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

A technology for metformin hydrochloride and sustained-release preparations, which is applied in the directions of non-active ingredient medical preparations, pill delivery, pharmaceutical formulations, etc., can solve problems such as literature and patent reports related to compound metformin hydrochloride and rosiglitazone sustained-release preparations that have not been seen.

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] Through the search, there are no relevant literature and patent reports on the compound metformin hydrochloride rosiglitazone sustained-release preparation

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Example 1 Metformin Hydrochloride Rosiglitazone Double Layer Sustained Release Tablets

[0018] prescription:

[0019] Metformin Hydrochloride

HPMC-15M

HPMC-4M

microcrystalline cellulose

500g

135g

35g

100g

Rosiglitazone

lactose

80% ethanol solution

Talc powder

Co-made

4g

20g

Appropriate amount

Appropriate amount

1000 pieces

[0020] Preparation:

[0021] Pass metformin hydrochloride through a 100-mesh sieve, HPMC-15M, HPMC-4M, and 80 g of microcrystalline cellulose pass through a 60-mesh sieve, mix the raw and auxiliary materials evenly, use 80% ethanol solution to make a soft material, granulate with a 20-mesh sieve, and dry at 40 ° C. Sieve through a 18-mesh sieve, add talcum powder, mix evenly, and set aside; in addition, sieve and mix rosiglitazone, lactose, and microcrystalline cellulose (20g) three times, and sieve in the same way. The...

Embodiment 2

[0022] Example 2 Compound metformin hydrochloride rosiglitazone film-coated sustained-release tablet

[0023] prescription:

[0024] Metformin Hydrochloride

500g

Rosiglitazone

8g

microcrystalline cellulose

Talc powder

purified water

Aqueous dispersion of ethyl cellulose

Co-made

250g

4g

Appropriate amount

Appropriate amount

1000 pieces

[0025] Preparation:

[0026] Pass metformin hydrochloride and rosiglitazone through a 100-mesh sieve, and set aside; take metformin hydrochloride, mix evenly with microcrystalline cellulose, use purified water to make a soft material, granulate with a 20-mesh sieve, dry, and granulate with a 18-mesh sieve; add talc powder, mix evenly, and press into tablets. In addition, rosiglitazone is dissolved in the EC water dispersion solution, stirred evenly, and set aside; open the coating granulator, and put the tablet into it. Adjust the air i...

Embodiment 3

[0027] Example 3 Compound metformin hydrochloride rosiglitazone sustained-release pellets and capsules

[0028] prescription:

[0029] Metformin Hydrochloride

250g

Rosiglitazone

HPMC-K4M

HPMC-K10M

microcrystalline cellulose

2g

120g

30g

10g

[0030] 60% ethanol solution

purified water

Co-made

Appropriate amount

Appropriate amount

1000 capsules

[0031] Preparation:

[0032] Pass metformin hydrochloride, HPMC-K4M, and HPMC-K10 through a 60-mesh sieve, add 60% ethanol solution to make wet soft materials, extrude strips with a 12-20 mesh aperture about 3-5cm in length, and adjust the rotation speed of the bottom turntable to 600-1200rpm , spheronized for about 5 minutes; rosiglitazone passed through a 100-mesh sieve, mixed evenly with microcrystalline cellulose, prepared a soft material by using an appropriate amount of purified water as a binder, and pre...

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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 rosiglitazone and its preparation process. The preparation consists of slow released metformin hydrochloride and quickly released rosiglitazone. The extracorporeal leaching test shows that rosiglitazone is released in over 75 % in 30 min. 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. The slow released preparation containing metformin hydrochloride and rosiglitazone 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 invention relates to a compound preparation composed of two hypoglycemic drugs rosiglitazone and metformin hydrochloride, a compound sustained-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] Rosiglitazone has the effect of lowering blood sugar by increasing the sensitivity of tissues to insulin and improving the utilization of glucose by cells. It can significantly reduc...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4439A61K9/16A61K9/20A61K9/22A61K9/52A61K47/10A61K47/14A61K47/32A61K47/36A61K47/38A61K47/44A61P3/10A61K31/155
Inventor 李胜飞
Owner BEIJING RUNDEKANG MEDICAL TECH CO LTD
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