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Osmotic pump preparation composition for treating hyperlipemia

A composition and osmotic pump controlled release technology, which is applied in the direction of drug combination, medical preparations with no active ingredients, medical preparations containing active ingredients, etc., can solve the most Optimum ratio and other issues

Active Publication Date: 2009-03-18
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Chinese patent application CN1425374A discloses the composition of acipimox and lovastatin, the disclosed ratio is that the weight ratio of acipimox and lovastatin is 25-50:1, and the preferred ratio is 25:1 or 37.5:1 , but does not involve the optimal ratio of acipimox and pitavastatin calcium compound, the corresponding pharmacological experimental data and reasonable pharmaceutical preparations

Method used

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  • Osmotic pump preparation composition for treating hyperlipemia
  • Osmotic pump preparation composition for treating hyperlipemia
  • Osmotic pump preparation composition for treating hyperlipemia

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0085] Chip composition:

[0086] Acipimus 100g

[0087] NaCl 55g

[0088] PVPk30 2g

[0089] Magnesium Stearate 3g

[0090] Coating film composition:

[0091] Cellulose acetate 7g

[0092] Macrogol 4000 1.5g

[0093] Diethyl phthalate 1g

[0094] Immediate release drug layer composition:

[0095] Pitavastatin Calcium 1g

[0096] HPMC 6cp 6g

[0097] Talc powder 1g

[0098] Isolation film coat layer:

[0099] Opadry II

[0100] Preparation Process:

[0101] (1) Tablet core preparation Take sodium chloride and pulverize, pass through a 100-mesh sieve, mix evenly with acipimox, use 70% ethanol solution containing 8% PVPk30 as a wetting agent, make soft material, pass through a 20-mesh sieve for granulation , dried at 45°C for 2 hours, sized, added with magnesium stearate, mixed evenly, compressed into tablets, about 1000 tablets were compressed using conventional tableting techniques. (2) Tablet core coating: take cellulose acetate, add 280ml of acetone, stir to diss...

Embodiment 2

[0104] Chip composition:

[0105] Acipimus 150g

[0106] Fructose 60g

[0107] Lactose 70g

[0108] PVPk30 5g

[0109] Magnesium Stearate 3g

[0110] Coating film composition:

[0111] Cellulose acetate 8g

[0112] Macrogol 4000 2g

[0113] Dibutyl sebacate 2g

[0114] Immediate release drug layer composition:

[0115] Pitavastatin Calcium 1g

[0116] HPMC 6cp 6g

[0117] Sodium Lauryl Sulfate 2g

[0118] Titanium dioxide 1g

[0119] Talc powder 0.5g

[0120] Preparation Process:

[0121] (1) Tablet core preparation Take sodium chloride and pulverize, pass through a 100-mesh sieve, mix evenly with acipimox, use 70% ethanol solution containing 8% PVPk30 as a wetting agent, make soft material, pass through a 20-mesh sieve for granulation , dried at 45°C for 2 hours, sized, added with magnesium stearate, mixed evenly, compressed into tablets, about 1000 tablets were compressed using conventional tableting techniques. (2) Tablet core coating: take cellulose acetate,...

Embodiment 3

[0124] Chip composition:

[0125] Acipimus 200g

[0126] NaCl 85g

[0127] pvp k30 5g

[0128] Magnesium Stearate 4g

[0129] Coating film composition:

[0130] Ethylcellulose 12g

[0131] HPMC6cp 2g

[0132] Macrogol 4000 1g

[0133] Immediate release drug layer composition:

[0134] Pitavastatin Calcium 1g

[0135] HPMC 6cp 6g

[0136] Talc powder 1g

[0137] Isolation film coat layer:

[0138] Opadry II

[0139] Preparation Process:

[0140] (1) Tablet core preparation Take sodium chloride and pulverize, pass through a 100-mesh sieve, mix evenly with acipimox, use 50% ethanol solution containing 5% HPMC6cp as a wetting agent, make soft material, pass through a 20-mesh sieve for granulation , dried at 5°C for 2 hours, granulated, added with magnesium stearate, mixed evenly, compressed into tablets, about 1000 tablets were compressed using conventional tableting techniques. (2) Core coating: take ethyl cellulose, add 320ml of ethanol,...

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Abstract

The invention provides a new osmotic pump controlled-release pharmaceutical composition for treating hyperlipemia and a preparation method thereof, one of which is a nicotinic acid drug of acipimox, and the other is a statin drug of pitavastatin calcium; wherein, the acipimox is the controlled-release part, the pitavastatin calcium is the rapid-release part; or the acipimox and the pitavastatin calcium are both the controlled-release parts. A compound osmotic pump preparation has the advantages of comprehensive action, low toxicity and side effects and convenient use.

Description

technical field [0001] The invention belongs to the field of medicine, and relates to an osmotic pump controlled-release preparation containing niacin and a statin and a preparation method thereof, in particular to a compound osmotic pump preparation containing acipimox and pitavastatin calcium and its preparation Preparation. Background technique [0002] With the continuous development of medical science, people realize that the high content of cholesterol and fat is the basic cause of cardiovascular disease, and hyperlipidemia is the main risk factor of coronary heart disease and hypertension. Therefore, people began to focus on the development of blood lipid regulating drugs as the prevention and treatment of cardiovascular diseases. Since the late 1980s, a large number of blood lipid-lowering drugs have been launched, among which statins have been well received by people, and their clinical efficacy is unmatched by other types of blood lipid regulating drugs. Over the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K9/28A61K47/38A61K45/06A61K31/4965A61P3/06A61P9/10A61K31/4709
Inventor 赵志全
Owner LUNAN PHARMA GROUP CORPORATION
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