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Medicinal composition for treating ulcerative colitis and preparation method thereof

A technology for positioning drugs and colons, which can be used in drug combinations, pharmaceutical formulations, medical preparations with inactive ingredients, etc. It can solve the problems of complex raw materials and components, and achieve the effects of convenient use, prevention of recurrence, and improvement of diarrhea.

Inactive Publication Date: 2010-11-03
杨明
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] To sum up, in the existing preparations, the effective components of Radix Astragali and Sophora flavescens are all administered in the colon. Due to the complexity of raw materials, whether this form of administration can achieve the best drug effect is a question for those skilled in the art. is unpredictable

Method used

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  • Medicinal composition for treating ulcerative colitis and preparation method thereof
  • Medicinal composition for treating ulcerative colitis and preparation method thereof
  • Medicinal composition for treating ulcerative colitis and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Example 1 Preparation of the drug of the present invention

[0038] 1. Preparation of astragalus gastric drug release unit:

[0039] Take 2.5g of astragalus saponin extract, 7.5g of astragalus polysaccharide extract, 18g of microcrystalline cellulose, 3.5g of micropowder silica gel, 2g of sodium carboxymethyl starch, powder, powder, and mix well. A soft material is prepared with an appropriate amount of 50% ethanol as a wetting agent, extruded, and rounded to obtain pellets. Eudragit E100 alcohol-soluble coating is used, and the coating prescription is Eudragit E100 10g; talc 5g; PEG6000 1g; water 2g; ethanol 140g. Dissolve Eudragit E100 in about 70g ethanol; dissolve PEG6000 in water; add talc powder to the remaining ethanol and homogenize at high speed for 20 minutes; add PEG6000 solution and talc powder suspension to Eudragit E100 solution and stir evenly to obtain coating liquid. Adopt fluidized bed coating technology to coat the pellets to increase the weight by 5%. ...

Embodiment 2

[0050] Example 2 Preparation of the drug of the present invention

[0051] 1. Prescription of gastric drug release unit preparations

[0052] Astragalus Coated Pellets

[0053] Astragalus polysaccharide extract 398mg (contains polysaccharide 355mg) Astragalus saponin extract 136mg (contains saponins 100mg)

[0054] Microcrystalline cellulose 961mg Micropowder silica gel 187mg

[0055] Sodium Carboxymethyl Starch 107mg Coating 90mg

[0056]

[0057] 1879mg total

[0058] 2. Prescription of colon-specific drug release unit formulations

[0059] 2.1 pH-sensitive single-layer coated pellets

[0060] Matrine extract 51mg (matrine 50mg) oxymatrine extract 153mg (oxymatrine 150mg)

[0061] Microcrystalline Cellulose 755mg Sodium Carboxymethyl Starch 61mg

[0062] Coating 306mg

[0063]

[0064] Total 1326mg

[0065] 2.2 pH-sensitive double-layer coated pellets

[0066] Matrine extract 51mg Oxymatrine extract 153mg

[0067] Microcr...

Embodiment 3

[0078] Example 3 Screening test of pharmaceutical excipients and preparation process of the present invention

[0079] 1. Preparation of the medicine gastric-colon separate release capsule of the present invention

[0080] The drug of the present invention is divided into two parts, in which astragaloside and polysaccharide are prepared into a preparation unit that can release the drug quickly in the stomach, and matrine and oxymatrine are prepared into a preparation unit with colon-specific drug release performance. The two preparation units are mixed and assembled into a compound drug delivery system containing two drug release behaviors.

[0081] See the specific process route figure 1 .

[0082] 1 Instruments and reagents:

[0083] 1.1 Instrument

[0084] Spherical pellet granulator (Institute of Chemical Machinery, East China University of Science and Technology)

[0085] Fragility monitor (FT-2000 type, Tianjin Sixin Technology Co., Ltd.)

[0086] Powder flow tester (GTB type, EWEKA...

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Abstract

The invention provides application of a gastric medicament release system prepared from astragalus or active ingredients thereof and a colon positioning medicament release system prepared from lightyellow sophora root or active ingredients thereof in the preparation of combined medicaments for treating ulcerative colitis, and also provides a medicinal composition for treating the ulcerative colitis, which is a preparation prepared by mixing the gastric medicament release system prepared from the astragalus or active ingredients thereof and the colon positioning medicament release system prepared from the lightyellow sophora root or active ingredients thereof. Through the comparative experimental study of medicinal effect of different administration modes of each component, compared with two preparation modes of total formula colon administration and total formula oral administration, a preparation prepared by combining the oral administration of astragalus polysaccharide and saponin with the enteroclysis of matrine and oxymatrine can resist rat colon tissue pathological injury caused by trinitro-benzene-sulfonic acid obviously, improve apparent physical signs such as hematochezia, diarrhoea, anorexia, indolence and the like of animals and play a role by regulating the peripheral blood TNF-alpha level and inflammatory reactions in colon tissue, has obvious curative effect and can both regulate the integral immunologic function and resist the local inflammatory reactions in colon.

Description

Technical field [0001] The present invention relates to the use of a gastric drug release system prepared from astragalus or its active ingredients and a colon-based drug release system prepared from sophora flavescens or its active ingredients in the preparation of a combined medicine for treating ulcerative colitis. Background technique [0002] Ulcerative colitis is a primary, non-specific chronic disease of the colon. Colonoscopy shows that only the mucosa and submucosa of the colon are invaded, and there are erosions and superficial ulcers. At present, the raw materials of Astragalus and Sophora flavescens are combined to treat ulcerative colitis. There have been related patents or literature reports, such as: Patent Application No. 200410040960.7, Title of Invention: A pharmaceutical composition for treating ulcerative colitis and its preparation method and application This patent application discloses a pharmaceutical composition for the treatment of ulcerative colitis, wh...

Claims

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Application Information

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IPC IPC(8): A61K36/489A61K47/38A61K9/16A61P1/04
Inventor 杨明谢兴亮韩丽曾敏顾原晓
Owner 杨明
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