A kind of rosuvastatin calcium dispersible tablet and preparation method thereof

A technology for rosuvastatin calcium and dispersible tablets, which is applied in the field of rosuvastatin calcium dispersible tablets and their preparation, can solve complex biopharmaceutical properties, low permeability of rosuvastatin calcium, and rosuvastatin calcium. Reduce permeability and other problems to achieve the effect of improving bioavailability and improving bioavailability

Inactive Publication Date: 2016-05-04
杨冬梅
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The permeability of rosuvastatin calcium is very low and also depends on the pH environment. In the gastrointestinal tract, the permeability of rosuvastatin calcium decreases when the environmental pH increases from acidic to neutral
Due to the complex biopharmaceutical properties of rosuvastatin calcium, it is challenging to develop dosage forms of rosuvastatin calcium with less individual variation and improved bioavailability

Method used

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  • A kind of rosuvastatin calcium dispersible tablet and preparation method thereof
  • A kind of rosuvastatin calcium dispersible tablet and preparation method thereof
  • A kind of rosuvastatin calcium dispersible tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028]

[0029] Preparation Process:

[0030] Take the prescription amount of hydroxypropyl-β-cyclodextrin and dissolve it in a proper amount of water to make a saturated aqueous solution. Pass the rosuvastatin calcium through a 120-mesh sieve, and dissolve it in a proper amount of ethanol. The ethanol solution was slowly added to the saturated aqueous solution of hydroxypropyl cyclodextrin, and after all was added, the stirring was continued at room temperature for 3 hours, and most of the ethanol was removed by rotary evaporation at 45°C. Put it into the shallow dish, put it in the freezer compartment of the refrigerator, the pre-freezing time is 12h, the temperature is -50℃, when the temperature of the cold trap in the freeze-drying box reaches -50℃, put in the sample, vacuum, the pressure does not exceed 20Pa, sublimation Dry for 24h to obtain inclusion compound.

[0031] The microcrystalline cellulose is passed through a 100-mesh sieve, and the rosuvastatin calcium hydroxypro...

Embodiment 2

[0034]

[0035]

[0036] Preparation Process:

[0037] Take the prescription amount of hydroxypropyl-β-cyclodextrin and dissolve it in a proper amount of water to make a saturated aqueous solution. Pass the rosuvastatin calcium through a 120-mesh sieve, and dissolve it in a proper amount of ethanol. The ethanol solution was slowly added to the saturated aqueous solution of hydroxypropyl-β-cyclodextrin, and after all was added, the stirring was continued at room temperature for 4 hours, and most of the ethanol was removed by rotary evaporation at 45°C. Put it into the shallow dish, put it in the freezer compartment of the refrigerator, the pre-freezing time is 12h, the temperature is -50℃, when the temperature of the cold trap in the freeze-drying box reaches -50℃, put in the sample, vacuum, the pressure does not exceed 20Pa, sublimation Dry for 24h to obtain inclusion compound;

[0038] The microcrystalline cellulose is passed through a 100-mesh sieve, and the rosuvastatin calcium...

Embodiment 3

[0041]

[0042]

[0043] Preparation Process:

[0044] Take the prescription amount of hydroxypropyl-β-cyclodextrin and dissolve it in a proper amount of water to make a saturated aqueous solution. Pass the rosuvastatin calcium through a 120-mesh sieve, and dissolve it in a proper amount of ethanol. The ethanol solution was slowly added to the saturated aqueous solution of hydroxypropyl cyclodextrin, and after all the addition was completed, stirring was continued at room temperature for 2 hours, and most of the ethanol was removed by rotary evaporation at 40°C. Put it into the shallow dish, put it in the freezer compartment of the refrigerator, the pre-freezing time is 12h, the temperature is -50℃, when the temperature of the cold trap in the freeze-drying box reaches -50℃, put in the sample, vacuum, the pressure does not exceed 20Pa, sublimation Dry for 24h to obtain inclusion compound;

[0045] The microcrystalline cellulose is passed through a 100-mesh sieve, and the rosuvasta...

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PUM

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Abstract

The invention belongs to the field of medical preparations, and particularly relates to a rosuvastatin calcium dispersible tablet and a preparation method thereof. Rosuvastatin calcium is low in bioavailability after being orally taken and absorbed, and the individuals for medication have large difference, therefore, the invention provides the rosuvastatin calcium dispersible tablet which comprises rosuvastatin calcium, hydroxypropyl-beta-cyclodextrin, a filler, a disintegrating agent, a binder and a lubricant. Rosuvastatin calcium is easily dissolved into water after being coated by hydroxypropyl-beta-cyclodextrin (HP-beta-CD), the stability of the tablet can be enhanced, the release and absorption of the drug in a human body can be promoted, the bioavailability can be improved, and the difference of the individuals for medication can be reduced.

Description

Invention field [0001] The invention relates to the field of chemical pharmacy, in particular to a rosuvastatin calcium dispersible tablet and a preparation method thereof. Background of the invention [0002] Cardiovascular disease is one of the most common and serious diseases that endanger human health (especially middle-aged and elderly people). Dyslipidemia is an important risk factor for atherosclerosis, coronary heart disease and other cardiovascular and cerebrovascular diseases. Lipid-lowering drugs can reduce these The incidence and mortality of diseases have a positive and profound impact on the prevention and treatment of cardiovascular diseases. With the advent of the aging society, the proportion of cardiovascular diseases in the elderly caused by hyperlipidemia and other diseases is increasing year by year, which seriously threatens people's lives. Therefore, searching for effective, safe and reliable lipid-lowering drugs has always been a long-term and quite popul...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/505A61K47/48A61P3/06A61K47/69
Inventor 孙常成王洪安
Owner 杨冬梅
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