Preparation containing Cetirizine Hydrochloride and hydrochloric pseudoephedrine and its prepn. method

A technique for pseudoephedrine hydrochloride and cetirizine hydrochloride, which is applied to the preparation field containing cetirizine hydrochloride and pseudoephedrine hydrochloride and the preparation field thereof, can solve the problem that cetirizine hydrochloride has a rapid onset and sustained release effect and the like, and achieves The effect of reducing the frequency of medication and maintaining the efficacy of the medication

Inactive Publication Date: 2004-05-26
SHANGHAI SINE PHARMA LAB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This preparation method cannot solve the problem of the rapid onset of cetirizine hydrochloride and the sustained release of pseudoephedrine hydrochloride. For example, the common drugs in the domestic market mainly include Xincontek, Riye Baifuning, Baijiahei, etc.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0108] 1. Preparation of pseudoephedrine hydrochloride inner tablet core (1000 tablets):

[0109] Raw materials and auxiliary materials Weight Function

[0110] Pseudoephedrine Hydrochloride 120g Active Ingredients

[0111]Glyceryl Behenate 70g Retarding Agent

[0112] Hypromellose K100MCR 30g release retarder

[0113] Magnesium Stearate 5g Lubricant

[0114] Total weight 225g

[0115] Crush and sieve pseudoephedrine hydrochloride, mix it with glyceryl behenate and hypromellose evenly, add 75% ethanol to make it evenly wet, pass through a 18-mesh or 24-mesh sieve, dry at 60-75°C, and use 16 Mesh or 20 mesh sieve sieve granules and add magnesium stearate, mix evenly, be the shallow concave punching die compression of 9mm with diameter (φ), prepare tablet core. spare.

[0116] 2. Preparation of outer core-coated granules (1000 tablets):

[0117] Raw materials and auxiliary materials Weight (g) Function

[0118] Cet...

Embodiment 2

[0128] 1. Preparation of pseudoephedrine hydrochloride inner tablet core (1000 tablets):

[0129] Raw materials and auxiliary materials Weight Function

[0130] Pseudoephedrine Hydrochloride 90g Active Ingredients

[0131] Glyceryl Behenate 40g Release Retardant

[0132] Hypromellose K100MCR 50g Release Retarder

[0133] Magnesium Stearate 5g Lubricant

[0134] Total weight 185g

[0135] Grind and sieve pseudoephedrine hydrochloride and mix it with glyceryl behenate through a 60-mesh sieve, bake at 70±5°C for 2 hours, pass through a 20-mesh sieve, mix it with hypromellose, add 75% ethanol to make it evenly moistened, Pass through 18-mesh or 24-mesh sieve, dry at 70±5°C, sieve through 18-mesh or 20-mesh sieve for granulation, add magnesium stearate, mix well, and use a shallow concave die with a diameter (φ) of 8mm Tablets are prepared to obtain tablet cores. spare.

[0136] 2. Preparation of outer core-coated granules (100...

Embodiment 3

[0149] 1. Preparation of pseudoephedrine hydrochloride inner tablet core (1000 tablets):

[0150] Raw materials and auxiliary materials Weight Function

[0151] Pseudoephedrine Hydrochloride 240g active ingredient

[0152] Glyceryl Behenate 50g Retarding Agent

[0153] Hypromellose K100MCR 50g Release Retarder

[0154] Magnesium Stearate 5g Lubricant

[0155] Total weight 345g

[0156] Crush and sieve pseudoephedrine hydrochloride, mix it with glyceryl behenate and hypromellose evenly, add 75% ethanol to make it evenly wet, pass through a 18-mesh or 24-mesh sieve, dry at 60-75°C, and use 16 Mesh or 20 mesh sieve sieve granules and add magnesium stearate, mix evenly, be the shallow concave punching die compression of 10mm with diameter (φ), prepare tablet core. spare.

[0157] 2. Preparation of outer core-coated granules (1000 tablets):

[0158] Raw materials and auxiliary materials Weight (g) Fu...

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Abstract

A medicine in the form of tablet is composed of the core tablet prepared from pseudoephedrine hydrochloride and pharmacologically receptable carrier and the coated layer prepared from cetirizine hydrochloride and pharmacologically receptable carrier. Its advantages are quick release of cetirizine hydrochloride, slow release of pseudoephedrine hydrochloride.

Description

technical field [0001] The invention relates to an antihistamine medicine, in particular to a preparation containing cetirizine hydrochloride and pseudoephedrine hydrochloride and a preparation method thereof. Background technique [0002] Cetirizine, its chemical name is (±)-2-[2-[4-[(4-chlorophenyl)benzyl]-1-piperazinyl]ethoxy]acetic acid, and its molecular formula is C 21 h 25 CIN 2 o 3 , pseudoephedrine, its chemical name is (1S.2S)-2-methylamino-1-phenyl-1-propanol, and its molecular formula is C 10 h 15 NO. [0003] Cetirizine, a metabolite of hydroxyzine, is a novel second-generation antihistamine-H 1 - Receptor antagonists, have little central sedative effect. At present, it is widely used clinically for year-round and seasonal indoor and outdoor allergic diseases, such as acute and chronic urticaria, allergic dermatitis, eczema and other symptoms. It has been widely used in Europe and America. And has been included in the European Pharmacopoeia and the Brit...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/495A61P11/02A61P37/08
Inventor 吴刚高原夏凌云
Owner SHANGHAI SINE PHARMA LAB
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