugs; the effective components of the loratadine syrup can be uniformly dispersed in the syrup, the contents of the upper layer, the middle layer and the lower layer of the syrup are uniform, and the quality is uniform; and the loratadine syrup produced by the preparation method provided by the invention does not contain an ethanol solvent, has no ethanol residue, and hasgood clinical safety. The loratadine syrup prepared by the method provided by the invention has stable quality and a shelf life of more than 36 months.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a loratadine syrup and a preparation method thereof. Background technique [0002] Loratadine is a second-generation antihistamine commonly used to treat allergy symptoms. Compared with the first-generation antihistamines, one of its major characteristics is that it has no drowsiness effect. It is widely used clinically for allergic rhinitis, acute or chronic urticaria, allergic conjunctivitis, hay fever and other allergic skin diseases. [0003] At present, there are loratadine tablets, capsules, granules, syrups, etc. for clinical use. Among them, syrup is more accurate and easier to take than tablets and capsules for children, and the sweet taste is more acceptable to children, so it has a great advantage in compliance with medication. Loratadine syrup preparations have been listed at home and abroad, but because loratadine is insoluble in wa...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/10A61K31/4545A61K47/10A61K47/18A61P37/08
CPCA61K9/0095A61K31/4545A61K47/10A61K47/183A61P37/08
Inventor 江强祝智熊友纯
Owner HUBEI KANGYUAN PHARMA
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