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Process for preparing gliclazide slow release capsule for oral sugar reducing method

A technology of gliclazide and sustained-release capsules, applied in the field of medicine, can solve the problems such as no research report on hydrophilic gel sustained-release capsules, and reduce the number of times of taking medicines, so as to reduce the times of medication, reduce the cost of treatment, and reduce the dose. Effect

Inactive Publication Date: 2005-05-18
SHANGHAI JIAO TONG UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] After literature search, Liu Baolin published "Preparation and Release Measurement of Gliclazide Sustained-release Tablets" in "Jiangsu Pharmaceutical and Clinical Research" 2004, 12(3): 27-28, proposing that Gliclazide sustained-release tablets Tablets are a new dosage form, made of high-viscosity polymer materials that absorb water and swell to form gels, 30mg / day, only need to be taken once a day, which reduces the number of medications. So far, no hydrophilic gel has been used as a matrix Research Report on Sustained Release Capsules

Method used

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  • Process for preparing gliclazide slow release capsule for oral sugar reducing method

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Embodiment 1

[0013] Gliclazide sustained-release capsules of the present invention consist of (percentage by weight, the same below): 10% of gliclazide, 70% of calcium hydrogen phosphate, 15% of HPMC100cp, 1% of EC100cp, 2% of magnesium stearate, 2% of talcum powder %.

[0014] The preparation method is as follows: pass the prescription amount of gliclazide, calcium hydrogen phosphate, HPMC 4000cp, HPMC 100cp and EC 100cp through a 100-mesh sieve respectively, mix them in a mixer, add 50% ethanol aqueous solution as a wetting agent and stir Make soft material, granulate through 14 mesh sieve, dry granules at 50°C for 1.5 hours, granulate with 14 mesh sieve, add magnesium stearate and talcum powder in prescribed amount, mix evenly, pack into capsules.

[0015] Implementation Effect:

[0016] The resulting granules were relatively hard, with a content of 0.172 g. According to the Chinese Pharmacopoeia 2000 Edition II Fuling regulations capsule inspection items, the weight difference meets ...

Embodiment 2

[0018] The gliclazide sustained-release capsules of the present invention consist of 15% gliclazide, 60% calcium hydrogen phosphate, 14.8% HPMC4000cp, 5% HPMC 100cp, 5% EC100cp, 0.1% magnesium stearate and 0.1% talcum powder.

[0019] The preparation method is: pass the prescription amount of gliclazide, calcium hydrogen phosphate, HPMC 4000cp, HPMC 100cp and EC 100cp through 80 mesh sieve respectively, put it in a mixer and mix well, add 60% ethanol aqueous solution as a wetting agent and stir Made into a soft material, granulated through a 16-mesh sieve, dried at 60°C for 1 hour, granulated through a 16-mesh sieve, then added with prescribed amounts of magnesium stearate and talcum powder, mixed evenly, and packed into capsules.

[0020] Implementation Effect:

[0021] Closer granules were produced with a content of 0.170 g. According to the Chinese Pharmacopoeia 2000 Edition II Fuling regulations capsule inspection items, the weight difference meets the requirements. Acco...

Embodiment 3

[0023] The composition of the gliclazide sustained-release capsule of the present invention is as follows: 25% of gliclazide, 48% of calcium hydrogen phosphate, 10% of HPMC4000cp, 7.5% of HPMC100cp, 7% of EC100cp, 1.5% of magnesium stearate, and 1% of talcum powder.

[0024] The preparation method is: pass the prescription amount of gliclazide, calcium hydrogen phosphate, HPMC 4000cp, HPMC 100cp and EC 100cp through an 80-mesh sieve respectively, mix them in a mixer, add 70% ethanol aqueous solution as a wetting agent and stir Make soft material, granulate through 18 mesh sieve, dry granule at 50°C for 2 hours, granulate with 18 mesh sieve, add magnesium stearate and talcum powder in prescribed amount, mix well, pack into capsules.

[0025] Implementation Effect:

[0026] Regular granules were obtained with a content of 0.162 g. According to the Chinese Pharmacopoeia 2000 Edition II Fuling regulations capsule inspection items, the weight difference meets the requirements. Ac...

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Abstract

The present invention discloses a preparation process of slowly releasing orally taken hypoglycemic gliclazide capsule, and belongs to the field of medicinal technology field. The capsule consists of gliclazide 10-40 wt%, calcium biphosphate 40-70 wt%, HPMC4000cp 0-20 wt%, HPMC100cp 0-20 wt%, EC100cp 0-9.3 wt%, magnesium stearate 0-2 wt% and talcum powder 0-2 wt%. The preparation process includes 60-100 mesh sieving the first mentioned five medicine materials, mixing, adding 50-75 % concentration alcohol as wetting agent and stirring to making soft material, 14-20 mesh sieve pelletizing, drying at 50-60 deg.c of 1-2 hr, 14-20 mesh sieve finishing, adding magnesium stearate and talcum powder, and capsulizing. The capsule is used in treating non-insulin dependent diabetes (type-II), is especially suitable for adult diabetes, diabetes accompanied by obesity or blood vessel pathologic change, and has the features of being safe and long in effect.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a preparation method of a sustained-release capsule, in particular to a preparation method of a hypoglycemic drug gliclazide sustained-release capsule for oral administration. Background technique [0002] Diabetes mellitus is an endocrine metabolic disease caused by insufficient insulin secretion and decreased sensitivity of target cells to insulin, resulting in metabolic disorders of sugar, protein, fat, water, and electrolytes. With the development of medicine, oral hypoglycemic drugs for diabetes are constantly being introduced. Commonly used oral hypoglycemic agents include sulfonylureas and biguanides. Among them, sulfonylurea drugs are the earliest discovered and widely used hypoglycemic drugs. Due to their economical nature and relatively few Chinese people with severe insulin resistance, these drugs are more in line with China's national conditions. [0003] Gliclazide...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K31/40A61P3/10
Inventor 贾伟邱明丰邱云平
Owner SHANGHAI JIAO TONG UNIV
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