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Multicomponent sustained-release preparation and preparation method thereof

A slow-release preparation, multi-component technology, applied in the field of medicine, can solve the problems of the initial release of the inner layer of the drug and the inability of the outer layer of the drug to achieve full dissolution, and achieve the effects of large dose, short half-life and long half-life.

Inactive Publication Date: 2011-05-18
TIANJIN INSTITUTE OF PHARMA RESEARCH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, this type of compound preparation should be made into a compound preparation of inner and outer layers, the outer layer releases quickly and the inner layer releases slowly, but if the matrix type sustained-release tablet is directly applied with the drug, the inner and outer layers interfere with each other, and the outer layer of the drug cannot achieve full release. Dissolution, the initial drug release of the inner layer is also affected

Method used

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  • Multicomponent sustained-release preparation and preparation method thereof
  • Multicomponent sustained-release preparation and preparation method thereof
  • Multicomponent sustained-release preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Compound Sustained Release Tablets Containing Metformin Hydrochloride 500mg Pioglitazone Hydrochloride 15mg

[0027] (1) Preparation of Metformin Hydrochloride Sustained Release Tablet Core

[0028] Get metformin hydrochloride 500g, hydroxypropyl methylcellulose (METHOCEL K100MCR) 200g, sodium carboxymethylcellulose 75g, microcrystalline cellulose 20g, mix well, add 5% PVP ethanol solution to make granules, add after drying 0.5% magnesium stearate, compressed into tablets, each containing 500mg of metformin hydrochloride. Put the above-mentioned tablet in a coating pan, and coat with the following coating solution, and the weight of the coating is increased to about 2-4%.

[0029] Eudragit RS 100 13g

[0030] Eudragit S 100 0.3g

[0031] Triethyl citrate 3.0g

[0032] Talc powder 7.0g

[0033] Ethanol 400ml

[0034] (2) Preparation of isolation layer

[0035] Take the above-mentioned metformin hydrochloride sustained-release tablet core, put it in a coating pan, ...

Embodiment 2

[0054] Compound Sustained Release Tablets Containing Metformin Hydrochloride 500mg Glimepiride 1mg

[0055] (1) Preparation of Metformin Hydrochloride Sustained Release Tablet Core

[0056] The preparation method is the same as in Example 1.

[0057] (2) Preparation of isolation layer

[0058] Take the above-mentioned metformin hydrochloride sustained-release tablet core, put it in a coating pan, and coat it with the following coating solution, and the weight of the coating will increase to about 1.5-2%.

[0059] Copovidone 12g

[0060] Micronized silica gel 0.4g

[0061] Macrogol 400 1.0g

[0062] Ethanol 200ml

[0063] (3) Glimepiride coated drug

[0064] Take by weighing hydroxypropyl methylcellulose E5, copovidone, polyethylene glycol 400, polysorbate 80 according to the prescription quantity, add appropriate amount of absolute ethanol to dissolve, take glimepiride and micropowder silica gel according to the prescription quantity, Add an appropriate amount of absolu...

Embodiment 3

[0075] Compound Sustained Release Tablets Containing Niacin 500mg Simvastatin 5mg

[0076] (1) Preparation of niacin sustained-release tablet core

[0077] Take niacin 500g, hydroxypropyl methylcellulose (METHOCEL K15MCR) 180g, mix well, add 5% PVP alcohol solution to make granules, add 0.5% magnesium stearate after drying, press into tablets, each tablet contains Niacin 500mg.

[0078] (2) Preparation of isolation layer

[0079] Take the above-mentioned niacin sustained-release tablet core, put it in a coating pan, and coat it with the following coating solution, and the weight of the coating will increase to about 1.5% to 2%.

[0080] Hydroxypropyl Methyl Cellulose E5 11.0g

[0081] Differential Silica Gel 0.6g

[0082] Triethyl citrate 1.1g

[0083] Ethanol 200ml

[0084] (3) Simvastatin coated drug

[0085] Take hydroxypropyl methylcellulose E5, copovidone, and triethyl citrate according to the prescription quantity, add appropriate amount of absolute ethanol to dis...

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Abstract

The invention provides a multicomponent sustained-release preparation and a preparation method thereof. An isolation layer is arranged between a sustained-release part and a quick release part in the sustained-release preparation to effectively isolate the interaction of a sustained-release tablet core and an external quick release coat, the external quick release part is quickly released completely, the isolation layer is quickly dissolved when meeting an aqueous medium, and the release of the sustained-release tablet core is not influenced. The technology can be applied to compound sustained-release preparations as required.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a multi-component sustained-release preparation and a preparation method thereof, more specifically to a multi-component sustained-release preparation composed of an inner layer sustained-release part and an outer layer quick-release part and its preparation method. Law. The drug in the outer layer of the sustained-release preparation can be dissolved rapidly, and the drug in the inner layer can be released slowly without interfering with each other. Background technique [0002] In compound sustained-release preparations, components with large differences in half-life are often composed of two parts, sustained-release and immediate-release, for coordinated release administration. Among them, the slow-release part is water-soluble drug and the dose is large, and the immediate-release part is water-insoluble drug and the dose is small. The multi-layer sustained-release tablet tech...

Claims

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Application Information

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IPC IPC(8): A61K9/24A61K31/4439A61K31/455A61K31/64A61K47/32A61K47/34A61K47/38A61P3/10A61K31/155A61K31/366A61K47/26
Inventor 王杏林陈志华尹东东张俊伟杨志强
Owner TIANJIN INSTITUTE OF PHARMA RESEARCH
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