Budesonide intestines sustained release dextromethorphan pellets and method of manufacturing the same

A slow-release pellet and enteric-coated technology, which is applied in the direction of pharmaceutical formulations, medical preparations with no active ingredients, medical preparations containing active ingredients, etc., can solve the problems of high price, unknown clinical effect, and high cost, and achieve Effect of good film formation and mechanical properties

Inactive Publication Date: 2008-01-23
FUDAN UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there is no enteric-coated sustained-release preparation of budesonide in the domestic market. If similar drugs are imported from abroad, the cost is too high, the price is expensive, and the clinical effect is unknown.

Method used

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  • Budesonide intestines sustained release dextromethorphan pellets and method of manufacturing the same
  • Budesonide intestines sustained release dextromethorphan pellets and method of manufacturing the same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Prescription for Blank Ball Core

[0051] Microcrystalline Cellulose 80g

[0052] Starch 60g

[0053] Hypromellose 20g

[0054] Silica 20g

[0055] Magnesium Stearate 20g

[0056] Drug Coating Solution Prescription

[0057] Blank ball core 80g

[0058] Budesonide 1g

[0059] Hypromellose 2g

[0060] 50% ethanol 50g

[0061] Sustained-release layer coating solution prescription

[0062] Drug-containing immediate-release pellet core 100g

[0063] Ethylcellulose 3g

[0064] Sodium Lauryl Sulfate 0.3g

[0065] Tributyl citrate 0.3

[0066] Talc powder 0.9g

[0067] 95% ethanol 60g

[0068] Enteric layer coating liquid prescription

[0069] Sustained-release pellets 100g

[0070] Eudragit L100 16.5g

[0071] Triethyl citrate 1.65g

[0072] Talc powder 4.125g

[0073] 95% ethanol 250g

[0074] According to the formula quantity of each layer above, mix the microcrystalline cellulose and starch with the prescription quantity of the blank ball core evenly, add ...

Embodiment 2

[0080] Prescription for Blank Ball Core

[0081] Lactose 100g

[0082] Starch 30g

[0083] Sucrose 40g

[0084] Talc powder 20g

[0085] Magnesium stearate 10g

[0086] Drug Coating Solution Prescription

[0087] Blank ball core 80g

[0088] Budesonide 1g

[0089] Polyvinylpyrrolidone 2g

[0090] 80% ethanol 50g

[0091] Sustained-release layer coating solution prescription

[0092] Drug-containing immediate-release pellet core 100g

[0093] Ethyl cellulose aqueous dispersion Surelease 8g (solid content is 2g)

[0094] Hypromellose 1g

[0095] water 10g

[0096] Enteric layer coating liquid prescription

[0097] Sustained-release pellets 100g

[0098] Eudragit L30D-55 55g (16.5g solids)

[0099] Triethyl citrate 1.65g

[0100] Talc powder 4.125g

[0101] water 50g

[0102] Mix the lactose and starch of the prescription amount of the blank ball core according to the above-mentioned formula quantity, add the adhesive prepared by sucrose, use a granulator or a c...

Embodiment 3

[0108] Drug-containing immediate-release pill core prescription

[0109] Lactose 90g

[0110] Starch 30g

[0111] Polyvinylpyrrolidone 40g

[0112] Talc powder 20g

[0113] Micronized Budesonide 3g

[0114] Sustained-release layer coating solution prescription

[0115] Drug-containing immediate-release pellet core 100g

[0116] Ethyl cellulose aqueous dispersion Aquacoat 15g (solid content 4.5g)

[0117] Tween 80 0.45g

[0118] water 15g

[0119] Enteric layer coating liquid prescription

[0120] Sustained-release pellets 100g

[0121] Eudragit S100 5.5g

[0122] Eudragit L100 11g

[0123] Polyethylene glycol 6000 1.65g

[0124] Talc powder 4.125g

[0125] 95% ethanol 250g

[0126] Mix the micronized drug with the prescribed amount of lactose, starch, polyvinylpyrrolidone, and talcum powder according to the above-mentioned formula quantities, and make pellets by rolling or extrusion-spheronization or centrifugal-fluidization Prepare the required micropills with ...

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PUM

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Abstract

The invention belongs to the technical field of medicinal preparation and relates to an enteric preparation and sustained or controlled release preparation, in particular to an enteric controlled release micro-granule with budesonide and its preparation method. The invention, which comprises a quick release celphere, a controlled release layer and an enteric layer, takes budesonide as active ingredient of the drug to coordinate with medicinal carrier supplementary materials. After the release level testing, it is proved that the enteric controlled release micro-granule, which adopts different enteric materials, controlled release material and different coating conditions, does not release in stomach but began to release slowly after entering the small intestine with even release level. Therefore, the enteric controlled release micro-granule in the invention can effectively prevent the release in stomach, ensure the slow release in small intestine and the release of drug in the affected section of small incestine, ileocecus and colon.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to pharmaceutical enteric-coated preparations and slow-controlled release preparations, in particular to an enteric-coated slow-release pellet containing budesonide and a preparation method thereof. Background technique [0002] Budesonide is a non-halogenated glucocorticoid with highly effective local anti-inflammatory effects, and has anti-inflammatory, anti-allergic, antipruritic and anti-exudative effects. Clinically, the aerosol, spray, and powder mist of budesonide are widely used in glucocorticoid-dependent or non-dependent bronchial asthma and asthmatic bronchitis. In October 2001, the U.S. FDA approved its enteric-coated Capsules of pills are used for maintenance treatment of mild to moderate Crohn's disease involving the ileum and / or ascending colon. In addition, studies have shown that budesonide is effective in treating inflammatory bowel diseases such as ulcera...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/32A61K9/48A61K31/58A61K47/34A61K47/38A61P29/00A61P37/08A61P17/04A61K47/10A61K47/14A61K47/32A61K47/36
Inventor 吴君华裴元英柳晨姜嫣嫣
Owner FUDAN UNIV
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