Medicine preparation and its production process

A preparation and vitamin technology, which is applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve problems such as delay in disintegration time

Inactive Publication Date: 2002-07-10
ROHTO PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

As a result, the disintegration time is delayed and the release of the active ingredient from the solid dosage form is inhibited

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] To the mixed powder of thiamine nitrate, glucosamine hydrochloride and crystalline cellulose which are uniformly mixed, hydroxypropyl cellulose dissolved in purified water is added, and the mixture is stirred and granulated. The dried and sieved powder granules were mixed with L-aspartic acid monopotassium salt and di-L-aspartic acid monomagnesium salt mixture, chondroitin sodium sulfate, croscarmellose sodium, light silicic anhydride and Magnesium stearate was mixed, and the mixture was stirred evenly. The mixture was molded with a rotary tablet machine to obtain round tablets (diameter 8.5 mm, weight 270 mg, hardness 5 kg (measured with a digital hardness tester)). The tablet formulation is as follows. Also the term "part" means "part by weight". The term "part" has the same meaning hereinafter.

[0056] Content (parts)

[0057] Thiamine nitrate 1.25

[0058] Mixture of monopotassium L-aspartate and monomagnesium di-...

Embodiment 2

[0068] Granules (dose or one bag = 1500 mg) were prepared according to the term "granule" in the General Chapter of Preparations of the Japanese Pharmacopoeia with the following formulation.

[0069] Content (parts)

[0070] Thiamine hydrochloride 0.6

[0071] Sodium Chondroitin Sulfate 17.8

[0072]Glucosamine Hydrochloride 22.2

[0073] Riboflavin tetrabutyrate 0.3

[0074] Pyridoxine hydrochloride 0.3

[0075] Hydroxypropyl Cellulose 2.4

[0076] Crystalline cellulose 24.4

[0077] Mannitol 31.8

[0078] Menthol 0.2

[0079] Total 100

Embodiment 3

[0080] Embodiment 3 (preparation containing vitamin B1, vitamin B6 and vitamin B12)

[0081] Tablets (one tablet = 280 mg) were prepared according to the term "tablet" in the General Chapter of Preparations of the Japanese Pharmacopoeia with the following formulation.

[0082] Content (parts)

[0083] Thiamine furan hydrochloride 4.0

[0084] Sodium Chondroitin Sulfate 23.8

[0085] Glucosamine Hydrochloride 35.7

[0086] Pyridoxine Hydrochloride 4.0

[0087] Hydroxocobalamin 0.06

[0088] Hydroxypropyl cellulose 0.7

[0089] Crystalline cellulose 31.24

[0090] Magnesium stearate 0.5

[0091] Total 100

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Abstract

Incorporation of an aminosugar (e.g., glucosamine) to a preparation make a vitamin B1 stable. The content of the aminosugar is an effective amount to stabilize the vitamin B1, and is, for example, not less than 0.1 part by weight relative to 1 part by weight of the vitamin B1. Incorporation of the aminosugar can improve the disintegrativity of a solid preparation comprising a glycosaminoglycan (a hyaluronic acid, a chondroitin or a salt thereof). The content of aminosugars is not less than 0.1 part by weight relative to 1 part by weight of glycosaminoglycans. The solid preparation can inhibit forming gel masses of glycosaminoglycan and can improve the disintegrativity. Moreover, a joint disorder such as arthralgia can be improved by combination of the vitamin B1 and the glucosamine (e.g., glucosamine or a salt thereof).

Description

field of invention [0001] The present invention relates to a preparation in which vitamin B1 is stabilized, especially a preparation (especially a solid preparation) improved in decomposability (decomposability) of vitamin B1 and in stabilization. The present invention also relates to a composition for preventing or treating arthropathy comprising vitamin B1 and aminosugars (especially glucosamine), and if necessary, glycosaminoglycans. Background of the invention [0002] Many pharmaceutical preparations containing vitamin B1 are commercially available. Specifically, vitamin B1 is used for Wernicke's encephalopathy, peripheral neuropathy (peripheral nervous system disorder), central nervous system disease (central nervous system disorder), neuralgia, myalgia, joint pain (low back pain, stiff shoulder, frozen shoulder), Numbness of hands and feet, treatment of visual fatigue, constipation, nutritional supplements, etc. Vitamin B1 is effective for ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/51A61K31/7008
CPCA61K31/51A61K31/7008A61P25/00A61K2300/00
Inventor 东清次三浦力饭田健太郎大中由纪子西森友春
Owner ROHTO PHARM CO LTD
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