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Cetirizine hydrochloride tablet and preparation method thereof

A technology of cetirizine hydrochloride and lizine 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 problem of adhesion, toughness, and isolation effects that do not meet the requirements , unable to meet the quality and storage requirements of cetirizine hydrochloride tablets, and achieve the effects of low water absorption, improved compressibility, and increased stability

Active Publication Date: 2019-12-06
XINHUA PHARMA GAOMI CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] For the cetirizine hydrochloride tablet product, its coating film needs to have better isolation effect and moisture resistance, but also to meet a certain degree of adhesion and toughness. Commercially available coating materials are mostly fixed prescriptions, such as Opadry ( Opadry), etc., whose prescription usually contains film-forming materials (such as hypromellose, acrylic resin, polyvinyl alcohol, etc.), plasticizers (such as polyethylene glycol 6000, triethyl citrate, etc.), anti-sticking agents (such as talcum powder), opacifiers (such as titanium dioxide), etc., because at least one of the properties such as adhesion, toughness, and isolation effect of commercially available coating materials does not meet the requirements, it cannot meet the requirements of cetirizine hydrochloride. Higher quality storage requirements for tablet products

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

[0047] A kind of cetirizine hydrochloride tablet, in parts by weight, the raw and auxiliary materials are composed as follows:

[0048]

[0049] The preparation method steps are as follows:

[0050] (1) Material preparation process: the raw materials are passed through an 80-mesh sieve, the silicon dioxide is passed through an 80-mesh sieve, and the remaining auxiliary materials are passed through a 60-mesh sieve if there is agglomeration.

[0051] (2) Mixing process: sequentially add microcrystalline cellulose, silicon dioxide Ⅰ, lactose, and cetirizine hydrochloride into the wet granulator, start stirring at 145rpm, cut at 300rpm, mix for 15min, and discharge; Add the powder, silicon dioxide II and magnesium stearate into a three-dimensional mixer, mix for 10 minutes, and discharge.

[0052] (3) Tablet pressing process: According to the content of the main drug in the mixed powder, calculate the theoretical tablet weight, use the GZP-40 tablet press machine, 10.0mm*4.0mm...

Embodiment 2

[0055] A kind of cetirizine hydrochloride tablet, in parts by weight, the raw and auxiliary materials are composed as follows:

[0056]

[0057] The preparation method steps are as follows:

[0058] (1) Material preparation process: the raw materials are passed through an 80-mesh sieve, the silicon dioxide is passed through an 80-mesh sieve, and the remaining auxiliary materials are passed through a 60-mesh sieve if there is agglomeration.

[0059] (2) Mixing process: sequentially add microcrystalline cellulose, silicon dioxide Ⅰ, lactose, and cetirizine hydrochloride into the wet granulator, start stirring at 140rpm, cut at 285rpm and mix for 15min, and discharge; Add silicon dioxide II and magnesium stearate into a three-dimensional mixer, mix for 13 minutes, and discharge.

[0060] (3) Tablet pressing process: According to the content of the main drug in the mixed powder, calculate the theoretical tablet weight, use the GZP-40 tablet press machine, 10.0mm*4.0mm single-s...

Embodiment 3

[0063] A kind of cetirizine hydrochloride tablet, in parts by weight, the raw and auxiliary materials are composed as follows:

[0064]

[0065] The preparation method steps are as follows:

[0066] (1) Material preparation process: the raw materials are passed through an 80-mesh sieve, the silicon dioxide is passed through an 80-mesh sieve, and the remaining auxiliary materials are passed through a 60-mesh sieve if there is agglomeration.

[0067] (2) Mixing process: sequentially add microcrystalline cellulose, silicon dioxide Ⅰ, lactose, and cetirizine hydrochloride into the wet granulator, start stirring at 150rpm, cut at 320rpm and mix for 20min, and discharge; Add silicon dioxide II and magnesium stearate into a three-dimensional mixer, mix for 15 minutes, and discharge.

[0068] (3) Tablet pressing process: According to the content of the main drug in the mixed powder, calculate the theoretical tablet weight, use the GZP-40 tablet press machine, 10.0mm*4.0mm single-s...

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Abstract

The invention belongs to the technical field of medicinal solid oral-taking preparation, relates to a cetirizine hydrochloride tablet and a preparation method thereof. The cetirizine hydrochloride tablet is prepared from the following raw materials and auxiliary materials of cetirizine hydrochloride, a filling agent, a flow aid, a bonding agent, a plasticizer, an opaquer, wherein the filling agentis prepared from microcrystalline cellulose and lactose; the flow aid is prepared from one or two of silicon dioxide, talcum powder and colloidal silicon dioxide; the lubricating agent is magnesium stearate; the bonding agent is prepared from one or two of hydroxypropyl methylcellulose, starch, dextrin or polyvinyl alcohol; the plasticizer is polyethylene glycol-400; and the opaquer is titanium dioxide. The product has high stability, can keep stable at high temperature and in a high-temperature environment; the product has high stability, can be stored for a longer time under the normal storage conditions, the shelf life of the product is prolonged, the product can be dissolved rapidly, bioavailability is high, as provided by external quality research, the product conforms to the regulation and standard, clinical bioequivalence can meet the requirement of the regulation. The invention further provides a preparation method, and the production prescription process is easy.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical solid oral preparations, and relates to a cetirizine hydrochloride tablet and a preparation method thereof. Background technique [0002] Cetirizine hydrochloride sheet is a kind of medicine commonly used, and present cetirizine hydrochloride sheet has the shortcoming of unstable property, because cetirizine hydrochloride is an acidic drug, it is very easy to react chemically with other substances in the formula, The content prepared by the prior art is unstable and has high impurity content, which exceeds the limit requirements of ICH Q3 preparation impurities, affects the dosage, has a short validity period, is not conducive to the transportation and storage of the product, and has potential safety problems. In addition, most of the existing cetirizine hydrochloride tablets are packaged in aluminum-plastic packaging. During storage, the appearance of ordinary tablets shows a change in col...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/30A61K31/495A61K47/38A61K47/26A61K47/10
CPCA61K9/2018A61K9/2054A61K9/2853A61K31/495
Inventor 王在英王晓燕赵海军高明才王周刚
Owner XINHUA PHARMA GAOMI CO LTD
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