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Atorvastatin and nicotinic acid sustained release preparation and method for preparing same

A technology of atorvastatin and niacin, applied in the field of atorvastatin niacin sustained-release preparation and preparation thereof, can solve the problems of weak LDL effect, increase HDL and the like, achieve stable blood drug concentration, simple preparation process, and reduce Effects of fluctuation phenomena and toxic side effects

Inactive Publication Date: 2012-07-18
NANJING CORE TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The effect of niacin is just the opposite, it has a strong effect of increasing HDL, but a weak effect of reducing LDL

Method used

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  • Atorvastatin and nicotinic acid sustained release preparation and method for preparing same
  • Atorvastatin and nicotinic acid sustained release preparation and method for preparing same
  • Atorvastatin and nicotinic acid sustained release preparation and method for preparing same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] prescription:

[0033] immediate release layer

[0034]

[0035] slow release layer

[0036]

[0037] Preparation method: Take atorvastatin, pass through 80-mesh sieve, fully mix with other auxiliary materials, use PVPK30 ethanol solution to make soft material manually, pass through 24-mesh sieve to granulate, dry at 60°C for 1.5 hours, and granulate with 24-mesh sieve , add magnesium stearate and mix well. Take the prescribed amount of niacin and crush it through a 80-mesh sieve, fully mix it with other auxiliary materials for the sustained-release layer, add water to make soft materials, pass through a 24-mesh sieve to make wet granules, dry at 60°C for 2 hours, sieve the granules with a 24-mesh sieve, and add stearin Magnesium acid mixed thoroughly.

[0038] After the sustained-release layer of niacin is pre-compressed on the special-shaped tablet press, the granules of the immediate-release layer of atorvastatin are filled in and compressed into tablets ...

Embodiment 2

[0040] prescription:

[0041] immediate release layer

[0042]

[0043]

[0044] slow release layer

[0045]

[0046] Preparation method: take atorvastatin, pass through 80-mesh sieve, fully mix with other auxiliary materials, use PVPK30 ethanol solution to make soft material manually, pass through 24-mesh sieve to granulate, dry at 60°C for 2 hours, and granulate with 24-mesh sieve , add magnesium stearate and mix well.

[0047] Take the prescribed amount of niacin and crush it through an 80-mesh sieve, fully mix it with other auxiliary materials for the sustained-release layer, add water to make soft materials, pass through a 24-mesh sieve to make wet granules, dry at 60°C for 3 hours, sieve the granules with a 24-mesh sieve, and add stearin Magnesium acid mixed thoroughly.

[0048] After the sustained-release layer of niacin is pre-compressed on the special-shaped tablet press, the granules of the immediate-release layer of atorvastatin are filled in and compre...

Embodiment 3

[0050] prescription:

[0051] immediate release layer

[0052]

[0053] slow release layer

[0054]

[0055] Preparation method: take atorvastatin, pass through 80-mesh sieve, fully mix with other auxiliary materials, use PVPK30 ethanol solution to make soft material manually, pass through 24-mesh sieve to granulate, dry at 60°C for 2 hours, and granulate with 24-mesh sieve , add magnesium stearate and mix well. Take the prescribed amount of niacin and crush it through an 80-mesh sieve, fully mix it with other auxiliary materials for the sustained-release layer, add water to make soft materials, pass through a 24-mesh sieve to make wet granules, dry at 60°C for 3 hours, sieve the granules with a 24-mesh sieve, and add stearin Magnesium acid mixed thoroughly.

[0056] After the sustained-release layer of niacin is pre-compressed on the special-shaped tablet press, the granules of the immediate-release layer of atorvastatin are filled in and compressed into tablets b...

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Abstract

The invention provides a bilayer tablet which contains nicotinic acid and atorvastatin and a method for preparing the same, in the bilayer tablet, according to parts by weight, a nicotinic acid sustained-release layer comprises 500-1000mg of nicotinic acid and 20-80mg of atorvastatin, a matrix tablet technology is adopted, the nicotinic acid is produced into a sustained-release part, the atorvastatin is produced into a quick release part, and then the two parts are pressed into a compound sustained-release tablet. Through adjusting the variety and dose of each component in each layer, the release rates of drugs in each layer are mutually matched, and a better curative effect can be reached. The preparation of the sustained-release tablet can effectively control the drug release, the drug release rate can reach the selected drug release rate, so the plasma concentration is more stable, the fluctuation phenomenon of common preparation is reduced, the toxic and side effects of the common tablet are reduced, and the defect of a plurality of times of medicine taking is overcome. The sustained-release tablet which is prepared by the invention not only has a good appearance, but also has an upper layer and a lower layer which are closely combined with each other, under the influence of the outside humiture, the swelling speeds and swelling degrees of the two layers are consistent, so the good appearance and drug release speed can be kept all the time. The method for preparing the bilayer tablet is simple, uses easily-obtained raw materials, is suitable to industrial production, and has a good application aspect, and the related equipment is common equipment.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to an atorvastatin nicotinic acid slow-release preparation and a preparation method thereof. Background technique [0002] Atorvastatin is a selective inhibitor of HMG-CoA reductase with the molecular formula C 33 h 35 FN 2 o 5 , the molecular weight is 558.65. On December 17, 1996, the U.S. FDA approved the atorvastatin preparation of Pfizer, whose trade name is [0003] It reduces plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol biosynthesis in the liver, and increases LDL uptake and catabolism by increasing the number of low-density lipoprotein (LDL) receptors on the surface of liver cells. Can reduce the generation of LDL and its particle number. It can also reduce low-density lipoprotein cholesterol (LDL-C) levels in certain types of homozygous familial hypercholesterolemia (FH), a type of population that rarely respond...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/455A61K31/40A61K9/26A61P3/06
Inventor 王雪根何凌云周元元金皓洁
Owner NANJING CORE TECH CO LTD