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Gliclazide tablets (II) and preparation method thereof

A technology for gliclazide tablets and tablet compression, which is applied in the field of gliclazide tablets and its preparation, can solve the problems of high risk factor, unfavorable explosion protection, etc., and achieve the effect of ensuring safety and avoiding sudden release

Pending Publication Date: 2019-12-20
SHANDONG LUKANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Chinese patent CN102440972A discloses the preparation of a gliclazide tablet (II). The adhesive is prepared using an ethanol solution with a volume percentage of 50% to 100% ethanol, which is not conducive to explosion protection in large-scale industrial production and has a high risk factor

Method used

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  • Gliclazide tablets (II) and preparation method thereof
  • Gliclazide tablets (II) and preparation method thereof
  • Gliclazide tablets (II) and preparation method thereof

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preparation example Construction

[0031] The present invention also provides the preparation method of the gliclazide tablet (II) described in the above technical scheme, comprising the following steps:

[0032] In a fluidized bed, gliclazide, diluent and binder are mixed to obtain a mixture;

[0033] After heating glyceryl behenate at 65-80°C to melt, fluidized spray granulation is carried out with the mixture to obtain granules;

[0034] The granules are mixed with a lubricant and then tableted to obtain the gliclazide tablet (II).

[0035] In the present invention, the gliclazide, the diluent and the binder are mixed in a fluidized bed to obtain a mixture. In the present invention, when the gliclazide, the diluent and the binder are mixed, the parameters of the fluidized bed are preferably: air inlet temperature 60°C, wind speed 20m 3 / h, atomization pressure 1.8kg / cm 2 , the liquid feeding speed is 0.5g~1.0g / min, after the liquid feeding is finished, reduce the wind speed to 18m 3 / h, then dry. In the...

Embodiment 1

[0040] prescription:

[0041]

[0042] Additional materials

[0043] Micronized silica gel 1.50g

[0044] Magnesium stearate 0.75g

[0045] Total weight 160g

[0046] Preparation Process:

[0047] ① Pass the lactose through an 80-mesh sieve for later use.

[0048] ②Take glyceryl behenate, heat it at 65°C until it melts, and keep it warm until it is fluidized and sprayed for granulation.

[0049] ③ Weigh gliclazide, lactose and povidone k30, place them in a multifunctional fluidized bed, set the inlet air temperature at 60°C, and wind speed at 20m 3 / h, atomization pressure 1.8kg / cm 2 , The feeding speed is controlled at 0.5g / min. After the liquid intake is over, reduce the wind speed to 18m 3 / h, continue to dry, and measure the moisture of the granules with a halogen moisture analyzer until the moisture content of the granules does not exceed 3.0%. 1.5mm sieve whole grain.

[0050] ④Add prescription amount of micropowder silica gel and magnesium stearate and mix ...

Embodiment 2

[0052] prescription:

[0053]

[0054] Additional materials

[0055] Micronized silica gel 1.50g

[0056] Magnesium stearate 0.75g

[0057] Total weight 160g

[0058] Preparation Process:

[0059] ① Pass the lactose through an 80-mesh sieve for later use.

[0060] ②Take glyceryl behenate, heat it at 65°C until it melts, and keep it warm until it is fluidized and sprayed for granulation.

[0061] ③ Weigh gliclazide, lactose and povidone k30, place them in a multifunctional fluidized bed, set the inlet air temperature at 60°C, and wind speed at 20m 3 / h, atomization pressure 1.8kg / cm 2 , The feeding speed is controlled at 0.5g / min. After the liquid intake is over, reduce the wind speed to 18m 3 / h, continue to dry, and measure the moisture of the granules with a halogen moisture analyzer until the moisture content of the granules does not exceed 3.0%. 1.5mm sieve whole grain.

[0062] ④Add prescription amount of micropowder silica gel and magnesium stearate and mix ...

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Abstract

The invention provides gliclazide tablets (II) and a preparation method thereof, and belongs to the field of pharmaceutical preparations. According to the invention, glyceryl behenate is used as a lipid sustained-release matrix, is used as a sustained-release skeleton at the same time, and is subjected to fluidization granulation, so that solid bridges are formed among the raw materials, raw material powder is bonded, sustained-release particles are formed, the release of gliclazide can be effectively controlled, the phenomenon of sudden release of active ingredients is avoided, and the medication safety is guaranteed. Meanwhile, the glyceryl behenate is subjected to the fluidization granulation, no explosive solvent such as ethanol is required to be used for preparing an adhesive, no residual solvent is generated, and industrial mass production is facilitated.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a gliclazide tablet (II) and a preparation method thereof. Background technique [0002] The chemical name of Gliclazide is 1-(3-azabicyclo[3,3,0]octyl)-3-p-toluenesulfonylurea, which is the second-generation sulfonylurea hypoglycemic drug with molecular formula C 15 h 21 N 3 o 3 S, relative molecular weight 323.41, is white crystal or crystalline powder, insoluble in water, slightly soluble in ethanol. Its structural formula is: [0003] [0004] Gliclazide is a second-generation sulfonylurea oral hypoglycemic drug, which promotes Ca 2+ Transport to β cells, thereby stimulating the secretion of insulin, and at the same time improving the metabolism of glucose by surrounding tissues, and finally lowering blood sugar. Its main features are fast oral absorption, hypoglycemic activity tens to hundreds of times greater than that of the first generation, a...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K47/14A61K31/64A61P3/10
CPCA61K9/2013A61K31/64A61P3/10
Inventor 刘鹏程侯金升高兴荣
Owner SHANDONG LUKANG PHARMA
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