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Cetirizine hydrochloride soft capsule and preparation method thereof

A technology of cetirizine hydrochloride and soft capsules, which is applied in the field of cetirizine hydrochloride soft capsules and its preparation, can solve the problems of dosage influence, unstable content, short validity period, etc., and improve stability and validity period , reduce potential adverse reactions, facilitate transportation and storage

Inactive Publication Date: 2014-10-29
HUMANWELL PURACAP PHARM WUHAN CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Yet present cetirizine hydrochloride soft capsule has the shortcoming of unstable property, because cetirizine hydrochloride is an acidic drug, it is very easy to react chemically with other materials in the formula, thereby affecting the quality of the product, and then having May affect the safety of the product
In addition, the content of the capsules prepared by the prior art is unstable and the content of impurities is high, which exceeds the limit requirements of ICH Q3 preparation impurities, which affects the dosage, has a short validity period, is not conducive to the transportation and storage of the product, and has potential safety question
[0004] Therefore, the current research on cetirizine hydrochloride soft capsules still needs to be deepened.

Method used

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  • Cetirizine hydrochloride soft capsule and preparation method thereof

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Comparison scheme
Effect test

Embodiment 1

[0048] 1) Prescription composition

[0049] Content composition: cetirizine hydrochloride 10g, water 150g, dipotassium hydrogen phosphate 35g, potassium dihydrogen phosphate 15g, polyethylene glycol 400640g,

[0050] Capsule shell composition: gelatin 1000g, glycerin 400g, sorbitol 50g, water 700g.

[0051] 2) Preparation method

[0052] a. Preparation of contents: Dissolve potassium dihydrogen phosphate in water, then add cetirizine hydrochloride to the obtained potassium dihydrogen phosphate solution, stir to dissolve, add polyethylene glycol 400, stir well, and degas , nitrogen protection.

[0053] b. Preparation of gelatin solution: mix glycerin, sorbitol, and water, heat to 70°C, add gelatin, stir the solution, degas, and keep warm at 60°C for later use.

[0054] c. Compress the contents and gelatin solution into soft capsules on a soft capsule machine, dry, polish, and pack.

Embodiment 2

[0056] 1) Prescription composition

[0057] Content composition: 10g of cetirizine hydrochloride, 50g of water, 10g of dipotassium hydrogen phosphate, 400-230g of polyethylene glycol,

[0058] Capsule shell composition: gelatin 1000g, glycerin 300g, sorbitol 125g, water 850g.

[0059] 2) Preparation method

[0060] a. Preparation of contents: Dissolve dipotassium hydrogen phosphate in water, then add cetirizine hydrochloride to the obtained dipotassium hydrogen phosphate solution, stir to dissolve, add polyethylene glycol 400, stir well, and degas , nitrogen protection.

[0061] b. Preparation of gelatin solution: Glycerin, sorbitol, and water were mixed and heated to 70° C., then gelatin was added to the obtained mixed solution, stirred, degassed, and kept at 60° C. for later use.

[0062] c. Compress the contents and gelatin solution into soft capsules on a soft capsule machine, dry, polish, and pack.

Embodiment 3

[0064] 1) Prescription composition

[0065] Content composition: cetirizine hydrochloride 10g, water 180g, dipotassium hydrogen phosphate 30g, potassium dihydrogen phosphate 18g, polyethylene glycol 400862g,

[0066] Capsule shell composition: gelatin 1000g, glycerin 200g, sorbitol 200g, water 1000g.

[0067] 2) Preparation method

[0068] a. Preparation of contents: Dissolve dipotassium hydrogen phosphate and potassium dihydrogen phosphate in water, then add cetirizine hydrochloride to the obtained solution, stir to dissolve, add polyethylene glycol 400, stir evenly, and degas , nitrogen protection.

[0069] b. Preparation of gelatin solution: Mix glycerin, sorbitol and water and heat to 70°C, add gelatin, stir the solution, degas, keep warm at 60°C for later use.

[0070] c. Compress the contents and gelatin solution into soft capsules on a soft capsule machine, dry, polish, and pack.

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Abstract

The invention provides a cetirizine hydrochloride soft capsule and a preparation method thereof. The cetirizine hydrochloride soft capsule comprises a capsule shell and content, wherein the capsule shell is prepared from gelatin, glycerinum, sorbitol and water; the content is prepared from cetirizine hydrochloride, buffer salt, polyethylene glycol and water. The cetirizine hydrochloride soft capsule has the advantages of good stability, little impurity production, relatively long acting period and few potential adverse responses, and is convenient to transport and store.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to cetirizine hydrochloride soft capsules and a preparation method thereof. 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. It is mil...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/495A61K47/42A61K47/02A61K47/34
Inventor 沈福星张群文学智秦巨波
Owner HUMANWELL PURACAP PHARM WUHAN CO LTD
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