Glipizide enteric sustained-release preparation composition and method for preparing the same

A technology of enteric and sustained-release preparations of glipizide, which is applied in the field of medicine, can solve problems such as poor patient compliance and gastric mucosal irritation, and achieve reduced nausea, delayed release speed, controllable quality of the preparation process, and good stability Effect

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 disadvantages of glipizide common gastric-soluble preparations: (1) it needs to be taken several times a day, resulting in poor patient compliance; (2) it is released and dissolved in the stomach, causing irritation to the gastric mucosa, thereby causing nausea, abdominal pain, and diarrhea and other adverse reactions, etc., the present invention provides glipizide enteric-coated sustained-release preparation composition

Method used

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  • Glipizide enteric sustained-release preparation composition and method for preparing the same
  • Glipizide enteric sustained-release preparation composition and method for preparing the same
  • Glipizide enteric sustained-release preparation composition and method for preparing the same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Enteric-coated sustained-release tablets

[0031] prescription:

[0032]

[0033] Preparation Process:

[0034] Pass glipizide, hydroxypropyl methylcellulose, starch, lactose, and magnesium stearate through 80-mesh sieve respectively for later use, weigh hydroxypropyl methylcellulose, starch, and lactose according to the prescription and put them in a mixer After mixing, mix with glipizide in equal increments, add an appropriate amount of 70% ethanol, granulate, dry at 45°C for 30 minutes, add the prescribed amount of magnesium stearate to the dry granules, mix them evenly, and pass through a swinging granulator for 16 Mesh sieve granules, carry out content determination on the granules, and determine the tablet weight range, tableting to obtain sustained-release tablets, use 85% ethanol to prepare coating powder containing enteric-coated material cellulose acetate phthalate to prepare enteric-coating solution , and then wrap the enteric coating on the obtained sus...

Embodiment 2

[0037] Enteric-coated sustained-release tablets

[0038] Prescription: plain tablet

[0039]

[0040] Prescription: Sustained-release coating solution

[0041] 25 parts of hydroxypropyl methylcellulose

[0042] 10 parts ethyl cellulose

[0043] Propylene glycol 5 parts

[0044] Tween 80 1.5 parts

[0045] Titanium dioxide 6 parts

[0046] 4 parts talcum powder

[0047] 2% ethyl cellulose ethanol solution appropriate amount

[0048] Preparation Process:

[0049] Pass glipizide, polyvinylpyrrolidone, starch, microcrystalline cellulose, and magnesium stearate through an 80-mesh sieve respectively, weigh polyvinylpyrrolidone, starch, and microcrystalline cellulose according to the prescription amount, and put them in a mixer to mix them evenly Then mix with glipizide in equal increments, add an appropriate amount of 80% ethanol, granulate, dry at 45°C for 30 minutes, add prescription amount of magnesium stearate to the dry granules, and pass through a 16-mesh sieve with...

Embodiment 3

[0052] Enteric-coated sustained-release capsules

[0053] prescription:

[0054]

[0055] Preparation Process:

[0056] Pass glipizide, hydroxypropyl methylcellulose, ethyl cellulose, microcrystalline cellulose, xylose, and magnesium stearate through 80 mesh sieves respectively, and weigh hydroxypropyl methylcellulose, Ethyl cellulose, microcrystalline cellulose, xylose, and magnesium stearate are mixed in a mixer and then mixed with glipizide in equal increments, and 4% polyvinylpyrrolidone ethanol solution is used to make soft materials. Granulate in a granulator. The granules prepared above were dried at 60° C. for 1.5 h. Then pass through a swinging granulator, and use a 20-mesh sieve to sieve the granules. The content of the mixed granules is determined, and the capacity range of the enteric-coated capsule shell is determined to be filled, and then packed after passing the inspection.

[0057] The glipizide enteric-coated sustained-release capsules prepared by the...

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PUM

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Abstract

The invention discloses a glipizide enteric sustained-release preparation combination and a preparation method thereof. The glipizide enteric sustained-release preparation combination is mainly prepared from glipizide bulk drugs, sustained-release materials, enteric materials and other appropriate auxiliary materials. The glipizide enteric sustained-release preparation provided by the invention can not only prevent glipizide from disintegrating in the stomach and causing irritation to gastric mucosa and avoid the adverse reactions caused by the administration, such as nausea, abdominal pain, diarrhea and the like, but also deaccelerate the release rate of drugs, reduce the frequency of administration and improve the patient compliance. The invention provides a novel form of drug featuring higher safety and better patient compliance and having 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 a group of glipizide enteric-coated sustained-release preparation compositions 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 inconvenien...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4965A61K9/00A61P3/10
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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