Gliclazide sustained release tablet and preparation method thereof

A technology of gliclazide and sustained-release tablets, which is applied in the direction of pharmaceutical formulas, medical preparations containing no active ingredients, and medical preparations containing active ingredients. Blood sugar gastrointestinal problems, etc., to achieve rapid onset, strong lipid-lowering effect, and increase the effect of lowering blood sugar

Inactive Publication Date: 2019-05-17
ANHUI LIANYI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The currently disclosed gliclazide sustained-release tablets are all prepared by adding conventional sustained-release preparations to gliclazide. With the increase of the dosage, the side effects are increasingly appearing, mainly causing hypoglycemia and harmful effects on the human gastrointestinal tract. It has a stimulating effect, which can easily cause vomiting, epigastric pain, diarrhea and other reactions, resulting in low compliance of patients with medication and restricting the use of many patients

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] A gliclazide sustained-release tablet, consisting of a sustained-release layer and an auxiliary material layer with a weight ratio of 1.8:0.8:

[0033] The slow-release layer includes the following components by weight: 132 parts of gliclazide, 330 parts of skeleton material, 180 parts of filler for the slow-release layer, 6 parts of povidone, and 4.5 parts of camellia oil;

[0034] The auxiliary material layer includes the following components by weight: 42 parts of hydroxymethylglutaryl-CoA reductase inhibitor, 40.5 parts of montmorillonite, 30 parts of fruit and vegetable powder, 36 parts of microcrystalline cellulose, and 5.25 parts of vitamin C , 2.4 parts of deionized water, 3 parts of camellia oil.

[0035] The specific preparation method is as follows:

[0036] (1) Take each raw material respectively according to the above proportioning ratio, and set aside;

[0037] (2) Gliclazide, hydroxymethylglutaryl-CoA reductase inhibitor passed through 80-100 mesh sieve...

Embodiment 2

[0047]A gliclazide sustained-release tablet, consisting of a sustained-release layer and an auxiliary material layer with a weight ratio of 1.8:0.8:

[0048] The slow-release layer includes the following components by weight: 100 parts of gliclazide, 330 parts of skeleton material, 180 parts of filler for the slow-release layer, 6 parts of povidone, and 4.5 parts of camellia oil;

[0049] The auxiliary material layer includes the following components by weight: 30 parts of hydroxymethylglutaryl-CoA reductase inhibitor, 40.5 parts of montmorillonite, 30 parts of fruit and vegetable powder, 36 parts of microcrystalline cellulose, and 5.25 parts of vitamin C , 2.4 parts of deionized water, 3 parts of camellia oil.

[0050] The specific preparation method is as follows:

[0051] (1) Take each raw material respectively according to the above proportioning ratio, and set aside;

[0052] (2) Gliclazide, hydroxymethylglutaryl-CoA reductase inhibitor passed through 80-100 mesh sieve,...

Embodiment 3

[0062] A gliclazide sustained-release tablet, consisting of a sustained-release layer and an auxiliary material layer with a weight ratio of 2:0.6:

[0063] The slow-release layer includes the following components by weight: 132 parts of gliclazide, 330 parts of skeleton material, 180 parts of filler for the slow-release layer, 6 parts of povidone, and 4.5 parts of camellia oil;

[0064] The auxiliary material layer includes the following components by weight: 42 parts of hydroxymethylglutaryl-CoA reductase inhibitor, 40.5 parts of montmorillonite, 30 parts of fruit and vegetable powder, 36 parts of microcrystalline cellulose, and 5.25 parts of vitamin C , 2.4 parts of deionized water, 3 parts of camellia oil.

[0065] The specific preparation method is as follows:

[0066] (1) Take each raw material respectively according to the above proportioning ratio, and set aside;

[0067] (2) Gliclazide, hydroxymethylglutaryl-CoA reductase inhibitor passed through 80-100 mesh sieve, ...

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Abstract

The invention discloses a gliclazide sustained release tablet and a preparation method thereof. The tablet is composed of a sustained release layer and an auxiliary layer with the weight ratio of 1-2:0.6-1.2. The sustained release layer comprises, by weight, 88-132 parts of gliclazide, 220-330 parts of skeleton material, 120-180 parts of sustained release layer filler, 4-6 parts of sustained release layer adhesive and 3-4.5 parts of slow release layer lubricant. The auxiliary layer comprises, by weight, 28-42 parts of hydroxymethylglutaryl-coenzyme A reductase inhibitor, 27-40.5 parts of montmorillonite, 20-30 parts of fruit and vegetable powder, 24-36 parts of auxiliary layer adhesive, 3.5-5.25 parts of vitamin C, 1.6-2.4 parts of deionized water and 2-3 parts of auxiliary layer lubricant. The gliclazide is combined with a drug for lowering blood lipids, a drug for treating diarrhea and a nutrient substance used by diabetic patients to make the tablet to significantly increase the hypoglycemic effect of the gliclazide, and adverse reactions such as hypoglycemia and diarrhea are not easy to cause.

Description

technical field [0001] The invention relates to a gliclazide sustained-release tablet and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Diabetes mellitus is a metabolic disease of multiple etiologies characterized by chronic hyperglycemia accompanied by disturbances in carbohydrate, fat and protein metabolism due to defects in insulin secretion and / or action. With my country's aging society and changes in people's lifestyles, the incidence of diabetes has risen rapidly, and it has become the third largest non-communicable disease after cardiovascular diseases and tumors. There are 1.2 million diabetic patients in my country every year, of which 95% are Type 2 diabetes. [0003] Gliclazide, as a second-generation sulfonylurea oral hypoglycemic drug, is mainly used for mild to moderate diabetes mellitus that is ineffective in adulthood and has no tendency to ketosis. It can also improve diabetic fu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K47/10A61K47/22A61K47/44A61K47/38A61K31/64A61K33/06A61K45/06A61P3/10
Inventor 时文龙卞学阁朱德亮徐新云
Owner ANHUI LIANYI PHARMA
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