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A kind of cetirizine hydrochloride tablet and preparation technology thereof

A technology of cetirizine hydrochloride and lizine tablets, applied to medical preparations containing active ingredients, pharmaceutical formulas, allergic diseases, etc., can solve problems such as unstable properties, short validity period, and influence on dosage, and achieve High bioavailability, rapid dissolution and good stability

Active Publication Date: 2019-06-11
SUZHOU DAWNRAYS PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, the current cetirizine hydrochloride has the disadvantage of unstable properties. Since cetirizine hydrochloride is an acidic drug, it is very easy to chemically react with other substances in the formula, thereby affecting the quality of the product and possibly affecting the quality of the product. product safety
In addition, the content prepared by the prior art is unstable, the impurity content is high, exceeds the limit requirements of ICHQ3 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

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Embodiment 1: the preparation of cetirizine hydrochloride liposome:

[0021] 1) Dissolve 10g of cetirizine hydrochloride, 50g of soybean lecithin, 40g of cholesterol, 20g of vitamin E, and 60g of Tween in an appropriate amount of ethanol, mix well, filter, evaporate and remove ethanol to obtain a phospholipid film, and dry; 2) add pH Phosphate buffer solution with a value of 7.0 makes the phospholipid film fully hydrated, then homogeneously emulsifies with a tissue masher, mixes the solution uniformly, and ultrasonically treats for 60 min to obtain a liposome suspension; 3) the liposome suspension obtained in step 2) The suspension is spray-dried to obtain cetirizine hydrochloride liposome powder.

Embodiment 2

[0022] Embodiment 2: the preparation of cetirizine hydrochloride liposome:

[0023] 1) Dissolve 10g of cetirizine hydrochloride, 80g of soybean lecithin, 60g of cholesterol, 30g of vitamin E, and 80g of Tween in an appropriate amount of ethanol, mix well, filter, evaporate and remove ethanol to obtain a phospholipid film, and dry; 2) add pH Phosphate buffer solution with a value of 6.5 makes the phospholipid film fully hydrated, then homogeneously emulsifies with a tissue masher, mixes the solution uniformly, and ultrasonically treats for 60 min to obtain a liposome suspension; 3) the liposome suspension obtained in step 2) The suspension is spray-dried to obtain cetirizine hydrochloride liposome powder.

Embodiment 3

[0024] Embodiment 3: the preparation of cetirizine hydrochloride sheet

[0025]

[0026] Preparation Process:

[0027] 1) get the cetirizine hydrochloride liposome prepared by the embodiment 1 of prescription quantity, and various adjuvant materials for subsequent use; 1. Crospovidone, add appropriate amount of ethanol to make soft material, dry after granulating with 20 mesh sieve, granulate with 20 mesh sieve, add micropowder silica gel and mix evenly, control tablet weight,

[0028] Tablets are obtained to obtain cetirizine hydrochloride tablets.

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PUM

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Abstract

The invention relates to a cetirizine hydrochloride tablet. The cetirizine hydrochloride tablet comprises cetirizine hydrochloride lipidosome, a filler and a disintegrating agent. The cetirizine hydrochloride lipidosome comprises cetirizine hydrochloride, soya bean lecithin, cholesterol, vitamin E and Tween. The cetirizine hydrochloride tablet is advantaged by being rapid in dissolution, high in bioavailability, good in stability, simple in preparing process, suitable for industrial production, and the like.

Description

technical field [0001] The invention belongs to the field of western medicine preparations, in particular to a tablet containing cetirizine hydrochloride liposome. Background technique [0002] 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 vasoactive peptides and Substance P can reduce the movement of inflammatory cells, effectively inhibit skin allergies, and inhibit the activation and chemotaxis of eosinophils during the onset of allergies; it is also effective for allergen skin tests, nasal mucosa and bronchial provocation tests. Obvious inhibitory effect. Cetirizine also has the original strong and long-acting specific H1 receptor antagonistic effect of hydroxyzine, and it is not easy to penetrate the blood-brain barrier, and has low affinity to central H1 receptors. Light,...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K9/127A61K31/495A61P37/08
Inventor 张国成姚益刘清马成孝
Owner SUZHOU DAWNRAYS PHARM CO LTD
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