Oral compound levocetirizine pseudoephedrine formulation and its preparation

A technology of levocetirizine and levocetirizine hydrochloride, which is applied in the field of levocetirizine and pseudoephedrine compound oral preparations and preparations, and can solve the problems of low incidence of side effects and adverse reactions

Inactive Publication Date: 2006-07-26
北京曙光药业有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It is also clinically shown that the antihistamine effect of 5mg levocetirizine is the same

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Sustained release tablet core:

[0033] Weight (mg / tablet)

[0034] 1. Pseudoephedrine hydrochloride 180

[0035] 2. Lactose 18.5

[0036] 3. HPMC (hypromellose) 80

[0037] 4. Ethyl cellulose 20

[0038] 5. Magnesium stearate 1.5

[0039] Process:

[0040] According to the above prescription, use 75% ethanol as a wetting agent, mix 1.2.3.4 evenly to make wet granules of suitable size, after drying, add 0.5% magnesium stearate as a lubricant, and press under a suitable pressure . Get extended release tablets.

[0041] Immediate release layer preparation:

[0042] Weight (mg / tablet)

[0043] Pseudoephedrine Hydrochloride Extended Release Tablets 300

[0044] Pseudoephedrine hydrochloride 60

[0045] Levocetirizine hydrochloride 5

[0046] Opadry 55.5

[0047] water 802.3

[0048] The tablet cores were coated in the coating pan according to the above prescription, and the air outlet temperature w...

Embodiment 2

[0051]Sustained release tablet core:

[0052] Weight (mg / tablet)

[0053] 1. Pseudoephedrine hydrochloride 200

[0054] 2. Lactose 25

[0055] 3. HPMC (hypromellose) 65

[0056] 4. Magnesium stearate 0.6

[0057] Process:

[0058] According to the above prescription, use 30% ethanol as a wetting agent, mix 1.2.3 evenly to make wet granules of suitable size, after drying, add 0.5% magnesium stearate as a lubricant, and press under a suitable pressure . Get extended release tablets.

[0059] Immediate release layer preparation:

[0060] Weight (mg / tablet)

[0061] Pseudoephedrine Hydrochloride Sustained Release Tablets 290.6

[0062] Pseudoephedrine hydrochloride 40

[0063] Levocetirizine hydrochloride 5

[0064] Opadry 27

[0065] water 700

[0066] The tablet cores were coated in the coating pan according to the above prescription, and the air outlet temperature was controlled at 35-40° C., until each...

Embodiment 3

[0069] Sustained release tablet core:

[0070] Weight (mg / tablet)

[0071] 1. Pseudoephedrine hydrochloride 240

[0072] 2. Lactose 45

[0073] 3. HPMC (hypromellose) 120

[0074] 4. Ethyl cellulose 45

[0075] 5. Magnesium stearate 12

[0076] Process:

[0077] According to the above prescription, use 90% ethanol as a wetting agent, mix 1.2.3.4 evenly to make wet granules of suitable size, after drying, add 0.5% magnesium stearate as a lubricant, and press under a suitable pressure . Get extended release tablets.

[0078] Preparation of immediate release layer:

[0079] Weight (mg / tablet)

[0080] Pseudoephedrine Hydrochloride Extended Release Tablets 462

[0081] Levocetirizine hydrochloride 5

[0082] Opadry 75

[0083] water 840

[0084] The tablet cores were coated in the coating pan according to the above prescription, and the air outlet temperature was controlled at 35-40° C. until each tablet co...

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PUM

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Abstract

The present invention belongs to the field of pharmaceutical technology, and discloses one kind of orally taken compound levo-cetirizine pseudoephedrine preparation. The preparation has activity similar to that of compound cetirizine pseudoephedrine preparation and is single optical isomer with half reduced dosage and thus long effect and reduced side effect. The preparation may be taken by adult and children. The preparation process is also provided.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations. Specifically relates to a levocetirizine pseudoephedrine compound oral preparation and a preparation method. Background technique [0002] Cetirizine (cetirizine) is the second generation of histamine H 1 Receptor antagonist is a racemic mixture consisting of equal amounts of Levocetirizine (R-enantiomer) and Dextrocetirizine (S-enantiomer) body) composition. The main active ingredient is levocetirizine, while dexetirizine has no antihistamine effect. The antihistamine effect of the levorotary body or its pharmaceutically acceptable salt (such as levocetirizine hydrochloride) is suitable for the antiallergic agent for treating the symptoms of allergic rhinitis. However, most rhinitis is accompanied by congestion of the nasal mucosa, that is, nasal congestion symptoms, and many colds and flu patients have both symptoms of allergies and nasal congestion. We choose pseudoeph...

Claims

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Application Information

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IPC IPC(8): A61K31/495A61P11/02A61P37/08
Inventor 沈志群
Owner 北京曙光药业有限责任公司
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