Rifaximin enteric sustained-release preparation composition and method for preparing the same

A technology for rifaximin and sustained-release preparations, applied in the field of medicine, can solve problems such as poor patient compliance and gastric mucosal irritation, and achieve the effects of improving compliance, delaying release speed, and avoiding nausea

Inactive Publication Date: 2009-08-12
山东淄博新达制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] In order to overcome the shortcomings of common gastric-soluble preparations of rifaximin: (1) multiple daily medications are required, resulting in poor compliance of patients; and other adverse reactions, etc., the present invention provides rifaximin enteric-coated sustained-release preparation composition

Method used

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  • Rifaximin enteric sustained-release preparation composition and method for preparing the same
  • Rifaximin enteric sustained-release preparation composition and method for preparing the same
  • Rifaximin enteric sustained-release preparation composition and method for preparing the same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Enteric-coated sustained-release tablets

[0031] prescription:

[0032]

[0033]

[0034] Preparation Process:

[0035] Pass rifaximin, hydroxypropyl methylcellulose, microcrystalline cellulose, and magnesium stearate through an 80-mesh sieve respectively for later use, and weigh rifaximin, hydroxypropyl methylcellulose, microcrystalline Put the crystalline cellulose in a mixer and mix evenly, add an appropriate amount of 80% ethanol, granulate and granulate, dry at 45°C for 30 minutes, add the prescribed amount of magnesium stearate to the dry granules and mix evenly, pass through a 16-mesh sieve with a swing granulator Whole the granules, measure the content of the granules, and determine the weight range of the tablets, press the tablets to obtain sustained-release tablets, use 85% ethanol to prepare the coating powder containing the enteric material cellulose acetate phthalate to prepare the enteric coating liquid, and then The obtained sustained-release ta...

Embodiment 2

[0038] Enteric-coated sustained-release tablets

[0039] Prescription: plain tablet

[0040]

[0041] Prescription: Sustained-release coating solution

[0042] 25 parts of hydroxypropyl methylcellulose

[0043] 10 parts ethyl cellulose

[0044] Propylene glycol 5 parts

[0045] Titanium dioxide 6 parts

[0046] 4 parts talcum powder

[0047] 2% ethyl cellulose ethanol solution appropriate amount

[0048] Preparation Process:

[0049]Pass rifaximin, polyvinylpyrrolidone, starch, lactose, and magnesium stearate through an 80-mesh sieve respectively, weigh rifaximin, polyvinylpyrrolidone, starch, and lactose according to the prescription amount, put them in a mixer and mix them evenly, add Appropriate amount of 80% ethanol, granulate, dry at 45°C for 30 minutes, add the prescribed amount of magnesium stearate to the dry granules and mix well, pass through a 16-mesh sieve with a swinging granulator for granulation, measure the content of the granules, and determine the r...

Embodiment 3

[0052] Enteric-coated sustained-release capsules

[0053] prescription:

[0054]

[0055] Preparation Process:

[0056] Pass rifaximin, hydroxypropyl methylcellulose, ethyl cellulose, lactose, and magnesium stearate through 80 mesh sieves respectively, and weigh rifaximin, hydroxypropyl methylcellulose, ethyl cellulose, Base cellulose, lactose, and magnesium stearate are placed in a mixer and mixed evenly, and an appropriate amount of 4% polyvinylpyrrolidone ethanol solution is used to make soft materials, and granulated in a granulator. The granules prepared above were dried at 60° C. for 1.5 h. Then pass through a swinging granulator, and use a 20-mesh sieve to sieve the granules. The content of the mixed granules is determined, and the capacity range of the enteric-coated capsule shell is determined to be filled, and then packed after passing the inspection.

[0057] The rifaximin enteric-coated sustained-release capsules prepared by the above method meet the require...

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PUM

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Abstract

The invention discloses a rifaximin enteric sustained-release preparation combination and a preparation method thereof. The rifaximin enteric sustained-release preparation combination is mainly prepared from rifaximin bulk drugs, medicinal sustained-release and enteric materials and other appropriate auxiliary materials. The rifaximin enteric sustained-release preparation provided by the invention can not only prevent rifaximin from disintegrating in the stomach and causing irritation to gastric mucosa and avoid the adverse reactions caused by the administration, such as nausea, abdominal pain, diarrhea and the like, but also deaccelerate the release rate of drugs, reduce the frequency of administration and improve the patient compliance. The invention provides a novel form of drug having higher safety and better patient compliance and having the advantages of high quality controllability and stability of the preparation process.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a rifaximin enteric-coated sustained-release preparation composition and a preparation method thereof. Background technique [0002] The intestinal organs are affected by many inflammatory diseases, usually inflammatory bowel disease. In particular, Crohn's disease is a severe chronic inflammatory disease that affects multiple levels of the digestive tract (from mouth to anus), especially in the posterior portion of the small intestine, ileum, colon, or both and is sometimes observed in the mucosal and anal regions of the colon. In the portion of the bowel of concern, inflammation, swelling, and ulceration can develop throughout the bowel wall, causing strictures, bleeding ulcers, and pain, while the unaffected portion appears normal. Crohn's disease presents alternating cycles of inflammatory symptoms of varying severity such as diarrhea, abdominal pain, weight loss, often with...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/437A61K9/00A61P1/00A61P31/00
Inventor 贺同庆贾法强安英张慧英张玲玲
Owner 山东淄博新达制药有限公司
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