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Levocetirizine hydrochloride chewable tablet and preparation method thereof

A technology of levocetirizine hydrochloride and chewable tablets, which can be applied to medical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., and can solve problems such as severe bitterness

Active Publication Date: 2012-10-10
湖南千金湘江药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Pfizer's Chinese patent ZL03807044.8 discloses a delicious cetirizine chewable tablet, wherein cyclodextrin is used as an inclusion agent, although the inclusion of cyclodextrin covers the bitter taste to a certain extent, but the There is still a heavy sense of bitterness, causing vomiting and other adverse effects, and it is still difficult for children or elderly patients to accept

Method used

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  • Levocetirizine hydrochloride chewable tablet and preparation method thereof
  • Levocetirizine hydrochloride chewable tablet and preparation method thereof
  • Levocetirizine hydrochloride chewable tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0088] Embodiment 1 (reference)

[0089] prescription:

[0090] Name of raw material

Prescription quantity (1000 tablets)

Levocetirizine Hydrochloride

2.5g

β-cyclodextrin

5g

Microcrystalline Cellulose (Heidemer)

15g

water

Appropriate amount

Mannitol

100g

Directly compressed lactose

50g

Microcrystalline Cellulose PH102

50g

Crospovidone

10g

Sucralose

4g

Cantaloupe Flavor

5g

Magnesium stearate

3g

[0091] Preparation Process:

[0092] 1. Weigh the prescribed amount of levocetirizine hydrochloride, put it in an appropriate amount of water, stir to dissolve, and set aside.

[0093] 2. Weigh the prescribed amount of β-cyclodextrin and microcrystalline cellulose (Haidemer) with an average particle size of 42 microns, mix well, add levocetirizine hydrochloride aqueous solution, stir well, and granulate with a 30-mesh sieve...

Embodiment 2

[0105] Embodiment 2 (the present invention)

[0106] prescription:

[0107] Drug-containing layer:

[0108]

[0109] Auxiliary layer:

[0110]

[0111] Preparation Process:

[0112] 1. Preparation of particles

[0113] Preparation of drug-containing layer:

[0114] 1. Weigh the prescribed amount of levocetirizine hydrochloride, put it in an appropriate amount of water, stir to dissolve, and set aside.

[0115] 2. Weigh the prescribed amount of β-cyclodextrin and microcrystalline cellulose, mix them evenly, add levocetirizine hydrochloride aqueous solution, stir evenly, granulate with a 30-mesh sieve, dry at 50°C, and sieve through a 30-mesh sieve grain.

[0116] 3. According to the amount of clathrate prepared, add direct compression lactose, microcrystalline cellulose PH102, and crospovidone according to the prescription amount, and mix well.

[0117] 4. Add the prescribed amount of magnesium stearate and mix evenly to obtain drug-containing layer granules.

[0...

Embodiment 3

[0131] Embodiment 3 (preferred embodiment of the present invention)

[0132] prescription:

[0133] Drug-containing layer:

[0134] Name of raw material

Prescription quantity (1000 tablets)

Levocetirizine Hydrochloride

2.5g

β-cyclodextrin

15g

Microcrystalline Cellulose (Heidemer)

15g

water

Appropriate amount

Directly compressed lactose

150g

Microcrystalline Cellulose PH102

50g

Crospovidone

10g

Magnesium stearate

3g

[0135] Auxiliary layer:

[0136] Name of raw material

Prescription quantity (1000 tablets)

Mannitol

150g

Microcrystalline Cellulose (Heidemer)

50g

lemon yellow

0.5g

water

Appropriate amount

Sucralose

4g

Cantaloupe Flavor

5g

Magnesium stearate

2g

[0137] Preparation Process:

[0138] 1. Preparation of particles

[0139] Preparat...

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Abstract

The invention relates to a levocetirizine hydrochloride chewable tablet for relieving hypersensitivity caused by allergy diseases and the preparation technology thereof. Levocetirizine hydrochloride has stronger bitterness, in the invention, by adopting the composite of Beta-cyclodextrin and microcrystalline cellulose, the medicine is prepared to be inclusion compound so as to cover up the bitterness of the medicine, the prepared medicine is better in mouth-feel and is convenient to take, the process operability in preparing the inclusion compound and the stability of the levocetirizine hydrochloride chewable tablet are enhanced at the same time, the levocetirizine hydrochloride chewable tablet is particularly suitable for old and child patients having difficulty in swallowing, enhances the compliance of the patients and has a better marketable value.

Description

technical field [0001] The present invention relates to a kind of medicine that is used for alleviating allergic symptoms caused by allergic diseases, such as: allergic rhinitis (including allergic symptoms of eyes), urticaria, angioneurotic edema, contact dermatitis, insect bite dermatitis, etc. The invention relates to levocetirizine hydrochloride chewable tablets for allergic diseases of mucous membranes, belonging to the field of pharmaceutical preparations. Background technique [0002] Oral absorption of levocetirizine hydrochloride is rapid, and the bioavailability is high. The protein binding rate of this product is 96%, and the concentration in the brain is lower than 1 / 10 of the plasma concentration. This product does not undergo liver metabolism, and the elimination half-life is 7 -8 hours, the vast majority is excreted by the kidneys in the form of the original drug, 85% of which is excreted in urine and 13% in feces. [0003] At present, levocetirizine hydrochl...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/495A61K47/40A61K47/38A61P37/08
Inventor 姚亮元袁秀菊钟爱军王雪姣王朝磊宿亮宋维
Owner 湖南千金湘江药业股份有限公司
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