Bezafibrate sustained-release composition

A sustained-release composition, the technology of bezafibrate, applied in the field of bezafibrate sustained-release composition, can solve the problems of difficult to meet the expansion of use, increase of individual differences, and decrease of repeatability in vivo, and the release rate can be easily controlled , low production cost, and small fluctuations in blood drug concentration

Inactive Publication Date: 2008-02-13
珠海天翼医药技术开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the sustained-release tablet adopts the skeleton technology, which swells after absorbing water to form viscose, which slowly dissolves in body fluids and can adhere to the wall of the gastrointestinal tract; since the sustained-release tablet is composed of a single dose and consists of one unit, the drug is locally concentrated in the body, It is easy to cause side effects on the gastrointestinal tract; the erosion of hypromellose is affected by different electrolytes, and the drug release process is also affected by electrolytes
Due to the differences in electrolytes in the digestive tract between individuals, the individual variability in the use of this product increases and the reproducibility in the body decreases
In addition, because a single dose is composed of a unit, manufacturing errors or defects can have a serious impact on the release behavior of the overall dose
Therefore, it is difficult to meet the expanded use of the drug by the medical community

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Example 1: Each 1000 bezafibrate sustained-release capsules contains the following substances:

[0038] Bezafibrate 400.0g main medicine

[0039] Ethyl cellulose 20.0g film forming material

[0040] Lactose 16.0g filler

[0041] PVP 10.0g adhesive

[0042] Magnesium stearate 0.5g lubricant

[0043] HPMC 10.0g adhesive

[0044] Blank pellet core 30.0g mother core

[0045] 1. Weigh PVP and prepare it into adhesive solution;

[0046] 2. Place the blank pellet core in the coating machine, take the mixture of bezafibrate, lactose, etc., spray the powder with the binder, and dry to obtain the drug-containing pellets;

[0047]3. Take the above-mentioned drug-containing pellets and place them in the coating machine, the speed of the pan is 10-50 revolutions per minute, the temperature in the pan is 20-50 ℃, and the coating liquid (such as the aqueous suspension of ethyl cellulose) is sprayed continuously. , The trade name is Surelease) onto the drug-containing pellets, evenly coat ...

Embodiment 2

[0050] Example 2: Each 1000 bezafibrate sustained-release capsules contains the following substances:

[0051] Bezafibrate 400.0g main medicine

[0052] Acrylic resin 30.0g slow release layer film forming material

[0053] Starch 10.0g Prepare blank pellet core

[0054] Sugar 20.0g Prepare blank pellet core

[0055] Xanthan gum 5.0g adhesive

[0056] Talc 10.0g lubricant

[0057] Triethyl citrate 3.0g plasticizer

[0058] 1. Weigh xanthan gum and prepare it into a binder solution;

[0059] 2. After preparing the blank pellet core with sugar and starch, place it in a coating machine, take a mixture of bezafibrate, lactose, etc., spray and coat with a binder, and then dry it to obtain medicated pellets;

[0060] 3. Take the above-mentioned drug-containing pellets and place it in the coating machine, the speed of the pan is 10-50 revolutions per minute, the temperature in the pan is 20-50 ℃, and the coating liquid (acrylic resin) is continuously sprayed onto the drug-containing pelle...

Embodiment 3

[0063] Example 3: Each 1000 bezafibrate sustained-release capsules contains the following substances:

[0064] Bezafibrate 200.0g main medicine

[0065] Ethyl cellulose 28.0g slow-release film-forming material

[0066] Microcrystalline cellulose 20.0g filler

[0067] Starch 65.0g filler

[0068] Talc 2.5g lubricant

[0069] HPMC 10.0g adhesive

[0070] Kaboom 5.0g adhesive

[0071] 1. Weigh HPMC and Carbomer and prepare it into a binder solution;

[0072] 2. Mix bezafibrate, microcrystalline cellulose and starch uniformly, make soft material with a binder, and obtain medicated pellets after extrusion, spheronization, drying and sieving;

[0073] 3. Take the above-mentioned drug-containing pellets and place in the coating machine, the speed of the pan is 10-50 revolutions per minute, the temperature in the pan is 20-50 ℃, and the coating liquid (ethyl cellulose) is sprayed continuously to the drug-containing pellets. On top, evenly coat a layer of sustained-release film coating, an...

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PUM

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Abstract

A slow-release compound of benzafibrate is a slow-release capsule, the main part of which are the slow-release pellets. The slow-release pellets comprise the benzafibrate served as the active component and the slow-release layer with slow-release property covering outer layer of the medical pellet. The other excipient comprises the excipient material with pharmaceutical approval after mixing with benzafibrate and the slow-release material with slow-release property. The ratio among the benzafibrate, the excipient material and the slow-release material (weight ratio) is 1 to 0.01 till 1 to 0.01 till 1. The compound can prolong residence time of the medicine in the stomach. The compound is also capable of controlling the drug release, reducing the administration times, reducing toxic and side effects and improving the treatment effect.

Description

Technical field: [0001] The invention relates to a medicine mainly used for lowering blood lipids, mainly refers to a sustained-release composition with bezafibrate as the main therapeutic component, and specifically refers to a sustained-release composition of bezafibrate. Background technique: [0002] At present, the bezafibrate commonly used in the medical field mainly includes tablets, capsules and sustained-release tablets. The sustained-release tablets have the advantages of long maintenance time and convenient use, and have significant lipid-lowering effects in actual clinical practice. However, sustained-release tablets use matrix technology, which swells to form viscose after absorbing water, and slowly dissolves in body fluids, while adhering to the wall of the gastrointestinal tract; because sustained-release tablets are a single dose composed of one unit, the drug is locally concentrated in the body. It is easy to cause side effects on the gastrointestinal tract; the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/58A61K9/62A61K31/195A61P3/06
Inventor 张晓明麦耀权吴苑燕
Owner 珠海天翼医药技术开发有限公司
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