Drug compound for curing hyperlipoidemia and preparation method thereof

A technology of hyperlipidemia and composition, applied in the field of compound preparations, can solve the problems such as patent reports of atorvastatin and niacin sustained-release preparations that have not yet been found, and achieve the effects of reduced adverse reactions, reduced occurrence and convenient use.

Inactive Publication Date: 2009-10-21
广西方略药业集团有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] At present, no patent reports on the combination of atorvastatin and niacin sustained-release preparations have been found

Method used

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  • Drug compound for curing hyperlipoidemia and preparation method thereof
  • Drug compound for curing hyperlipoidemia and preparation method thereof
  • Drug compound for curing hyperlipoidemia and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] Embodiment 1 Atorvastatin Calcium Niacin Double Layer Sustained Release Tablet (20 / 500mg)

[0049] prescription:

[0050] Nicotinic acid layer

[0051] Component Dosage

[0052] Niacin 500.0g

[0053] HPMC-K15M 180.0g

[0054] Lactose 20.0g

[0055] Talc powder 7.00g

[0056] Magnesium Stearate 3.5g

[0057] 5% starch slurry appropriate amount

[0058] Atorvastatin calcium layer

[0059] Component Dosage

[0060] Atorvastatin Calcium 20.0g

[0061] Microcrystalline Cellulose 100.0g

[0062] Lactose 40.0g

[0063] Talc powder 2.0g

[0064] Magnesium Stearate 1.0g

[0065] 5% starch slurry appropriate amount

[0066] A total of 1000 pieces were made

[0067] Preparation:

[0068] Pass the prescribed amount of niacin through a 100-mesh sieve, and pass the prescribed amount of HPMC-K15M and lactose through a 60-mesh sieve. Mix the above raw and auxiliary materials evenly, make soft material with 5% starch slurry, granulate with 18 mesh sieve, dry at 50°C, g...

Embodiment 2

[0071] Example 2 Atorvastatin Calcium Niacin Double Layer Sustained Release Tablet (20 / 750mg)

[0072] prescription:

[0073] Nicotinic acid layer

[0074] Component Dosage

[0075] Niacin 750.0g

[0076] HPMC-K15M 230.0g

[0077] Lactose 30.0g

[0078] Talc powder 9.0g

[0079] Magnesium Stearate 4.5g

[0080] 5% starch slurry appropriate amount

[0081] Atorvastatin calcium layer

[0082] Component Dosage

[0083] Atorvastatin Calcium 20.0g

[0084] Microcrystalline Cellulose 120.0g

[0085] Lactose 50.0g

[0086]Talc powder 2.0g

[0087] Magnesium Stearate 1.0g

[0088] 5% starch slurry appropriate amount

[0089] A total of 1000 pieces were made

[0090] Preparation:

[0091] Pass the prescribed amount of niacin through a 100-mesh sieve, and pass the prescribed amount of HPMC-K15M and lactose through a 60-mesh sieve. Mix the above raw and auxiliary materials evenly, make soft material with 5% starch slurry, granulate with 18 mesh sieve, dry at 50°C, granul...

Embodiment 3

[0094] Example 3 Atorvastatin Calcium Niacin Double Layer Sustained Release Tablet (20 / 1000mg)

[0095] prescription:

[0096] Nicotinic acid layer

[0097] Component Dosage

[0098] Niacin 1000.0g

[0099] HPMC-K100M 300.0g

[0100] Lactose 40.0g

[0101] Talc powder 15.0g

[0102] Magnesium Stearate 7.5g

[0103] 5% starch slurry appropriate amount

[0104] Atorvastatin calcium layer

[0105] Component Dosage

[0106] Atorvastatin Calcium 20.0g

[0107] Microcrystalline Cellulose 140.0g

[0108] Lactose 60.0g

[0109] Talc powder 2.0g

[0110] Magnesium Stearate 1.0g

[0111] 5% starch slurry appropriate amount

[0112] A total of 1000 pieces were made

[0113] Preparation:

[0114] Pass the prescribed amount of niacin through a 100-mesh sieve, and pass the prescribed amount of HPMC-K100M and lactose through a 60-mesh sieve. Mix the above raw and auxiliary materials evenly, make soft material with 5% starch slurry, granulate with 18 mesh sieve, dry at 50°C, ...

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Abstract

The invention relates to a drug compound for curing hyperlipoidemia and a preparation method thereof. The compound contains atorvastatin and nicotinic acid, can be a slow releasing agent and a quick releasing agent and is used for curing essential hyperlipidemia (familial heterozygote and nonfamilial) and hybrid dyslipidemia (Frederickson IIa and IIb type).

Description

technical field [0001] The present invention relates to a compound preparation containing atorvastatin and niacin sustained-release preparation, which is used for treating primary hyperlipidemia (heterozygous familial and non-familial) and mixed dyslipidemia ( Frederickson types II a and II b). Background technique [0002] Hyperlipidemia refers to a systemic disorder in which serum cholesterol (TC), triglyceride (TG) and / or low-density lipoprotein (LDL) are too high and / or serum high-density lipoprotein (HDL) is too low Abnormal lipid metabolism. [0003] Mixed dyslipidemia refers to high low-density lipoprotein (LDL) with high triglyceride (TG) and / or low high-density lipoprotein (HDL) and severe high-low-density lipoprotein (LDL) Hyperlipidemia and other mixed types of dyslipidemia. [0004] In the treatment of these two diseases, it is difficult to achieve a satisfactory blood lipid level with a single lipid-lowering drug, and often requires a combination of lipid-low...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/455A61K31/40A61P3/06A61K9/20A61K9/28
Inventor 杨进明王德武莫国飞
Owner 广西方略药业集团有限公司
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