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Gliclazide sustained release tablet and preparation method thereof

A technology of gliclazide and sustained-release tablets, which is applied in the field of medicine and can solve problems such as uncertainty

Active Publication Date: 2020-06-26
SHANDONG LUKANG PHARMACEUTICAL GROUP SAITE CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the formula recorded in CN1160061C has certain similarity with the above-mentioned formula, the current commercially available Whether it is consistent with the literature formula process more than 20 years ago is completely uncertain

Method used

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  • Gliclazide sustained release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0075] Embodiment 1: Preparation of Gliclazide Sustained-release Tablets

[0076] prescription:

[0077] Gliclazide: 30mg,

[0078] Calcium hydrogen phosphate dihydrate: 83.64mg,

[0079] Maltodextrin: 11.24mg,

[0080] 4000cp hypromellose (4000mPa s, K4M RC): 16mg,

[0081] 100cp hypromellose (100mPa·s, K100-LV CR): 18mg,

[0082] Magnesium stearate: 0.8mg,

[0083] Colloidal silicon dioxide: 0.32mg.

[0084] Preparation method:

[0085] (a) Mix gliclazide, calcium hydrogen phosphate dihydrate and maltodextrin, prepare wet material with pure water as wetting agent, then granulate and dry the obtained wet material (to a moisture content of less than 4%) , use a 20-mesh sieve to granulate to obtain drug-containing granules;

[0086] (b) uniformly mixing the drug-containing granules with two kinds of hypromellose, and then uniformly mixing the resulting mixture with magnesium stearate and colloidal silicon dioxide;

[0087] (c) Press the mixed material obtained in step...

Embodiment 2

[0089] Embodiment 2: Preparation of Gliclazide Sustained-release Tablets

[0090] prescription:

[0091] Gliclazide: 30mg,

[0092] Calcium hydrogen phosphate dihydrate: 80mg,

[0093] Maltodextrin: 12mg,

[0094] 4000cp hypromellose (4000mPa s, K4M): 15mg,

[0095] 100cp hypromellose (100mPa·s, K100-LV): 17mg,

[0096] Magnesium stearate: 0.9mg,

[0097] Colloidal silicon dioxide: 0.31 mg.

[0098] Preparation method:

[0099] (a) Mix gliclazide, calcium hydrogen phosphate dihydrate and maltodextrin, prepare wet material with pure water as wetting agent, then granulate and dry the obtained wet material (to a moisture content of less than 4%) , use a 20-mesh sieve to granulate to obtain drug-containing granules;

[0100] (b) uniformly mixing the drug-containing granules with two kinds of hypromellose, and then uniformly mixing the resulting mixture with magnesium stearate and colloidal silicon dioxide;

[0101] (c) Compress the mixed material obtained in step (b) in...

Embodiment 3

[0102] Embodiment 3: Preparation of Gliclazide Sustained-release Tablets

[0103] prescription:

[0104] Gliclazide: 30mg,

[0105] Calcium hydrogen phosphate dihydrate: 85mg,

[0106] Maltodextrin: 10mg,

[0107] 4000cp hypromellose (4000mPa s, F4M): 17mg,

[0108] 100cp hypromellose (100mPa·s, K100-LV CR): 19mg,

[0109] Magnesium stearate: 0.7mg,

[0110] Colloidal silicon dioxide: 0.33 mg.

[0111] Preparation method:

[0112] (a) Mix gliclazide, calcium hydrogen phosphate dihydrate and maltodextrin, prepare wet material with pure water as wetting agent, then granulate and dry the obtained wet material (to a moisture content of less than 4%) , use a 20-mesh sieve to granulate to obtain drug-containing granules;

[0113] (b) uniformly mixing the drug-containing granules with two kinds of hypromellose, and then uniformly mixing the resulting mixture with magnesium stearate and colloidal silicon dioxide;

[0114] (c) Compress the mixed material obtained in step (b) i...

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Abstract

The invention discloses a gliclazide sustained release tablet and a preparation method thereof. The gliclazide sustained release tablet comprises gliclazide, calcium hydrogen phosphate, maltodextrin,hydroxypropyl methylcellulose, magnesium stearate and colloidal silicon dioxide. The gliclazide sustained release tablet is prepared by the following method: mixing gliclazide, a calcium hydrogen phosphate dihydrate and maltodextrin, preparing a wet material by using pure water as a wetting agent, then granulating the wet material, and performing drying and grading to obtain medicine-containing granules; uniformly mixing the medicine-containing granules with hydroxypropyl methylcellulose, and then uniformly mixing the obtained mixture with magnesium stearate and colloidal silicon dioxide; andpressing the mixture obtained in the previous step into tablets by using a die with proper size on a rotary tablet press. The tablet provided by the present invention has excellent performance and excellent stability.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a hypoglycemic drug, in particular to a pharmaceutical composition containing gliclazide, more particularly to a pharmaceutical composition in tablet form of gliclazide with sustained release properties . The pharmaceutical composition of the present invention exhibits excellent technical effects as described in the present invention. Background technique [0002] Diabetes mellitus (DM, Diabetes Mellitus) is a metabolic disease with multiple etiologies, characterized by chronic hyperglycemia, accompanied by disorders of sugar, fat and protein metabolism caused by defects in insulin (Insulin) secretion and / or action. Diabetes is a chronic and progressive disease that requires long-term medication. If the medication is taken more times a day, it will bring a lot of inconvenience to the patient. If it is made into a sustained-release preparation that is taken once a day, it will gre...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K31/64A61K47/38A61K47/12A61K47/18A61P3/10
CPCA61K9/2013A61K9/2054A61K31/64A61P3/10
Inventor 高芳旺张咏梅张瑜吕丽梅高涛涛王彦俊魏同瑶
Owner SHANDONG LUKANG PHARMACEUTICAL GROUP SAITE CO LTD
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