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Lovastatin capsule and preparation method thereof

A technology of lovastatin and capsules, applied in the field of lovastatin capsules and its preparation, which can solve the problems of hard tablets and inability to disintegrate

Inactive Publication Date: 2014-07-02
王洪安
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

original film (Merck) After 10 days at 60°C, 90% relative humidity, or 3 months at 40°C, 75% relative humidity, the tablet becomes very hard and cannot disintegrate

Method used

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  • Lovastatin capsule and preparation method thereof
  • Lovastatin capsule and preparation method thereof
  • Lovastatin capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0066] prescription:

[0067] Lovastatin 20g

[0068] Low-substituted hydroxypropyl cellulose 50g

[0069] Crospovidone 5g

[0070] Sodium Lauryl Sulfate 2g

[0071] Povidone K30 5g

[0072] Magnesium Stearate 3g

[0073] Makes 1000 capsules

[0074] Preparation:

[0075] (1) Adhesive preparation: take by weighing sodium lauryl sulfate and povidone K30 of recipe quantity, add water to dissolve, be mixed with the solution of 10% povidone K30;

[0076] (2) Sieving: Excipients low-substituted hydroxypropyl cellulose, crospovidone and magnesium stearate were respectively passed through a 60-mesh sieve; (3) Granulation and drying: Weighed the prescription amount of lovastatin raw material and mixed In the machine, add the above-mentioned adhesive to make soft materials, and then use the granulator to granulate; after the wet granules are dried at 40°C to 45°C for 1 to 3 hours, the granules are sized;

[0077] (4) Mixing: put the above-mentioned granules in a mixer, add low-...

Embodiment 2

[0081] prescription:

[0082] Lovastatin 20g

[0083] Low-substituted hydroxypropyl cellulose 200g

[0084] Crospovidone 5g

[0085] Sodium Lauryl Sulfate 5g

[0086] Povidone K30 10g

[0087] Magnesium Stearate 3g

[0088] Makes 1000 capsules

[0089] The preparation method is the same as in Example 1.

Embodiment 3

[0091] prescription:

[0092] Lovastatin 20g

[0093] Low-substituted hydroxypropyl cellulose 150g

[0094] Crospovidone 2.5g

[0095] Sodium Lauryl Sulfate 3g

[0096] Povidone K30 7.5g

[0097] Magnesium Stearate 2g

[0098] Makes 1000 capsules

[0099] The preparation method is the same as in Example 1.

[0100] biological test

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Abstract

The invention relates to a lovastatin capsule and a preparation method thereof. The lovastatin capsule comprises 20 parts of lovastatin, 50-200 parts of low-substituted hydroxypropyl cellulose, 1-10 parts of polyvinyl polypyrrolidone, 1-5 parts of lauryl sodium sulfate, 1-10 parts of povidone K30 and 1-30 parts of magnesium stearate. The lovastatin capsule disclosed by the invention can be used for reducing blood fat. The lovastatin capsule disclosed by the invention is reasonable in prescription, feasible in process, stable and reliable in quality, and relatively good in stability, dissolution rate and bioavailability. The lovastatin capsule is prepared by adopting a wet-process granulation process, a method of adding a solubilizer lauryl sodium sulfate is proper, adhesive concentration is proper, and therefore, the lovastatin capsule belongs to powder with relatively good liquidity, and can satisfy capsules filling needs. Besides, the lovastatin capsule is short in production period, low in production cost and easy for industrial production.

Description

field of invention [0001] The invention relates to the field of chemical pharmacy, in particular to a lovastatin capsule and a preparation method thereof. Background of the invention [0002] Cardiovascular disease is one of the most common and serious diseases that endanger human health (especially middle-aged and elderly people). Dyslipidemia is an important risk factor for atherosclerosis, coronary heart disease and other cardiovascular and cerebrovascular diseases. Lipid-lowering drugs can reduce these The incidence and mortality of diseases have a positive and far-reaching impact on the prevention and treatment of cardiovascular diseases. With the advent of the aging population, the proportion of hypertension and other diseases caused by hyperlipidemia in the cardiovascular diseases of the elderly is increasing year by year, which seriously threatens people's life safety. Therefore, seeking effective, safe and reliable blood lipid-lowering drugs has always been a long-...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/366A61K31/22A61K47/32A61K47/20A61P3/06
Inventor 王洪安孙常成
Owner 王洪安
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