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Slow released preparation containing metformin hydrochloride and gliclazide and its preparing process

A technology of metformin hydrochloride and sustained-release preparations, which is applied in the fields of non-active ingredient medical preparations, pill delivery, pharmaceutical formulations, etc.

Inactive Publication Date: 2007-06-27
BEIJING RUNDEKANG MEDICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] At present, there have been patents for common preparations with metformin hydrochloride and gliclazide as active ingredients, but only common preparations
There are no relevant literature and patent reports on the compound metformin hydrochloride gliclazide sustained-release preparation

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Example 1 Metformin Hydrochloride Gliclazide Double Layer Sustained Release Tablets

[0017] prescription:

[0018] Metformin Hydrochloride

HPMC-15M

microcrystalline cellulose

500g

150g

30g

Grecht

5g

HPMC-100M

EC

Calcium hydrogen phosphate

80% ethanol solution

Talc powder

Co-made

30g

1.5g

105g

Appropriate amount

Appropriate amount

1000 pieces

[0019] Preparation:

[0020] Pass metformin hydrochloride through a 100-mesh sieve, HPMC-15M and microcrystalline cellulose through a 60-mesh sieve, mix the raw and auxiliary materials evenly, make a soft material with 80% ethanol solution, granulate with a 16-mesh sieve, dry at 40°C, and granulate with a 16-mesh sieve , add talcum powder and mix evenly, and set aside; in addition, gliclazide, HPMC-4M, lactose, and microcrystalline cellulose are sieved and mixed three times, and the soft...

Embodiment 2

[0021] Example 2 Compound metformin hydrochloride gliclazide film-coated sustained-release tablet

[0022] prescription:

[0023] Metformin Hydrochloride

250g

Grecht

15g

HPMC-K100M

5g

microcrystalline cellulose

Talc powder

2% PVP-k30 ethanol solution

Aqueous dispersion of ethyl cellulose

Co-made

350g

4g

Appropriate amount

Appropriate amount

1000 pieces

[0024] Preparation:

[0025] Pass metformin hydrochloride and gliclazide through a 100-mesh sieve, and set aside; get metformin hydrochloride, mix it with an equivalent amount (250g) of microcrystalline cellulose, make a soft material with 2% PVP-k30 ethanol solution, and granulate with a 20-mesh sieve. Dry and sieve into 18-mesh sieve; take another gliclazide, mix it with the remaining microcrystalline cellulose and HPMC-K100, and prepare granules in the same way; take the two kinds of granules, m...

Embodiment 3

[0026] Example 3 Compound metformin hydrochloride gliclazide sustained-release pellets and capsules

[0027] prescription:

[0028] Metformin Hydrochloride

250g

Grecht

HPMC-K100

Glyceryl behenate

15g

80g

15g

[0029] microcrystalline cellulose

70% alcohol solution

Co-made

45g

Appropriate amount

1000 capsules

[0030] Preparation:

[0031] Pass metformin hydrochloride and gliclazide through a 100-mesh sieve, HPMC-K100, microcrystalline cellulose, and glyceryl behenic acid through a 60-mesh sieve, mix the raw and auxiliary materials evenly, add 70% alcohol solution to make a wet soft material, 12- Extrude strips with a 20-mesh aperture of about 3-5cm in length, adjust the rotation speed of the bottom turntable to 600-1200rpm, roll into a ball for about 5 minutes, dry, and fill the pellets in the No. 2 ordinary capsule shell to obtain the above-mentioned sustained rele...

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PUM

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Abstract

The present invention relates to a kind of slow released preparation containing metformin hydrochloride and glicazide and its preparation process. The preparation consists of slow released metformin hydrochloride and slow released glicazide. The metformin hydrochloride is released in 15-40 % in the first 1 hr, 50-70 % in the first 4 hr, and over 75 % in the first 8 hr; and the glicazide is released in 20-40 % in the first 2 hr, 40-65 % in the first 4 hr and over 75 % in the first 10 hr. The slow released preparation containing metformin hydrochloride and glicazide has mild and lasting blood sugar reduction, capacity of avoiding hypoglycemia, gastrointestinal discomfort and other untoward reaction, decreased medicine taking times and raised compliance. The present invention also discloses the extracorporeal slow releasing characteristic and preparation process of the slow released preparation.

Description

technical field [0001] The present invention relates to a compound preparation composed of two hypoglycemic drugs gliclazide and metformin hydrochloride, a compound slow-release preparation for treating type II diabetes that cannot effectively control blood sugar by diet control and exercise and a preparation method thereof . Background technique [0002] This compound is composed of two hypoglycemic drugs, but their mechanism of action is different. The two complement each other. [0003] Metformin hydrochloride does not promote insulin secretion. Its hypoglycemic effect is mainly to promote the uptake of glucose by adipose tissue, increase the anaerobic glycolysis of muscle tissue, increase the utilization of glucose, and reduce the absorption of glucose through the digestive tract. [0004] Gliclazide is a second-generation sulfonylurea oral hypoglycemic drug. Its mechanism is to selectively act on pancreatic β cells, promote endogenous insulin secretion, and increase i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/403A61K9/16A61K9/20A61K9/22A61K9/52A61K47/10A61K47/14A61K47/32A61K47/36A61K47/38A61K47/44A61P3/10A61K31/155
Inventor 李胜飞
Owner BEIJING RUNDEKANG MEDICAL TECH CO LTD
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