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Bezafibrate sustained release preparation and its preparation method

A sustained-release preparation, bezafibrate technology, applied in the field of bezafibrate sustained-release preparations and its preparation, can solve problems such as difficult to achieve treatment, low plasma peak concentration, and slow peak time

Active Publication Date: 2014-07-09
JIANGSU TASLY DIYI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The bezafibrate slow-release preparation prepared by the prior art has a low plasma peak concentration and a slow time to reach the peak, making it difficult to achieve the purpose of treatment. After research, the present invention finds a suitable bezafibrate slow-release preparation formula, Fixed issue with unbalanced release

Method used

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  • Bezafibrate sustained release preparation and its preparation method
  • Bezafibrate sustained release preparation and its preparation method
  • Bezafibrate sustained release preparation and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Adopt the method known in the pharmaceutical industry to make this embodiment 1 tablet core to be made up of the raw and auxiliary materials of following weight ratio:

[0048] Bezafibrate 400g Polyoxyethylene 85g Macrogol 4000 15g

[0049] Magnesium Stearate 10g

[0050] Wetting agent: 95% ethanol

[0051] Coating material: gastric soluble film coating premix 15g

[0052] The core preparation process is as follows:

[0053] Polyoxyethylene and polyvinylpyrrolidone are mixed uniformly, bezafibrate is added in equal increments, mixed uniformly, 95% ethanol is added to granulate, dried, granulated, lubricant is added and mixed uniformly, compressed into tablets to obtain tablet cores.

[0054] Preparation of coating solution:

[0055] Use ethanol solution to prepare a coating solution of gastric-soluble film coating premix with a concentration of 12%. Stir the coating liquid to dissolve until it is uniform and fine without clumping before use.

[0056] Coating metho...

Embodiment 2

[0059] Adopt the known method of pharmaceutical industry to make this implementation 2 tablet cores to be made up of the raw and auxiliary materials of following weight ratio:

[0060] Bezafibrate 400g Polyoxyethylene N10 70g Polyoxyethylene N12K 30g Magnesium Stearate 7.5g

[0061] Wetting agent: 95% ethanol

[0062] The coating material used is a commercially available gastric-soluble film coating premix, and its main components are talcum powder, hypromellose, polyethylene glycol and titanium dioxide. The film coating material has the characteristics of moisture-proof and light-proof, and can improve the stability of the tablet.

[0063]We used the hydrophilic gel matrix technology to prepare bezafibrate sustained-release tablets with polyoxyethylene as the hydrophilic gel matrix sustained-release material. Usually high-molecular-weight polyoxyethylene is used as a release retardant in tablets. When high-molecular-weight polyoxyethylene is used as a skeleton material alon...

Embodiment 3

[0069] Adopt the method known in the pharmaceutical industry to make this embodiment 3 cores to be made up of the raw and auxiliary materials of following weight ratio:

[0070] Bezafibrate 400g Microcrystalline Cellulose 100g Hypromellose 4g Magnesium Stearate 6g

[0071] The binder used is a 4% hypromellose solution

[0072] The coating agent used is the coating material: polyacrylic acid resin 50g polyvinylpyrrolidone 3g absolute ethanol

[0073] The solution of polyacrylic acid resin and polyvinylpyrrolidone dissolved in absolute ethanol is coated to achieve sustained release. Polyacrylic acid resin is the coating material, and a small amount of polyvinylpyrrolidone solution is added to the coating solution as a porogen, which can be dissolved in the digestive juice, so that there are micropores on the coating film, and the drug is released from the micropores to play a slow-release effect. .

[0074] The core preparation process is as follows:

[0075] Mix bezafibrate...

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Abstract

The invention relates to a bezafibrate release preparation, which comprises a tablet core and a coating layer, wherein the tablet core comprises the following ingredients by weight percentage.

Description

Technical field: [0001] The invention relates to a bezafibrate sustained-release preparation and a preparation method thereof. Background technique: [0002] Bezafibrate belongs to the second generation of fibrate drugs. It was first launched in the market 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 proven to significantly reduce triglycerides, increase HDL-C concentration can delay the progression of coronary atherosclerotic lesions and reduce the risk of coronary heart disease events. Recent in-depth research on bezafibrate has shown that bezafibrate has a very unique effect, not only can improve lipid metabolism, but more importantly, it can also improve glucose metabolism. Foreign studies have confirmed that long-term use of bezafibrate can prevent diabetes , to improve insulin sensitivity. This is significantly better than other second-generation fibrates. [0003...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K9/30A61K9/32A61K31/192A61K47/32A61K47/34A61P3/06
Inventor 丁爱忠刘金平杨国军王国成赵锦花陈建明成芳
Owner JIANGSU TASLY DIYI PHARMA CO LTD
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