Glimepiride tablet composition preparation and preparation method thereof

A composition and glimeide technology, applied in the field of medicine, can solve the problems of tablet moisture absorption, difficult to remove, increase safety risks, etc., achieve high economic and social significance, improve bioavailability, and good quality stability.

Inactive Publication Date: 2019-03-19
SHANDONG DYNE MARINE BIOTECHCAL PHARM HLDG CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although this preparation method improves the dissolution rate of glimepiride tablets, it uses a second-class solvent (chloroform), which increases potential safety risks; Chinese patent 201510056193.7 discloses a glimepiride tablet, which is a combination of glimepiride, Hydroxypropyl cellulose is dissolved in diethylene glycol monoethyl ether, added with fumed silica for adsorption, then mixed evenly with pharmaceutically acceptable excipients, and compressed by direct

Method used

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  • Glimepiride tablet composition preparation and preparation method thereof
  • Glimepiride tablet composition preparation and preparation method thereof
  • Glimepiride tablet composition preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Prescription composition:

[0050]

[0051] Preparation Process:

[0052] After the glimepiride raw material is pulverized by a universal method, the particle size distribution is required to be D 90 20 μm ~ 40 μm, weigh the glimepiride raw material and various excipients according to the above prescription.

[0053] Glimepiride and 6 kg of lactose were gradually mixed in an HLSG20B wet mixing granulator at a stirring speed of 200 rpm and a chopping speed of 1500 rpm by an equal-volume incremental method to obtain mixture A.

[0054] Add the mixture A and the remaining lactose, microcrystalline cellulose, crospovidone, and copovidone into the HLSG110C wet granulator at a stirring speed of 200 rpm and a chopping speed of 1500 rpm, and mix for 60 seconds to obtain mixture B.

[0055] Mixture B and magnesium stearate were added together into a lifting column mixer, and mixed at a speed of 8 rpm for 15 minutes to obtain mixture C.

[0056] The mixture C was compressed i...

Embodiment 2

[0059] Prescription composition:

[0060]

[0061]

[0062] Preparation Process:

[0063] After the glimepiride raw material is pulverized by a universal method, the particle size distribution is required to be D 90 20 μm ~ 40 μm, weigh the glimepiride raw material and various excipients according to the above prescription.

[0064] Glimepiride and 6 kg of lactose were gradually mixed in an HLSG20B wet mixing granulator at a stirring speed of 300 rpm and a chopping speed of 1800 rpm by an equal-volume incremental method to obtain mixture A.

[0065] Add the mixture A and the remaining lactose, microcrystalline cellulose, crospovidone, and copovidone into the HLSG110C wet granulator at a stirring speed of 300 rpm and a chopping speed of 1800 rpm, and mix for 90 seconds to obtain mixture B.

[0066] Mixture B and magnesium stearate were added together into a lifting column mixer, and mixed at a speed of 12 rpm for 10 minutes to obtain mixture C.

[0067] The mixture C w...

Embodiment 3

[0070] Prescription composition:

[0071]

[0072] Preparation Process:

[0073] After the glimepiride raw material is pulverized by a universal method, the particle size distribution is required to be D 90 20 μm ~ 40 μm, weigh the glimepiride raw material and various excipients according to the above prescription.

[0074] Glimepiride and 6 kg of lactose were gradually mixed in an HLSG20B wet mixing granulator at a stirring speed of 400 rpm and a chopping speed of 2100 rpm, using an equal-volume incremental method to obtain mixture A.

[0075] Add the mixture A and the remaining lactose, microcrystalline cellulose, crospovidone, and copovidone into the HLSG110C wet granulator at a stirring speed of 400 rpm, a chopping speed of 2100 rpm, and mix for 120 seconds to obtain mixture B.

[0076] Mixture B and magnesium stearate were added together into a lifting column mixer, and mixed at a speed of 15 rpm for 8 minutes to obtain mixture C.

[0077] The mixture C was compress...

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Abstract

The invention provides a glimepiride tablet composition preparation and a preparation method thereof. The glimepiride tablet is prepared from glimepiride, lactose, microcrystalline cellulose, copovidone, crospovidone and magnesium stearate. According to the glimepiride composition preparation, the dissolving and releasing behaviors of glimepiride tables can be effectively ensured in vitro by sufficiently utilizing the hydrogen bond effect among the crospovidone, povidone and glimepiride, the defects of low yield, large energy consumption, high cost and the like caused by micronizing glimepiride in the prior art can be overcome. The preparation process is simple, has good reproducibility and good stability, is suitable for industrial production, and has relatively high economic and social magnificence.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a glimepiride tablet composition preparation and a preparation method thereof. Background technique [0002] Glimepiride is a sulfonylurea drug that can be used together with insulin. It lowers blood sugar by stimulating insulin secretion. The structural formula is as follows: [0003] [0004] Developed by the Sanofi-Aventis company of the United States, it was first launched in Sweden in September 1995. It was approved by the FDA to enter the US market in November of the same year. It is used to treat type Ⅱ diabetes that cannot be controlled by diet and exercise. In view of its stable and effective hypoglycemic effect, and less adverse reactions, clinical application is becoming more and more extensive. However, glimepiride is a BCS Ⅱ drug, that is, a low-solubility and high-osmosis drug, and ensuring its solubility is the key to ensuring that the drug reaches an effective ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/32A61K47/38A61K31/64A61P3/10
CPCA61K9/2027A61K9/2054A61K9/2095A61K31/64A61P3/10
Inventor 陶元景马莉景亚军
Owner SHANDONG DYNE MARINE BIOTECHCAL PHARM HLDG CO LTD
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