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Glibenclamide tablet and preparation method thereof

A technology of glyburide and urea tablets, applied in the directions of sulfonylurea active ingredients, pill delivery, metabolic diseases, etc., to reduce the cost of excipients, improve the stability and quality controllability, and improve the dissolution rate.

Inactive Publication Date: 2014-06-25
XINAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] Therefore, it is necessary to provide a new glibenclamide tablet and its preparation method, which can comprehensively use the "blank granule method", "solid dispersion technology" and "equal incremental method" according to the physical and chemical properties of glibenclamide itself. ", to solve the sensitivity of glibenclamide to heat and humidity; improve the dissolution rate of glibenclamide, an insoluble drug, and solve the problem of content uniformity of small doses of drugs

Method used

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  • Glibenclamide tablet and preparation method thereof
  • Glibenclamide tablet and preparation method thereof
  • Glibenclamide tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034]

[0035] Preparation method and steps:

[0036] 1) Mix the above weight of microcrystalline cellulose, mannitol and low-substituted hydroxypropyl cellulose to obtain mixed powder I; add mixed powder I to a high-efficiency wet granulator, and stir at high speed for 3 minutes; 2) Add 175g2 % hypromellose E50 aqueous solution into the mixed powder I to make fine sand-like blank granules; 2% hypromellose E50 aqueous solution is prepared by hypromellose E50 and water in a weight ratio of 2:98 3) Move the blank granules into an oven, ventilate and dry at 70°C for 2 hours, so that the moisture content in the blank granules is controlled at 2.2-3.0%; after drying, pass the blank granules through a 20-mesh sieve, and pass through The blank granule of 50 mesh sieve is not less than 80%; 4) 25g of glibenclamide is fully mixed with 15% of the blank granule according to the equal amount incremental method to obtain the mixed powder II; in this embodiment, the equal amount increme...

Embodiment 2

[0038]

[0039] Preparation method and steps:

[0040]1) Mix the above weight of microcrystalline cellulose, mannitol and low-substituted hydroxypropyl cellulose to obtain mixed powder I; add mixed powder I to a high-efficiency wet granulator, and stir at high speed for 5 minutes; 2) Add 750g2 % hypromellose E50 aqueous solution into the mixed powder I to make fine sand-like blank granules; 2% hypromellose E50 aqueous solution is prepared by hypromellose E50 and water in a weight ratio of 2:98 3) Move the blank granules into an oven, ventilate and dry at 73°C for 2 hours, so that the moisture content in the blank granules is controlled at 2.2-3.0%; after drying, pass the blank granules through a 30-mesh sieve, and pass through The blank granule of 50 mesh sieve is not less than 80%; 4) 25g of glibenclamide is fully mixed with 18% of the blank granule according to the equal amount incremental method to obtain the mixed powder II; in this embodiment, the equal amount incremen...

Embodiment 3

[0042]

[0043] Preparation method and steps:

[0044] 1) Mix the above weight of microcrystalline cellulose, mannitol and low-substituted hydroxypropyl cellulose to obtain mixed powder I; add mixed powder I to a high-efficiency wet granulator, and stir at high speed for 7 minutes; 2) Add 700g2 % hypromellose E50 aqueous solution into the mixed powder I to make fine sand-like blank granules; 2% hypromellose E50 aqueous solution is prepared by hypromellose E50 and water in a weight ratio of 2:98 3) Move the blank granules into an oven, ventilate and dry at 75°C for 2 hours, so that the moisture content in the blank granules is controlled at 2.2-3.0%; after drying, pass the blank granules through a 40-mesh sieve, and pass through The blank granule of 50 mesh sieve is not less than 80%; 4) 25g of glibenclamide is fully mixed with 20% of the blank granule according to the equal amount incremental method to obtain the mixed powder II; in this embodiment, the equal amount increme...

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Abstract

The invention discloses a glibenclamide tablet and a preparation method thereof. The preparation method comprises the following steps of: 1) uniformly mixing microcrystalline cellulose, mannitol and low substituted hydroxy propyl cellulose in a predetermined amount to obtain mixed power I; 2) adding an aqueous solution containing hydroxypropyl methylcellulose E50 in a predetermined amount to the mixed powder I to prepare fine sand hollow particles; 3) drying and screening the hollow particles; 4) mixing glibenclamide with 15-20% of hollow particles according to an equivalent progressively increase method to obtain mixed powder II; 5) uniformly mixing the mixed powder II and residual hollow particles to obtain mixed powder III; 6) uniformly mixing the mixed powder III with magnesium stearate to obtain mixed powder IV; and 7) tabletting the mixed powder IV according to predetermined weight of tablets to prepare the glibenclamide tablet. The glibenclamide tablet and the preparation method disclosed by the invention solve the problem that glibenclamide is sensitive to damp and hot and the problem of content uniformity, so that the dissolution rate of the glibenclamide tablet is improved.

Description

technical field [0001] The invention relates to an oral tablet and a preparation method thereof, in particular to a glibenclamide tablet and a preparation method thereof. Background technique [0002] Diabetes is caused by genetic factors, immune dysfunction, microbial infection and its toxins, free radical toxins, mental factors and other pathogenic factors acting on the body, leading to hypofunction of islets, insulin resistance, etc. disordered disease. Clinically, hyperglycemia is the main feature. In typical cases, polyuria, polydipsia, polyphagia, and emaciation may appear. Diabetes is one of the major chronic diseases identified by the United Nations Chronic Disease Summit and needs priority control. my country is a big country with diabetes, and the incidence of type II diabetes is increasing year by year. As of 2012, the total number of patients in my country has exceeded 90 million. [0003] Glibenclamide, as the first representative drug of the second-generation...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/64A61K47/38A61P3/10
Inventor 余春梅李标周成林蒲道俊孔灵敏郑小锋罗宏徐洁蒋猛贺因之
Owner XINAN PHARMA
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