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Stable taste-masking levocetirizine medicine composition and preparation method thereof

A technology of levocetirizine and its composition, which is applied in the field of levocetirizine pharmaceutical composition and its preparation, can solve the problems of stability investigation and no taste masking technology, and achieve improved stability and pleasant taste , the effect of increasing safety

Inactive Publication Date: 2013-01-09
天津市聚星康华医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] Among the above five patents, patent CN101669913A selected several excipients through compatibility experiments to prepare relatively stable levocetirizine hydrochloride granules, but did not involve taste-masking technology; patent CN1660098A used taste-masking technology to prepare Cetirizine hydrochloride pharmaceutical composition with good taste, but its stability has not been investigated; patent CN101310711A, patent CN102038654A and patent CN1875970A involve conventional preparation prescriptions and processes

Method used

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  • Stable taste-masking levocetirizine medicine composition and preparation method thereof
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Embodiment 1

[0026] Levocetirizine hydrochloride granules are prepared by using the levocetirizine pharmaceutical composition of the present invention.

[0027] Each bag contains 5 mg of levocetirizine hydrochloride, and the composition of 1000 bags of levocetirizine hydrochloride granules is:

[0028]

[0029] The preparation process is as follows:

[0030] A. Mannitol, sucrose, and aspartame are passed through 80 mesh sieves respectively for subsequent use; the aqueous solution of 3% hydroxypropyl methylcellulose is prepared as a binder for subsequent use;

[0031] B. Weigh the prescribed amount of β-cyclodextrin, add 80ml of water, stir, add levocetirizine, then add sodium citrate, stir evenly, and make a stable taste-masked levocetirizine drug combination thing;

[0032] C. Take by weighing prescription amount mannitol, sucrose, aspartame, hypromellose, mix;

[0033] D. Mix B and C, granulate through a 20-mesh sieve, dry the wet granules at 60°C, granulate with a 16-mesh sieve, a...

Embodiment 2

[0036] Levocetirizine hydrochloride granules are prepared by using the pharmaceutical composition without adding a taste-masking agent in the present invention.

[0037] Each bag contains 5 mg of levocetirizine hydrochloride, and the composition of 1000 bags of levocetirizine hydrochloride granules is:

[0038]

[0039] The preparation process is as follows:

[0040] A. Pass levocetirizine hydrochloride, sodium citrate, mannitol, sucrose, and aspartame through 80 mesh sieves for subsequent use; prepare an aqueous solution of 3% hydroxypropylmethylcellulose as a binder for subsequent use;

[0041] B. take levocetirizine hydrochloride, sodium citrate, mannitol, sucrose, aspartame, mix uniformly, make soft material with binder, cross 20 mesh sieves and granulate;

[0042] C. Dry the wet granules at 60°C, sieve the granules with a 16-mesh sieve, and mix them together to obtain a semi-finished product;

[0043] D. After passing the inspection, subpackage and pack to obtain lev...

Embodiment 3

[0045] The levocetirizine hydrochloride granules are prepared by using the pharmaceutical composition without adding a stabilizer in the present invention.

[0046] Each bag contains 5 mg of levocetirizine hydrochloride, and the composition of 1000 bags of levocetirizine hydrochloride granules is:

[0047]

[0048] The preparation process is as follows:

[0049] A. Mannitol, sucrose, aspartame, and hydroxypropyl methylcellulose are passed through 80 mesh sieves for subsequent use; the aqueous solution of 3% hydroxypropyl methylcellulose is prepared as a binder for subsequent use;

[0050] B. Weigh the prescription amount of β-cyclodextrin, add 80ml of water, add levocetirizine after stirring, stir evenly, and make a mixture for subsequent use;

[0051] C. take by weighing recipe quantity mannitol, sucrose, aspartame mix;

[0052] D. Mix B and C, granulate through a 20-mesh sieve, dry the wet granules at 60°C, granulate with a 16-mesh sieve, and finally mix to obtain a semi-...

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Abstract

The invention provides a stable taste-masking levocetirizine medicine composition and a preparation method thereof. The medicine composition comprises levocetirizine, a taste masking agent and a stabilizer, the levocetirizine is levocetirizine hydrochloride, the taste masking agent is beta-cyclodextrin or a derivative thereof, and the stabilizer is sodium citrate. Other pharmaceutically acceptable auxiliary materials are selectively added in the medicine composition, the medicine composition can be further prepared into granules, orally disintegrating tablets and chewable tablets, tastes good, is quick in absorption, stable in quality, simple and feasible in preparation process, and can be produced in batches by using the conventional pharmaceutical equipment, and the related medicinal auxiliary materials are easy to purchase and low in cost.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a stable taste-masked levocetirizine pharmaceutical composition and a preparation method thereof. Background technique [0002] Levocetirizine hydrochloride is a third-generation antihistamine with high efficiency and no sedative side effects. It is the R-type single optical isomer of the second-generation antihistamine cetirizine hydrochloride. Its affinity for H1 receptors is Twice that of cetirizine, a highly selective peripheral H1 receptor antagonist, the dosage of its preparation is half of cetirizine hydrochloride 10mg. As early as 2001, levocetirizine hydrochloride tablets were listed in Germany and the UK successively, mainly for the treatment of allergic diseases in the respiratory system, skin and eyes, such as seasonal and perennial allergic rhinitis, itchy eyes and skin, Chronic idiopathic urticaria, allergic asthma, etc. Compared with cetirizine and othe...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K9/20A61K31/495A61K47/40A61P37/08
Inventor 赵伟王红霞康静李化淋
Owner 天津市聚星康华医药科技有限公司
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