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Simvastatin apellagrin sustained-release capsule and method of producing the same

A technology for simvastatin and sustained-release capsules, which is applied in the field of compound simvastatin niacin sustained-release capsules and its preparation, can solve the problems of lowering LDL, high blood drug concentration, and reduced synthesis, so as to reduce the number of times of taking medicine and blood lipid levels Improve and reduce the effect of toxic and side effects

Inactive Publication Date: 2009-05-13
BEIJING HONGYANG HENGFENG MEDICINE TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

effect; but due to the instantaneous blood concentration is too high, it often has liver toxicity
Simvastatin is an inhibitor of HMG-COA reductase, which competitively inhibits endogenous cholesterol synthesis rate-limiting enzyme 1_tMG-COA reductase, blocks intracellular mevalonate metabolic pathway, and reduces intracellular cholesterol synthesis. As a result, feedback stimulates the increase in the number and activity of LDL receptors on the surface of cell membranes (mainly liver cells), increases serum cholesterol clearance, and significantly reduces LDL, but the effect of increasing HDL-C is weak

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] The preparation method of the blank pellets is as follows: 500g of starch and 500g of sucrose are respectively crushed through a 100-mesh sieve, mixed evenly, and 50% ethanol solution is used as a wetting agent. The mold is drawn in a coating granulator, the pellets are rolled, and dried at 60°C. Finally, screen 30-40 mesh pellets for later use:

[0027] The preparation method of nicotinic acid sustained-release pellets is as follows: pulverize 250 g of nicotinic acid and pass through a 100-mesh sieve; take 70 g of blank pellets and put them in a coating granulator, keep the rotating speed at 100 rpm, and spray 30% ethanol solution to the pellets Sprinkle the nicotinic acid evenly, continue to roll for 10 minutes after the sprinkling, take out the pellets, dry them at 60°C, screen the 20-24 mesh pellets, put the plain pellets in the coating granulator, and keep the speed at 100 rpm , blowing hot air to keep the temperature of the pellets at 50°C, spraying 15% ethyl cell...

Embodiment 2

[0032] The preparation method of blank pellets is: respectively pulverize 500g of starch and 500g of sucrose through a 100-mesh sieve, mix evenly, use 50% ethanol solution as a wetting agent, release the mold in a coating granulator, roll the pellets, and dry at 60°C , Screen 30-40 mesh pellets for later use:

[0033] The preparation method of nicotinic acid sustained-release pellets is as follows: crush 500 g of nicotinic acid and pass through a 100-mesh sieve; take 70 g of blank pellets and put them in a coating granulator, keep the rotating speed at 100 rpm, and spray 30% ethanol solution to the pellets. Sprinkle the nicotinic acid evenly, sprinkle it into the knot and continue to roll for 10 minutes, take out the pellets, and dry them at 60°C. Screen the 20-24 mesh pellets, place the pellets in a coating granulator, keep the rotating speed at 100 rpm, blow in hot air to keep the pellet temperature at 50°C, spray 15% ethyl cellulose coating solution, and make The weight of...

Embodiment 3

[0038] The preparation method of the blank pellets is as follows: 500g of starch and 500g of sucrose are respectively pulverized through a 100-mesh sieve, mixed evenly, and 50% ethanol solution is used as a wetting agent, molded in a coating granulator, rolled, and dried at 60°C , screen 30-40 mesh pellets for later use;

[0039] The preparation method of the niacin sustained-release pellets is as follows: crush 250 g of niacin and pass through a 100-mesh sieve; take 70 g of blank pellets and put them in a coating granulator. Keep the rotation speed at 100 rpm, spray 30% ethanol solution on the pellets and sprinkle niacin evenly, continue rolling for 10 minutes after sprinkling, take out the pellets, dry them at 60°C, screen the 20-24 mesh pellets, and Place the vegetarian pills in a coating granulator, keep the speed at 100 rpm, blow in hot air to keep the temperature of the pellets at 50°C, spray 15% Surelease aqueous solution to increase the weight of the pellets by 25%, an...

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PUM

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Abstract

The invention provides a compound simvastatin niacin sustained-release capsule and a preparation method thereof. In the compound sustained-release capsule preparation, each capsule comprises 200 to 500 mg of niacin and 20 mg of simvastatin. The compound sustained-release capsule is prepared by the following steps: preparing blank pills, preparing niacin sustained-release pills; preparing simvastatin sustained-release pills, and preparing capsules. The product is suitable for treating primary hypercholesterolemia and mixed dyslipidemia; according to the characteristics, the niacin part is used as the sustained-release part and the simvastatin is used as the immediate-release part to produce the compound preparation, so that all the components exert synergism in the body, exert the efficacy to the largest extent, reduce the toxic and side effects of the drug, reduce the fluctuation of the plasma drug concentration in the body and reduce the drug taking times of the patient; the efficacy on relieving hypercholesterolemia of the product is obviously superior to that of any single prescription preparation.

Description

technical field [0001] The invention relates to a compound simvastatin nicotinic acid sustained-release capsule and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] Primary hypercholesterolemia and mixed dyslipidemia are common clinical diseases and frequently-occurring diseases. There is a significant correlation between serum cholesterol concentration and the severity of cardiovascular diseases such as atherosclerosis and coronary heart disease. When the serum cholesterol concentration increases, the incidence of atherosclerosis also increases significantly. The treatment of cardiovascular disease has become a worldwide problem, and its morbidity and mortality are the first, claiming the lives of 12 million people around the world every year, which is close to 1 / 4 of the total death toll of the world's population. [0003] Hyperlipidemia is one of the main causes of coronary heart disease and stroke, and ca...

Claims

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Application Information

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IPC IPC(8): A61K9/56A61K31/366A61K31/455A61P3/06
Inventor 谷雨
Owner BEIJING HONGYANG HENGFENG MEDICINE TECH
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