Cetirizine hydrochloride oral solution and preparation method thereof

Abstract

The invention discloses a cetirizine hydrochloride oral solution, which comprises cetirizine hydrochloride, mannitol, hydroxy propyl cellulose and water. The oral solution provided by the invention effectively covers up the strong titter taste of the active component cetirizine, obviously improves the stability of the oral solution, effectively reduces the chemical degradation and the toxic or side effects of the cetirizine, reduces the molecular aggregation phenomenon of the active component, reduces the using risk and improves the medicine safety.

Description

technical field [0001] The invention relates to a pharmaceutical composition, in particular to a pharmaceutical composition oral solution of cetirizine hydrochloride, which belongs to the field of pharmaceutical preparations. Background technique [0002] Cetirizine hydrochloride (cetirizine hydrochloride), chemical name: (±)-2-[2-[4-[(4-chlorophenyl)benzyl]-1-piperazinyl]ethoxy]acetic acid di Hydrochloride, molecular formula: C 21 h 25 ClN 2 o 3 2HCl; molecular weight: 461.81; chemical structural formula as follows: [0003] [0004] Cetirizine hydrochloride is white or off-white crystalline powder; odorless, bitter, hygroscopic. Soluble in water, soluble in methanol or ethanol, almost insoluble in chloroform or acetone. Cetirizine is a metabolite of hydroxyzine in the human body. Animal experiments have proved that cetirizine hydrochloride is a selective histamine H1 receptor antagonist, which can inhibit the transmission of histamine, and can also inhibit the vas...

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Problems solved by technology

[0009] Another example is that the patent No. 201110059091.2 discloses a stable oral solution of cetirizine, which contains 1 g of cetirizine hydrochloride, 80-100 g of propylene glycol, and 360-400 g of sorbitol in a 1000 ml solution; Simple, few types of auxiliary materials, by adding propylene glycol and sorbitol, the stability of the oral solution has been improved, but a large amount of sorbitol has been added in the oral solution of this invention, because sorbitol is a sugar alcohol compound, its sweetness is about sucrose 60% of sorbitol, although adding a large amount of sorbitol improves the mouthfeel, the usage amount of sorbitol is not investigated in detail, and the amount of propylene glycol added in this aspect also has the above-mentioned problems

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