Isosorbide mononitrate micro-porous osmotic pump tablet and preparation method thereof

A technology of isosorbide dinitrate and osmotic pump tablets, applied in the directions of pharmaceutical formulation, drug delivery, sugar-coated pills, etc., can solve the problems such as unavoidable complex process, unstable in vivo effect, unavoidable trouble, etc. The effect of stable blood concentration

Inactive Publication Date: 2012-04-25
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Isosorbide mononitrate osmotic pump tablets prepared by the above methods are all prepared by laser or mechanical pore formation, which cannot avoid the defects of complicated process and unstable in vivo

Method used

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  • Isosorbide mononitrate micro-porous osmotic pump tablet and preparation method thereof
  • Isosorbide mononitrate micro-porous osmotic pump tablet and preparation method thereof
  • Isosorbide mononitrate micro-porous osmotic pump tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Chip composition:

[0020]

[0021] Coating liquid composition:

[0022]

Embodiment 2

[0024] Chip composition:

[0025]

[0026] Coating liquid composition:

[0027]

Embodiment 3

[0029] Chip composition:

[0030]

[0031] Coating liquid composition:

[0032]

[0033] Preparation process: the raw and auxiliary materials are respectively passed through a 100-mesh sieve, and the isosorbide mononitrate, the osmotic pressure active substance and the filler are mixed through a 60-mesh sieve and mixed evenly, and an appropriate amount of 5% polyvinylpyrrolidone K30 ethanol solution is added to make a soft material, and a 20-mesh sieve is used Granulate, dry at 40°C, sieve through a 18-mesh sieve, add talcum powder and press into tablet cores. Dissolve cellulose acetate, plasticizer and porogen in acetone, coat the tablet core, increase the weight to the desired thickness, and cure at 40°C for 12 hours.

[0034] Example 2 with the best effect was selected to evaluate the release characteristics of the drug in release media with different pH and different osmotic pressures.

[0035] The present invention has selected four kinds of release media (pH1, pH...

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Abstract

The invention relates to an isosorbide mononitrate micro-porous osmotic pump tablet and a preparation method thereof. The preparation can release isosorbide mononitrate at a constant drug release rate. The isosorbide mononitrate micro-porous osmotic pump tablet is mainly composed of a tablet core, a semipermeable coating film and drug release pores, wherein the tablet core consists of isosorbide mononitrate, an osmotic pressure active substance, filler and other pharmaceutical auxiliary materials; and the semipermeable coating film consists of cellulose acetate, a plasticizer and a pore former. The osmotic pressure between the outside and inside of the semipermeable film is used as the driving force and the osmotic pump tablet releases the drug at a zero order release rate, thus the tablet has the characteristics that the blood concentration is stable, the in-vivo drug action time is proper, the side effects are little and the drug resistance is hardly caused after multiple administration.

Description

technical field [0001] The invention relates to a controlled-release preparation for treating angina pectoris, in particular to a microporous osmotic pump controlled-release preparation composed of a tablet core prepared from isosorbide mononitrate, a semipermeable membrane and drug release holes and a preparation method thereof. Background technique [0002] Isosorbide mononitrate is the main biologically active metabolite of isosorbide dinitrate. Like other organic nitrates, the main pharmacological effect is to relax vascular smooth muscle. Isosorbide mononitrate releases nitric oxide (NO). NO is the same as endothelial relaxation factor, activates guanylate cyclase, increases cyclic guanylate (cGMP) in smooth muscle cells, and relaxes vascular smooth muscle, making peripheral arteries and Vein dilation, the expansion effect on the veins is stronger. Venous dilatation causes blood retention in the periphery, decreases blood return to the heart, and reduces left ventricul...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K9/28A61K31/34A61P9/10
Inventor 王柏姜建平
Owner CHINA PHARM UNIV
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