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Bezafibrate sustained-release tablet and preparation method thereof

A technology of bezafibrate and sustained-release tablets, which is applied in the direction of pharmaceutical formulations, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc., and can solve the problems of difficulty in achieving identity, difficulties in sustained-release tablets, and the amount of excipients minor issues

Pending Publication Date: 2021-10-29
JIANGSU TASLY DIYI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] There are many studies on the sustained-release tablets of bezafibrate, including matrix tablets, film-coated tablets, and osmotic pumps. Among them, film-coated tablets are especially suitable for large doses of bezafibrate due to their small amount of excipients. The existing patents for bezafibrate film-coated sustained-release tablets include CN102462675A (application number 201010535713.X), CN103908437A (application number 201310001932.3), and US patent US5840330. The release effect of the drug depends on the hardness of the tablet to a large extent, and the above-mentioned prior art does not provide a solution, which makes it difficult to achieve identity in practice. Although the technical solution disclosed in U.S. Patent No. 5,840,330 can solve this problem to some extent , but how to grasp the stability of the operation during the preparation process, it is still difficult to produce sustained-release tablets with high release consistency and identity. To overcome the shortcomings of the prior art, the inventor improved the existing formula and preparation process to obtain the present invention

Method used

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  • Bezafibrate sustained-release tablet and preparation method thereof
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  • Bezafibrate sustained-release tablet and preparation method thereof

Examples

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Effect test

Embodiment 1

[0090] Embodiment 1: Bezafibrate sustained-release tablet and preparation method thereof

[0091] 1. Composition:

[0092] 1) Tablet core: Weigh 400g of bezafibrate, 31g of 200 mesh lactose, 30g of povidone K25, 15g of sodium lauryl sulfate, 51g of hydroxypropyl methylcellulose K100LV, 3g of colloid, magnesium stearate 10g, spare.

[0093] 2) Coating layer: ethyl acrylate-methyl methacrylate copolymer aqueous dispersion 47.4mg, polysorbate 8014.1mg, hydroxypropyl methylcellulose E5 269.4mg, polyethylene glycol 8000141.7mg, 200 mesh lactose 472.5mg, talc 685.0mg, titanium dioxide 283.5mg, sodium citrate 9.5mg.

[0094] 2. Preparation method:

[0095] 1) Tablet core preparation

[0096] Take lactose, povidone K25, sodium lauryl sulfate, hydroxypropyl methylcellulose K100LV, colloidal silicon dioxide, magnesium stearate respectively according to weight, then pass through 40 mesh sieves respectively, for subsequent use;

[0097] Raw material wetting: take bezafibrate, put it ...

Embodiment 2

[0107] Embodiment 2: Bezafibrate sustained-release tablet and preparation method thereof

[0108] 1. Tablet core: bezafibrate 400g, lactose 29g, povidone K25 28g, sodium lauryl sulfate 12g, hydroxypropyl methylcellulose K100LV 48g, colloidal silicon dioxide 1g, magnesium stearate 8g .

[0109] 2. Coating layer: ethyl acrylate-methyl methacrylate copolymer aqueous dispersion 47.4mg, polysorbate 8014.1mg, hydroxypropyl methylcellulose E5 269.4mg, polyethylene glycol 8000141.7mg, 200 mesh lactose 472.5mg, talcum powder 685.0mg, titanium dioxide 283.5mg, sodium citrate 9.5mg, spare.

[0110] 3. The preparation process is the same as in Example 1.

Embodiment 3

[0111] Embodiment 3: Bezafibrate sustained-release tablet and preparation method thereof

[0112] 1. Tablet core: bezafibrate 400g, lactose 34g, povidone K25 32g, sodium lauryl sulfate 18g, hydroxypropyl methylcellulose K100LV 55g, colloidal silicon dioxide 5g, magnesium stearate 12g .

[0113] 2. Coating layer: ethyl acrylate-methyl methacrylate copolymer aqueous dispersion 47.4mg, polysorbate 8014.1mg, hydroxypropyl methylcellulose E5 269.4mg, polyethylene glycol 8000141.7mg, 200 mesh lactose 472.5mg, talc 685.0mg, titanium dioxide 283.5mg, sodium citrate 9.5mg.

[0114] 3. The preparation process is the same as in Example 1.

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Abstract

The invention relates to a bezafibrate sustained-release tablet and a preparation method thereof. The bezafibrate sustained-release tablet comprises a tablet core and a coating layer, wherein the tablet core is prepared from the following raw materials in parts by mass: 400 parts of bezafibrate, 25-38 parts of lactose, 28-32 parts of povidone, 10-20 parts of sodium lauryl sulfate, 30-59 parts of hydroxypropyl methylcellulose, 1-5 parts of colloidal silicon dioxide and 8-12 parts of magnesium stearate. According to the preparation prescription provided by the invention, the prepared bezafibrate sustained-release tablet is uniform in weight and balanced in dissolution, and the problem that the dissolution is fast before and slow after is solved.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to bezafibrate sustained-release tablets and a preparation method thereof. Background technique [0002] Bezafibrate, alias sodium gluconate, chemical name N-(4-chlorobenzoyl)-tyramide, molecular formula C19H20ClNO4, molecular weight 361.81900, structural formula: [0003] [0004] Bezafibrate is a blood lipid-regulating drug, and it is mainly used clinically for hyperlipoproteinemia type Ⅰ, hyperlipoproteinemia type Ⅱ, hyperlipoproteinemia type Ⅲ, hyperlipoproteinemia type Ⅳ and hyperlipoproteinemia type Syndrome type V. It is the second-generation fibrate drug, which was first launched in the 1970s. It has undergone a large number of clinical application tests and large-scale systematic clinical trials around the world. It has been confirmed that it can significantly reduce triglycerides and increase HDL- C concentration can delay the progressi...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K47/32A61K47/38A61K47/20A61K31/192A61P3/06
CPCA61K9/2866A61K9/284A61K9/2095A61K9/2027A61K9/2013A61K9/2054A61K31/192A61P3/06
Inventor 蔡金勇丁爱忠杨国军赵锦花陈建明高保安成芳
Owner JIANGSU TASLY DIYI PHARMA CO LTD
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