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Rupatadine fumarate tablets and preparation method thereof

A technology for rupatadine fumarate and tablets, which is applied in the fields of pill delivery, pharmaceutical formulations, medical preparations containing active ingredients, etc., and can solve the problems of reddish rupatadine fumarate, unsatisfactory solubility, Problems such as unqualified tablet properties, to achieve the effect of improving rapid dissolution, ensuring bioavailability in vivo, and ensuring quality

Inactive Publication Date: 2014-04-30
YANGTZE RIVER PHARM GRP NANJING HAILING PHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because of its unsatisfactory solubility, it is necessary to pay attention to the appearance, formability, and dissolution rate of insoluble main ingredients when making tablets.
[0011] Because rupatadine fumarate is prone to reddish problems during storage, the tablets are prone to unqualified properties within the validity period
Patent CN103120650A (published on May 29, 2013) discloses a preparation method of rupatadine fumarate. In this invention, iron oxide is used as a dye to prepare tablets into yellow to red tablets, which cannot be effectively Effect of color change of raw materials of rupatadine fumarate during preparation and storage on the quality of rupatadine fumarate tablets

Method used

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  • Rupatadine fumarate tablets and preparation method thereof
  • Rupatadine fumarate tablets and preparation method thereof
  • Rupatadine fumarate tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Embodiment 1-sheet of the present invention and preparation method thereof

[0045] prescription:

[0046]

[0047] Preparation method:

[0048] (1) Pulverize rupatadine fumarate, pass through an 80-mesh sieve, and reserve the rest of the auxiliary materials;

[0049] (2) Take Povidone K 30 , add an appropriate amount of 50% ethanol to dissolve, and make 10% povidone ethanol solution, and set aside;

[0050] (3) Mix rupatadine fumarate, microcrystalline cellulose, mannitol, and sodium starch glycolate evenly, add an appropriate amount of 10% povidone ethanol solution to make a soft material, granulate with a 24-mesh sieve, and dry at 60°C , control the water content at 2.0%, and use a 24-mesh sieve to granulate;

[0051] (4) Add magnesium stearate and mix evenly, measure the particle content;

[0052] (5) Tablet compression, control the tablet weight within ±5% of the theoretical tablet weight, and the friability within 1.0%, and test the properties, dissolution...

Embodiment 2

[0056] Embodiment 2-sheet of the present invention and preparation method thereof

[0057] prescription:

[0058]

[0059]

[0060] Preparation method:

[0061] (1) Pulverize rupatadine fumarate, pass through an 80-mesh sieve, and reserve the rest of the auxiliary materials;

[0062] (2) Take hydroxypropyl cellulose, add 50% ethanol to dissolve it in an appropriate amount, and make a 5% hydroxypropyl cellulose ethanol solution for later use;

[0063] (3) Mix rupatadine fumarate, microcrystalline cellulose, lactose, and cross-linked polyvinylpyrrolidone evenly, add an appropriate amount of 5% hydroxypropyl cellulose ethanol solution to make a soft material, granulate with a 24-mesh sieve, 55 Dry at ℃, control the moisture content at 2.5%, and sieve with a 24-mesh sieve;

[0064] (4) Add magnesium stearate and mix evenly, measure the particle content;

[0065] (5) Tablet compression, control the tablet weight within ±5% of the theoretical tablet weight, and the friabil...

Embodiment 3

[0069] Embodiment 3-sheet of the present invention and preparation method thereof

[0070] prescription:

[0071]

[0072] Preparation method:

[0073] (1) Pulverize rupatadine fumarate, pass through an 80-mesh sieve, and reserve the rest of the auxiliary materials;

[0074] (2) Mix rupatadine fumarate, microcrystalline cellulose, dextrin, and crospovidone evenly, use a dry granulator to granulate, and granulate with a 20-mesh sieve.

[0075] (3) Add magnesium stearate and mix evenly, measure the particle content;

[0076] (4) Tablet compression, control the tablet weight within ±5% of the theoretical tablet weight, and the friability within 1.0%, and test the properties, dissolution rate and content of the plain tablet;

[0077] (5) Packaging, ready to serve.

[0078] (7) Specification: 10mg / tablet (press C 26 h 26 ClN 3 calculate)

[0079] (8) Usage and dosage: take orally, 10mg each time, once a day.

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PUM

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Abstract

The invention discloses rupatadine fumarate tablets and a preparation method thereof, belonging to the technical field of medicine. The tablets are prepared by making granules from rupatadine fumarate as active ingredient, and pharmaceutical adjuvants including a filler, a binder and a disintegrant, adding a lubricant, and making into tablets. Through the screening of the type and use amount of the filler, disintegrant, binder and lubricant and the use of specific sieving mesh to sieve raw materials during a preparation process, the prepared tablets have stable properties, good content uniformity, good dissolution, small tablet weight difference and high stability, so as to ensure in vivo bioavailability and clinical curative effect.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a rupatadine fumarate tablet and a preparation method thereof. Background technique [0002] Allergy is a kind of immune allergy. The medical interpretation is an abnormal or pathological immune response produced by the body being sensitized by the antigenic substance and then stimulated by the same antigenic substance again. The onset is more rapid, usually after 1 to 10 minutes, but also after a few days. It can be caused by a variety of substances, including foreign serum (such as tetanus antiviral), certain animal proteins (eggs, mutton, chicken, duck, fish, shrimp, crab, and even milk, etc.), bacteria, viruses, parasites, animal Fur, plant pollen and dust mites in the air, as well as paints, dyes, chemicals, plastics, chemical fibers or drugs, etc., and even starch can also cause allergies, all of which are called allergens. The degree of al...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4545A61P37/08A61J3/00
Inventor 王罗李娟丁菲张璐
Owner YANGTZE RIVER PHARM GRP NANJING HAILING PHARM CO LTD
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