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A kind of glipizide composition based on microenvironment pH regulation and its preparation method

A technique for glipizide and composition, applied in the field of glipizide composition based on microenvironment pH regulation and preparation thereof, can solve the problem that the solubility of glipizide is pH-dependent and the drug blood concentration is unfavorable. and other problems, to achieve good market prospects, easy industrial production, and low production costs.

Active Publication Date: 2020-12-08
GUANGDONG PHARMA UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, no matter whether it is a commercially available product or a literature report, it is rarely considered that the solubility of glipizide is pH-dependent, that is, the solubility in water and acidic environment is very low, but it increases with the increase of pH; therefore, glipizide The dissolution or release rate of oxazine is affected by pH changes, which is unfavorable for stabilizing the blood drug concentration of the drug in the body

Method used

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  • A kind of glipizide composition based on microenvironment pH regulation and its preparation method
  • A kind of glipizide composition based on microenvironment pH regulation and its preparation method
  • A kind of glipizide composition based on microenvironment pH regulation and its preparation method

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Embodiment 1

[0028]

[0029] Preparation process: (1) Preparation of glipizide inclusion compound; (2) Passing the clathrate powder obtained in (1) and excipients in prescription ratio through 80-mesh sieve; (3) Mixing the raw materials and excipients obtained in (2) (4) Add lubricant in the prescribed proportion to the solid mixture obtained in (3), mix again evenly, and the obtained powder is directly compressed into tablets, and the hardness of the tablets is controlled within the range of 4-12kg.

Embodiment 2

[0031]

[0032] Preparation process: (1) Preparation of glipizide inclusion compound; (2) Passing the clathrate powder obtained in (1) and excipients in prescription ratio through 80-mesh sieve; (3) Mixing the raw materials and excipients obtained in (2) (4) Add lubricant in the prescribed proportion to the solid mixture obtained in (3), mix again evenly, and the obtained powder is directly compressed into tablets, and the hardness of the tablets is controlled within the range of 4-12kg.

Embodiment 3

[0034]

[0035] Preparation process: (1) Preparation of glipizide inclusion compound; (2) Passing the clathrate powder obtained in (1) and excipients in prescription ratio through 80-mesh sieve; (3) Mixing the raw materials and excipients obtained in (2) (4) Add lubricant in the prescribed proportion to the solid mixture obtained in (3), mix again evenly, and the obtained powder is directly compressed into tablets, and the hardness of the tablets is controlled within the range of 4-12kg.

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Abstract

The invention relates to a glipizide composition based on microenvironment pH regulation and a preparation method thereof. The glipizide composition is composed of the following components in percentage by mass: 1-20% of a pH regulator, 5-20% of a glipizide inclusion compound, 0.5-2.0% of a lubricating agent and 65-80% of auxiliary materials. The microenvironment pH regulation technology is combined with an inclusion compound technology, so that release of glipizide is not influenced by pH change; release behaviors under different pH media are similar, the release time can reach 24 hours, anddrug release is complete. Compared with the prior art, the glipizide composition disclosed by the invention has the characteristics of being simple in process, low in production cost and easy for industrial production and has excellent market prospects.

Description

technical field [0001] The invention relates to the technical field of medicine and medicine production, in particular to a glipizide composition based on microenvironmental pH regulation and a preparation method thereof. Background technique [0002] Glipizide is a second-generation sulfonylurea oral hypoglycemic drug, which mainly reduces blood sugar levels in the body by stimulating pancreatic β cells to secrete insulin. Glipizide belongs to BCS Ⅱ drugs, that is, low solubility and high permeability drugs. Its solubility is very low in water and acidic environment, and it is pH dependent, so its dissolution rate is also affected by pH changes; different patients after oral administration The blood drug concentration fluctuates greatly, so the oral bioavailability is affected; its pKa value is 5.9, and the half-life is short, only 2-4 hours, and its common preparation (tablet) needs to be taken 2-3 times a day, so that the patient's Adherence decreases. [0003] The exis...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K47/69A61K31/64A61P3/10
CPCA61K9/2054A61K31/64A61K47/6951A61P3/10
Inventor 林华庆谢燕贤黄劲恒余楚钦符方方
Owner GUANGDONG PHARMA UNIV