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A kind of cetirizine hydrochloride tablet and preparation method thereof

A technology of cetirizine hydrochloride and rizine tablets, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., and can solve the risk of explosion, stickiness, complicated preparation process, etc. Problems, to achieve the effect of small decrease in dissolution rate, not easy to compress, and rapid dissolution

Active Publication Date: 2022-02-15
微研优仿医药科技(江苏)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the existing preparation process is still complicated. When preparing the drug, the applicant found that there is a serious sticking phenomenon in the tableting process, which is prone to separation and streaks, and the compression performance and stability need to be solved.
In addition, when fillers, disintegrants, and lubricants are used as excipients, they cannot interact well and achieve full effect, resulting in the addition of a large amount of excipients in order to improve the processing technology, thereby affecting the dissolution of the drug. and other properties, and in the preparation process and the use of organic solvents in the preparation process, there are risks of explosion and environmental pollution in actual production

Method used

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  • A kind of cetirizine hydrochloride tablet and preparation method thereof
  • A kind of cetirizine hydrochloride tablet and preparation method thereof
  • A kind of cetirizine hydrochloride tablet and preparation method thereof

Examples

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Comparison scheme
Effect test

Embodiment 1

[0042] Embodiment 1 provides a kind of cetirizine hydrochloride tablet, and its preparation raw material comprises following component:

[0043]

[0044] The average particle size of the microcrystalline cellulose is 80 mesh (about 180 microns).

[0045] Preparation process: Dissolve cetirizine hydrochloride in povidone K30 aqueous solution, put microcrystalline cellulose into fluidized bed, use cetirizine hydrochloride aqueous solution to perform fluidized bed granulation, dry and granulate to obtain cetirizine hydrochloride Lizine pretreatment granules are then uniformly mixed with prescription amounts of lactose, silicon dioxide and magnesium stearate, and compressed into tablets.

Embodiment 2

[0047] Embodiment 2 provides a kind of cetirizine hydrochloride tablet, and its preparation raw material comprises following component:

[0048]

[0049] The average particle size of the microcrystalline cellulose is 80 mesh (about 180 microns).

[0050] Preparation process: Dissolve cetirizine hydrochloride in povidone k30 water, put microcrystalline cellulose into a high-efficiency wet granulator, use cetirizine hydrochloride aqueous solution for wet granulation, dry and granulate to obtain cetirizine hydrochloride The granules are pretreated, then mixed evenly with the prescribed amount of croscarmellose sodium, mannitol, silicon dioxide and magnesium stearate, and compressed into tablets.

Embodiment 3

[0052] Embodiment 3 provides a kind of cetirizine hydrochloride tablet, and its preparation raw material comprises following component:

[0053]

[0054] The average particle size of the microcrystalline cellulose is 100 mesh (about 150 microns).

[0055] Preparation process: Dissolve cetirizine hydrochloride in povidone k30 water, put microcrystalline cellulose into a high-efficiency wet granulator, use cetirizine hydrochloride aqueous solution for wet granulation, dry and granulate to obtain cetirizine hydrochloride The granules are pretreated, then mixed evenly with the prescribed amount of croscarmellose sodium, mannitol, silicon dioxide and magnesium stearate, and compressed into tablets.

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Abstract

The invention relates to the technical field of pharmaceutical solid oral preparations, in particular to a cetirizine hydrochloride tablet and a preparation method thereof. The cetirizine hydrochloride tablet is prepared by the following method: cetirizine hydrochloride is dissolved in povidone aqueous solution, and then wet granulated with microcrystalline cellulose to obtain cetirizine hydrochloride pretreatment granules, Finally, it is mixed uniformly with pharmaceutically available auxiliary materials and pressed into tablets; the weight ratio of cetirizine hydrochloride to microcrystalline cellulose is 1:1-1:15.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical solid oral preparations, in particular to a cetirizine hydrochloride tablet and a preparation method thereof. Background technique [0002] Cetirizine hydrochloride is a second-generation H1 antihistamine, a long-acting and selective oral potent antiallergic drug. H1 receptor antagonists have good anti-allergic effects, and are often used for allergic rhinitis, allergic skin itching, conjunctivitis, etc. [0003] Currently, cetirizine hydrochloride is mainly in the form of tablets, which are highly acidic. Direct tableting or ordinary wet granulation is prone to sticking, and it is prone to esterification and degradation reactions with excipients under hot and humid conditions. [0004] Existing patents such as CN103340865A, CN104800178B, etc. disclose the preparation method of cetirizine hydrochloride tablets, which mainly avoids the direct contact of cetirizine hydrochloride with the ext...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/495A61K47/38A61P37/08A61P11/02A61P17/04A61P27/02
CPCA61P11/02A61P17/04A61P27/02A61P37/08A61K9/2054A61K9/2095A61K31/495
Inventor 贾梦虹徐震亚秦秋明
Owner 微研优仿医药科技(江苏)有限公司
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