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Compound osmotic pump controlled release preparation and preparation method thereof

A technology of controlled-release preparations and osmotic pumps, which is applied in the directions of pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc. than the problem

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 , but it does not involve the optimal ratio of acipimox and simvastatin and the corresponding pharmacological experimental data

Method used

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  • Compound osmotic pump controlled release preparation and preparation method thereof
  • Compound osmotic pump controlled release preparation and preparation method thereof
  • Compound osmotic pump controlled release preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0109] Chip composition:

[0110] Acipimus 100g

[0111] NaCl 50g

[0112] PVPk30 2.5g

[0113] Magnesium Stearate 3g

[0114] Coating film composition:

[0115] Cellulose acetate 6g

[0116] Macrogol 4000 1.5g

[0117] Diethyl phthalate 1g

[0118] Immediate release drug layer composition:

[0119] Simvastatin 10g

[0120] HPMC 6cp 6g

[0121] Talc powder 1g

[0122] Isolation film coat layer:

[0123] Opadry II

[0124] 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, s...

Embodiment 2

[0127] Chip composition:

[0128] Acipimus 150g

[0129] Fructose 45g

[0130] Lactose 45g

[0131] PVPk30 5g

[0132] Magnesium Stearate 5g

[0133] Coating film composition:

[0134] Cellulose acetate 8g

[0135] Macrogol 4000 2g

[0136] Dibutyl sebacate 2g

[0137] Immediate release drug layer composition:

[0138] Simvastatin 10g

[0139] HPMC 6cp 6g

[0140] Sodium Lauryl Sulfate 2g

[0141] Titanium dioxide 1g

[0142] Talc powder 0.5g

[0143] 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 a...

Embodiment 3

[0146] Chip composition:

[0147] Acipimus 200g

[0148] NaCl 90g

[0149] pvp k30 5g

[0150] Magnesium Stearate 5g

[0151] Coating film composition:

[0152] Ethylcellulose 12g

[0153] HPMC6cp 2g

[0154] Macrogol 4000 1g

[0155] Immediate release drug layer composition:

[0156] Simvastatin 10g

[0157] HPMC 6cp 6g

[0158] Talc powder 1g

[0159] Isolation film coat layer:

[0160] Opadry II

[0161]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, s...

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Abstract

The invention provides a new osmotic pump controlled release pharmaceutical composition 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 simvastatin; wherein, the nicotinic acids medicine such as acipimox is a controlled release part, and the estatina medicine such as simvastatin is a quick release part; or both the acipimox and the simvastatin 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 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 controlled-release preparation containing acipimox and simvastatin and its preparation method. 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. Ove...

Claims

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Application Information

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