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

An osmotic pump controlled release and composition technology, applied in the field of medicine, can solve problems such as short half-life

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 the half-life of acipimox is short, only 2h, and its minimum effective plasma concentration is 0.2ug / ml
Ordinary immediate-release preparations and matrix-type sustained-release preparations are difficult to maintain effective blood drug concentrations during the dosing interval, and it is difficult to make compound drugs produce better synergy

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

[0086] Chip composition:

[0087] Acipimus 250g

[0088] NaCl 100g

[0089] PVPk30 5g

[0090] Magnesium Stearate 5g

[0091] Coating film composition:

[0092] Cellulose acetate 12g

[0093] Macrogol 4000 2.5g

[0094] Diethyl phthalate 2g

[0095] Immediate release drug layer composition:

[0096] Fluvastatin 6g

[0097] HPMC 6cp 5g

[0098]Talc powder 0.8g

[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, with 70% ethanol solution containing 8% PVPk30 as wetting agent, Make soft material, granulate through a 20-mesh sieve, dry at 45°C for 2 hours, granulate, add magnesium stearate, mix well, and compress into tablets, using conventional tableting technology to compress 1000 tablets. (2) Tablet core coating: Take cellulose acetate, add 280ml of acetone, stir to dissolve; take another...

Embodiment 2

[0104] Chip composition:

[0105] Acipimus 250g

[0106] Fructose 50g

[0107] Lactose 50g

[0108] PVPk30 5g

[0109] Magnesium Stearate 5g

[0110] Coating film composition:

[0111] Cellulose acetate 12g

[0112] Macrogol 4000 1.5g

[0113] Dibutyl sebacate 2g

[0114] Immediate release drug layer composition:

[0115] Fluvastatin 15g

[0116] HPMC 6cp 7g

[0117] Sodium Lauryl Sulfate 2g

[0118] Titanium dioxide 1g

[0119] Talc powder 0.8g

[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, with 70% ethanol solution containing 8% PVPk30 as wetting agent, Make soft material, granulate through a 20-mesh sieve, dry at 45°C for 2 hours, granulate, add magnesium stearate, mix well, and compress into tablets, using conventional tableting technology to compress 1000 tablets. (2) Tablet core coating: Take cellulose acetate, add 280ml of aceto...

Embodiment 3

[0123] Chip composition:

[0124] Acipimus 250g

[0125] NaCl 100g

[0126] pvp k30 5g

[0127] Magnesium Stearate 5g

[0128] Coating film composition:

[0129] Ethylcellulose 12g

[0130] HPMC6cp 2g

[0131] Macrogol 4000 1g

[0132] Immediate release drug layer composition:

[0133] Fluvastatin 30g

[0134] HPMC 6cp 15g

[0135] Talc powder 2.5g

[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 ...

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Abstract

The invention relates to an osmotic pump preparation containing acipimox, fluvastatin and other pharmaceutical excipients, wherein, the acipimox is the controlled-release part, the fluvastatin is the rapid-release part; or the acipimox and the fluvastatin are both the controlled-release parts. In addition, the invention further discloses a preparation method of osmotic pump tablets 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 fluvastatin into play.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to an osmotic pump controlled-release formulation composition for treating hyperlipidemia containing two active ingredients of medicines. 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 completion of several international large-scale coronary heart disease pre...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4965A61K9/22A61K9/34A61K9/36A61P3/06A61K31/404
Inventor 赵志全
Owner LUNAN PHARMA GROUP CORPORATION
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