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Rosuvastatin calcium dispersible tablet and preparation method thereof

A technology of rosuvastatin calcium and dispersible tablets, which is applied in the field of rosuvastatin calcium dispersible tablets and its preparation, can solve the problem of low permeability of rosuvastatin calcium, complex biopharmaceutical properties, rosuvastatin calcium Reduced permeability and other issues, to achieve the effect of improving bioavailability and improving bioavailability

Inactive Publication Date: 2014-06-18
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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  • Rosuvastatin calcium dispersible tablet and preparation method thereof
  • Rosuvastatin calcium dispersible tablet and preparation method thereof
  • 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 an appropriate amount of water to make a saturated aqueous solution. Pass rosuvastatin calcium through a 120-mesh sieve and dissolve it in an appropriate 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 3 hours, and most of the ethanol was removed by rotary evaporation at 45°C. Put it into a shallow tray and put it in the freezer of the refrigerator. The pre-freezing time is 12 hours and the temperature is -50°C. When the temperature of the cold trap in the freeze-drying box reaches -50°C, put the sample in, vacuumize, and the pressure does not exceed 20Pa. Sublimation After drying for 24 hours, the clathrate was obtained.

[0031] Microcrystalline cellulose is passed through a 100-mesh sie...

Embodiment 2

[0034]

[0035]

[0036] Preparation Process:

[0037] Take the prescription amount of hydroxypropyl-β-cyclodextrin and dissolve it in an appropriate amount of water to make a saturated aqueous solution. Pass rosuvastatin calcium through a 120-mesh sieve and dissolve it in an appropriate amount of ethanol. The ethanol solution was slowly added to the saturated aqueous solution of hydroxypropyl-β-cyclodextrin, and after all the addition was completed, 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 a shallow tray and put it in the freezer of the refrigerator. The pre-freezing time is 12 hours and the temperature is -50°C. When the temperature of the cold trap in the freeze-drying box reaches -50°C, put the sample in, vacuumize, and the pressure does not exceed 20Pa. Sublimation Dry for 24 hours to obtain clathrate;

[0038] Microcrystalline cellulose is passed through a 100-mesh sieve,...

Embodiment 3

[0041]

[0042]

[0043] Preparation Process:

[0044] Take the prescription amount of hydroxypropyl-β-cyclodextrin and dissolve it in an appropriate amount of water to make a saturated aqueous solution. Pass rosuvastatin calcium through a 120-mesh sieve and dissolve it in an appropriate amount of ethanol. The ethanol solution was slowly added into 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 a shallow tray and put it in the freezer of the refrigerator. The pre-freezing time is 12 hours and the temperature is -50°C. When the temperature of the cold trap in the freeze-drying box reaches -50°C, put the sample in, vacuumize, and the pressure does not exceed 20Pa. Sublimation Dry for 24 hours to obtain clathrate;

[0045] Microcrystalline cellulose passed through a 100-mesh sieve, mi...

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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

field of invention [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 far-reaching impact on the prevention and treatment of cardiovascular diseases. With the advent of the aging population, the proportion of hypertension and other diseases caused by hyperlipidemia in the cardiovascular diseases of the elderly is increasing year by year, which seriously threatens people's life safety. Therefore, seeking effective, safe and reliable blood lipid-lowering drugs ha...

Claims

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Application Information

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Patent Type & Authority Applications(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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