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Rupatadine fumarate tablets and preparation method thereof

A technology for rupatadine fumarate and tablets, which is applied in the field of pharmaceutical preparations, can solve problems such as poor stability, and achieve the effects of improving stability, being easy to implement, and reducing discoloration.

Active Publication Date: 2021-04-27
HAINAN BRIGHT FUTURE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The object of the present invention is to provide a rupatadine fumarate tablet and a preparation method thereof, aiming at solving the technical problem of poor stability existing in the existing rupatadine fumarate tablet

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

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preparation example Construction

[0020] The embodiment of the present invention provides a preparation method of rupatadine fumarate tablet, which comprises the following steps:

[0021] S1. Provide prescription amount of rupatadine fumarate, microcrystalline cellulose and other excipients;

[0022] S2. Mixing and granulating rupatadine fumarate with other excipients to obtain granules;

[0023] S3. Mixing and tableting the granules and microcrystalline cellulose to obtain rupatadine fumarate tablets.

[0024] Microcrystalline cellulose is α-cellulose (obtained from plant fiber pulp) dilute inorganic acid solution through controlled hydrolysis, the hydrolyzed cellulose is filtered and purified, and the aqueous suspension is spray-dried to obtain dry, via particles. The impurities of microcrystalline cellulose are glucose, formaldehyde, nitrate and nitrite. The inventors of the present invention found in the research and development process that the hygroscopicity of the above-mentioned impurities will lead ...

Embodiment 1

[0049] This embodiment provides a preparation method of rupatadine fumarate tablet, the steps are as follows:

[0050] (11) Rupatadine fumarate 12.8g (D 90 32 μm), lactose 60.1g, pregelatinized starch 10g, red iron oxide 0.025g and yellow iron oxide 0.075g were mixed uniformly in a wet granulator, and pregelatinized starch slurry 18g (solid content 10%) was added to make soft material, the drying temperature is 55°C, drying until the moisture content is ≤3.0%, and sizing with a 0.8mm aperture screen to obtain granules;

[0051] (12) Add 15 g of microcrystalline cellulose to the granules, and mix them uniformly in a mixer; then add 2 g of magnesium stearate, mix evenly, and perform tablet compression to obtain rupatadine fumarate tablets.

[0052] In the rupatadine fumarate tablets obtained in this example, the raw materials and contents used for every 1000 rupatadine fumarate tablets are shown in Table 1.

[0053] Table 1 Raw materials and content used in every 1000 rupatadi...

Embodiment 2

[0056] This embodiment provides a preparation method of rupatadine fumarate tablet, the steps are as follows:

[0057] (21) Rupatadine fumarate 12.8g (D 90 32 μm), 60.1 g of lactose, 10 g of pregelatinized starch, 0.025 g of red iron oxide and 0.075 g of yellow iron oxide were mixed uniformly in a wet granulator, and 18 g of corn starch slurry (solid content 10%) was added to make a soft material. The drying temperature is 55°C, drying until the moisture content is ≤3.0%, and sizing with a 0.8mm aperture sieve to obtain granules;

[0058] (22) Add 15 g of microcrystalline cellulose to the granules, and mix them uniformly in a mixer; then add 2 g of magnesium stearate, mix evenly, and perform tablet compression to obtain rupatadine fumarate tablets.

[0059] In the rupatadine fumarate tablets obtained in this example, the raw materials and contents used for every 1000 rupatadine fumarate tablets are shown in Table 2.

[0060] Table 2 Raw materials and content used in every 10...

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to rupatadine fumarate tablets and a preparation method thereof. Rupatadine fumarate and other excipients except microcrystalline cellulose are granulated, and then microcrystalline cellulose is added, so that the microcrystalline cellulose can be prevented from generating an adsorption effect on the rupatadine fumarate, and the contact between the rupatadine fumarate and moisture in the microcrystalline cellulose is reduced, thereby avoiding the increase of impurities, and improving the particle flowability; and the rupatadine fumarate tablets have the advantages of high stability, high main drug dissolution speed, high bioavailability and the like, and have a bright application prospect.

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] The chemical name of rupatadine fumarate is 8-chloro-11-[1-[(5-methyl-3-pyridyl)methyl]-4-piperidinylidene]-6,11-dihydro -5H-Benzo[5,6]cyclohepta[1,2-b]pyridine fumarate with formula C 26 h 26 ClN 3 ·C 4 h 4 o 4 , the structural formula is: [0003] [0004] Rupatadine fumarate has dual effects of antihistamine and platelet activating factor (PAF) antagonism, and is suitable for treating allergic rhinitis and allergic urticaria. However, the existing rupatadine fumarate preparations have defects in various aspects during the preparation process, resulting in the general problems of poor stability and poor patient compliance of the obtained preparations. Contents of the invention [0005] The object of the present invention is to provide a rupat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4545A61K47/38A61P37/08A61P11/02A61P17/00
CPCA61K9/2054A61K31/4545A61P37/08A61P11/02A61P17/00
Inventor 刘路路魏建华孟中斌李海华
Owner HAINAN BRIGHT FUTURE PHARMA
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