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Lovastatin sustained-release tablets and method of producing the same

A technology of lovastatin and sustained-release tablets, which is applied in the direction of pharmaceutical formulas, medical preparations containing no active ingredients, and medical preparations containing active ingredients. Good cumulative release effect

Inactive Publication Date: 2008-02-27
SHANDONG HUAXIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the Lovastatin Sustained-release Tablet developed by Andrx Group of the United States uses the osmotic pump technology, and the process is relatively complicated.

Method used

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  • Lovastatin sustained-release tablets and method of producing the same
  • Lovastatin sustained-release tablets and method of producing the same
  • Lovastatin sustained-release tablets and method of producing the same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Embodiment 1: every 1000 tablets are made of the following prescription raw materials and auxiliary materials:

[0043] Lovastatin 20.0g

[0044] Hypromellose 32.0g

[0045] Lactose 224.0g

[0046] BHT 30mg

[0047] 4% povidone K30 in 95% ethanol solution 124ml

[0048] Magnesium Stearate 2.8g

[0049] Made in 1000 pieces.

[0050] The preparation method is as follows:

[0051] 1. Weighing, mixing and sieving Weigh the raw and auxiliary materials according to the prescription, and pass through a 100-mesh sieve respectively. First mix the original lovastatin powder with hypromellose, and then gradually add lactose using the method of increasing the dilution factor until it is evenly mixed with the above two materials.

[0052] 2. Granulation, drying and granulation Put the material in a mixing tank, add 124ml of 4% povidone K3095% ethanol solution (dissolve the prescribed amount of BHT) as a binder, and stir to make a suitable soft material , granulated with a 20...

Embodiment 2

[0054] Embodiment 2: every 1000 tablets are made of the following prescription raw materials and auxiliary materials:

[0055]Lovastatin 15.0g

[0056] Vinyl polymer 105.0g

[0057] Lactose 610.0g

[0058] BHA 92mg

[0059] 80% ethanol solution of 10% arabic mucilage 424ml

[0060] Sodium Lauryl Sulfate 9.8g

[0061] Made in 1000 pieces.

[0062] The preparation method is as follows:

[0063] 1. Weighing, mixing and sieving Weigh the raw and auxiliary materials according to the prescription, and pass through a 100-mesh sieve respectively. First mix the original lovastatin powder with the vinyl polymer, and then gradually add lactose by using the method of increasing the dilution factor until it is evenly mixed with the above two materials.

[0064] 2. Granulation, drying and granulation Place the material in a mixing tank, add 424ml of 80% ethanol solution of Arabic mucilage (dissolving the BHA of the prescribed amount) as a binder, stir to make a suitable soft material...

Embodiment 3

[0066] Embodiment 3: every 1000 tablets are made of the following prescription raw materials and auxiliary materials:

[0067] Lovastatin 60.0g

[0068] Potassium alginate 70.0g

[0069] Lactose 108.0g

[0070] Ascorbyl Brown 50mg

[0071] 14% polyethylene glycol solution in 50% ethanol 315ml

[0072] Talc powder 6.8g

[0073] Made in 1000 pieces.

[0074] The preparation method is as follows:

[0075] 1. Weighing, mixing and sieving Weigh the raw and auxiliary materials according to the prescription, and pass through a 100-mesh sieve respectively. First mix the original lovastatin powder with potassium alginate, and then gradually add lactose by using the method of increasing dilution times until it is evenly mixed with the above two materials.

[0076] 2. Granulation, drying and granulation Put the material in a mixing tank, add 315ml of 50% ethanol solution of 14% polyethylene glycol (dissolve the prescribed amount of ascorbic acid palm into it) as a binder, and stir...

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Abstract

The invention discloses a Luovastatin slow release tablet and making method in the drug agent domain, which comprises the following parts per 1000g: 5-80g Luovastatin, 8-128g frame material, 56-896g filler, 7. 5-120mg anti-oxidant, 31-496ml binder alcohol solution with content at 0. 25%-16% and 0. 7-11. 2g lubricant. The invention has good accumulated releasing effect with good curative effect for irregular diet patients, which is beneficial for diabetic patient with little side effect.

Description

(1) Technical field [0001] The invention relates to a lovastatin sustained-release tablet and a preparation method thereof, belonging to the field of pharmaceutical preparations. (2) Background technology [0002] Lovastatin (Lovastatin) is the first statin lipid-lowering drug used in clinical practice. INN named it Lovastatin. Its listing is hailed as a milestone in the research progress of blood lipid-lowering drugs. Lovastatin is most suitable for the treatment of hypercholesterolemia, especially for patients with elevated low-density lipoprotein (LDL), and is the lipid-lowering drug of choice. Important foreign cardiovascular journals reported that people with normal cholesterol can generally prevent acute coronary heart disease with Lovastatin. [0003] At present, Deng Rongling from the Sichuan Provincial Drug Administration and He Qin from the School of Pharmacy of West China University have conducted research on the preparation and in vitro release of lovastatin su...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/366A61K9/22A61K47/32A61K47/36A61K47/38A61P3/06
Inventor 马继永楚大祥赵远民
Owner SHANDONG HUAXIN PHARMA
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