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Gliclazide gastric-floating tablet and preparation method thereof

A technology of gastric floating tablets and gel materials, which is applied in the direction of pharmaceutical formulas, medical preparations of non-active ingredients, pill delivery, etc., can solve problems such as fluctuations, amplify adverse reactions of gliclazide, increase blood drug concentration, etc., and achieve The effect is long-lasting, improves bioavailability, and reduces toxic and side effects

Inactive Publication Date: 2017-06-13
HUAYI PHARMA ANHUI CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The existing dosage forms of gliclazide are mainly tablets, capsules, etc. These drugs are metabolized too quickly and require multiple administrations, which increases the fluctuation of blood drug concentration and magnifies the adverse reactions of gliclazide

Method used

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  • Gliclazide gastric-floating tablet and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] A gliclazide gastric floating tablet, each tablet contains 10 mg of gliclazide, the total tablet weight is 0.2 g, and the dosage per 1000 tablets includes the following raw and auxiliary materials:

[0025] Gliclazide 10g, gel material 50g, waxy framework material 45g, foaming material 6g, malic acid 24g, microcrystalline cellulose 55g, zinc stearate 6g and polyvinylpyrrolidone 4g.

[0026] The gel material is hypromellose, the waxy skeleton material is beeswax, and the foaming material is sodium carbonate and calcium carbonate.

[0027] The preparation method comprises the following steps:

[0028] 1) Weighing gliclazide, gel material, waxy framework material, foaming material, malic acid, microcrystalline cellulose, zinc stearate and polyvinylpyrrolidone, crushing and sieving, and set aside;

[0029] 2) heat and melt malic acid and microcrystalline cellulose in a hot-melt extruder, then add gliclazide to melt, and extrude the melt to obtain granules;

[0030] 3) Pol...

Embodiment 2

[0034] A gliclazide gastric floating tablet, each tablet contains 10 mg of gliclazide, the total tablet weight is 0.2 g, and the dosage per 1000 tablets includes the following raw and auxiliary materials:

[0035] Gliclazide 10g, gel material 60g, waxy framework material 35g, foaming material 8g, tartaric acid 28g, microcrystalline cellulose 54g, zinc stearate 4g and polyvinylpyrrolidone 1g.

[0036] The gel material is hydroxymethyl cellulose, the waxy skeleton material is butyl stearate, and the foaming material is calcium carbonate.

[0037] The preparation method comprises the following steps:

[0038] 1) Weighing gliclazide, gel material, waxy framework material, foaming material, tartaric acid, microcrystalline cellulose, zinc stearate and polyvinylpyrrolidone, crushing and sieving, and set aside;

[0039] 2) heat and melt tartaric acid and microcrystalline cellulose in a hot-melt extruder, then add gliclazide to melt, and extrude the melt to obtain granules;

[0040] ...

Embodiment 3

[0044] A gliclazide gastric floating tablet, each tablet contains 18mg of gliclazide, the total tablet weight is 0.2g, and the dosage per 1000 tablets includes the following raw and auxiliary materials:

[0045] Gliclazide 18g, gel material 30g, waxy framework material 55g, foaming material 8g, malic acid 32g, microcrystalline cellulose 52g, zinc stearate 3g and polyvinylpyrrolidone 2g.

[0046] The gel material is hydroxymethyl cellulose and chitin, the waxy skeleton material is butyl stearate, and the foaming material is calcium carbonate and sodium bicarbonate.

[0047] The preparation method comprises the following steps:

[0048] 1) Weighing gliclazide, gel material, waxy framework material, foaming material, malic acid, microcrystalline cellulose, zinc stearate and polyvinylpyrrolidone, crushing and sieving, and set aside;

[0049] 2) heat and melt malic acid and microcrystalline cellulose in a hot-melt extruder, then add gliclazide to melt, and extrude the melt to obta...

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Abstract

The invention provides a gliclazide gastric-floating tablet and a preparation method thereof. The gliclazide gastric-floating tablet comprises the following raw materials and auxiliary materials: 6 to 18 parts of gliclazide, 20 to 60 parts of gel materials, 25 to 55 parts of wax skeleton materials, 2 to 8 parts of foaming materials, 12 to 32 parts of organic acid, 25 to 65 parts of microcrystalline cellulose, 2 to 6 parts of zinc stearate and 1 to 4 parts of polyvinylpyrrolidone. The preparation method comprises the following steps: 1) weighing the raw materials and the auxiliary material, pulverizing and sieving for later use; 2) heating and melting the organic acid and the microcrystalline cellulose in a hot-melt extruder, adding the gliclazide, melting, and extruding the melted liquid to obtain granules; 3) preparing polyvinylpyrrolidone into a solution; 4) mixing the granules in the step 2), the gel materials, the wax skeleton material, the foaming material and the zinc stearate uniformly, spraying the solution in the step 3), pelleting, drying and performing size stabilization; and 5) tabletting the granules obtained by size stabilization in the step 4). The preparation is fast-acting and durable, releases the medicine constantly and completely, and improves the bioavailability of the medicine.

Description

technical field [0001] The invention belongs to the technical field of diabetes drugs, and in particular relates to a gliclazide gastric floating tablet and a preparation method thereof. Background technique [0002] Gliclazide (gliclazide) belongs to the second generation of sulfonylurea oral hypoglycemic drugs, its main features are fast oral absorption, hypoglycemic activity tens to hundreds of times greater than the first generation, and it can cause hypoglycemia , granulocytopenia and the incidence of cardiovascular adverse reactions are small. It has the dual functions of lowering blood sugar and improving blood coagulation function. It can not only improve the metabolism of diabetic patients, but also improve or delay the occurrence of diabetic vascular complications. One of the commonly used drugs. [0003] One of the main pharmacological effects of gliclazide is the hypoglycemic effect. Taking ordinary tablets may cause hypoglycemia and other adverse reactions due...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/64A61K47/44A61K47/12A61K47/38A61K47/32A61P3/10
CPCA61K9/2054A61K9/0002A61K9/0065A61K9/2013A61K9/2027A61K31/64
Inventor 高煜操铖
Owner HUAYI PHARMA ANHUI CO LTD
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