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Isosorbide mononitrate sustained-release pallets, preparation prepared from same and preparation method for isosorbide mononitrate sustained-release pallets

A technology of isosorbide mononitrate and sustained-release pellets, which is applied in the field of medicine, can solve the problems of poor stability of isosorbide mononitrate sustained-release capsules, and achieve the effects of avoiding significant changes, simple operation, and stable properties

Active Publication Date: 2014-03-05
珠海润都制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, these isosorbide mononitrate slow-release capsule products that we obtain from the market are not stable, and there are obvious defects and deficiencies

Method used

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  • Isosorbide mononitrate sustained-release pallets, preparation prepared from same and preparation method for isosorbide mononitrate sustained-release pallets
  • Isosorbide mononitrate sustained-release pallets, preparation prepared from same and preparation method for isosorbide mononitrate sustained-release pallets
  • Isosorbide mononitrate sustained-release pallets, preparation prepared from same and preparation method for isosorbide mononitrate sustained-release pallets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0110] The preparation of embodiment 1 isosorbide mononitrate slow-release pellets

[0111] Add 25g of HPMC E3 into 500g of purified water at 50°C, stir and swell until clear, and cool to the greenhouse for use; add 175g of isosorbide mononitrate, stir evenly, and obtain a suspension. Pass the above suspension through an 80-mesh sieve, rinse it with 250 g of purified water, add 500 g of purified water, and stir evenly to obtain a drug-loaded layer solution. Fill 500g of sucrose-starch microspheres (particle size 0.6~0.8mm) into the fluidized bed granulation coating machine, fan frequency 20~40Hz, air inlet temperature 50~70℃, material temperature 40~50℃, atomization The air pressure is 0.05-0.10MPa, and the spraying pump speed is 10-30 rpm to carry out the drug feeding operation (coating) until the solution of the drug-loaded layer is sprayed out. Set the material temperature at 40°C, fluidize and dry the pellets coated with the drug-loaded layer solution for 2 hours until th...

Embodiment 2

[0118] The preparation of embodiment 2 isosorbide mononitrate slow-release pellets

[0119] Add 25g of HPMC E3 to 500g of purified water at 50°C, stir and swell to clarification, and cool to the greenhouse for use; take 43.8g of lactose monohydrate, add to the above solution and stir to dissolve; add 175g of isosorbide mononitrate, stir evenly, and obtain suspension. Pass the above suspension through an 80-mesh sieve, rinse it with 250 g of purified water, add 500 g of purified water, and stir evenly to obtain a drug-loaded layer solution. Fill 500g of sucrose-starch microspheres (particle size 0.6~0.8mm) into the fluidized bed granulation coating machine, fan frequency 20~40Hz, air inlet temperature 50~70℃, material temperature 40~50℃, atomization The air pressure is 0.05-0.10MPa, and the spraying pump speed is 10-30 rpm to carry out the drug feeding operation (coating) until the solution of the drug-loaded layer is sprayed out. Set the material temperature at 40°C, fluidiz...

Embodiment 3

[0126] The preparation of embodiment 3 isosorbide mononitrate slow-release pellets

[0127] Add 25g of PVP K90 to 500g of purified water at 25°C, stir and dissolve until clear and ready for use; take 43.8g of lactose monohydrate, add to the above solution and stir to dissolve; add 175g of isosorbide mononitrate, stir well to obtain a suspension. Pass the above suspension through an 80-mesh sieve, rinse it with 250 g of purified water, add 500 g of purified water, and stir evenly to obtain a drug-loaded layer solution. Fill 500g of sucrose-starch microspheres (particle size 0.6~0.8mm) into the fluidized bed granulation coating machine, fan frequency 20~40Hz, air inlet temperature 50~70℃, material temperature 40~50℃, atomization The air pressure is 0.05-0.10MPa, and the spraying pump speed is 10-30 rpm to carry out the drug feeding operation (coating) until the solution of the drug-loaded layer is sprayed out. Set the material temperature at 40°C, fluidize and dry the pellets c...

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Abstract

The invention relates to the field of medicaments, and in particular relates to isosorbide mononitrate sustained-release pallets, a preparation prepared from the same and a preparation method for the isosorbide mononitrate sustained-release pallets. Each sustained-release pallet consists of a blank pallet core, a medicament-carrying layer, a sustained-release layer and a quick-release layer, wherein the medicament-carrying layer consists of isosorbide mononitrate, a first filling agent and a first adhesive; the sustained-release layer consists of a sustained-release material, a pore-forming agent, an anti-sticking agent, a plasticizer and a second adhesive; the quick-release layer consists of isosorbide mononitrate, a second filling agent and a third adhesive. The isosorbide mononitrate sustained-release pallets and the preparation prepared from the same are stable in property, reliable in quality and high in bioavailability, remarkable changes in the in-vitro release of a medicament caused by the crystallization of isosorbide mononitrate can be avoided, and the stability of the isosorbide mononitrate sustained-release pallets and the preparation prepared from the same is improved.

Description

technical field [0001] The invention relates to the field of medicines, in particular to an isosorbide mononitrate sustained-release pellet and its preparation and preparation method. Background technique [0002] What we often say isosorbide mononitrate is the abbreviation of isosorbide 5-mononitrate. It uses sorbitol dehydration and nitration to produce 2,5-isosorbide dinitrate, and then further reduces the reaction to generate 5-isosorbide mononitrate. Sorbitate. Isosorbide 5-mononitrate is a new generation of anti-anginal drugs, used for vasodilation and relief, prevention of angina, and also for congestive heart failure. Experiments have proved that it has similar effect of dilating blood vessels and smooth muscle to nitroglycerin, but the effect is more significant than nitroglycerin, and lasts longer, can significantly increase coronary flow and lower blood pressure. It has the same function as 2,5-isosorbide dinitrate, because after 2,5-isosorbide dinitrate enters ...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K9/22A61K9/52A61K31/34A61K47/32A61K47/26A61P9/10A61P9/04
Inventor 谢斌张志刚杨刘增黄积勇黄俊鹏
Owner 珠海润都制药股份有限公司
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