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Rebamipide gastric floating tablet and preparation method thereof

A technology of Rebapai and floating tablets, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., and can solve the problems of difficult industrial production, poor solubility and permeability, and production process requirements Strict and other issues, to achieve the effect of fast onset time, short drift time and simple process

Pending Publication Date: 2022-07-15
ZENJI RES LAB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Rebamipide is a BCS class IV drug with poor solubility and permeability, and the main absorption site of rebamipide is the upper end of the small intestine, specifically the stomach and duodenum, which results in a relatively narrow absorption window for rebamipide. Narrow, low bioavailability, conventional preparations of rebamipide need to be taken three times a day to achieve good curative effect, poor patient compliance
[0005] Patent CN109078186A discloses a rebamipide gastric floating preparation, which uses a hot-melt extrusion process. It starts to release after about 10 minutes, and the onset time is longer

Method used

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  • Rebamipide gastric floating tablet and preparation method thereof
  • Rebamipide gastric floating tablet and preparation method thereof
  • Rebamipide gastric floating tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Element Content (mg) / each tablet Percentage (%) / per tablet Rebappet 100 37.74％ Microcrystalline Cellulose 102 48 18.11％ Hypromellose K100M 75 28.30％ Cross-linked polyvinylpyrrolidone 40 15.09％ Magnesium stearate 2 0.75％

[0032] Preparation Process:

[0033] (1) Weigh rebamipide and each auxiliary material according to the prescription ratio;

[0034] (2) Rebamipide is fully mixed with each adjuvant except magnesium stearate;

[0035] (3) the mixture of step (2) gained is crossed 30 mesh sieves;

[0036] (4) the mixture after step (3) sieving is mixed with magnesium stearate again;

[0037] (5) The mixed powder obtained in step (4) is directly compressed into tablets, and the hardness is controlled at 60N-70N.

[0038] Determination method of release degree:

[0039] According to the first method of appendix XD of the 2020 edition of the Chinese Pharmacopoeia, place the rebamipide gastric floating tablet in the ro...

Embodiment 2

[0045]

[0046]

[0047] The specific preparation process, the measurement method of the release degree and the measurement method of the floating behavior are the same as those in Example 1.

[0048] The release degree of rebamipide gastric floating tablet in Example 2 is shown in figure 2 . Has a good sustained release effect.

[0049] In Example 2, the floating time of rebamipide gastric floating tablet was 2 minutes, and the continuous floating time was 10 hours.

Embodiment 3

[0051] Element Content (mg) / each tablet Percentage (%) / per tablet Rebappet 100 37.74％ Microcrystalline Cellulose 102 48 18.11％ Hypromellose K100M 37.5 14.15％ Carbomer 971 37.5 14.15％ Cross-linked polyvinylpyrrolidone 40 15.09％ Magnesium stearate 2 0.75％

[0052] The specific preparation process, the measurement method of the release degree and the measurement method of the floating behavior are the same as those in Example 1.

[0053] The release degree of rebamipide gastric floating tablet in Example 3 is shown in image 3 . Has a good sustained release effect.

[0054] In Example 3, the floating time of rebamipide gastric floating tablet was 5 minutes, and the continuous floating time was 12 hours.

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Abstract

The invention discloses a rebamipide gastric floating tablet which comprises the following raw materials in percentage by weight: 30-40% of rebamipide, 10-40% of a framework material, 10-30% of an expanding agent, 0-20% of a floating aid, 0.5-10% of a lubricant and 0-30% of a diluent, the tablet is short in floating starting time, can continuously float for 10 hours, prolongs the residence time in the stomach and the upper end of the small intestine, and has the advantages of no toxic or side effect and no toxic or side effect. The bioavailability is correspondingly improved. The invention further relates to a preparation method of the rebamipide tablet, the preparation process is simple and easy to implement, and the prepared finished product is stable in quality and suitable for large-scale production.

Description

technical field [0001] The invention relates to a tablet and a preparation method thereof, in particular to a rebamipide gastric floating tablet and a preparation method thereof. Background technique [0002] Studies have shown that ulcer disease or peptic ulcer is a common digestive tract disease that can occur in the esophagus, stomach or duodenum, as well as in the vicinity of the gastro-jejunal anastomosis or in the Meckel's diverticulum containing the gastric mucosa, because Gastric ulcer and duodenal ulcer are the most common, so the so-called peptic ulcer generally refers to gastric ulcer and duodenal ulcer. It is called peptic ulcer because gastric ulcer and duodenal ulcer were thought to be formed by gastric acid and pepsin's self-digestion of mucosa. In fact, gastric acid and pepsin are only one of the main causes of ulcer formation , and there are other reasons why peptic ulcers can form. With the growth rate of modern social and economic development and the enh...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K31/4704A61K47/38A61P1/04
CPCA61K9/2054A61K9/0065A61K31/4704A61P1/04
Inventor 罗林钟国锋康振华蒋荷
Owner ZENJI RES LAB
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