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Glipizide tablet and its preparation method and application

A technology of glipizide tablets and glipizide, which is applied in the direction of pill delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc., to achieve the effects of improving bioavailability, increasing drug release, and improving product quality

Active Publication Date: 2017-04-26
KANGYA OF NINGXIA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] According to the item of glipizide in the second part of the Chinese Pharmacopoeia in 2010, it can be seen that the raw material drug of glipizide is a poorly soluble drug. How to improve the solubility of glipizide has been paid attention to by researchers, but no good solution has been obtained yet.

Method used

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  • Glipizide tablet and its preparation method and application
  • Glipizide tablet and its preparation method and application
  • Glipizide tablet and its preparation method and application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] prescription

[0028]

[0029] Preparation Process

[0030] (1) take starch (adhesive) and be mixed with purified water into 8wt% starch slurry, as adhesive;

[0031] (2) Glipizide is micronized to obtain the glipizide whose particle size D50 is 100 μm, and the glipizide that has been sieved is weighed according to the prescription amount, mixed with microcrystalline cellulose, starch, poloxa The sodium carboxymethyl starch of 4 / 5 in the total amount and the prescription quantity is mixed by the method of equal increment;

[0032] (3) Add an appropriate amount of binder to make soft materials, pass through a 20-mesh sieve to granulate, dry the wet granules at 40°C, and pass through a 20-mesh sieve for granulation after drying for 1 hour;

[0033] (4) the magnesium stearate and the remaining sodium carboxymethyl starch are mixed with the dry granule after the granulation and the prescription amount;

[0034] (5) After mixing evenly, use a Φ6.5mm shallow concave pun...

Embodiment 2

[0036] prescription

[0037]

[0038] Preparation Process

[0039] (1) Take by weighing the prescription amount of povidone K30, join concentration and be in the 50wt% ethanol solution, be mixed with 5wt% povidone K30-ethanol solution, use this as adhesive;

[0040] (2) Glipizide is micronized to obtain Glipizide whose particle size D50 is 75 μm, and the micronized Glipizide is weighed according to the prescription amount, mixed with microcrystalline cellulose, starch, poloxamer And the crospovidone of 4 / 5 in the prescription quantity is mixed by the equal amount increasing method;

[0041](3) Add an appropriate amount of binder to make soft materials, pass through a 20-mesh sieve to granulate, dry the wet granules at 40°C, and pass through a 20-mesh sieve for granulation after drying for 1 hour;

[0042] (4) mix the dry granule after granulation with the magnesium stearate of the prescription amount and the remaining crospovidone;

[0043] (5) After mixing evenly, use a...

Embodiment 3

[0045] prescription

[0046]

[0047]

[0048] Preparation Process

[0049] (1) Take by weighing the prescription amount of povidone K30, join concentration and be in the 50wt% ethanol solution, be mixed with 5wt% povidone K30-ethanol solution, use this as adhesive;

[0050] (2) Glipizide is micronized to obtain the glipizide whose particle size D50 is 50 μm, and the micronized glipizide is weighed according to the prescription quantity, mixed with microcrystalline cellulose, starch, SDS and prescription quantity The sodium carboxymethyl starch of 4 / 5 is mixed according to the method of equal increment;

[0051] (3) Add an appropriate amount of binder to make soft materials, pass through a 20-mesh sieve to granulate, dry the wet granules at 40°C, and pass through a 20-mesh sieve for granulation after drying for 1 hour;

[0052] (4) the magnesium stearate and the remaining sodium carboxymethyl starch are mixed with the dry granule after the granulation and the prescript...

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Abstract

The invention discloses a glipizide tablet as well as a preparation method and an application thereof. The glipizide tablet comprises the following components in percentage by weight: 1-5% of glipizide with the particle diameter D50 being 50-100 micrometers, 1-10% of a solubilizer, 50-90% of a filler, 5-15% of a disintegrating agent, 0.1-5% of a lubricant, and a suitable amount of 2-15% adhesive, wherein glipizide is preferably glipizide with the particle diameter D50 being 50-75 micrometers. According to the invention, the active ingredient glipizide is micronized, so that the particle diameter of the bulk drug is reduced, meanwhile, the solubilizer is added to be matched with glipizide, so that the drug release rate is increased, further, the bioavailability is improved, and the quality of the product is improved.

Description

technical field [0001] The invention relates to the field of medicine preparation, in particular to a pharmaceutical preparation (tablet) of glipizide, a preparation method and application thereof. Background technique [0002] The prevalence of diabetes is on the rise worldwide, and has become a chronic epidemic that seriously endangers human health. Sulfonylurea hypoglycemic drugs, as the first-line drug for type 2 diabetes, have been recognized by doctors after nearly half a century of application since the 1950s, and are currently the most experienced oral hypoglycemic drugs. [0003] Glipizide, a lipophilic weak acid, is a second-generation sulfonylurea oral hypoglycemic drug. Oral gastrointestinal absorption is complete and rapid, and there is no first-pass effect. After 30 minutes, blood sugar can be seen to drop significantly, pKa is 5.9, t 1 / 2 It takes 2-4 hours. If it is taken together with food, the absorption can be delayed for 30-40 minutes. The protein bindi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/64A61K47/10A61P3/10
Inventor 李娟杨亚军
Owner KANGYA OF NINGXIA PHARMA
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