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Lovastatin and nicotinic acid double-layer sustained release tablets and preparation process

A lovastatin, double-layer tablet technology, applied in the field of lovastatin niacin double-layer sustained-release tablets and its preparation technology, can solve the problems of liver toxicity and low incidence of myopathy, and achieve quality control and product stability , the effect of smooth

Inactive Publication Date: 2010-06-30
YANGTZE RIVER PHARMA GRP BEIJING HAIYAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Patients taking extended-release niacin formulations had lower rates of hepatotoxicity and myopathy

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Extended-release niacin layer prescription

[0021] Niacin 500g

[0022] Hypromellose 252g

[0023] Povidone K30 20.5g

[0024] Stearic acid 9.8g

[0025] Proper amount of ethanol

[0026] lovastatin immediate release layer

[0027] Lovastatin 20g

[0028] Lactose 50g

[0029] Microcrystalline Cellulose 200g

[0030] Sodium carboxymethyl starch 13g

[0031] Magnesium Stearate 3g

[0032] tert-Butyl-p-Hydroxyanisole 1.5g

[0033] Yellow iron oxide 0.2g

[0034] Proper amount of ethanol

Embodiment 2

[0036] Extended-release niacin layer prescription

[0037] Niacin 750g

[0038] Hypromellose 258g

[0039] Povidone K30 21g

[0040] Stearic acid 9.8g

[0041] Proper amount of ethanol

[0042] lovastatin immediate release layer

[0043]Lovastatin 20g

[0044] Lactose 50g

[0045] Microcrystalline Cellulose 200g

[0046] Sodium carboxymethyl starch 13g

[0047] Magnesium Stearate 3g

[0048] tert-Butyl-p-Hydroxyanisole 1.5g

[0049] Yellow iron oxide 0.2g

[0050] Proper amount of ethanol

Embodiment 3

[0052] Extended-release niacin layer prescription

[0053] Niacin 1000g

[0054] Hypromellose 263g

[0055] Povidone K30 21.4g

[0056] Stearic acid 9.8g

[0057] Proper amount of ethanol

[0058] lovastatin immediate release layer

[0059] Lovastatin 20g

[0060] Lactose 50g

[0061] Microcrystalline Cellulose 200g

[0062] Sodium carboxymethyl starch 13g

[0063] Magnesium Stearate 3g

[0064] tert-Butyl-p-Hydroxyanisole 1.5g

[0065] Yellow iron oxide 0.2g

[0066] Alcohol in moderation.

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Abstract

The invention provides a preparation method of double-layer sustained release tablets containing nicotinic acid and Lovastatin. The combination is a double-layer tablet, wherein a nicotinic acid layer is a slow release layer, and the Lovastatin layer is a quick release layer. The invention solves the problems of different drug releasing velocity required by the nicotinic acid and Lovastatin, the nicotinic acid is prepared into the slow release layer, the Lovastatin is prepared into the quick release layer, and the two layers are pressed into the double-layer tablet. The invention solves the common problem that the double-layer tablet splits after long time setting, the prepared Lovastatin and nicotinic acid double-layer sustained release tablets not only have good appearance, but also the upper and lower layers of the tablets are tightly combined with each other; and the speed and degree of expansion of the two layers are consistent, so that the excellent appearance and the drug releasing velocity can always be maintained. The product of the invention has simple preparation method and easily available raw and auxiliary materials, is suitable for industrialized production and has excellent application prospect.

Description

technical field [0001] The invention provides a preparation method of a double-layer sustained-release tablet containing niacin and lovastatin. The combination is a double-layer tablet, wherein the niacin layer is a sustained-release layer, and the lovastatin layer is an immediate-release layer. Background technique [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. With the aging of the social population, the proportion of other cardiovascular diseases caused by hyperlipidemia in the elderly is increasing year by year, which seriously threatens people's life safety. Therefore, seeking effective, safe and reliable hypolipidemic drugs has always been a long-term and popular research topic in the medical field. [0003] Nicotinic acid, also...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/455A61K31/366A61K31/22A61P3/06
Inventor 宋志涛石和鹏侯鹏周津梅张培龙
Owner YANGTZE RIVER PHARMA GRP BEIJING HAIYAN PHARMA
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