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A kind of dexlansoprazole sustained-release preparation and its preparation method and medicine

A technology of dexlansoprazole and sustained-release preparations, which is applied in the field of sustained-release drugs, and can solve the problem of drug effect and food delivery rhythm, large impact on gastric emptying, limited sustained-release ability of proton pump inhibitor drugs, and inability to take long-term onset To achieve the effects of drug efficacy and other issues, it is beneficial to the sub-packaging of the preparation, improving the bioavailability, and good reproducibility of the drug release pattern.

Active Publication Date: 2019-11-05
乐普药业科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] In related technologies, proton pump inhibitors have limited sustained-release ability, cannot exert drug effect for a long time, cannot be well dispersed in the gastrointestinal tract, have great stimulation to the gastrointestinal tract, and have low bioavailability. The impact of gastric emptying is large, the reproducibility of drug release is poor, and the drug effect is limited

Method used

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  • A kind of dexlansoprazole sustained-release preparation and its preparation method and medicine
  • A kind of dexlansoprazole sustained-release preparation and its preparation method and medicine
  • A kind of dexlansoprazole sustained-release preparation and its preparation method and medicine

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Effect test

preparation example Construction

[0118] The preparation method of above-mentioned a kind of dexlansoprazole slow-release preparation, granulation after mixing base pellet raw material, coating isolation layer on the surface of gained base pellet, coating on the isolation layer surface of the base pellet coated with isolation layer The coating layer obtains a sustained-release preparation of dexlansoprazole.

[0119] The preparation method of the dexlansoprazole sustained-release preparation of the present invention has simple process, small variation factors, controllable quality and is suitable for large-scale production.

[0120] In a preferred embodiment of the present invention, in the granulation process, water or syrup is used as the liquid phase for granulation.

[0121] In a preferred embodiment of the present invention, the syrup is an aqueous sucrose solution.

[0122] Preferably, the mass fraction of the sucrose aqueous solution is 25%.

[0123] In a preferred embodiment of the present invention, a...

Embodiment 1

[0199] A kind of preparation method of the capsule drug that contains dexlansoprazole slow-release preparation, adopts above-mentioned preparation method to finish, and the quality ratio of each raw material is as follows:

[0200] Dexlansoprazole in base pill raw materials: sodium carboxymethylcellulose: sucrose: dextrin: starch: anhydrous sodium carbonate = 150:50:200:100:50;

[0201] Hypromellose: talc powder: titanium dioxide = 50:15:10 in the raw material of the isolation layer;

[0202] Coating layer A raw material methacrylic resin copolymer L100: polyethylene glycol 6000: Tween 80: triethyl citrate: titanium dioxide: talc = 50:2:10:30:4:15;

[0203] Polyacrylic acid resin S100: polyethylene glycol 6000: Tween 80: triethyl citrate: titanium dioxide: talcum powder in the coating layer B raw material = 150:6:30:100:12:60;

[0204] In the preparation coated pellet A, the mass ratio of the used dexlansoprazole, hypromellose and methacrylic resin copolymer L100 is dexlansop...

Embodiment 2

[0209] A kind of preparation method of the capsule drug that contains dexlansoprazole slow-release preparation, adopts above-mentioned preparation method to finish, and the quality ratio of each raw material is as follows:

[0210] Dexlansoprazole in base pill raw materials: sodium carboxymethylcellulose: sucrose: dextrin: starch: anhydrous sodium carbonate = 450: 150: 600: 200: 100;

[0211] Hypromellose in the raw material of the isolation layer: talc powder: titanium dioxide = 100:45:20;

[0212] The methacrylic resin copolymer L100 in the coating layer A raw material: polyethylene glycol 6000: Tween 80: triethyl citrate: titanium dioxide: talcum powder = 100: 6: 20: 70: 12: 45;

[0213] Polyacrylic acid resin S100: polyethylene glycol 6000: Tween 80: triethyl citrate: titanium dioxide: talcum powder in the coating layer B raw material = 300: 18: 60: 200: 36: 120;

[0214] In the preparation coated pellet A, the mass ratio of the used dexlansoprazole, hypromellose and meth...

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Abstract

The invention provides a dexlansoprazole slow-release preparation as well as a preparation method and a medicine thereof. The dexlansoprazole slow-release preparation provided by the invention is of a specific slow-release structure and comprises a base pill, wherein the base pill is wrapped by an isolating layer and a coating layer in sequence; the base pill, the isolating layer and the coating layer are respectively prepared from raw materials of specific components and amounts. The obtained dexlansoprazole slow-release preparation can be used for preparing various medicinal medicines, is particularly applicable to preparation of capsule medicines, can be widely and uniformly distributed inside gastrointestinal tracts after being taken, is large in distribution area on surfaces of stomachs and intestines, is capable of improving bioavailability and reducing or eliminating irritation of the medicines to the gastrointestinal tracts, is not influenced by food conveying rules and empty stomachs when being conveyed in the gastrointestinal tracts, and is good in medicine release rule repeatability, relatively good in mobility and beneficial to preparation subpackaging. The dexlansoprazole slow-release preparation provided by the invention is simple in preparation method process, small in variation factor, controllable in quality and applicable to large-scale production.

Description

technical field [0001] The invention relates to the technical field of sustained-release medicines, in particular to a sustained-release preparation of dexlansoprazole, a preparation method thereof and medicines. Background technique [0002] Dexlansoprazole is a proton pump inhibitor. Proton pump inhibitors are benzimidazole derivatives that specifically and noncompetitively act on H + / K + -ATPase, treat peptic ulcer. Most proton pump inhibitors are fat-soluble and weakly alkaline. After being absorbed into the blood, they enter the acidic environment of the parietal cell secretory tubules and tubule cavities, and the activated products are generally active sulfenic acid and sulfenamide. + -K + -ATPase sulfhydryl coupling forms an irreversible covalent disulfide bond, blocking H + -K + transport mechanism, thereby inhibiting gastric acid secretion. [0003] In related technologies, proton pump inhibitors have limited sustained-release ability, cannot exert drug effe...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/54A61K31/4439A61K47/32A61K47/38A61P1/04
CPCA61K9/0002A61K9/5026A61K9/5047A61K9/5073A61K9/5084A61K31/4439
Inventor 李春丽于力强胡春振卢志宏孙继
Owner 乐普药业科技有限公司
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