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Sustained releasing formulation of compound glucosamine, preparation process and application thereof

A technology of glucosamine salts and sustained-release preparations, applied in anti-inflammatory agents, pharmaceutical formulations, non-central analgesics, etc. The effect of eliminating toxic side effects

Inactive Publication Date: 2007-05-16
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 of the People's Republic of China "Biochemical Drugs First Volume" included glucosamine enteric-coated tablets, which are compound constant-release preparations of glucosamine hydrochloride and indomethacin. Clinical trials It has been 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. The active ingredient of Xinchang-coated Tablets is an ordinary long-release preparation, and the release rate of indomethacin in it is too fast, resulting in serious adverse reactions in the gastrointestinal tract and nervous system caused by indomethacin, and some patients cannot continue to adhere to it. take

Method used

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  • Sustained releasing formulation of compound glucosamine, preparation process and application thereof
  • Sustained releasing formulation of compound glucosamine, preparation process and application thereof
  • Sustained releasing formulation of compound glucosamine, preparation process and application thereof

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Effect test

Embodiment 1

[0045] The preparation of embodiment 1 matrix type sustained-release tablet

[0046] formula:

[0047] Glucosamine Hydrochloride 150.0g

[0048] Indomethacin 50.0g

[0049] Ethylcellulose (100 centipoise) 5.0g

[0050] Hydroxypropyl methylcellulose (4000 centipoise) 5.0g

[0051] Microcrystalline Cellulose 8.0g

[0052] Polyvinylpyrrolidone K30 ethanol solution 3.0g

[0053](K30 is the molecular weight index of the polymer obtained by measuring the viscosity of the polymer)

[0054] Magnesium Stearate 1.0g

[0055] Makes 1000 pieces

[0056] Hydroxypropyl methylcellulose is a hydrophilic skeleton material polymer, and ethyl cellulose is a non-erodible skeleton material. The two are used in combination to control the release of indomethacin and glucosamine hydrochloride in the preparation.

[0057] Preparation:

[0058] 1. Both glucosamine salt and indomethacin are made into sustained-release preparations: the amount of indomethacin, glucosamine hydrochloride, ethyl c...

Embodiment 2

[0062] The preparation of embodiment 2 matrix type sustained-release tablets

[0063] formula:

[0064] Indomethacin 25.0g

[0065] Glucosamine Hydrochloride 75.0g

[0066] Cornstarch 15.0g

[0067] Cellulose acetate phthalate 45.0g

[0068] Microcrystalline Cellulose 15.0g

[0069] 1% aqueous solution of hydroxypropyl methylcellulose 0.5g (calculated as dry matter)

[0070] Magnesium Stearate 1.0g

[0071] Makes 1000 pieces

[0072] 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.

[0073] Preparation:

[0074] 1. Both glucosamine salt and indomethacin are made into sustained-release preparations: the amount of glucosamine hydrochloride and indomethacin, cornstarch, cellulose acetate phthalate required for the above formula of this embodiment , microcrysta...

Embodiment 3

[0077] The preparation of embodiment 3 film-controlled sustained-release capsules

[0078] formula:

[0079] Glucosamine Hydrochloride 150.0g

[0080] Indomethacin 50.0g

[0081] 1.0% hydroxypropyl methylcellulose (4000 centipoise) aqueous solution 2.0g (calculated as dry matter)

[0082] Pregelatinized starch 30.0g

[0083] Trimethylammonium ethyl methacrylate-methacrylate copolymer 21.0g

[0084] (Eudragit RS100)

[0085] Polyvinylpyrrolidone K30 ethanol solution 4.0g

[0086] (K30 is the molecular weight index of the polymer obtained by measuring the viscosity of the polymer)

[0087] Makes 1000 capsules

[0088] 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.

[0089] Preparation:

[0090] 1. Both glucosamine salt and indometh...

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Abstract

The invention relates to a composite slow-release agent, wherein it contains indomethacin, aminoglucose salt, slow-release material and other findings, while their ratios are 5-45%, 20-80%, 1-75%, and the left is findings. Its preparation comprises that mixing indomethacin and / or aminoglucose salt, and slow-release material and / or packs, then adding other findings, using general slow-release technique to obtain one or several skeleton or mould-contoro slow-release agent. The invention can be made into particle, oral, tablet or capsule. The invention can keep stable blood drug density in 8-36h, reduce side effect.

Description

technical field [0001] The invention relates to a compound sustained-release preparation and a preparation method thereof, in particular to a compound sustained-release preparation composed of indomethacin and glucosamine salt, a preparation method and an application thereof. Background technique [0002] Glucosamine salt is a natural amino monosaccharide, which can also be obtained by acid hydrolysis of chitin. It stimulates chondrocytes to produce proteoglycan and collagen with normal multimer structure, which is an essential substance for the synthesis of proteoglycan and the basic substance for the synthesis of aminoglycan, and has certain physiological activity as a component of articular cartilage; and can be specific Actively 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 matrix. In addition, ...

Claims

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Application Information

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