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New composition for treating seasonal and perennial allergic rhinitis

A technology of levocetirizine hydrochloride and pseudoephedrine, which can be used in allergic diseases, drug combinations, organic active ingredients, etc., and can solve the problems of inconvenient administration for patients

Inactive Publication Date: 2011-10-19
HANGZHOU MINSHENG PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

These treatments are inconvenient for patients to take

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] Levocetirizine rapid release layer

[0015] Ingredient mg / composition

[0016] Levocetirizine 2.5

[0017] Starch 30.0

[0018] Lactose 70.0

[0019] Sodium carboxymethyl starch 5.0

[0020] 5% hypromellose solution appropriate amount

[0021] Lake 0.1

[0022] Magnesium Stearate 1.0

[0023] Pseudoephedrine Sustained Release Layer

[0024] Ingredient mg / component

[0025] Pseudoephedrine 120

[0026] Hypromellose K100M 120

[0027] Microcrystalline Cellulose 60

[0028] Proper amount of ethanol

[0029] Appropriate amount of pure water

[0030] Micronized silica gel 0.6

[0031] Magnesium Stearate 3

[0032] Preparation process: take an appropriate amount of levocetirizine, starch, lactose, carboxymethyl starch sodium and color lake in the prescribed amount, mix well, place in a high-speed stirring granulator, add an appropriate amount of binder, cut, granulate, pass Sieve, dry at 50-60°C, add an appropriate amount of magnesium stearate, and set aside; t...

Embodiment 2

[0034] Levocetirizine Hydrochloride Rapid Release Layer

[0035] Ingredient mg / composition

[0036] Levocetirizine Hydrochloride 2.5

[0037] Starch 30.0

[0038] Lactose 70.0

[0039] Sodium carboxymethyl starch 5.0

[0040] 5% hypromellose solution appropriate amount

[0041] Lake 0.1

[0042] Magnesium Stearate 1.0

[0043] Pseudoephedrine Hydrochloride Sustained Release Layer

[0044] Ingredient mg / component

[0045] Pseudoephedrine hydrochloride 120

[0046] Hypromellose K100M 120

[0047] Microcrystalline Cellulose 60

[0048] Proper amount of ethanol

[0049] Appropriate amount of pure water

[0050] Micronized silica gel 0.6

[0051] Magnesium Stearate 3

[0052]Preparation process: Take the prescribed amount of levocetirizine hydrochloride, starch, lactose, sodium carboxymethyl starch and appropriate amount of color lake, mix evenly, place in a high-speed stirring granulator, add an appropriate amount of binder, cut, granulate, Sieve, dry at 50-60°C, ad...

Embodiment 3

[0054] Levocetirizine Hydrochloride Rapid Release Layer

[0055] Ingredient mg / composition

[0056] Levocetirizine Hydrochloride 5.0

[0057] Starch 30.0

[0058] Lactose 70.0

[0059] Sodium carboxymethyl starch 5.0

[0060] 5% hypromellose solution 20

[0061] Lake 0.1

[0062] Magnesium Stearate 1.0

[0063] Pseudoephedrine Hydrochloride Sustained Release Layer

[0064] Ingredient mg / component

[0065] Pseudoephedrine hydrochloride 240

[0066] Hypromellose K100M 200

[0067] Microcrystalline Cellulose 60

[0068] Ethanol 100

[0069] Pure water 50

[0070] Micronized Silica Gel 1.0

[0071] Magnesium Stearate 5.0

[0072] Preparation process: Take an appropriate amount of levocetirizine hydrochloride, starch, lactose, sodium carboxymethyl starch and color lake in the prescribed amount, mix well, place in a high-speed stirring granulator, add an appropriate amount of binder, cut, granulate, Sieve, dry at 50-60°C, add an appropriate amount of magnesium stearat...

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PUM

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Abstract

The present invention relates to one new kind of medicine composition containing levocetirizine (or its pharmaceutically acceptable salt) and pseudoepherine (or its pharmaceutically acceptable salt). The medicine composition is pressed into double layer including the first layer containing levocetirizine (or its pharmaceutically acceptable salt) in the amount for resisting allergy effectively andthe second layer containing pseudoepherine (or its pharmaceutically acceptable salt) in the amount as effective decongestant for nose. The medicine composition is used in treating seasonal and perennial allergic rhinitis.

Description

technical field [0001] The invention relates to a double-layer sustained-release oral composition. One layer contains the non-sedating antihistamine levocetirizine (or a pharmaceutically acceptable salt thereof) and the other layer contains the nasal decongestant pseudoephedrine (or a pharmaceutically acceptable salt thereof). The one containing levocetirizine (or its pharmaceutically acceptable salt) is the immediate release layer, and the one containing pseudoephedrine (or its pharmaceutically acceptable salt) is the slow release layer. Background technique [0002] Levocetirizine (or its pharmaceutically acceptable salt) is first listed in Germany, and then listed in the United Kingdom, Belgium, France and other countries. Clinically used for the treatment of various allergic diseases caused by histamine, such as seasonal and perennial allergic rhinitis, EP058146, WO9406429, US5698558, etc. have described the antiallergic effects of levocetirizine. Levocetirizine has a ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/495A61K9/20A61K47/38A61P37/08A61P11/02A61K31/137
Inventor 陈丽珍李艳芹周成云郭殿武严易青
Owner HANGZHOU MINSHENG PHARM CO LTD
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