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Dexibuprofen slow-release capsule and production method thereof

A sustained-release capsule and the technology inside the capsule, which is applied in the direction of pharmaceutical formulations, medical preparations of non-active ingredients, drug delivery, etc., can solve problems such as large side effects, increased burden on patients, and large changes in the concentration of dextroibuprofen

Active Publication Date: 2012-07-04
武汉长联来福制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Many times of taking medicine not only increases the burden of the patient, but also the concentration of Dexibuprofen in the patient's blood changes greatly, and the side effects are also large.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Dexibuprofen sustained-release capsules are filled with pellets. The pellets are composed of a pellet core and four layers of materials wrapped around the pellet core. The four layers of materials are in order from inside to outside: inner isolation layer, coating layer I, coating layer II and coating layer III, ball core, internal isolation layer, coating layer I, coating layer II and coating layer III are composed as follows: ball core is a pharmaceutical excipient composed of sucrose and starch ; The inner isolation layer is stearic acid; Coating layer I is a coating mixture; Coating layer II contains coating mixture and stearic acid; Coating layer III is a coating mixture; : 1 composition of dextrobuprofen and povidone K30, the weight ratio of the coating mixture in the coating layer I, coating layer II and coating layer III is 85:3:10, and the coating layer II is coated with The weight ratio of coating liquid and stearic acid is 2: 1, and the weight of dextrobuprof...

Embodiment 2

[0034] Dexibuprofen sustained-release capsules are filled with pellets. The pellets are composed of a pellet core and four layers of materials wrapped around the pellet core. The four layers of materials are in order from inside to outside: inner isolation layer, coating layer I, coating layer II and coating layer III, ball core, internal isolation layer, coating layer I, coating layer II and coating layer III are composed as follows: ball core is a pharmaceutical excipient composed of sucrose and starch ; The inner isolation layer is stearic acid; Coating layer I is a coating mixture; Coating layer II contains coating mixture and stearic acid; Coating layer III is a coating mixture; The coating mixture is 30% by weight Composition of dextrobuprofen and povidone K30 in 1:1, the weight ratio of the coating mixture in the above coating layer I, coating layer II and coating layer III is 80:4:10, and the coating layer II is coated with The weight ratio of coating solution and stea...

Embodiment 3

[0037]Dexibuprofen sustained-release capsules are filled with pellets. The pellets are composed of a pellet core and four layers of materials wrapped around the pellet core. The four layers of materials are in order from inside to outside: inner isolation layer, coating layer I, coating layer II and coating layer III, ball core, internal isolation layer, coating layer I, coating layer II and coating layer III are composed as follows: ball core is a pharmaceutical excipient composed of sucrose and starch ; The inner isolation layer is stearic acid; Coating layer I is a coating mixture; Coating layer II contains coating mixture and stearic acid; Coating layer III is a coating mixture; The coating mixture is 35% by weight Composition of dextrobuprofen and povidone K30 in 1:1, the weight ratio of the coating mixture in the coating layer I, coating layer II and coating layer III is 88:6:10, and the coating layer II is coated with The weight ratio of coating solution and stearic aci...

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PUM

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Abstract

The invention discloses a dexibuprofen slow-release capsule. Pellets are filled in the capsule, each pellet consists of a pellet core and four layers of materials wrapped outside the pellet core, the four layers of materials are sequentially an inner isolation layer, a first coating layer, a second coating layer and a third coating layer from inside to outside, and the pellet core, the inner isolation layer, the first coating layer, the second coating layer and the third coating layer respectively have the following compositions: the pellet core is prepared by medicine auxiliary materials, the inner isolation layer is stearic acid, the first coating layer is a coating mixture, the second coating layer comprises the coating mixture and the stearic acid, the third coating layer is the coating mixture, and the coating mixture consists of dexibuprofen and polyvidone K30. The invention also provides a production method of the dexibuprofen slow-release capsule. Compared with an ordinary capsule, the dexibuprofen slow-release capsule disclosed by the invention has the same absorption degree, but the dexibuprofen blood maximum concentration (Cmax) of the dexibuprofen slow-release capsule disclosed by the invention in human bodies is lower, the maximum time (Tmax) from the administration to the blood Cmax reaching is longer, and a good slow release effect is realized.

Description

technical field [0001] The invention relates to a dextrobuprofen sustained-release capsule and a production method thereof. Background technique [0002] Dexibuprofen is the S(+)-isomer of ibuprofen, which was launched in Austria in 1994. Its activity is 160 times that of the L-isomer and 1.6 times that of the racemate. Ibuprofen is composed of equal amounts of dextrorotary and levorotatory forms. It has been clinically used for 30 years. It is one of the most common NSAIDs in clinical use and is considered to be the safest non-steroidal anti-inflammatory drug ( NSAIDs) were approved as OTC drugs by the US FDA in 1984. Clinical data show that dextroibuprofen has a faster onset of action than racemic ibuprofen, with the same mechanism of action but better pharmacological effects. It is a non-selective cyclooxygenase (COX) inhibitor and is widely used in therapeutic classes. Rheumatic diseases, as well as joint and muscle pain, headache, dysmenorrhea and other pains. [00...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K31/192A61K47/32A61P29/00
Inventor 张勇慧张琳黄心王亚芬
Owner 武汉长联来福制药股份有限公司
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