Osmotic pump controlled release preparation composition and preparation thereof

An osmotic pump controlled release and composition technology, which is applied in the directions of drug combinations, active ingredients of heterocyclic compounds, pharmaceutical formulations, etc., can solve the problem of not mentioning preparation into osmotic pump preparations, etc.

Active Publication Date: 2009-01-28
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 ; Chinese patent application 200410047857.5 reported acipimox and atorvastatin calcium compound preparation in free acid, but did not mention to be prepared as an osmotic pump preparation

Method used

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  • Osmotic pump controlled release preparation composition and preparation thereof
  • Osmotic pump controlled release preparation composition and preparation thereof
  • Osmotic pump controlled release preparation composition and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0086] Chip composition:

[0087] Acipimus 100g

[0088] NaCl 25g

[0089] PVPk30 1.5g

[0090] Magnesium Stearate 2g

[0091] Coating film composition:

[0092] Cellulose acetate 7g

[0093] Macrogol 4000 3g

[0094] Diethyl phthalate 2g

[0095] Immediate release drug layer composition:

[0096] Atorvastatin 10g

[0097] HPMC 6cp 6g

[0098] Talc powder 1g

[0099] Isolation film coat layer:

[0100] Opadry II

[0101] Make 1000 tablets by the following preparation method: (1) Tablet core preparation Get sodium chloride and pulverize, cross 100 mesh sieves, mix with acipimox evenly, take 70% ethanol solution containing 8% PVPk30 as wetting agent, prepare Soft material, passed through a 20-mesh sieve to granulate, dried at 45°C for 2 hours, granulated, added with magnesium stearate, mixed evenly, compressed into tablets, and compressed into 1000 tablets by conventional tableting technology. (2) Tablet core coating: take cellulose acetate, add 280ml of acetone, st...

Embodiment 2

[0104] Chip composition:

[0105] Acipimus 150g

[0106] Fructose 45g

[0107] Lactose 40g

[0108] PVPk30 4g

[0109] Magnesium Stearate 4g

[0110] Coating film composition:

[0111] Cellulose acetate 8g

[0112] Macrogol 4000 2g

[0113] Dibutyl sebacate 1.5g

[0114] Immediate release drug layer composition:

[0115] Atorvastatin 10g

[0116] HPMC 6cp 6g

[0117] Sodium Lauryl Sulfate 2g

[0118] Titanium dioxide 1g

[0119] Talc powder 0.5g

[0120] Make 1000 tablets by the following preparation method: (1) Tablet core preparation Get sodium chloride and pulverize, cross 100 mesh sieves, mix with acipimox evenly, take 70% ethanol solution containing 8% PVPk30 as wetting agent, prepare Soft material, passed through a 20-mesh sieve to granulate, dried at 45°C for 2 hours, granulated, added with magnesium stearate, mixed evenly, compressed into tablets, and compressed into 1000 tablets by conventional tableting technology. (2) Tablet core coating: take cellulos...

Embodiment 3

[0123] Chip composition:

[0124] Acipimus 200g

[0125] NaCl 90g

[0126] PVPk30 4.8g

[0127] Magnesium Stearate 5g

[0128] Coating film composition:

[0129] Ethyl cellulose 10g

[0130] HPMC6cp 3g

[0131] Macrogol 4000 1g

[0132] Immediate release drug layer composition:

[0133] Atorvastatin 10g

[0134] HPMC 6cp 6g

[0135] Talc powder 1g

[0136] Isolation film coat layer:

[0137] Opadry II

[0138] Make 1000 tablets by the following preparation method: (1) tablet core preparation Get sodium chloride and pulverize, cross 100 mesh sieves, mix with acipimox evenly, take the 50% ethanol solution containing 5% HPMC6cp as wetting agent, prepare Soft material, passed through a 20-mesh sieve to granulate, dried at 5°C for 2 hours, granulated, added with magnesium stearate, mixed evenly, compressed into tablets, and compressed into 1000 tablets by conventional tableting technology. (2) Core coating: take ethyl cellulose, add 320ml of ethanol, stir to dissolve; ...

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Abstract

The invention relates to an osmotic pump controlled release pharmaceutical composition which contains two medicine active ingredients and is used for treating hyperlipoidemia and a preparation method thereof, the pharmaceutical composition has a nicotinic acids medicine such as acipimox and the other one estatina medicine such as atorvastatin; wherein, the nicotinic acids medicine such as acipimox is a controlled release part, and the estatina medicine such as atorvastatin is a quick release part; or both the acipimox and the atorvastatin are the controlled release part. The compound osmotic pump preparation of the invention has the advantages of comprehensive action, low toxicity and side effects and convenient use.

Description

Technical field: [0001] The invention relates to an osmotic pump controlled-release preparation composition for treating hyperlipidemia containing two active ingredients of medicines, wherein one medicine is nicotinic acid medicine, such as acipimox, and the other medicine is statins, such as azilimus Torvastatin. 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 past ten yea...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/42A61K45/06A61K31/455A61K31/4965A61K47/38A61P3/06A61K31/366A61K31/40A61K31/22
Inventor 赵志全刘全志牛童杨文斌
Owner LUNAN PHARMA GROUP CORPORATION
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