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Metformin hydrochloride sustained-release tablet

A technology of metformin hydrochloride and sustained-release tablets, which can be used in medical preparations with non-active ingredients, metabolic diseases, organic active ingredients, etc., can solve problems such as high price, and achieve the effect of low raw material cost and good sustained-release performance.

Active Publication Date: 2014-05-28
YOUCARE PHARMA GROUP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The cellulose used can ensure stable quality and clear sustained-release effect, but the price is relatively expensive, so domestic pharmaceutical companies gradually adopt domestic high-viscosity hypromellose to reduce costs, optimize product quality, and increase profits

Method used

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  • Metformin hydrochloride sustained-release tablet
  • Metformin hydrochloride sustained-release tablet
  • Metformin hydrochloride sustained-release tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Raw material: Metformin hydrochloride (raw material, calculated as C4H in dry form) 11 N 5 HCl content 98.5-99.0%) 500g, sodium carboxymethylcellulose (viscosity 750-1400mpa s) 45g, hypromellose (Shandong Ruitai 75RT100000) with a viscosity of 100000mpa s at 20°C 160g, at 20°C 78g of hypromellose (Shandong Ruitai 75RT4000) with a viscosity of 4000mpa·s, 191g of ethyl acrylate-methyl methacrylate copolymer aqueous dispersion, and 8g of magnesium stearate.

[0035] Plant environment: temperature 18°C-26°C Humidity requirement: 45%-65%, dust-producing rooms (such as crushing, granulation) have a relative negative pressure of 5-8 Pa.

[0036] Among the raw materials, the ethyl acrylate-methyl methacrylate copolymer aqueous dispersion permeates the slow-release material, which is made of the following raw materials in the following weight ratio: ethyl acrylate: 105, methyl methacrylate: 55, purified water: 390, potassium persulfate 0.9, alkylphenol polyoxyethylene ether (O...

Embodiment 2

[0048] Raw material: Metformin hydrochloride (API, C4H calculated as dry product 11 N 5 ·HCl content 98.5-99.0%) 500g, sodium carboxymethyl cellulose (viscosity 750-1400mpa s) 47g, hypromellose with viscosity 100000mpa s at 20℃ (Shandong Ruitai 75RT100000) 154g, at 20℃ Hypromellose with a viscosity of 4000 mpa·s (Shandong Ruitai 75RT4000) 81 g, ethyl acrylate-methyl methacrylate copolymer aqueous dispersion 193 g, and magnesium stearate 8 g.

[0049] Others are the same as in Example 1.

[0050] The product is 0.5g white film-coated tablet, which appears white after removing the coating. This product + water shake to dissolve metformin, filter, add 10% sodium nitroferricyanide-potassium ferricyanide-10% sodium hydroxide solution to the filtrate, the solution turns red within 3 minutes. According to UV-visible spectrophotometry, it has the maximum absorption at 233nm wavelength.

Embodiment 3

[0052] Raw material: Metformin hydrochloride (API, C4H calculated as dry product 11 N 5 ·HCl content 98.5-99.0%) 500g, sodium carboxymethyl cellulose (viscosity 750-1400mpa s) 43g, 2% aqueous solution, hypromellose with viscosity 100000mpa s at 20°C (Shandong Ruitai 75RT100000) 120g , 80g of hypromellose (Shandong Ruitai 75RT4000) with a viscosity of 4000mpa·s at 20°C, 186g of ethyl acrylate-methyl methacrylate copolymer aqueous dispersion, and 8g of magnesium stearate.

[0053] Others are the same as in Example 1.

[0054] The product is 0.5g white film-coated tablet, which appears white after removing the coating. This product + water shake to dissolve metformin, filter, add 10% sodium nitroferricyanide-potassium ferricyanide-10% sodium hydroxide solution to the filtrate, the solution turns red within 3 minutes. According to UV-visible spectrophotometry, it has the maximum absorption at 233nm wavelength.

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Abstract

The invention provides a metformin hydrochloride sustained-release tablet. The metformin hydrochloride sustained-release tablet is prepared from the components by weight: 400-600 parts of metformin hydrochloride, 30-60 parts of sodium carboxymethylcellulose, 200-250 parts of hydroxypropyl methylcellulose, 180-220 parts of ethyl acrylate-methyl methacrylate copolymer aqueous dispersion and 5-10 parts of magnesium stearate. Suitable auxiliary materials and a suitable preparation method are adopted to prepare the metformin hydrochloride sustained-release tablet with lower raw material cost and simpler process, and the sustained-release performance of the obtained product is good, the release amounts at 1 hour, 3 hours and 10 hours are respectively 20-45 percent, 45-75 percent and above 80 percent, and the drug has good stability and can be preserved for 24 months at the room temperature.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a preparation method for sustained release medicaments. Background technique [0002] Metformin hydrochloride (molecular formula: C 4 H 11 N 5 HCl, molecular weight: 165.63) is a hypoglycemic drug that can promote the combination of insulin and receptors to improve the sensitivity of diabetic patients to insulin, increase the anaerobic glycolysis of surrounding tissues to promote sugar utilization, and inhibit fat decomposition , Reduce plasma free fatty acid levels, weaken insulin resistance and improve glucose utilization to play a role in lowering blood sugar, blood lipids, and inhibiting arteriosclerosis. At present, it has become the drug of choice for patients with mild to moderate type 2 diabetes, especially obese patients with type 2 diabetes. [0003] Metformin hydrochloride sustained-release matrix tablets commonly used sustained-release auxili...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/155A61K47/38A61K47/32A61P3/10
Inventor 李琦杨磊
Owner YOUCARE PHARMA GROUP
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