Preparation method of melbinum osmotic pump controlled release tablets

An osmotic pump controlled-release, metformin technology, applied in the directions of non-active ingredients medical preparations, active ingredients-containing medical preparations, pharmaceutical formulas, etc., can solve the problems of large intestinal irritation, inconvenience in taking, poor compliance, etc. Achieve the effect of less administration times, stable drug release, and improved compliance

Active Publication Date: 2011-07-27
SHANDONG XINHUA PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although this preparation can be continuously released for 24 hours, the problem in the tablets obtained by this method is that it is more irritating to the intestinal tract.
The problem that the tablet that this preparation method points out is that volume is too large, and the tablet that specification is 0.5g, its tablet weighs about about 1g
Therefore, the preparation has problems such as poor compliance and inconvenient taking.

Method used

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  • Preparation method of melbinum osmotic pump controlled release tablets
  • Preparation method of melbinum osmotic pump controlled release tablets
  • Preparation method of melbinum osmotic pump controlled release tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] A method for preparing metformin osmotic pump controlled-release tablets, wherein steps (1) to (5) are the preparation process of the tablet core:

[0053] Tablet prescription:

[0054]

[0055] (1) Granulation: mix Poloxamer 188 (German BASF Company, the same below), hypromellose K4M (U.S. Dow Company) and metformin hydrochloride (Shandong Keyuan Pharmaceutical Co., Ltd., the same below), and place In the wet granulator, add 40% ethanol (V / V) as a wetting solution, granulate, and pass the wet granules through a 16-mesh sieve;

[0056] (2) Drying of wet granules: place the prepared granules in a fluidized bed, set the inlet air temperature to 65°C for drying, until the moisture content is within 5%;

[0057] (3) whole grain: whole grain, through 16 mesh sieve;

[0058] (4) Total mixing: add magnesium stearate (Liaocheng Ahua Pharmaceutical Co., Ltd., the same below), and mix well;

[0059] (5) Tablet compression: Take the above-mentioned granules and place them in...

Embodiment 2

[0071] A method for preparing metformin osmotic pump controlled-release tablets, wherein steps (1) to (5) are the preparation process of the tablet core:

[0072] Tablet prescription:

[0073] Metformin Hydrochloride 1000g

[0074] Poloxamer 407 52g

[0075] water 400g

[0076] Magnesium Stearate 11g

[0077] (1) Granulation: poloxamer 407 (Germany BASF company, the same below) and metformin hydrochloride were placed in a wet granulator, mixed, added water, granulated, and the wet granules were passed through a 16-mesh sieve;

[0078] (2) Drying of wet granules: place the prepared granules in a fluidized bed, set the inlet air temperature to 70°C for drying, until the moisture content is within 5%;

[0079] (3) whole grain: whole grain, through 16 mesh sieve;

[0080] (4) Total blending: add magnesium stearate and mix well;

[0081] (5) Tablet compression: Take the above granules, place them in a rotary tablet press, use oval punched tablets with a diameter of 9×18 mm, a...

Embodiment 3

[0103] A kind of preparation method of metformin osmotic pump controlled-release tablet, preparation method is the same as embodiment 1, tablet core prescription is as follows:

[0104] Tablet prescription:

[0105] Metformin Hydrochloride 750g

[0106] Poloxamer 188 60g

[0107] 60% ethanol (V / V) 160mL

[0108] Magnesium Stearate 5g

[0109] The above can be made into each tablet containing 750mg of metformin hydrochloride.

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Abstract

The invention relates to a preparation method of melbinum osmotic pump controlled release tablets for treating type 2 diabetes. The preparation method comprises the steps of preparing tablet cores, coating semi-permeable membrane layers, perforating, drying and coating damp-proof layers, characterized in that when the tablet cores are prepared, a medicinal salt of melbinum and a nonionic surfactant are added, and the nonionic surfactant accounts for 2-20wt.% of the medicinal salt of melbinum. The medicament disclosed by the invention has stable release, no irritation on intestinal tracts and few times of administration, is acceptable by patients, and greatly improves the compliance of patients.

Description

technical field [0001] The invention relates to a preparation method of metformin osmotic pump controlled release tablet, which is used for treating type 2 diabetes. Background technique [0002] Metformin is a biguanide antidiabetic drug, which mainly acts on the extrapancreatic tissue, inhibits intestinal absorption of glucose, increases the utilization and intake of glucose in peripheral tissues, reduces hepatic glycogenogenesis, thereby achieving the effect of lowering blood sugar, and at the same time has the effect of lowering insulin The role of resistance. It is mainly used clinically for obese diabetic patients. [0003] Because metformin hydrochloride has low permeability in the intestinal tract, it is less absorbed in the body, and most of the absorption site is at the upper end of the gastrointestinal tract (the absorption window is at the end of the small intestine). The oral bioavailability of metformin hydrochloride is about 40% to 60%. As the dose increases...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/155A61K47/34A61K47/44A61P3/10A61K47/10
Inventor 汪洋潘西海孙艳华郑忠辉
Owner SHANDONG XINHUA PHARMA CO LTD
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