Preparation method of pharmaceutical composition for treating type II diabetes

A type 2 diabetes and composition technology, which is applied in the field of preparation of pharmaceutical compositions for the treatment of type 2 diabetes, can solve the problems of large fluctuations in blood drug concentration, large amount of excipients, multiple slow-release materials, etc., and achieve blood drug concentration Effects of small fluctuation, less frequency of administration, and improved compliance

Active Publication Date: 2013-04-17
SHANDONG XINHUA PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0016] 1. The drug release of metformin hydrochloride in the sustained-release preparation is not stable enough, and the blood drug concentration in the body still fluctuates greatly;
[0017] 2. Since metformin hydrochloride is very water-soluble, in order to control drug release, more sustained-release materials are needed, and the amount of excipients is large, resulting in large tablet volume and poor patient compliance;
[0018] 3. Although the side effects of sustained-release preparations are smaller than those of ordinary tablets, the incidence of hypoglycemia and gastrointestinal discomfort is still high;

Method used

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  • Preparation method of pharmaceutical composition for treating type II diabetes
  • Preparation method of pharmaceutical composition for treating type II diabetes

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0086] The present invention is prepared according to the following steps.

[0087] A: Preparation of metformin hydrochloride osmotic pump core

[0088] prescription:

[0089] (1) Plain tablets

[0090] Metformin Hydrochloride 500g

[0091] Sodium Lauryl Sulfate 12.6g

[0092] Povidone K30 11.4g

[0093] 40% ethanol (V / V) 185mL

[0094] Magnesium Stearate 6g

[0095] (2) Semi-permeable membrane layer

[0096] Dichloromethane 620g

[0097] Purified water 80g

[0098] Cellulose acetate 398-10 24g

[0099] Macrogol 400 2.5g

[0100] (1) Making granules Dissolve sodium lauryl sulfate and povidone K30 in 40% ethanol (V / V) as a wetting solution, put metformin hydrochloride in a wet granulator, and add a marketed wetting solution , the wet granules are passed through a 16-mesh sieve, placed in a fluidized bed, and the air inlet temperature is set to 65°C for drying until the water content is within 3%, granulated with a 16-mesh sieve, added with magnesium stearate, and mixed...

Embodiment 2

[0115] A: Preparation of Metformin Hydrochloride Tablets

[0116] prescription:

[0117] Metformin Hydrochloride 1000g

[0118] Polysorbate 80 17.4g

[0119] Povidone K90 18.6g

[0120] Purified water 400g

[0121] Sodium stearyl fumarate 10g

[0122] (1) Preparation of granules Dissolve polysorbate 80 and povidone K90 in purified water as a wetting solution, metformin hydrochloride is placed in a wet granulator, add a listed wetting solution, and the wet granules pass through a 16-mesh sieve. Place in a fluidized bed, set the air inlet temperature to 70°C for drying, until the water content is within 2.5%, granulate with 16 mesh, add sodium stearyl fumarate, and mix well.

[0123] (2) Tablet Take the above-mentioned granules, place them in a rotary tablet press, use an oval punched tablet with a diameter of 9×18mm, adjust the tablet weight and pressure, control the tablet weight at 1084mg, and control the hardness at 200-350N.

[0124] B: Coating of barrier layer 4

[...

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Abstract

The invention relates to a preparation method of a pharmaceutical composition for treating type II diabetes, belonging to the medical preparations containing organic ingredients, particularly relating to a preparation method of a pharmaceutical composition of metformin hydrochloride and glimepiride. In the preparation method, the metformin hydrochloride and the glimepiride are taken as active ingredients of the pharmaceutical composition, the metformin hydrochloride is firstly prepared into pill cores by adopting an osmotic pump technology and then the metformin hydrochloride pill cores are coated with the glimepiride by using a coating technology. The preparation method comprises the following steps: 1), preparing the metformin hydrochloride and pharmaceutically acceptable auxiliary materials into pills which are coated with semipermeable membrane layers, punching by laser and producing the pill cores; and 2), preparing the glimepiride and the pharmaceutically acceptable auxiliary materials into a coating liquid dissolved in stomach and carrying out coating on the pill cores in step 1. The invention provides the preparation method of the pharmaceutical composition for treating the type II diabetes, wherein the pharmaceutical composition steady and slowly releases drugs, has reduced administration times, good patients compliance, small side effect and small tablet volume, is less influenced by pH values of different segments of a gastrointestinal tract, and is convenient for administration for the patients.

Description

technical field [0001] The invention is a preparation method of a pharmaceutical composition for treating type 2 diabetes. It belongs to pharmaceutical preparations containing organic ingredients. In particular, it relates to a preparation method of the pharmaceutical composition of metformin hydrochloride and glimepiride. Background technique [0002] Metformin hydrochloride is a biguanide antidiabetic drug, which mainly acts on extrapancreatic islet tissues, inhibits intestinal absorption of glucose, increases the utilization of glucose by peripheral tissues, reduces hepatic glycogenogenesis, thereby achieving the effect of lowering blood sugar, and at the same time, it has the effect of reducing insulin resistance. effect. It is mainly used clinically for obese diabetic patients. [0003] Andrx Company of the United States developed metformin hydrochloride osmotic pump tablets using SCOT (single-composition osmotic technology) technology, and it was launched in the Uni...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/64A61K9/30A61K9/36A61P3/10A61J3/00A61K31/155
Inventor 汪洋潘西海孙艳华刘怀林
Owner SHANDONG XINHUA PHARMA CO LTD
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