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A kind of pravastatin sodium dispersible tablet and preparation method thereof

A technology for pravastatin sodium and dispersible tablets, applied in the field of pravastatin sodium dispersible tablets and their preparation, can solve the problems of reduced permeability of pravastatin sodium, low permeability of pravastatin sodium, complexity and the like, and achieves the The effect of rapid disintegration, improved dissolution rate, and reduced inter-individual variability

Inactive Publication Date: 2016-03-30
兰丽伟
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

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

Method used

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  • A kind of pravastatin sodium dispersible tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Pravastatin Sodium 10g

[0039] Hydroxypropyl-β-cyclodextrin 45g

[0040] Mannitol 150g

[0041] Compressible starch 75g

[0042] Microcrystalline Cellulose 75g

[0043] Low-substituted hydroxypropyl cellulose 45g

[0044] 2% polyvinylpyrrolidone aqueous solution 650g

[0045] Talc powder 3g

[0046] Made in 1000 pieces.

[0047] Preparation Process:

[0048] Take the prescription amount of hydroxypropyl-β-cyclodextrin and dissolve it in an appropriate amount of water to make a saturated aqueous solution. Pass pravastatin sodium through a 120-mesh sieve and dissolve it in an appropriate amount of ethanol. Under magnetic stirring, the ethanol solution of pravastatin sodium Slowly add the saturated aqueous solution of hydroxypropyl cyclodextrin, continue to stir at room temperature for 3 hours after all the addition is complete, and remove most of the ethanol by rotary evaporation at 45°C. Put it into a shallow tray and put it in the freezer of the refrigerator. The...

Embodiment 2

[0052] Pravastatin Sodium 10g

[0053] Hydroxypropyl-β-cyclodextrin 30g

[0054] Mannitol 150g

[0055] Compressible starch 75g

[0056] Microcrystalline Cellulose 75g

[0057] Low-substituted hydroxypropyl cellulose 45g

[0058] 2% polyvinylpyrrolidone aqueous solution 650g

[0059] Magnesium stearate 2g

[0060] Magnesium Lauryl Sulfate 1g

[0061] Made in 1000 pieces.

[0062] Preparation Process:

[0063] Take the prescription amount of hydroxypropyl-β-cyclodextrin and dissolve it in an appropriate amount of water to make a saturated aqueous solution. Pass pravastatin sodium through a 120-mesh sieve and dissolve it in an appropriate amount of ethanol. Under magnetic stirring, the ethanol solution of pravastatin sodium Slowly add the saturated aqueous solution of hydroxypropyl-β-cyclodextrin, continue stirring at room temperature for 4 hours after all the addition is complete, and remove most of the ethanol by rotary evaporation at 45°C. Put it into a shallow tray ...

Embodiment 3

[0067] Pravastatin Sodium 10g

[0068] Hydroxypropyl-β-cyclodextrin 45g

[0069] Mannitol 150g

[0070] Compressible starch 75g

[0071] Microcrystalline Cellulose 75g

[0072] Croscarmellose Sodium 45g

[0073] 2% polyvinylpyrrolidone aqueous solution 650g

[0074] Magnesium stearate 3g

[0075] Made in 1000 pieces.

[0076] Preparation Process:

[0077] Take the prescription amount of hydroxypropyl-β-cyclodextrin and dissolve it in an appropriate amount of water to make a saturated aqueous solution. Pass pravastatin sodium through a 120-mesh sieve and dissolve it in an appropriate amount of ethanol. Under magnetic stirring, the ethanol solution of pravastatin sodium Slowly add the saturated aqueous solution of hydroxypropyl cyclodextrin, continue to stir at room temperature for 2 hours after all the addition is complete, and remove most of the ethanol by rotary evaporation at 40°C. Put it into a shallow tray and put it in the freezer of the refrigerator. The pre-free...

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Abstract

The invention belongs to the field of pharmaceutical preparations and in particular relates to pravastatin sodium dispersible tablets and a preparation method thereof. Because the oral absorption bioavailability of pravastatin sodium is low, and the difference between medication individuals is large, the invention provides pravastatin sodium dispersible tablets. The pravastatin sodium dispersible tablets contain pravastatin sodium, hydroxypropyl-beta-cyclodextrin, filler, a disintegrating agent, an adhesive and a lubricating agent. The pravastatin sodium easily dissolves in water after being subjected to inclusion of hydroxypropyl-beta-cyclodextrin (HP-beta-CD), the stability of the medicine is improved, release of the medicine in vivo is promoted, the absorption is improved, the bioavailability is improved, and the difference between medication individuals is reduced.

Description

field of invention [0001] The invention relates to the field of chemical pharmacy, in particular to a pravastatin sodium 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 has ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/48A61K9/20A61K31/22A61P3/06
Inventor 王洪安孙常成
Owner 兰丽伟
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