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A kind of rosuvastatin calcium fenofibric acid choline salt sustained-release tablet

A technology of fenofibric acid choline salt and rosuvastatin calcium is applied in the field of rosuvastatin calcium fenofibric acid choline salt sustained-release tablet and its preparation, which can solve the problems such as complicated preparation process, Achieve the effects of simple preparation process, reduction of adverse reactions, and complementary prescriptions

Active Publication Date: 2018-05-18
CHANGSHA BAISHUN BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, its preparation process is relatively cumbersome

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Prescription (to make 1000 tablets):

[0032] Rosuvastatin Calcium 500g

[0033] Fenofibrate Choline Salt 200g

[0034] Ethyl cellulose 400g

[0035] Sodium chloride 25g

[0036] Lactose 150g

[0037] Tragacanth Gum 75g

[0038] Talc powder 15g

[0039] Iron oxide 1g

[0040] Preparation process:

[0041] 1. Processing of raw and auxiliary materials: Rosuvastatin calcium and fenofibric acid choline salt are placed in a pulverizer and passed through an 80-mesh sieve for grinding, and the auxiliary materials are directly sieved with a 100-mesh sieve;

[0042] 2. Making soft materials: Dry mix the processed raw and auxiliary materials (except lubricants such as magnesium stearate) for 5 minutes and stir evenly, then use 70% alcohol to make soft materials, knead them into balls, and disperse when rubbed appropriate;

[0043] 3. Wet granulation: take the above-mentioned soft material and pass it through a 18-mesh nylon sieve to granulate;

[0044] 4. Drying: the we...

Embodiment 2

[0050] Prescription (1000 tablets made):

[0051] Rosuvastatin Calcium 500g

[0052] Fenofibrate Choline Salt 200g

[0053] Ethyl cellulose 350g

[0054] Sodium chloride 15g

[0055] Lactose 150g

[0056] Tragacanth Gum 75g

[0057] Talc powder 15g

[0058] Iron oxide 0.5g

[0059] Preparation process:

[0060] 1. Processing of raw and auxiliary materials: put rosuvastatin calcium in a pulverizer and pass through an 80-mesh sieve for grinding, and the auxiliary materials are directly sieved with a 100-mesh sieve;

[0061] 2. Making soft materials: Dry mix the processed raw and auxiliary materials (except lubricants such as magnesium stearate) for 5 minutes and stir evenly, then use 70% alcohol to make soft materials, knead them into balls, and disperse when rubbed appropriate;

[0062] 3. Wet granulation: take the above-mentioned soft material and pass it through a 18-mesh nylon sieve to granulate;

[0063] 4. Drying: the wet granules are sent into the dryer, so that t...

Embodiment 3

[0069] Prescription (1000 tablets made in total):

[0070] Rosuvastatin Calcium 500g

[0071] Fenofibrate Choline Salt 200g

[0072] Ethylcellulose 450g

[0073] Sodium chloride 15g

[0074] Lactose 150g

[0075] Tragacanth Gum 75g

[0076] Talc powder 15g

[0077] Iron oxide 0.5g

[0078] Preparation process:

[0079] 1. Processing of raw and auxiliary materials: put rosuvastatin calcium in a pulverizer and pass through an 80-mesh sieve for grinding, and the auxiliary materials are directly sieved with a 100-mesh sieve;

[0080] 2. Making soft materials: Dry mix the processed raw and auxiliary materials (except lubricants such as magnesium stearate) for 5 minutes and stir evenly, then use 70% alcohol to make soft materials, knead them into balls, and disperse when rubbed appropriate;

[0081] 3. Wet granulation: take the above-mentioned soft material and pass it through a 18-mesh nylon sieve to granulate;

[0082] 4. Drying: the wet granules are sent into the dryer,...

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Abstract

The invention discloses a rosuvastatin calcium fenofibrate choline salt sustained-release tablet, which is characterized in that the formula weight percentage of the rosuvastatin calcium fenofibrate choline salt sustained-release tablet is calculated as: Suvastatin calcium 10-40%, fenofibric acid choline salt 10-30%, skeleton material 15-40%, electrolyte 0-10%, sugar 10-30%, hydrophilic gel 10-20% , lubricant 0-5%, stabilizer 0.1-5%. The invention is a compound preparation, the prescriptions are complementary, synergistic, and the preparation process is simple, the obtained sustained-release tablet can continuously release the drug, provide stable and long-lasting effective blood drug concentration, avoid or reduce the peak-valley phenomenon, and is beneficial to improve the safety of drug use. Safety, reducing adverse drug reactions; the total dose of medication is reduced, and the minimum dose is used to achieve the maximum efficacy. It is an efficient and safe blood lipid regulating drug.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a rosuvastatin calcium fenofibric acid choline salt sustained-release tablet and a preparation method thereof. Background technique [0002] Rosuvastatin Calcium (Rosubastatin Calcium), chemical name: bis-[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl) )amino]-pyrimidin-5-yl](3R,5R)-3,5-dihydroxyhept-6-enoic acid] calcium salt (2:1). [0003] In recent years, with the change of eating habits, the improvement of living standards and the increase of work pressure, there are more and more patients with hyperlipidemia and hyperalbuminemia, and the patients are getting younger and younger. Epidemiological studies have shown that increased levels of plasma low-density lipoprotein (LDL) and very low-density lipoprotein (VLDL) are important causes of premature atherosclerosis and coronary heart disease. Statistical analysis shows that for every 1% decrease in...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/505A61K9/20A61K47/38A61P3/06A61K31/205
Inventor 不公告发明人
Owner CHANGSHA BAISHUN BIOTECH
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