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Bilayer tablet containing niacin and simvastatin, and preparation method thereof

A technology of simvastatin and double-layer tablets, applied in the field of pharmaceutical preparations, can solve the problems of high requirements for coating operation equipment and operation process, complex process, large fluctuation of simvastatin dosage, etc. Reliable release effect, simple equipment effect

Active Publication Date: 2013-04-03
BEIJING RED SUN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the defect of this process is that the drug-coated granules are easily damaged during the tableting process, resulting in large fluctuations in the dose of simvastatin for each tablet, and the requirements for the coating operation equipment and operation process are relatively high, and the process is relatively complicated

Method used

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  • Bilayer tablet containing niacin and simvastatin, and preparation method thereof
  • Bilayer tablet containing niacin and simvastatin, and preparation method thereof
  • Bilayer tablet containing niacin and simvastatin, and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Niacin 500mg / Simvastatin 20mg double-layer tablet prescription (1000 tablets)

[0052] Niacin extended-release layer prescription:

[0053] Niacin 475g

[0054] Lactose 10g

[0055] 30% (g / L) ethyl cellulose aqueous suspension 40g

[0056] Hydroxypropyl methylcellulose (viscosity 100000cp) 100g

[0057] Stearic acid 30g

[0058] Simvastatin Layer Prescription:

[0059] Simvastatin 20g

[0060] Niacin 25g

[0061] Lactose 120g

[0062] Polysorbate 80 1g

[0063] Sodium carboxymethyl starch 4g

[0064] 5% (g / L) povidone k29 / 32 2g

[0065] 50% (L / L) ethanol aqueous solution

[0066] Stearic acid 0.5g

[0067] Coating Solution Prescription:

[0068] Hydroxypropyl methylcellulose (viscosity 50cp) 20g

[0069] Titanium dioxide 16g

[0070] Talc powder 20g

[0071] Polysorbate 80 8g

[0072] Ethanol 400g

[0073] water 500g

[0074] Preparation:

[0075] First prepare the niacin sustained-release layer granules and simvastatin layer granules respectively, ...

Embodiment 2

[0090] Niacin 750mg / Simvastatin 20mg double-layer tablet prescription (1000 tablets)

[0091] Niacin extended-release layer prescription:

[0092] Niacin 710g

[0093] Lactose 10g

[0094] 30% (g / L) ethyl cellulose aqueous suspension 60g

[0095] Hydroxypropyl methylcellulose (viscosity 100000cp) 100g

[0096] Stearic acid 30g

[0097] Simvastatin Layer Prescription:

[0098] Simvastatin 20g

[0099] Niacin 40g

[0100] Lactose 120g

[0101] Polysorbate 80 1g

[0102] Sodium carboxymethyl starch 6g

[0103] 5% (g / L) povidone k29 / 32 3g

[0104] 50% (mL / mL) ethanol in water

[0105] Stearic acid 0.5g

[0106] Coating Solution Prescription:

[0107] Hydroxypropyl methylcellulose (viscosity 50cp) 20g

[0108] Titanium dioxide 16g

[0109] Talc powder 20g

[0110] Polysorbate 80 8g

[0111] Ethanol 400g

[0112] water 500g

[0113] Preparation:

[0114] First prepare the niacin sustained-release layer granules and simvastatin layer granules respectively, then p...

Embodiment 3

[0129] Niacin 1000mg / Simvastatin 20mg double-layer prescription (1000 tablets)

[0130] Niacin extended-release layer prescription:

[0131] Niacin 950g

[0132] Lactose 10g

[0133] 30% (g / L) ethyl cellulose aqueous suspension 80g

[0134] Hydroxypropyl methylcellulose (viscosity 100000cp) 100g

[0135] Stearic acid 30g

[0136] Simvastatin Layer Prescription:

[0137] Simvastatin 20g

[0138] Niacin 50g

[0139] Lactose 120g

[0140] Polysorbate 80 1g

[0141] Carboxymethyl starch sodium 8g

[0142] 5% (g / L) povidone k29 / 32 4g

[0143] 50% (L / L) ethanol aqueous solution

[0144] Stearic acid 0.5g

[0145] Coating Solution Prescription:

[0146] Hydroxypropyl methylcellulose (viscosity 50cp) 20g

[0147] Titanium dioxide 16g

[0148] Talc powder 20g

[0149] Polysorbate 80 8g

[0150] Ethanol 400g

[0151] water 500g

[0152] Preparation:

[0153] First prepare the niacin sustained-release layer granules and simvastatin granules respectively, then press t...

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Abstract

The invention provides a bilayer tablet containing niacin and simvastatin, and a preparation method thereof, wherein the bilayer tablet containing niacin and simvastatin comprises the following compositions in parts by weight: in niacin sustained release layer, 475-950 parts of niacin, 12-24 parts of ethyl cellulose and 100 parts of hydroxypropyl methyl cellulose; and in a simvastatin layer, 120 parts of simvastatin, and 25-50 parts of niacin. Due to addition of the niacin in the simvastatin, the constitution and elastic deformation of the two tablet layers can be closer, and the phenomena ofseparation and split can not be generated during preparation process. Through adjustment on types and dose of each composition of each layer, the releasing speed of the medicine in each layer can be matched so as to achieve better curative effect; in addition, respective preparation of the two layers can ensure the releasing effect of the niacin to be more reliable, and no hidden damage hazard ofcoating capsules does not exist. The main process step adopted by the preparation method is a double-layer table pressing process, the related equipment is simpler and the pharmacy cost can be saved.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a double-layer tablet and a preparation method thereof, in particular to a double-layer tablet containing niacin and simvastatin and a preparation method thereof. Background technique [0002] The molecular formula for niacin is C 6 h 5 NO 2 , the molecular weight is 123.11, and the structure is shown in formula I. Niacin is converted into nicotinamide adenine dinucleotide in the body through the nicotinamide adenine dinucleotide coenzyme system. The mechanism by which niacin regulates lipids is not fully understood and may involve several steps, including partial inhibition of fatty acid release from adipose tissue and increased lipoprotein lipase activity (which increases the rate at which triglyceride chylomicrons are cleared from plasma). Niacin can reduce the rate of hepatic synthesis of very low-density lipoprotein (VLDL-C) and low-density lipoprotein (LDL-C), w...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/455A61K31/366A61K9/24A61K9/28A61P3/06
Inventor 林德良
Owner BEIJING RED SUN PHARMA
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