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Glimepiride dispersible tablet and preparation method thereof

A technology for glimepiride and dispersible tablets, applied in the field of medicine, can solve the problems of complicated operation, high investment, waste of raw materials, etc., and achieve the effects of simple preparation process, simplified operation process and reduced production cost

Active Publication Date: 2013-02-20
石药集团中诺药业(石家庄)有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, on the one hand, the micronization process has high requirements on equipment, and the producer needs a high investment. On the other hand, the micronization process also requires high levels of personnel operation. Static electricity is easily generated during the operation process, which poses a great safety hazard. Moreover, improper operation will easily lead to the phenomenon of rising impurities in raw materials due to frictional heat generation, resulting in a great waste of raw materials
In addition, in the preparation process of the glimepiride dispersible tablet in this patent application, the equal-volume incremental method is also used for material mixing, which is cumbersome to operate and not convenient for industrial production and application.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Example 1 Preparation of Glimepiride Dispersible Tablets

[0042] Each 1000 glimepiride dispersible tablets (specification: 1mg) contains the following components:

[0043] Glimepiride 1g lactose 83g Crospovidone 2.5g povidone 0.45g microcrystalline cellulose 9.55g Croscarmellose Sodium 3g Magnesium stearate 0.5g gross weight 100g

[0044] Preparation process: Glimepiride raw materials are crushed and passed through a 80-mesh sieve, lactose is passed through a 150-mesh sieve, the remaining auxiliary materials are passed through a 60-mesh sieve, and the binder povidone is prepared into a 3% aqueous solution for later use. Premix the raw materials of glimepiride, lactose, and crospovidone in the prescribed amount in a wet mixing granulator, add an aqueous binder solution, and make a soft material. 20-mesh granulation, drying at 50°C, 20-mesh granulation. Adding excipients (microcrystalline cellulose, croscarmello...

Embodiment 2

[0045] Example 2 Preparation of Glimepiride Dispersible Tablets

[0046] Each 1000 glimepiride dispersible tablets (specification: 2mg) contains the following components:

[0047] Glimepiride 2g lactose 178g Croscarmellose Sodium 4g povidone 0.9g Low-substituted hydroxypropyl cellulose 5.1g microcrystalline cellulose 8.3g Magnesium stearate 1.7g gross weight 200g

[0048] Preparation process: Glimepiride raw materials are crushed and passed through a 100-mesh sieve, lactose is passed through a 200-mesh sieve, the remaining auxiliary materials are passed through a 60-mesh sieve, and the binder povidone is prepared into a 3% aqueous solution for later use. Premix the raw materials of glimepiride, lactose, and croscarmellose sodium in the prescribed amount in a wet mixing granulator, add an aqueous binder solution, and make a soft material. 20-mesh granulation, drying at 50°C, 20-mesh granulation. Add excipients (low-su...

Embodiment 3

[0049] Example 3 Preparation of Glimepiride Dispersible Tablets

[0050] Each 1000 glimepiride dispersible tablets (specification: 1mg) contains the following components:

[0051] Glimepiride 1g lactose 63g Low-substituted hydroxypropyl cellulose 3.25g starch 0.4g microcrystalline cellulose 3.1g Carboxymethyl Starch Sodium 3.5g stearic acid 0.75g gross weight 75g

[0052] Preparation process: Glimepiride raw materials are crushed and passed through a 80-mesh sieve, lactose is passed through a 150-mesh sieve, the remaining auxiliary materials are passed through a 60-mesh sieve, and the binder starch is prepared into a 6% aqueous solution for later use. Premix the raw materials of glimepiride, lactose, and low-substituted hydroxypropyl cellulose in the prescribed amount in a wet mixing granulator, add an aqueous binder solution, and make a soft material. 24-mesh granulation, drying at 50°C, 24-mesh granulation. Adding ...

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PUM

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Abstract

The invention discloses a glimepiride dispersible tablet. After filling agent lactose contained in the prescription is screened by a 150-mesh sieve, micronization treatment does not need to be carried out to the basic remedy, glimepiride, the dissolution rate at the time of 15 minutes can reach above 90 percent, all indexes meet the medical standard, and the stability is good. The invention also discloses a preparation method of the dispersible tablet, which has no special requirement on equipment, and is simple in operation and suitable for industrial production and application.

Description

technical field [0001] The invention belongs to the technical field of medicine and relates to a pharmaceutical preparation and a preparation method thereof, in particular to a dispersible tablet of glimepiride and a preparation method thereof. Background technique [0002] Diabetes is a metabolic disorder that causes carbohydrate metabolism disorders due to hypofunction of pancreatic islets. Patients not only suffer from the disease itself, but also often suffer from its complications. According to relevant statistics, there are more than 80 acute or chronic complications caused by diabetes in the heart, brain, liver, lung, kidney, eyes, limbs, skin, nerves, etc., which seriously affect the daily life of patients and cause great pain to patients physically and mentally. . [0003] Glimepiride is a new third-generation sulfonylurea hypoglycemic drug, suitable for type Ⅱ diabetic patients whose blood sugar cannot be controlled by simple diet control and exercise. The drug p...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/64A61K47/26A61P3/10
Inventor 王蓓朱亚芳杜淑朋张小幸
Owner 石药集团中诺药业(石家庄)有限公司
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