Gliclazide gastric floating tablet and preparation method thereof

The technology of gastric floating tablet and formula is applied in the field of gliclazide gastric floating tablet and its preparation, which can solve the problems of amplifying adverse reactions, fluctuations, and increasing blood concentration of gliclazide, and achieves the improvement of bioavailability and effect. Long-lasting and less toxic effects

Active Publication Date: 2013-05-22
CHENGDU HENGRUI PHARMA
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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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] A gliclazide gastric floating tablet, the powder is directly compressed into tablets, each tablet contains 10 mg of gliclazide, the total tablet weight is 0.2 g, it includes the following components and the dosage of each component per 1000 tablets is:

[0030] Gliclazide 10g,

[0031] Gel material 60g,

[0032] Waxy material 40g,

[0033] Foaming material 5g,

[0034] Lactose 80g,

[0035] Magnesium Stearate 5g.

[0036] The gel material is hypromellose (HPMC).

[0037] The waxy material includes fatty acid and fatty alcohol, the fatty acid is stearic acid, the fatty alcohol is stearyl alcohol, and the amount of stearyl alcohol is 20g, and the amount of stearic acid is 20g.

[0038] The foaming material is sodium bicarbonate.

[0039] The particle size of the gliclazide is ≤100 mesh, the particle size of the gel material and the foaming material is ≤80 mesh, and the particle size of the waxy material is ≤60 mesh.

[0040] A preparation method of gliclazide gastr...

Embodiment 2

[0045] A gliclazide gastric floating tablet, shaped after wet granulation, each tablet contains 10 mg of gliclazide, the total tablet weight is 0.2 g, it includes the following components and the dosage of each component per 1000 tablets is:

[0046] Gliclazide 10g,

[0047] Gel material 60g,

[0048] Waxy material 40g,

[0049] Foaming material 5g,

[0050] Lactose 77g,

[0051] Magnesium Stearate 5g,

[0052] PVPK30 3g.

[0053] The gel material is hypromellose (HPMC).

[0054] The waxy material is fatty alcohol, and the fatty alcohol is stearyl alcohol.

[0055] The foaming material is sodium bicarbonate.

[0056] The particle size of the gliclazide is ≤100 mesh, the particle size of the gel material and the foaming material is ≤80 mesh, and the particle size of the waxy material is ≤60 mesh.

[0057] A preparation method of gliclazide gastric floating tablet, which comprises the following steps:

[0058] S1. Weigh each component according to the above formula, cru...

Embodiment 3

[0062] A gliclazide gastric floating tablet, the powder is directly compressed into tablets, each tablet contains 30 mg of gliclazide, the total tablet weight is 0.3 g, it includes the following components and the dosage of each component per 1000 tablets is:

[0063] Gliclazide 30g,

[0064] Gel material 120g,

[0065] Waxy material 90g,

[0066] Foaming material 20g,

[0067] Lactose 50g,

[0068] Magnesium Stearate 5g.

[0069] The gel material is water-soluble resin and chitosan, and the water-soluble resin is 100g, and the chitosan is 20g.

[0070] The waxy material includes beeswax and esters, the esters are triglycerides, 50g of beeswax and 40g of triglycerides.

[0071] The foaming materials are sodium carbonate and calcium carbonate, and the sodium carbonate is 10 g and the calcium carbonate is 10 g.

[0072] A preparation method of gliclazide gastric floating tablet, which comprises the following steps:

[0073] S1, weigh each component according to the above-me...

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Abstract

The invention discloses a gliclazide gastric floating tablet. The gliclazide gastric floating tablet comprises the following ingredients in proportion by weight: 5-15 parts of gliclazide, 20-60 parts of gel material, 20-50 parts of wax material, 1-10 parts of foaming material, 15-40 parts of lactose, 1-5 parts of magnesium stearate, and 0-5 parts of PVPK30 (Polyvinylpyrrolidone-K30). The invention also discloses a preparation method of the gliclazide gastric floating tablet. The gliclazide gastric floating tablet has the following beneficial effects: the gliclazide gastric floating tablet can keep a floating state in gastric juice, gastric transit time is 8-12 hours, the tablet can keep sustained medicine release in an acidic gastric juice environment, therefore, medicine release is constant and complete, medicine bioavailability is improved, administration dosage and times are reduced, medicine absorption at a certain part is promoted, and the toxic and side effect is relieved.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical manufacturing, in particular to a gliclazide gastric floating tablet and a preparation method thereof. Background technique [0002] Diabetes mellitus is a group of clinical syndromes caused by the interaction of genetic and environmental factors. Absolute or relative insufficiency of insulin secretion and decreased sensitivity of target tissue cells to insulin lead to a series of metabolic disorders such as sugar, protein, fat, water and electrolytes. Clinically, hyperglycemia is the main sign, and prolonged illness can cause damage to multiple systems. [0003] Gliclazide is mainly applicable to non-insulin-dependent diabetes, obese diabetes, senile diabetes and diabetes with cardiovascular complications. Gliclazide directly acts on pancreatic β cells, can restore the early peak secretion of insulin, and restore the physiological secretion mode of insulin. Therefore, gliclazide control...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/64A61P3/10
Inventor 沈桦朱德其
Owner CHENGDU HENGRUI PHARMA
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