Chitosamine hydrochloride pellet preparation and preparation method thereof

A technology of glucosamine hydrochloride and glucosamine, which is applied in the field of glucosamine hydrochloride pellet preparation and its preparation, can solve the problems of limited application, insufficient bioavailability, etc., and achieves high bioavailability, good reproducibility of absorption kinetics, Excellent performance

Inactive Publication Date: 2015-04-29
HANGZHOU SHARPLY PHARM R&D INSTIT +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the first-pass effect, the bioavailability of this product after oral administration is less than 30%.
This limits its application to some extent

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Embodiment 1: Preparation of glucosamine hydrochloride pellets is as follows.

[0031] Preparation of glucosamine hydrochloride pills:

[0032] Glucosamine hydrochloride (particle size 50μm) 240g

[0033] Micronized silica gel 2.4g

[0034] Microcrystalline cellulose core (0.45~0.6mm) 60g

[0035] Povidone K30 (PVP K30) 12g

[0036] 95% ethanol 252.3g

[0037] Purified water 135.8g

[0038] Made 314.4g

[0039] making process

[0040] 1. Pretreatment: crush glucosamine hydrochloride to a suitable particle size, and then mix it with micronized silica gel;

[0041] 2. Prepare adhesive: weigh PVP K30, dissolve in purified water, add 95% ethanol, and stir evenly;

[0042] 3. Put the microcrystalline cellulose pellet core in a centrifugal granulator, adjust the parameters, and apply the drug with the above-mentioned binder. The specific parameters are as follows:

[0043] Host: 200rpm;

[0044] Shotcrete: 20rpm;

[0045] Powder supply: 20rpm;

[0046] Air volume...

Embodiment 2

[0071] Embodiment 2: Preparation of glucosamine hydrochloride pellets is as follows.

[0072] Preparation of glucosamine hydrochloride pills:

[0073] Glucosamine Hydrochloride 240g

[0074] Talc powder 1.2g

[0075] Simethicone 1.2g

[0076] Starch core (0.45~0.6mm) 60g

[0077] HPMC (3CP) 12g

[0078] 95% ethanol 204g

[0079] Purified water 109.6g

[0080] Made 314.4g

[0081] making process

[0082] 1. Prepare the drug solution: weigh HPMC (3CP), dissolve in purified water, add glucosamine hydrochloride, stir to dissolve; add 95% ethanol, stir; add talcum powder and simethicone, stir evenly;

[0083] 2. Put the starch pellet core in the fluidized bed, adjust the parameters, and use the above adhesive to apply the drug. The specific parameters are as follows:

[0084] Fan: 20rpm;

[0085] Liquid supply: 10rpm;

[0086] Inlet air temperature: 40°C;

[0087] Material temperature: 30°C;

[0088] Air outlet temperature: 35°C;

[0089] Atomization pressure: 0.1mPa...

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Abstract

The invention relates to a chitosamine hydrochloride pellet preparation and its preparation method. By using glucosamine extracted from marine organism as an active ingredient, the chitosamine hydrochloride pellet preparation comprises glucosamine pellets and a coating layer. The glucosamine pellets contain the following materials, by weight, 70-90% of chitosamine hydrochloride with the particle size being 30-100 microns, 10-20% of blank drug core pellets with the particle size being 0.2-1 mm, 2-10% of a binder and 0.1-1% of a flow aid. According to the chitosamine hydrochloride pellet preparation, as the whole drug release body is composed of multiple drug release units, abnormal drug release behaviors of an individual unit will not influence the whole situation. Thus, an ideal overall drug release rate can be obtained, and an expected blood concentration can be achieved. Therefore, an ideal curative effect is achieved, and the irritant effect on the gastrointestinal tract can be reduced.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, in particular to a glucosamine hydrochloride pellet preparation for treating osteoarthritis prepared by using glucosamine extracted from shrimp and crab shells in the sea and a preparation method thereof. Background technique [0002] Glucosamine hydrochloride is a marine biological preparation, white crystal, slightly sweet, soluble in water, and is the main component of chondroitin sulfate. It can promote the synthesis of mucopolysaccharides in the human body, increase the viscosity of joint synovial fluid, improve the metabolism of articular cartilage, and benefit the repair of articular cartilage. Has obvious anti-inflammatory and analgesic effects. This product improves the metabolic function and nutrition of bone and cartilage tissue by stimulating the biochemical synthesis of mucopolysaccharides and increasing the intake of bone calcium. It can also improve and enhance the viscosity of syn...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/7008A61P19/08A61P19/02
Inventor 范敏华孙军刘华
Owner HANGZHOU SHARPLY PHARM R&D INSTIT
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