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Glipizide sustained-release granular formulation and preparation method thereof

A technology of sustained-release granules and glipizide, which is applied in the field of medicine, can solve problems such as poor patient compliance, achieve the effects of delayed release speed, controllable process quality and good stability, and reduce the number of times of taking

Inactive Publication Date: 2009-08-12
山东淄博新达制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] In order to overcome the shortcomings of glipizide taking medicine multiple times a day, resulting in poor patient compliance, the invention provides glipizide sustained-release granules

Method used

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  • Glipizide sustained-release granular formulation and preparation method thereof
  • Glipizide sustained-release granular formulation and preparation method thereof
  • Glipizide sustained-release granular formulation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] prescription:

[0029]

[0030] Preparation Process:

[0031] Pass glipizide, hydroxypropyl methylcellulose, microcrystalline cellulose, starch, lactose, and magnesium stearate through an 80-mesh sieve for later use, and weigh hydroxypropyl methylcellulose, microcrystalline Cellulose, starch, lactose, magnesium stearate, mixed in a mixer, and then mixed with glipizide in equal increments, added an appropriate amount of 70% ethanol, granulated, granulated, dried at 45°C for 45 minutes, and used The swinging granulator passes through a 16-mesh sieve for granulation, and the content of the granules is determined. After passing the inspection, they are packaged.

[0032] The glipizide sustained-release granules prepared by the above method meet the requirements of the relevant testing items stipulated in the "General Rules for Preparations" of the "Chinese Pharmacopoeia 2005 Edition Part II".

Embodiment 2

[0034] Prescription: vegetarian granules

[0035]

[0036] Prescription: Sustained-release coating solution

[0037] 25 parts of hydroxypropyl methylcellulose

[0038] 10 parts ethyl cellulose

[0039] Propylene glycol 5 parts

[0040] Tween 80 1.5 parts

[0041] Titanium dioxide 6 parts

[0042] 4 parts talcum powder

[0043] 2% ethyl cellulose ethanol solution appropriate amount

[0044] Preparation Process:

[0045] Pass glipizide, polyvinylpyrrolidone, starch, xylose, and magnesium stearate through a 120-mesh sieve respectively, weigh the polyvinylpyrrolidone, starch, xylose, and magnesium stearate according to the prescription amount, and mix them in a mixer Then mix it with glipizide in equal increments, place it in a centrifugal granulator, spray an appropriate amount of 80% ethanol solution to make granules, and prepare a coating solution to coat the plain granules according to the prescription of the slow-release coating solution. , for content determinatio...

Embodiment 3

[0048] prescription:

[0049]

[0050]

[0051] Preparation Process:

[0052] Pass glipizide, hydroxypropyl methylcellulose, ethyl cellulose, microcrystalline cellulose, starch, xylose, and magnesium stearate through an 80-mesh sieve respectively, and weigh the hydroxypropyl methylcellulose according to the prescription amount Vegetables, ethyl cellulose, microcrystalline cellulose, starch, xylose, magnesium stearate, mixed in a mixer and then mixed with glipizide in equal increments, 4% polyvinylpyrrolidone ethanol solution in appropriate amount Soft materials, granulated in a granulator. The granules prepared above were dried at 60 °C for 1 h. Then pass through a swinging granulator, and use a 20-mesh sieve to sieve the granules. The content of the mixed particles is determined, and then packed after passing the inspection.

[0053] The glipizide sustained-release granules prepared by the above method meet the requirements of the relevant testing items stipulated i...

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Abstract

The invention discloses a glipizide sustained-release granule and a preparation method thereof. The glipizide sustained-release granule is mainly prepared from glipizide bulk drugs, sustained-release materials and other appropriate auxiliary materials. The glipizide sustained-release granule can deaccelerate the release rate of main drugs, reduce the frequency of administration and improve the patient compliance. The glipizide sustained-release granule provided by the invention has the advantages of high quality controllability and stability of the preparation process.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to glipizide sustained-release granules and a preparation method thereof. Background technique [0002] With the improvement of people's living standards, the prevalence of diabetes is increasing rapidly. According to the statistics of the World Health Organization, there were about 30 million diabetics in the world in 1985, which increased to 135 million in 1997 and 143 million in 1999. It is estimated to reach 240 million in 2010; 90% of them have type 2 diabetes. The current treatments for type 2 diabetes mainly include insulin therapy, biguanide drug therapy, sulfonylurea drug therapy, thiazolidinediones, drugs that reduce carbohydrate absorption, and aldose reductase inhibitors. Insulin is generally not used as the first-line drug for the treatment of diabetes due to the difficulty in controlling the dose of the drug and the inconvenience of use; aldose reductase inhibitors are...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4965A61K9/20A61P3/10
Inventor 贺同庆贾法强安英张慧英张玲玲
Owner 山东淄博新达制药有限公司
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