Skeleton type lovastatin sustained-release micropill and preparation method thereof

A technology of lovastatin and sustained-release pellets, applied in the field of medicine, can solve problems such as being unsuitable for industrial production, difficult to mix evenly, affecting drug release, etc., achieve prevention and treatment of atherosclerosis and coronary heart disease, reduce gastrointestinal Stimulating, bioavailability-enhancing effects

Inactive Publication Date: 2013-11-20
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This process directly mixes the drug and the excipients, the mixing efficiency is low, it is not easy to mix evenly, and affects the release of the drug, so it is not suitable for industrial production

Method used

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  • Skeleton type lovastatin sustained-release micropill and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Embodiment 1 (making 300 grains):

[0030] The raw materials of skeleton-type lovastatin sustained-release pellets are as follows: 5g of lovastatin, 0.1g of hydroxypropylmethylcellulose E5, 0.5g of sodium metabisulfite, 15g of lactose, 8g of microcrystalline cellulose, 2g of stearic acid, Dicarboxymethylcellulose sodium 5g, distilled water 15g. The preparation method of matrix type lovastatin sustained-release pellets:

[0031]1. Preparation of lovastatin microcrystalline dispersion: Make an aqueous solution with 0.1g hydroxypropylmethylcellulose E5 and 5g distilled water, then add 0.5g sodium metabisulfite and 5g lovastatin, mix well and put it into a basket grinder In the grinding cylinder, the working parameters of the basket mill are: the rotation frequency of the main machine is 1500 rpm; the grinding time is 3 hours, and the lovastatin microcrystalline dispersion is made. After grinding, the lovastatin particle size ranges from 0.1 μm to 100 μm, and the particle...

Embodiment 2

[0034] Embodiment 2 (making 300 grains):

[0035] The raw materials of skeleton-type lovastatin sustained-release pellets are as follows: 10 g of lovastatin, 0.5 g of polyvinylpyrrolidone K30, 0.2 g of sodium metabisulfite, 10 g of lactose, 35 g of microcrystalline cellulose, 5 g of stearic acid, and croscarmellose Sodium cellulose base 10g, distilled

[0036] water 25 g.

[0037] The preparation method of skeleton type lovastatin sustained-release pellets is as follows:

[0038] 1. Preparation of lovastatin microcrystalline dispersion: Prepare an aqueous solution with 0.5g polyvinylpyrrolidone K30 and 10g distilled water, then add 0.2g sodium metabisulfite and 10g lovastatin, mix well and put it into the grinding cylinder of the basket mill In the process, the frequency of the main machine is 1500 rpm, and the grinding is performed for 3 hours to prepare a lovastatin microcrystalline dispersion.

[0039] 2. Preparation of lovastatin sustained-release pellets: get the lovas...

Embodiment 3

[0041] Embodiment 3 (make 300 grains)

[0042] The raw materials of skeleton-type lovastatin sustained-release pellets are as follows: 20g of lovastatin, 2g of hydroxypropylmethylcellulose E5, 1.2g of sodium metabisulfite, 48g of microcrystalline cellulose, 17g of stearyl alcohol, 15g of carbomer, manna Alcohol 45g, croscarmellose sodium 15g, distilled water 45g.

[0043] The preparation method of skeleton type lovastatin sustained-release pellets is as follows:

[0044] 1. Preparation of lovastatin microcrystalline dispersion: 2g of hydroxypropylmethylcellulose E5 and 20g of distilled water were made into an aqueous solution, then 1.2g of sodium metabisulfite and 20g of lovastatin were added, mixed evenly, and then put into the basket grinder In the grinding cylinder, the frequency of the main machine is 1500 rpm; grind for 3 hours to make lovastatin microcrystalline dispersion.

[0045] 2. Preparation of lovastatin sustained-release pellets: get the lovastatin microcrystal...

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Abstract

The invention discloses a skeleton type lovastatin sustained-release micropill and a preparation method thereof, and belongs to the technical field of medicines. The skeleton type lovastatin sustained-release micropill is mainly prepared from the following raw materials in parts by weight: 5 to 25 parts of lovastatin, 0.1 to 5 parts of hydrophilic carrier and adhesive, 10 to 80 parts of a skeleton material, 20 to 60 parts of pore former, 0.2 to 1.5 parts of antioxidant, and 15 to 70 parts of distilled water. The skeleton type lovastatin sustained-release micropill is a sustained-release preparation which is taken orally one time a day, and an in-vitro release test proves that drug release of the micropill can be 12 hours. The skeleton-type lovastatin sustained-release micropill has simple process and stable blood concentration, has the characteristics of safety, high efficiency, low toxicity, convenience in administration and the like, can be used for treating hypercholesterolemia and combined hyperlipidemia, and has prevention and treatment effects to atherosclerosis and coronary heart disease.

Description

technical field [0001] The invention relates to an oral medicine sustained-release preparation and a preparation method thereof, in particular to a skeleton-type lovastatin sustained-release pellet and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Statins, as hydroxymethylglutaryl coenzyme A (HMG-CoA) reductase inhibitors, can reduce blood cholesterol and low-density lipoprotein cholesterol levels, reduce serum triglyceride levels and increase blood high-density lipoprotein cholesterol levels etc., thereby exerting an effect on the prevention and treatment of atherosclerosis and coronary heart disease. Lovastatin was approved by the FDA in 1987 as the first HMG-CoA reductase inhibitor on the market. Since then, it has been put on the market in more than a dozen countries such as Germany, Canada, and Denmark, and quickly ranked among the top ten in the world in the early 1990s. The ranks of best-selling drugs. my c...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/366A61K9/16A61K47/38A61P3/06
Inventor 唐星何海冰张宇
Owner SHENYANG PHARMA UNIVERSITY
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