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Composition for treating hyperlipemia

A technology for hyperlipidemia and a composition, which is applied in the field of compositions for treating hyperlipidemia, can solve the problems that do not involve the optimal ratio of axiolimus and pitavastatin compound formulations and the like

Inactive Publication Date: 2009-12-09
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] 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 pitavastatin compound and the corresponding pharmacological experimental data

Method used

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  • Composition for treating hyperlipemia
  • Composition for treating hyperlipemia
  • Composition for treating hyperlipemia

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] a. Acipimox 200g

[0020] Blank ball core 250g

[0021] 7% PVP solution (solvent is 90% ethanol) 200g

[0022] Preparation process: Pass acipimox through a 120-mesh sieve, weigh the prescription amount, and pour it into the lower hopper. Turn on the granulation coating machine, the air inlet pressure is 0.5bar, the air inlet temperature is 30°C, the spray gun pressure (CYL) is 3bar, the atomization pressure (CAP1) is 0.8bar, pour blank ball cores, granulate, the feeding speed is 4rpm, the creeping Pump 12%, turntable speed 145rpm, spray 7% PVP solution (solvent is 90% ethanol). After granulation is completed, dry at 50°C and discharge.

[0023] b. Pitavastatin calcium 0.5g (calculated as pitavastatin free acid)

[0024] Blank ball core 30g

[0025] 7% PVP solution (solvent is 90% ethanol) 30g

[0026] Preparation process: Pass pitavastatin calcium through a 120-mesh sieve, weigh the prescription amount, and pour it into the lower hopper. Start the granulation coa...

Embodiment 2

[0029] a. Acipimox 200g

[0030] Lactose 30g

[0031]Sodium carboxymethyl starch 30g

[0032] Microcrystalline Cellulose 18g

[0033] 6% PVP in absolute ethanol 100g

[0034] Magnesium Stearate 2g

[0035] Preparation process: Acipimox is passed through a 100-mesh sieve, lactose, sodium carboxymethyl starch, and microcrystalline cellulose are passed through a 80-mesh sieve, and the prescribed amount of acipimox, lactose, sodium carboxymethyl starch, and microcrystalline cellulose is weighed Mix the ingredients evenly, add an appropriate amount of 6% PVP absolute ethanol solution to granulate, dry at 60°C, sieve the dry granules with a 16-mesh sieve, and add the prescribed amount of magnesium stearate to the dry granules.

[0036] b. Pitavastatin calcium 1g (calculated as pitavastatin free acid)

[0037] Hydroxypropyl Cellulose 30g

[0038] 20g pregelatinized starch

[0039] 6% PVP in absolute ethanol solution 30g

[0040] Glyceryl Behenate 1g

[0041] Preparation proc...

Embodiment 3

[0044] a. Acipimox 200g

[0045] Lactose 30g

[0046] Sodium carboxymethyl starch 30g

[0047] Microcrystalline Cellulose 18g

[0048] 6% PVP in absolute ethanol 100g

[0049] Magnesium Stearate 2g

[0050] Preparation process: Acipimox is passed through a 100-mesh sieve, lactose, sodium carboxymethyl starch, and microcrystalline cellulose are passed through a 80-mesh sieve, and the prescribed amount of acipimox, lactose, sodium carboxymethyl starch, and microcrystalline cellulose is weighed Mix the ingredients evenly, add an appropriate amount of 6% PVP absolute ethanol solution to granulate, dry at 60°C, sieve the dry granules with a 16-mesh sieve, and add the prescribed amount of magnesium stearate to the dry granules.

[0051] b. Pitavastatin calcium 1.5g (calculated as pitavastatin free acid)

[0052] Hydroxypropyl Cellulose 50g

[0053] 40g pregelatinized starch

[0054] 6% PVP in absolute ethanol solution 50g

[0055] Glyceryl Behenate 2g

[0056] Preparation p...

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Abstract

The present invention provides a new pharmaceutical composition for treating hyperlipidemia, which includes acipimox as the first active ingredient, pitavastatin as the second active ingredient, or pharmaceutically acceptable salts, esters or Solvate; the weight ratio of the first and second active ingredients (calculated as free acid) is (50-800):1, preferably (100-400):1, more preferably 200:1. The combined application of acipimox and pitavastatin, its lipid-lowering effect is significantly better than that of the same dosage alone, indicating that the combination of the two drugs has a synergistic effect, and at the same time there is no obvious toxic effect, and combined with acipimox and pravastatin Compared with the combined use of acipimus and lovastatin, the lipid-lowering effect is more obvious.

Description

technical field [0001] The present invention is a divisional application of the patent application submitted on May 25, 2005 with the application number 200580007179.2 and the title of the invention "composition for treating hyperlipidemia". [0002] The invention relates to a novel composition for treating hyperlipidemia, which comprises a first active ingredient acipimox and a second active ingredient pitavastatin calcium or pharmaceutically acceptable salts, esters or solvates thereof. Background technique [0003] 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 bee...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4965A61K31/47A61K31/22A61P3/06
Inventor 赵志全
Owner LUNAN PHARMA GROUP CORPORATION