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Osmotic pump controlled release preparation composition for treating hyperlipemia and preparation method thereof

A technology of osmotic pump controlled release and composition, which is applied in the field of medicine and can solve problems such as preparation of osmotic pump preparations that have not been mentioned

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 ; Chinese patent application 200410047857.5 reported acipimox and rosuvastatin calcium compound preparation in free acid, but did not mention the preparation of osmotic pump preparation

Method used

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  • Osmotic pump controlled release preparation composition for treating hyperlipemia and preparation method thereof
  • Osmotic pump controlled release preparation composition for treating hyperlipemia and preparation method thereof
  • Osmotic pump controlled release preparation composition for treating hyperlipemia and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0084] Chip composition:

[0085] Acipimus 250g

[0086] NaCl 100g

[0087] PVPk30 5g

[0088] Magnesium Stearate 5g

[0089] Coating film composition:

[0090] Cellulose acetate 12g

[0091] Macrogol 4000 3.5g

[0092] Diethyl phthalate 2g

[0093] Immediate release drug layer composition:

[0094] Rosuvastatin 4.5g

[0095] HPMC 6cp 2.5g

[0096] Talc powder 0.4g

[0097] Isolation film coat layer:

[0098] Opadry II

[0099] 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, use 70% alcohol 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...

Embodiment 2

[0102] Chip composition:

[0103] Acipimus 250g

[0104] Fructose 50g

[0105] Lactose 50g

[0106] PVPk30 5g

[0107] Magnesium Stearate 5g

[0108] Coating film composition:

[0109] Cellulose acetate 12g

[0110] Macrogol 4000 1.5g

[0111] Dibutyl sebacate 2g

[0112] Immediate release drug layer composition:

[0113] Rosuvastatin 8g

[0114] HPMC 6cp 5g

[0115] Sodium Lauryl Sulfate 2g

[0116] Titanium dioxide 1g

[0117] Talc powder 0.5g

[0118] 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, use 70% alcohol 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...

Embodiment 3

[0121] Chip composition:

[0122] Acipimus 250g

[0123] NaCl 100g

[0124] PVPk30 5g

[0125] Magnesium Stearate 5g

[0126] Coating film composition:

[0127] Ethylcellulose 12g

[0128] HPMC6cp 3g

[0129] Macrogol 4000 1g

[0130] Immediate release drug layer composition:

[0131] Rosuvastatin 12.5g

[0132] HPMC 6cp 7g

[0133] Talc powder 1g

[0134] Isolation film coat layer:

[0135] Opadry II

[0136] 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 preparation containing acipimox, rosuvastatin and other pharmaceutical excipients, wherein, the acipimox is the controlled-release part, the rosuvastatin is the rapid-release part; or the acipimox and the rosuvastatin are both the controlled-release parts. In addition, the invention further discloses a preparation method of an osmotic pump tablet of the composition, and the osmotic pump table which is prepared by applying the method can better bring the synergy of the acipimox and the rosuvastatin into play.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to an osmotic pump controlled-release preparation composition for treating hyperlipidemia containing two active ingredients of medicines, wherein one medicine is acipimox and the other medicine is rosuvastatin. 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 years, the c...

Claims

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Application Information

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IPC IPC(8): A61K31/506A61K9/22A61K9/36A61P3/06A61K31/4965
Inventor 赵志全
Owner LUNAN PHARMA GROUP CORPORATION
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