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Method for preparing pravastatin sodium long-acting sustained release microsphere

A technology of pravastatin sodium and slow-release microspheres, applied in the field of preparation of pharmaceutical preparations

Inactive Publication Date: 2015-09-16
SOUTHERN MEDICAL UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the pharmaceutical preparations of the above-mentioned patent applications all have the therapeutic effect of pravastatin sodium, they all need to be administered every day.

Method used

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  • Method for preparing pravastatin sodium long-acting sustained release microsphere
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  • Method for preparing pravastatin sodium long-acting sustained release microsphere

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] 1. Preparation of long-acting sustained-release microspheres of pravastatin sodium

[0020] (1) Mix Tween-80 and liquid paraffin according to the volume ratio of Tween-80: liquid paraffin = 2: 100, and mix evenly under electric stirring at a speed of 500 r / min to obtain an oil phase;

[0021] (2) join the chitosan that viscosity is lower than 200mPa.s in the acetic acid solution that volume concentration is 1%, magnetic force stirs 1h, is made into the chitosan solution that mass concentration is 1.5%; Pravastatin sodium is dissolved in In the water, make the concentration of pravastatin sodium in water be 66.6g / L, obtain the pravastatin sodium aqueous solution; Then, mix the chitosan solution prepared with the pravastatin sodium aqueous solution, stir, and obtain the mass ratio Be the aqueous phase of pravastatin sodium: chitosan=1:1;

[0022] (3) dissolving genipin in 30% aqueous ethanol, so that the concentration of genipin in ethanol with a volume concentration of ...

Embodiment 2

[0032] 1. Preparation of long-acting sustained-release microspheres of pravastatin sodium

[0033] (1) Mix span-80 and ethyl benzoate according to the volume ratio of span-80: ethyl benzoate = 8: 100, and mix evenly under electric stirring at a speed of 1000r / min to obtain an oil phase;

[0034] (2) Adding chitosan with a viscosity of 200 to 400mPa.s into an acetic acid solution with a volume concentration of 1%, magnetic stirring for 5 hours, and preparing a chitosan solution with a mass concentration of 3%; dissolving pravastatin sodium In water, make the concentration of pravastatin sodium in water be 16.6g / L, obtain pravastatin sodium aqueous solution; Then, mix the prepared chitosan solution and pravastatin sodium aqueous solution, stir well, make the Ratio is the aqueous phase of pravastatin sodium: chitosan=1:4;

[0035](3) Genipin is dissolved in 40% aqueous ethanol, so that the concentration of genipin in 40% ethanol by volume concentration is 7.8g / L to obtain a cros...

Embodiment 3

[0042] 1. Preparation of long-acting sustained-release microspheres of pravastatin sodium

[0043] (1) Mix span-80 and liquid paraffin according to the volume ratio of span-80: liquid paraffin = 4: 100, and mix evenly under electric stirring at a speed of 850 r / min to obtain an oil phase;

[0044] (2) Add chitosan with a viscosity of 200 to 400mPa.s into an acetic acid solution with a volume concentration of 1%, magnetically stir for 1h, and prepare a chitosan solution with a mass concentration of 1.5%; dissolve pravastatin sodium In water, make the concentration of pravastatin sodium in water be 33.3g / L, obtain pravastatin sodium aqueous solution; Ratio is the aqueous phase of pravastatin sodium: chitosan=1:2;

[0045] (3) dissolving genipin in 90% aqueous ethanol, so that the concentration of genipin in ethanol with a volume concentration of 90% is 13g / L to obtain a crosslinking agent solution;

[0046] (4) Add the water phase prepared in step (2) dropwise to the oil phase...

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Abstract

The invention relates to a method for preparing a pravastatin sodium long-acting sustained release microsphere. The method comprises the first step of oil phase preparing, the second step of water phase preparing, the third step of cross-linking agent solution preparing, the fourth step of mixing a water phase and an oil phase to obtain w / o emulsion and the fifth step of adding a cross-linking agent for cross-linking solidifying, centrifugal separating and vacuum drying to obtain the pravastatin sodium long-acting sustained release microsphere. The pravastatin sodium long-acting sustained release microsphere prepared through the method has the advantages of being long in releasing time and capable of being degraded.

Description

technical field [0001] The invention relates to a pharmaceutical preparation characterized by a special physical shape, in particular to a preparation method of a granular pharmaceutical preparation loaded with statin compounds made of chitin. Background technique [0002] Elevated cholesterol in the human body can easily lead to cardiovascular diseases such as arteriosclerosis, coronary heart disease and other diseases and death. Statins are competitive inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A reductase (HMG-COA reductase), which is the rate-limiting enzyme in the biosynthesis of cholesterol. Drugs can block or reduce the biosynthesis of cholesterol in the body by inhibiting the activity of the rate-limiting enzyme, stimulate the expression of low-density lipoprotein (LDL) receptors on the surface of liver cells, and promote the removal of LDL and LDL precursors from the circulation, thereby reducing blood The concentration of cholesterol in the. Statins also h...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/22A61K47/36A61L27/54A61P3/06A61P9/10
Inventor 卢玲冯婕游文玮刘中秋刘瑞源路新卫
Owner SOUTHERN MEDICAL UNIVERSITY
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