Gliclazide sustained-release tablet and preparation method thereof

A technology for gliclazide and sustained-release tablets, applied in the field of gliclazide sustained-release tablets and its preparation, can solve problems such as hypoglycemia, achieve the effects of reducing toxic and side effects, improving bioavailability, and stabilizing blood drug concentration

Inactive Publication Date: 2017-06-30
HUAYI PHARMA ANHUI CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the fast disintegration time and fast absorption of gliclazide tablets, the drug will reach a high blood concentration in the body in a short time, causing hypoglycemia.

Method used

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  • Gliclazide sustained-release tablet and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] A gliclazide sustained-release tablet, consisting of a tablet core and a coating layer, calculated in parts by weight, the tablet core includes the following raw and auxiliary materials: 80 parts of gliclazide, 40 parts of lactose, 1 part of magnesium stearate, 4 parts of micropowder silica gel, 42 parts of microcrystalline cellulose and 26 parts of hydroxypropyl methylcellulose; the coating layer is a polymer coating layer containing titanium dioxide and polyethylene glycol, and the coating layer is 2% of the tablet core weight . Gliclazide was ultrafinely pulverized in advance.

[0020] The preparation method comprises the following steps:

[0021] 1) Glicazide is ultrafinely pulverized, and then sieved with magnesium stearate, microcrystalline cellulose, hydroxypropyl methylcellulose, and lactose for subsequent use;

[0022] 2) Add gliclazide, lactose, microcrystalline cellulose and hydroxypropyl methylcellulose into a high-efficiency wet granulator for dry mixing,...

Embodiment 2

[0026] A gliclazide sustained-release tablet, consisting of a tablet core and a coating layer. Calculated in parts by weight, the tablet core includes the following raw and auxiliary materials: 60 parts of gliclazide, 30 parts of lactose, 1 part of magnesium stearate, 1 part of micropowder silica gel, 30 parts of microcrystalline cellulose and 30 parts of hydroxypropyl methylcellulose; the coating layer is a polymer coating layer containing titanium dioxide and polyethylene glycol, and the coating layer is 2.3% of the tablet core weight . Gliclazide was ultrafinely pulverized in advance.

[0027] The preparation method comprises the following steps:

[0028] 1) Glicazide is ultrafinely pulverized, and then sieved with magnesium stearate, microcrystalline cellulose, hydroxypropyl methylcellulose, and lactose for subsequent use;

[0029] 2) Add gliclazide, lactose, microcrystalline cellulose and hydroxypropyl methylcellulose into a high-efficiency wet granulator for dry mixing...

Embodiment 3

[0033] A gliclazide sustained-release tablet, consisting of a tablet core and a coating layer. Calculated in parts by weight, the tablet core includes the following raw and auxiliary materials: 100 parts of gliclazide, 50 parts of lactose, 2 parts of magnesium stearate, 4 parts of micropowder silica gel, 50 parts of microcrystalline cellulose and 10 parts of hydroxypropyl methylcellulose; the coating layer is a polymer coating layer containing titanium dioxide and polyethylene glycol, and the coating layer is 3% of the weight of the tablet core . Gliclazide was ultrafinely pulverized in advance.

[0034] The preparation method comprises the following steps:

[0035] 1) Glicazide is ultrafinely pulverized, and then sieved with magnesium stearate, microcrystalline cellulose, hydroxypropyl methylcellulose, and lactose for subsequent use;

[0036] 2) Add gliclazide, lactose, microcrystalline cellulose and hydroxypropyl methylcellulose into a high-efficiency wet granulator for dr...

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Abstract

The invention brings forward a gliclazide sustained-release tablet and a preparation method thereof. The gliclazide sustained-release tablet is composed of a tablet core and a coating layer. The tablet core comprises the following raw materials and auxiliary materials (by weight): 60-100 parts of gliclazide, 30-50 parts of lactose, 2-6 parts of a lubricant, 30-50 parts of microcrystalline cellulose and 10-30 parts of hydroxypropyl methyl cellulose. The coating layer is a polymer coating layer containing titanium dioxide and polyethylene glycol. The gliclazide needs to undergo superfine grinding in advance. The preparation method comprises the following steps: firstly carrying out wet granulation to prepare the tablet core, then adding a coating solution into the tablet core, and finally coating to obtain the gliclazide sustained-release tablet. The sustained-release tablet's components can be slowly released in body to maintain the blood concentration of gliclazide in body to be greater than effective treatment concentration so as to guarantee the efficacy.

Description

technical field [0001] The invention belongs to the technical field of sulfonylurea hypoglycemic drugs, and in particular relates to a gliclazide sustained-release tablet and a preparation method thereof. Background technique [0002] Gliclazide, the chemical name is 1-(3-azabicyclo[3,3,0]octyl)-3-p-toluenesulfonylurea. Gliclazide is one of the commonly used oral hypoglycemic drugs. It belongs to the second generation of sulfonylurea hypoglycemic drugs. It has been recorded in the British Pharmacopoeia (2000 edition) and the Chinese Pharmacopoeia (2005 edition) , and listed as national essential medicines. It reduces blood sugar levels in healthy volunteers and non-insulin-dependent diabetic patients (NIDDM) by improving insufficient insulin secretion and the body's utilization of insulin. [0003] After taking gliclazide, by affecting the secretion of insulin in the first and second phases, it promotes the increase of stimulatory and non-stimulatory secretion of insulin b...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K9/32A61K47/10A61K47/02A61K31/64A61P3/10
CPCA61K9/0002A61K9/2095A61K9/2813A61K9/2853A61K31/64
Inventor 高煜操铖
Owner HUAYI PHARMA ANHUI CO LTD
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