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Glipizide enteric-coated formulation composition and method for preparing the same

A technology of glipizide enteric and glipizide, which is applied in the field of medicine, can solve problems such as no reports of glipizide enteric-coated capsules and enteric-coated granules, and achieve controllability and good stability of the preparation process quality , to avoid the nauseating effect

Active 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

[0009] According to the search results of related patents and prior art literature, there have been reports on glipizide enteric-coated tablets (name of invention: glipizide enteric-coated tablets and its preparation method, application number 200510200033.1), but no Glipizide enteric-coated tablets have been reported. Report on pyrazine enteric-coated capsules and enteric-coated granules

Method used

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  • Glipizide enteric-coated formulation composition and method for preparing the same
  • Glipizide enteric-coated formulation composition and method for preparing the same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Enteric-coated capsules

[0025] prescription:

[0026]

[0027] Preparation Process:

[0028] Pass glipizide, starch and dextrin through 80-mesh sieve respectively, weigh starch and dextrin according to the prescription amount, put them in a mixer and mix them with glipizide in equal increments, add 50% ethanol solution Appropriate amount of soft material is prepared, granulated in a granulator, and the granules are dried at 45°C for 30 minutes, then passed through a swing granulator, and sized with a 20-mesh sieve. The content of the mixed granules is determined, and the filling capacity of the enteric-coated capsule shell is determined. After passing the inspection, pack.

[0029] The glipizide enteric-coated capsules prepared by the above-mentioned method meet the requirements of the relevant testing items stipulated in the "General Rules of Preparations" of the "Chinese Pharmacopoeia 2005 Edition Part II".

Embodiment 2

[0031] Enteric-coated pellets and capsules

[0032] Prescription: Su Micropills

[0033] Glipizide 1.00g

[0034] Xylose 15.00g

[0035] Microcrystalline Cellulose 25.00g

[0036] Magnesium stearate 0.50g

[0037] 50% ethanol solution appropriate amount

[0038] Makes 1000 capsules

[0039] Prescription: enteric coating solution

[0040] 4 parts talcum powder

[0041] Titanium dioxide 6 parts

[0042] Polyacrylic resin II 20 parts

[0043] Polyacrylic resin III 10 parts

[0044] Tween 80 1.5 parts

[0045] 3 parts propylene glycol

[0046] 50% ethanol solution appropriate amount

[0047] Preparation Process:

[0048] Pass the glipizide, xylose, microcrystalline cellulose, and magnesium stearate through a 120-mesh sieve respectively, weigh the xylose, microcrystalline cellulose, and magnesium stearate according to the prescription amount of the plain pellets, put them in a mixer and mix them Then mix it with glipizide in equal increments, place it in a centrifugal...

Embodiment 3

[0051] Enteric-coated granules

[0052] Prescription: vegetarian granules

[0053]

[0054] Prescription: enteric coating solution

[0055] 4 parts talcum powder

[0056] Titanium dioxide 6 parts

[0057] Hypromellose Phthalate 35 parts

[0058] Tween 80 1 serving

[0059] 3 parts propylene glycol

[0060] 50% ethanol solution appropriate amount

[0061] Preparation Process:

[0062] Glipizide, polyvinylpyrrolidone, lactose, microcrystalline cellulose, and magnesium stearate were passed through a 120-mesh sieve respectively, and polyvinylpyrrolidone, lactose, microcrystalline cellulose, and magnesium stearate were weighed according to the prescription amount of plain granules. After mixing in a mixer, mix with glipizide in equal increments, place in a centrifugal granulator, spray an appropriate amount of 50% ethanol solution to prepare the granules, and prepare the coating solution for the granules according to the prescription of the enteric coating solution. The gr...

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Abstract

The invention discloses a glipizide enteric preparation combination and a preparation method thereof. The glipizide enteric preparation combination is mainly prepared from glipizide bulk drugs and other appropriate auxiliary materials. Compared with the common glipizide preparation, the glipizide enteric preparation provided by the invention has the advantages that the glipizide enteric preparation is less irritant to the stomach, thereby reducing the adverse reactions. The glipizide enteric preparation combination is particularly suitable for patients with stomach-upset diseases. The invention provides a novel form of drug featuring higher safety and better curative effect than the existing relevant glipizide preparations 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 glipizide enteric-coated preparation composition 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 ...

Claims

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Application Information

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IPC IPC(8): A61K31/4545A61K9/00A61K9/48A61P37/08A61P11/02
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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