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Preparation for treating allergic rhinitis and preparation method thereof

A technology for allergic rhinitis and preparations, which is applied in the field of drugs for the treatment of rhinitis. It can solve the problems of side effects, unsatisfactory safety, lack of sedative and anticholinergic effects, and achieve ideal safety, good consistency, and small side effects. Effect

Inactive Publication Date: 2012-01-04
TIANSHENG PHARMA GROUP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

selective histamine H 1 The receptor antagonist cetirizine hydrochloride (Cetirizine hydrochloride) treats allergic rhinitis except nasal congestion quickly, but the existing therapeutic dose of cetirizine hydrochloride has no sedative and anticholinergic effects
The compound drug of cetirizine hydrochloride and pseudoephedrine hydrochloride has been marketed. The compound drug is comprehensive and effective in anti-allergic rhinitis, but it has certain side effects and unsatisfactory safety.

Method used

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  • Preparation for treating allergic rhinitis and preparation method thereof
  • Preparation for treating allergic rhinitis and preparation method thereof
  • Preparation for treating allergic rhinitis and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] A sustained-release tablet for treating allergic rhinitis, prepared according to the following steps:

[0040] Chip composition

[0041]

[0042] Coating composition:

[0043]

[0044]Immediate release layer:

[0045] (1) Pulverize the above-mentioned levocetirizine hydrochloride and auxiliary materials, pass the main drug through a 100-mesh sieve, and pass the auxiliary materials through a 80-mesh sieve, and set aside.

[0046] (2) take the levocetirizine hydrochloride of above-mentioned amount and lactose, microcrystalline cellulose, carboxymethyl starch sodium and mix;

[0047] (3) wet granulation with 0.5% hypromellose (5CPS);

[0048] (4) Dry at 40°C-60°C, granulate, add the prescribed amount of magnesium stearate, mix well, detect the content of the intermediate product of levocetirizine hydrochloride, and calculate the weight of the immediate-release layer.

[0049] Slow release layer:

[0050] (1) Pulverize the above-mentioned pseudoephedrine hydrochl...

Embodiment 2

[0091] A preparation for treating allergic rhinitis, prepared according to the following steps:

[0092] Chip composition

[0093]

[0094]

[0095] Coating composition:

[0096]

[0097] Immediate release layer:

[0098] (1) Pulverize the above-mentioned levocetirizine hydrochloride and auxiliary materials, pass the main drug through a 100-mesh sieve, and pass the auxiliary materials through a 80-mesh sieve, and set aside.

[0099] (2) Take the above-mentioned amount of levocetirizine hydrochloride and lactose, microcrystalline cellulose, low-substituted hydroxypropyl cellulose and mix uniformly;

[0100] (3) wet granulation with 0.5% hypromellose (5CPS);

[0101] (4) Dry at a temperature of 40°C to 60°C, granulate, add the above-mentioned amount of magnesium stearate, mix well, detect the content of the intermediate product of levocetirizine hydrochloride, and calculate the weight of the immediate-release layer.

[0102] Slow release layer:

[0103] (1) Pulveri...

Embodiment 3

[0127]A sustained-release tablet for treating allergic rhinitis, prepared according to the following steps:

[0128] Chip composition

[0129]

[0130]

[0131] Coating composition:

[0132]

[0133] Immediate release layer:

[0134] (1) above-mentioned levocetirizine hydrochloride and adjuvant are pulverized, main ingredient is passed through 100 mesh sieve, adjuvant is passed through 80 mesh sieve, for subsequent use;

[0135] (2) Take the above-mentioned amount of levocetirizine hydrochloride and lactose, microcrystalline cellulose, low-substituted hydroxypropyl cellulose and mix uniformly;

[0136] (3) wet granulation with 0.5% hypromellose (5CPS);

[0137] (4) Dry at a temperature of 40°C to 60°C, granulate, add the above-mentioned amount of magnesium stearate, mix well, detect the content of the intermediate product of levocetirizine hydrochloride, and calculate the weight of the immediate-release layer.

[0138] Slow release layer:

[0139] (1) Pulverize t...

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Abstract

The invention relates to a preparation for treating allergic rhinitis. The preparation is prepared by pressing a quick release layer and a sustained-release layer into bilayer tablets and coating, wherein the quick release layer consists of the following components in percentage by mass: 1 to 10 percent of levocetirizine hydrochloride, 1 to 15 percent of disintegrating agent, 0.5 to 3 percent of lubricating agent, 0 to 8 percent of adhesive and the balance of filler; the sustained-release layer consists of the following components in percentage by mass: 20 to 30 percent of pseudoephedrine hydrochloride, 50 to 60 percent of sustained-release framework material, 0.5 to 3 percent of lubricating agent, 0 to 8 percent of adhesive and the balance of filler; and the mass ratio of the levocetirizine hydrochloride to the pseudoephedrine hydrochloride is 1:48. The sustained-release tablets for treating the allergic rhinitis have bright and clean surfaces, and the release behavior of the main medicine pseudoephedrine hydrochloride of the sustained-release tablets has high consistency with that of American marketed medicine cetirizine hydrochloride and pseudoephedrine hydrochloride sustained-release tablets through detection; and the dissolution rate of the main medicine levocetirizine hydrochloride of the sustained-release tablets in 30 minutes is over 90 percent, so that the sustained-release preparation for treating the allergic rhinitis has high bioavailability, a good absorption effect, comprehensive and effective clinical curative effects, small side effects and ideal safety.

Description

technical field [0001] The invention relates to a medicine for treating rhinitis, in particular to a medicine preparation for treating allergic rhinitis and a preparation method thereof, belonging to the technical field of medicines. Background technique [0002] Histamine-mediated perennial or seasonal allergic rhinitis with symptoms including nasal congestion, sneezing, rhinorrhea, itchy nose, palate, and throat, itchy, watery, and red eyes, nasal pain, headache, loss of sense of smell, and Chronic pharyngitis, recurrent nasal cavity and sinus infections, etc., are conditions with a very high incidence. Epidemiological studies show that: 20%-30% of young people suffer from allergic rhinitis, and the incidence of allergic rhinitis among adults over 30 years old is about 2 / 3. Allergic rhinitis not only seriously affects the health and quality of life of patients, but also causes a heavy economic burden to families and society. The annual direct and indirect medical expenses...

Claims

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Application Information

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IPC IPC(8): A61K31/495A61K31/137A61K9/28A61P37/08A61P11/02
Inventor 向洪刘群昝琼刘行鹏
Owner TIANSHENG PHARMA GROUP
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