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Composite for treating hyperlipidemia

A technology for hyperlipidemia and composition, applied in the field of new compositions, can solve the problems that do not involve the optimal ratio of acyclolimus and fluvastatin compound formulations, etc.

Inactive Publication Date: 2008-01-02
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] 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 did not involve the optimal ratio of acipimox and fluvastatin compound and the corresponding pharmacological experimental data

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0016] a. Acipimox 200g

[0017] Blank ball core 250g

[0018] 7% PVP solution (solvent is 90% ethanol) 200g

[0019] 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.

[0020] b. Fluvastatin sodium 10g (calculated as fluvastatin free acid)

[0021] Blank ball core 30g

[0022] 7% PVP solution (solvent is 90% ethanol) 30g

[0023] Preparation process: pass fluvastatin sodium through a 120-mesh sieve, weigh the prescription amount, and pour it into the lower hopper. Start the granulation coating m...

example 2

[0026] a. Acipimox 200g

[0027] Lactose 30g

[0028] Sodium carboxymethyl starch 30g

[0029] Microcrystalline Cellulose 18g

[0030] 6% PVP in absolute ethanol 100g

[0031] Magnesium Stearate 2g

[0032] 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.

[0033] b. Fluvastatin sodium 20g (calculated as fluvastatin free acid)

[0034] Hydroxypropyl Cellulose 30g

[0035] 20g pregelatinized starch

[0036] 6% PVP in absolute ethanol solution 30g

[0037] Glyceryl Behenate 1g

[0038]Preparation proces...

example 3

[0041] a. Acipimox 200g

[0042] Lactose 30g

[0043] Sodium carboxymethyl starch 30g

[0044] Microcrystalline Cellulose 18g

[0045] 6% PVP in absolute ethanol 100g

[0046] Magnesium Stearate 2g

[0047] 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.

[0048] b. Fluvastatin sodium 30g (calculated as fluvastatin free acid 30g)

[0049] Hydroxypropyl Cellulose 50g

[0050] 40g pregelatinized starch

[0051] 6% PVP in absolute ethanol solution 50g

[0052] Glyceryl Behenate 2g

[0053] Preparation p...

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Abstract

The present invention provides a drug composite for treating hyperlipidemia, the characteristics of which lies in containing effective amount Acipimox and Fluvastatin natrium, the weight ratio is (5~30):1, the optimal selection weight ratio is (5~15):1, the further optimal selection weight ratio is 10:1. The lipid-lowering effect is superior to the simple recipe with same dose significantly, which shows that there is synergistic effect and no distinct toxicity function under taking the Acipimox and the Fluvastatin both.

Description

Technical field [0001] The invention relates to a new composition for treating hyperlipidemia, especially a composition containing Acipimox, Fluvastatin salt and pharmaceutical auxiliary materials. 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 prevention and treatment trials has conf...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4965A61K31/405A61P3/06
Inventor 赵志全
Owner LUNAN PHARMA GROUP CORPORATION
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