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Pravastatin preparation formula

A technology of pravastatin and pravastatin sodium, which is applied in the formulation field of pravastatin preparations, can solve problems such as unfavorable absorption, damage to natural acidic environment, and influence on human body functions, and achieve good stability

Inactive Publication Date: 2004-06-30
SHANGHAI TECHWELL BIOPHARMACEUTICALS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The formula of pravastatin preparation that has been reported at present or by adding alkaline inorganic substance, as magnesium oxide, makes preparation maintain alkaline environment, thereby improves the stability of pravastatin, but after this preparation enters human stomach by oral administration, after dissolving Sometimes it will cause the local pH value to be too high, greater than 9, generally 10, thereby destroying the natural acidic environment of the stomach, which may affect the body's own body functions; or by adding cyclodextrin substances to wrap pravastatin so that it is not affected The impact of acidic environment, thereby improving the stability of pravastatin, but cyclodextrin substances will hinder the release of pravastatin in the stomach, which is not conducive to its absorption by the human body

Method used

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  • Pravastatin preparation formula

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Prepare the pravastatin preparation according to the following formula:

[0023] Element weight percentage (%)

[0024] Pravastatin sodium 5

[0025] Monosodium Glutamate 1

[0026] Lactose 74

[0027] Microcrystalline Cellulose 15

[0028] Croscarmellose Sodium 2.5

[0029] Polyvinylpyrrolidone 1.5

[0030] Magnesium Stearate 1

[0031] Weigh 2 grams of sodium glutamate and dissolve in an appropriate amount of water, adjust the pH value to 8.8, add 10 grams of pravastatin sodium and stir to dissolve, add 3 grams of polyvinylpyrrolidone and stir to dissolve, add 148 grams of lactose, 30 grams of microcrystalline cellulose and stir Mix evenly to form wet granules. The wet granules are passed through a 24-mesh sieve, and then dried in an airflow oven at 50°C for 3 hours. After drying, the granules are passed through a 30-mesh sieve. Magnesium fatty acid, stirred and mixed, and then punched into tablets.

[0032] After the above-mentioned tablet was stored for 2...

Embodiment 2

[0039] Prepare the pravastatin preparation according to the following formula:

[0040] Element weight percentage (%)

[0041] Pravastatin sodium 5

[0042] Lysine hydrochloride 5

[0043] Lactose 70

[0044] Microcrystalline Cellulose 15

[0045] Croscarmellose Sodium 2

[0046] Polyvinylpyrrolidone 1.5

[0047] Magnesium stearate 1.5

[0048]Weigh 10 grams of lysine hydrochloride and dissolve in an appropriate amount of water, adjust the pH value to 8.8, add 10 grams of pravastatin sodium and stir to dissolve, add 3 grams of polyvinylpyrrolidone and stir to dissolve, add 140 grams of lactose, 30 grams of microcrystalline fiber Stir and mix evenly to make into wet granules. The wet granules are passed through a 24-mesh sieve, and then dried in an airflow oven at 50° C. for 3 hours. After drying, the granules are passed through a 30-mesh sieve. gram of magnesium stearate, stirred and mixed, and then punched into tablets.

[0049] After the above-mentioned tablet was...

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Abstract

The present relates to a pravastatin preparation formula for curing angiocardiopathy. It is characterized by that said formula contains medicinal active component pravastatin sodium, at the same time contains one or several kinds of amino acids or amino acid salts as stabilizing agent, and the pH value of pravastatin preparation aqueous emulsion is 6.0-8.9.

Description

Technical field: [0001] The invention relates to a pravastatin formulation, which can be used for treating cardiovascular diseases caused by hyperlipidemia, and belongs to the technical field of cardiovascular drugs. Background technique: [0002] Cardiovascular disease has become the main cause of human death, and its morbidity and mortality rate rank first among all diseases. In the middle of the last century, there was a cardiovascular disease epidemic in industrialized countries, and the number of deaths from cardiovascular diseases accounted for half of the total death toll. In terms of absolute numbers, my country is a big country with cardiovascular diseases. And along with the continuous improvement of people's living standards, the change of lifestyle and eating habits makes the incidence of various cardiovascular diseases tend to rise. Studies have confirmed that the main pathological basis of cardiovascular diseases is atherosclerosis, and hyperlipidemia is the ...

Claims

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Application Information

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IPC IPC(8): A61K31/192A61P9/10
Inventor 梅民权季晓铭李严姚勇卓忠浩
Owner SHANGHAI TECHWELL BIOPHARMACEUTICALS CO LTD
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