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Antiallergic pharmaceutical composition and preparation method thereof

A composition and anti-allergic technology, which can be used in drug combinations, pharmaceutical formulations, allergic diseases, etc., and can solve the problems of cumbersome parameter setting, high preparation cost, and complex process.

Inactive Publication Date: 2014-05-07
BEIJING VENTUREPHARM BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Patent CN102451167 uses a freeze-drying process to prepare orally disintegrating tablets. The process is more complicated, the setting parameters are more cumbersome, and the cost of the preparation is higher, which is not conducive to subsequent scale-up production and process reproduction.

Method used

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  • Antiallergic pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Name of raw material Proportion(%) Levocetirizine Hydrochloride 5.0 lactose 63.5 silica 2.0 microcrystalline cellulose 27.5 Sucralose 1.0 essence 0.2 Magnesium stearate 0.8

[0019] Preparation Process:

[0020] 1. Mix the active ingredient levocetirizine hydrochloride and silicon dioxide, mix well, add microcrystalline cellulose and mix for about 5 minutes.

[0021] 2. The above mixture is subjected to dry granulation to obtain dry granules.

[0022] 3. Prepare 40% ethanol solution for later use.

[0023] 4. Mix the prescription amount of mannitol and other wet granulation auxiliary materials evenly, and use the pre-prepared wetting agent for wet granulation.

[0024] 5. Dry at 40-50°C, sieve through a 24-mesh sieve, calculate the yield, add sucralose, essence, and magnesium stearate, and mix well.

[0025] 6. Adjust the weight and pressure of the tablet, and press it into a tablet.

Embodiment 2

[0027] Name of raw material Proportion(%) Levocetirizine Hydrochloride 10.2 silica 6.0 lactose 63.5 microcrystalline cellulose 77.8 Sucralose 1.0 Menthol 0.2 Magnesium stearate 1.0

[0028] Preparation process: same as above.

Embodiment 3

[0030] Name of raw material Proportion(%) Levocetirizine Hydrochloride 5.0 lactose 39.0 microcrystalline cellulose 27.0 Mannitol 8.0 Low-substituted hydroxypropyl cellulose 17.0 Sucralose 1.0 Menthol 0.2 silica 2.0 Magnesium stearate 0.8

[0031] Preparation process: Same as above, both microcrystalline cellulose and low-substituted hydroxypropyl cellulose need to be added internally and externally.

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Abstract

The invention belongs to the field of pharmaceutical preparations, and relates to an antiallergic pharmaceutical composition and a preparation method thereof. The preparation is orally disintegrating tablets, and contains an active ingredient with a general formula of (R)-(-)-2-[3-[4-[(4-chlorphenyl)benzyl]-1-piperazinyl]ethoxy]acetic acid dihydrochloride. The preparation of the invention can be rapidly disintegrated in oral cavity, and has the characteristics of no gritty feel, good mouth feel and rapid dissolution.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to an anti-allergic oral solid preparation and a preparation method thereof. The active ingredient of the preparation is levocetirizine hydrochloride, and the dosage form is an orally disintegrating tablet. The common name of the active ingredient is (R) -(-)-2-[2-[4-[(4-Chlorophenyl)benzyl]-1-piperazinyl]ethoxy]acetic acid dihydrochloride. Background technique [0002] Under the influence of the deterioration of the global ecological environment, all kinds of allergic reactions are showing an increasing trend. According to the data of the World Health Organization, about 40% of the world's people have allergic symptoms. Anaphylaxis is a severe allergic reaction, the ultimate reaction to allergic phenomena. The allergen outbreak usually occurs within minutes and the entire body is affected. The triggers are food, insect stings and pollen. [0003] Levocetirizine hydrochlo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/495A61K47/38A61K47/36A61K47/32A61P37/08
Inventor 贾煜娇刁媛媛郭夏
Owner BEIJING VENTUREPHARM BIOTECH
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