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Rifaximin enteric-coated preparation composition and preparation method thereof

A technology for rifaximin and enteric-coated preparations, applied in the field of medicine, can solve the problems such as no reports on the composition of enteric-coated preparations of rifaximin, and achieve the effects of good curative effect and safety, good stability and good curative effect.

Inactive Publication Date: 2010-02-24
北京瑞伊人科技发展有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] According to the search results of relevant patents and prior art literature, there is no relevant report on the composition of rifaximin enteric-coated preparations

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Example 1 (A1)

[0022] Enteric-coated tablets

[0023] prescription:

[0024] Rifaximin 200.0g

[0025] Sucrose powder 15.0g

[0026] Sodium carboxymethyl starch 12.0g

[0027] Starch 50.0g

[0028] Sodium Lauryl Sulfate 0.5g

[0029] 5% aqueous solution of polyvinylpyrrolidone appropriate amount

[0030] Magnesium Stearate 2.5g

[0031]

[0032] Makes 1000 pieces

[0033] Preparation Process:

[0034] Pass rifaximin, sucrose powder, sodium carboxymethyl starch, starch, sodium lauryl sulfate and magnesium stearate through an 80-mesh sieve respectively for later use, weigh sucrose powder, sodium carboxymethyl starch, Put the starch and sodium lauryl sulfate in a mixer and mix them evenly with rifaximin, then add an appropriate amount of 5% polyvinylpyrrolidone aqueous solution, granulate, granulate, dry at 50°C for 30 minutes, and dry the granules Add the prescribed amount of magnesium stearate and mix well, pass t...

Embodiment 2

[0035] Example 2 (A2)

[0036] Enteric-coated soft capsules

[0037] prescription:

[0038] Rifaximin 50.0g

[0039] Microcrystalline Cellulose 50.0g

[0040] 20% ethanol solution appropriate amount

[0041]

[0042] Makes 1000 capsules

[0043] Preparation Process:

[0044] Pass the rifaximin and the crystal cellulose through an 80-mesh sieve respectively, weigh the rifaximin and the crystal cellulose according to the prescription amount, mix them in a mixer for 10-15 minutes, add 20% ethanol solution to make a soft material , Granulated in a granulator. The granules prepared above were dried at 45° C. for 30 min. 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 filling range of the enteric-coated soft capsule shell is determined. After passing the inspection, pack.

Embodiment 3

[0045] Example 3 (A3)

[0046] Enteric-coated hard capsules

[0047] prescription:

[0048] Rifaximin 100.0g

[0049] Lactose 25g

[0050] Dextrin 15g

[0051] 5% starch slurry appropriate amount

[0052]

[0053] Made into 1000g grains

[0054] Preparation Process:

[0055] Pass rifaximin, dextrin, and lactose through 80-mesh sieve respectively, weigh rifaximin, dextrin, and lactose according to the prescription amount, mix them in a mixer for 10-15 minutes, add 5% starch slurry in an appropriate amount to make a soft material , granulate in a granulator, dry the granules at 50°C for 30 minutes, pass through a swing granulator, and sieve the granules with a 20-mesh sieve. The content of the mixed granules is determined, and the filling capacity of the enteric-coated hard capsule shell is determined. After passing the inspection, pack.

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PUM

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Abstract

The invention discloses a rifaximin enteric-coated preparation composition and a preparation method thereof. The rifaximin enteric-coated preparation composition is mainly prepared from a rifaximin bulk drug and proper auxiliary materials. The rifaximin enteric-coated preparation provided by the invention is effective and safe for the improvement on a rifaximin preparation, and has the advantagesof less stimulations to the stomach to reduce side effects and the like compared with a common rifaximin preparation. The rifaximin enteric-coated preparation composition is particularly suitable forpatients with stomach upset diseases and can maximize the contact between an active component rifaximin and intestinal mucus. The invention provides a novel dosage form which is safer and has better curative effect; and the preparation process of the rifaximin enteric-coated preparation composition has good quality controllability and stability.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a group of rifaximin enteric-coated preparation compositions 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 fissure...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/437A61P1/00A61P31/04
Inventor 安英张慧英张玲玲
Owner 北京瑞伊人科技发展有限公司
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