Rebamipide sustained release tablet and preparation method thereof

A technology of rebamipide and sustained-release tablets, which is applied in the direction of pharmaceutical formulations, medical preparations containing no active ingredients, and medical preparations containing active ingredients. and other issues, to achieve good compliance, reduce toxicity, and reduce the amount of raw materials

Pending Publication Date: 2022-04-29
杭州沐源生物医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] As an ordinary tablet with a specification of 100mg, it needs to be taken three times a day. There is an urgent need to develop sustained-release tablets to increase patient compliance. At present, there is no sustained-release preparation of rebamipide on the market, and rebamipide once a day has been developed. There are currently several problems with sustained-release tablets: first, the need to increase the specification to 300 mg results in excessive tablet weight and the risk of high toxicity; second, there is a burst release phenomenon in 2 hours for rebamipide sustained-release preparations
The preparation adopts thermoplastic polymer and adopts hot-melt extrusion process, so that rebamipide with poor solubility is wrapped in layers, which seriously hinders drug release. The preparation process is complicated and the production process is strict. A series of problems in the above links lead to production costs. High, difficult to achieve industrial production

Method used

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  • Rebamipide sustained release tablet and preparation method thereof
  • Rebamipide sustained release tablet and preparation method thereof
  • Rebamipide sustained release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] The formulation of the rebamipide sustained-release tablet in this embodiment is shown in Table 1 below.

[0043] Table 1 Recipe table

[0044]

[0045]

[0046] The preparation method is as follows:

[0047] (1) After mixing the raw materials except the lubricant magnesium stearate, wet granulate with 70% ethanol solvent;

[0048] (2) drying wet granulated granules, and then mixing with a lubricant for tableting; mixing hypromellose and titanium dioxide with a mass ratio of 1:1 to obtain a film coating premix;

[0049] (3) Dissolving the film coating premix with ethanol to obtain a coating solution, and coating the tablet with the coating solution.

Embodiment 2

[0051] The formulation of the rebamipide sustained-release tablet in this embodiment is shown in Table 2.

[0052] Table 2 Formulation table

[0053]

[0054] The preparation method is as follows:

[0055] (1) After mixing the raw materials except lubricant, wet granulation with 70% ethanol solvent;

[0056] (2) The dried wet granulated granules are mixed with a lubricant and pressed into tablets; polyvinyl alcohol, lecithin and titanium dioxide are mixed with a mass ratio of 1:0.5:1 to obtain a film coating premix;

[0057](3) Dissolving the film coating premix with ethanol to obtain a coating solution, and coating the tablet with the coating solution.

Embodiment 3

[0059] The formulation of the rebamipide sustained-release tablet in this embodiment is shown in Table 3 below.

[0060] Table 3 recipe table

[0061]

[0062]

[0063] The preparation method is as follows:

[0064] (1) After mixing the raw materials except lubricant, wet granulation with 70% ethanol solvent;

[0065] (2) The dried wet granulated granules are then mixed with a lubricant and compressed into tablets;

[0066] (3) Dissolving the film coating premix with ethanol to obtain a coating solution, and coating the tablet with the coating solution. Wherein the film coating premix is ​​hypromellose.

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Abstract

The invention relates to the technical field of pharmaceutical preparations, in particular to a rebamipide sustained release tablet and a preparation method thereof. The rebamipide sustained release tablet is prepared from rebamipide, a framework material and a microcrystalline cellulose-carboxymethyl cellulose sodium compound. The preparation method comprises the following steps: firstly, mixing the rebamipide with the framework material and the microcrystalline cellulose-carboxymethylcellulose sodium compound, and granulating; and mixing the granulated particles with a lubricant, tabletting, and coating. The rebamipide sustained release tablet provided by the invention not only can improve the bioavailability of the rebamipide tablet, but also can improve the common burst release phenomenon of a sustained release preparation, not only has important clinical significance, but also can reduce the production cost.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a rebamipide sustained-release tablet and a preparation method thereof. Background technique [0002] Peptic ulcer is common in gastroduodenal ulcer. It is mainly manifested in patients with rhythmic abdominal pain, which may be accompanied by nausea, vomiting, loss of appetite and other symptoms, which can affect normal work and life, and the quality of life of patients is low. [0003] Combination therapy of antibiotics and proton pump inhibitors is a commonly used treatment for peptic ulcer, but the clinical effect of some patients is poor, and recurrence may occur after treatment. [0004] Rebamipide is mainly used to treat gastric ulcer, acute gastritis, chronic gastritis, acute exacerbation of gastric mucosal lesions (erosion, hemorrhage, congestion and edema), and can stimulate the synthesis of endogenous prostaglandin E2 in gastric mucosa, resulting in...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K9/22A61K47/38A61K31/4704A61P1/04A61P1/00
CPCA61K9/2866A61K9/2054A61K31/4704A61P1/04A61P1/00
Inventor 蒋晨庹皓范东东李艳马昕陈渊黄燕斌韩上上蔡广读李元飞
Owner 杭州沐源生物医药科技有限公司
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