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Sustained release formulation of glucosamine salt and preparation

A technology of glucosamine salts and sustained-release preparations, which can be used in anti-inflammatory agents, pharmaceutical formulations, non-central analgesics, etc., and can solve problems such as serious adverse reactions

Active Publication Date: 2006-04-05
ZHEJIANG HAILISHENG PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In 1998, the sixth volume of the second volume of the Ministry of Standards issued by the Ministry of the People's Republic of China (the first volume of biochemical drugs) included glucosamine enteric-coated tablets, which are compound constant-release preparations of glucosamine hydrochloride and indomethacin. Experiments have proved that this product not only has obvious anti-inflammatory and analgesic effects, but also can promote the synthesis of mucopolysaccharides, improve the viscosity of joint synovial fluid, and is more conducive to the repair of articular cartilage. It is a drug that treats both symptoms and root causes. The active ingredient of Mexin Enteric-Coated Tablets adopts the normal release mode, which makes the indomethacin release too fast, resulting in very serious adverse reactions in the gastrointestinal tract and nervous system caused by indomethacin, so some patients cannot continue to take

Method used

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  • Sustained release formulation of glucosamine salt and preparation
  • Sustained release formulation of glucosamine salt and preparation
  • Sustained release formulation of glucosamine salt and preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] The preparation of embodiment 1 matrix type sustained-release tablet

[0036] Indomethacin

Glucosamine Hydrochloride

Hydroxypropyl methylcellulose (4000 centipoise)

3% hydroxypropyl methylcellulose (50 centipoise) in ethanol

microcrystalline cellulose

Magnesium stearate

25.0g

75.0g

51.7g

5.3g (calculated as dry matter)

17.5g

0.9g

production

1000 pieces

[0037] Hydroxypropyl methylcellulose is a polymer of hydrophilic skeleton material, which swells with water or digestive juice to form a gel barrier to control the release rate of indomethacin and glucosamine hydrochloride and achieve the purpose of sustained release.

[0038] Preparation:

[0039] 1. Both glucosamine and indomethacin are made into sustained-release preparations: the amount of glucosamine hydrochloride and indomethacin, hydroxypropyl methylcellulose, microcrystalline fiber Mix well, add 3% hydroxypropyl methylcellulose e...

Embodiment 2

[0042] The preparation of embodiment 2 matrix type sustained-release tablets

[0043] Glucosamine hydrochloride

Indomethacin

Ethylcellulose (50 centipoise)

stearic acid

2% ethylcellulose (50 centipoise) in absolute ethanol

Magnesium stearate

225.0g

75.0g

42.8g

123.0g

20.0g (calculated as dry matter)

64.0g

production

1000 pieces

[0044] Stearic acid is a bioerodible material, and ethyl cellulose is a non-erodible framework material. The two are used in combination to control the release of indomethacin and glucosamine hydrochloride in the preparation.

[0045] Preparation:

[0046] 1. Both glucosamine and indomethacin are made into sustained-release preparations: mix the indomethacin, glucosamine hydrochloride, ethyl cellulose and stearic acid in the amount of the above-mentioned formula of this embodiment, and then add Ethyl cellulose solution in absolute ethanol is mixed well, granulated thro...

Embodiment 3

[0049] The preparation of embodiment 3 film-controlled sustained-release capsules

[0050] Glucosamine Hydrochloride

Indomethacin

2% hydroxypropyl methylcellulose (50 centipoise) in water

Trimethylammonium ethyl acrylate-methacrylate copolymer

(Eudragit RS100)

microcrystalline cellulose

Polyvinylpyrrolidone K30 ethanol solution

(K30 is the molecular weight index of the polymer obtained by measuring the viscosity of the polymer)

150.0g

50.0g

6.3g (calculated as dry matter) methyl

50.0g

43.8g

12.5g

production

1000 capsules

[0051] Using Eudragit RS100 as the coating material, a small amount of polyvinylpyrrolidone ethanol solution (PVPk30) was added to the coating solution as a porogen. After the porogen dissolved in the digestive juice, micropores were formed on the coating. Slow and smooth release in the hole.

[0052] Preparation:

[0053] 1. Both glucosamine and indomethacin a...

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Abstract

The invention relates to a sustained release formulation of glucosamine salt, its preparation and usage, wherein the slow release preparation comprises (by weight percentage of dry substance) indomethacin 5-45%, glucosamine salt 5-45%, slow release material 1-75%, and balancing adjuvant. The preparation is prepared through conventional controlled release formulation technology, and is made into the forms of granule, pill, tablet, and capsule.

Description

technical field [0001] The invention relates to a compound sustained-release preparation and its preparation method and application, in particular to a compound sustained-release preparation composed of indomethacin and glucosamine salt, its preparation method, and its application in medical treatment. Background technique [0002] Glucosamine is a natural amino monosaccharide, which can also be obtained by acid hydrolysis of chitin. It has a certain physiological activity. It can stimulate chondrocytes to produce proteoglycan and collagen with normal multimer structure. It is an essential substance for the synthesis of proteoglycan and the basic substance for the synthesis of aminoglycan, and becomes a component of articular cartilage; It specifically acts on articular cartilage, restores the normal metabolic function of chondrocytes, stimulates chondrocytes to produce proteoglycans with normal polyplasmic structure, and maintains the morphological structure of cartilage ma...

Claims

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Application Information

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IPC IPC(8): A61K31/7008A61K9/16A61K9/22A61K9/52A61P19/02A61P29/00A61K31/405
Inventor 郑海辉夏志国
Owner ZHEJIANG HAILISHENG PHARM CO LTD
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