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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 no active ingredients, medical preparations containing active ingredients, etc., can solve the problem of difficult control of process quality, failure to completely overcome die corrosion and Problems such as sticking, cumbersome process, etc., achieve the effect of reducing the difficulty of process quality control, simplifying production operation procedures, and reducing additives

Pending Publication Date: 2022-05-10
CHENGDU HENGRUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Cetirizine hydrochloride tablets have been on the market for more than 30 years. The preparation process includes wet granulation, dry granulation and direct compression process (requires pretreatment of cetirizine hydrochloride), but the die corrosion has not been completely overcome in the production process. And sticky punching problems, while the process is cumbersome, the process quality is not easy to control

Method used

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  • Cetirizine hydrochloride tablet and preparation method thereof
  • Cetirizine hydrochloride tablet and preparation method thereof
  • Cetirizine hydrochloride tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] A kind of cetirizine hydrochloride tablet is prepared from following components by weight:

[0033] 10 parts of cetirizine hydrochloride, 50 parts of porous silicon, and 60 parts of microcrystalline cellulose 102.

[0034] Among them, the pore size distribution of porous silicon measured by laser particle size analyzer is 17-25 μm at D50, and the pore size distribution is 55-70 μm at D90 measured by laser particle size analyzer.

[0035] Cetirizine hydrochloride is a drug raw material, which is a off-white powder, and the content of cetirizine hydrochloride in this type of white powder reaches the Chinese Pharmacopoeia standard (greater than 99.0%). In this program, the cetirizine hydrochloride drug raw material is directly used, No preprocessing is required.

[0036] In this solution, the particle size of the microcrystalline cellulose 102 is greater than 60 mesh, and the loss on drying is less than 7.0%.

[0037] A kind of preparation method of cetirizine hydrochlor...

Embodiment 2

[0042] A kind of cetirizine hydrochloride tablet is prepared from following components by weight:

[0043] 10 parts of cetirizine hydrochloride, 40 parts of porous silicon, 40 parts of microcrystalline cellulose 112, and 30 parts of lactose.

[0044] Among them, the pore size distribution of porous silicon measured by laser particle size analyzer is 17-25 μm at D50, and the pore size distribution is 55-70 μm at D90 measured by laser particle size analyzer.

[0045] Cetirizine hydrochloride is a drug raw material, which is a off-white powder, and the content of cetirizine hydrochloride in this type of white powder reaches the Chinese Pharmacopoeia standard (greater than 99.0%). In this program, the cetirizine hydrochloride drug raw material is directly used, No preprocessing is required.

[0046] Further, the particle size of the microcrystalline cellulose 112 is greater than 60 mesh, and the loss on drying is less than 1.5%.

[0047] Further, the lactose is spray-dried lacto...

Embodiment 3

[0053] A kind of cetirizine hydrochloride tablet is prepared from following components by weight:

[0054] 10 parts of cetirizine hydrochloride, 30 parts of porous silicon, 40 parts of microcrystalline cellulose 112, and 40 parts of lactose.

[0055] Among them, the pore size distribution of porous silicon measured by laser particle size analyzer is 17-25 μm at D50, and the pore size distribution is 55-70 μm at D90 measured by laser particle size analyzer.

[0056] Cetirizine hydrochloride is a drug raw material, which is a off-white powder, and the content of cetirizine hydrochloride in this type of white powder reaches the Chinese Pharmacopoeia standard (greater than 99.0%). In this program, the cetirizine hydrochloride drug raw material is directly used, No preprocessing is required.

[0057] In this solution, the particle size of the microcrystalline cellulose 112 is greater than 60 mesh, and the loss on drying is less than 1.5%.

[0058] The lactose is spray-dried lacto...

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Abstract

The invention relates to the technical field of pharmacy, and discloses a cetirizine hydrochloride tablet and a preparation method thereof, the cetirizine hydrochloride tablet comprises cetirizine hydrochloride and porous silicon; the weight ratio of cetirizine hydrochloride to porous silicon is 1: (3-5); the cetirizine hydrochloride tablet also comprises microcrystalline cellulose, and the weight ratio of cetirizine hydrochloride to microcrystalline cellulose is 1: (2-6); the microcrystalline cellulose is one or a combination of microcrystalline cellulose 102 and microcrystalline cellulose 112. According to the invention, the production operation procedure is simplified, the addition of auxiliary materials is reduced, the process quality control difficulty is reduced, and industrial mass production is facilitated.

Description

technical field [0001] The invention relates to the technical field of pharmacy, in particular to a cetirizine hydrochloride tablet and a preparation method thereof. Background technique [0002] Cetirizine hydrochloride is an oral selective histamine H1 receptor antagonist. No obvious anticholinergic and anti-serotonin effects, less central inhibitory effect; used to treat allergy-related diseases, relieve the following symptoms: allergic rhinitis (including seasonal persistent allergic rhinitis and perennial persistent allergic rhinitis) and chronic idiopathic urticaria. The dosage form of this drug is mainly oral solid, and because it has a strong pungent smell, the dosage form is mainly tablets. [0003] Cetirizine hydrochloride tablets have been on the market for more than 30 years. The preparation process includes wet granulation, dry granulation and direct compression process (requires pretreatment of cetirizine hydrochloride), but the die corrosion has not been com...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/495A61K47/69A61K47/38A61K47/26A61K47/04A61P11/02A61P17/00A61P39/06
CPCA61K31/495A61K9/2095A61K9/2054A61K9/2009A61K9/2018A61K47/6949A61P39/06A61P11/02A61P17/00
Inventor 朱德其张茂沈桦韩朋芩肖仕远其他发明人请求不公开姓名
Owner CHENGDU HENGRUI PHARMA
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