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Irbesartan liposome solid preparation

A technology of irbesartan fat and solid preparations, which is applied in the field of medicine, can solve the problems of increasing materials, pollution, and unguaranteed drug quality, and achieves high encapsulation efficiency, good sustained release effect, and excellent dissolution properties

Inactive Publication Date: 2013-09-25
HAINAN MEILAN SMITH KLINE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, the sieving step of micropowder silica gel is often carried out in the general mixing process, and generally uses a sieve to manually sieve, which also increases the possibility of material contamination, and the quality of the drug cannot be guaranteed.

Method used

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  • Irbesartan liposome solid preparation
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  • Irbesartan liposome solid preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0076] Example 1 Irbesartan liposome tablets

[0077]

[0078] Irbesartan liposome tablets were prepared by the following production process:

[0079] (1) Accurately weigh 75g irbesartan, 100g β-sitosterol, 20g stearylamide, 72g dipalmitoylphosphatidylglycerol, 30g Tween 80, dissolve in 700ml dichloromethane with a volume ratio of 2:1 and isopropanol mixed solvent, stirring to dissolve;

[0080] (2) Place the above solution in an eggplant-shaped bottle, remove methylene chloride and isopropanol under reduced pressure in a 45°C water bath, and form a uniform transparent film on the wall of the bottle;

[0081] (3) Add 700ml of phosphate buffer solution with a pH value of 6.8 to the eggplant-shaped bottle, and continue to rotate in a water bath at 45°C under normal pressure to swell and hydrate the film;

[0082] (4) The above solution is filtered with a 0.45 μm microporous membrane, and the filtrate is placed in a -20°C refrigerator to freeze overnight, then taken out an...

Embodiment 2

[0086] Example 2 Irbesartan liposome capsules

[0087]

[0088] The following production process is adopted to prepare irbesartan liposome capsules:

[0089] (1) Accurately weigh 75g irbesartan, 40g β-sitosterol, 10g stearylamide, 50g dipalmitoylphosphatidylglycerol, 20g Tween 80, dissolve in 700ml dichloromethane with a volume ratio of 2:1 and isopropanol mixed solvent, stirring to dissolve;

[0090] (2) Place the above solution in an eggplant-shaped bottle, remove methylene chloride and isopropanol under reduced pressure in a 45°C water bath, and form a uniform transparent film on the wall of the bottle;

[0091] (3) Add 700ml of phosphate buffer solution with a pH value of 6.8 to the eggplant-shaped bottle, and continue to rotate in a water bath at 45°C under normal pressure to swell and hydrate the film;

[0092] (4) The above solution is filtered with a 0.45 μm microporous membrane, and the filtrate is placed in a -20°C refrigerator to freeze overnight, then taken ...

Embodiment 3

[0096] Example 3 Irbesartan liposome capsules

[0097]

[0098] The following production process is adopted to prepare irbesartan liposome capsules:

[0099] (1) Accurately weigh 150g irbesartan, 100g β-sitosterol, 30g stearylamide, 110g dipalmitoylphosphatidylglycerol, 50g Tween 80, dissolve in 1400ml dichloromethane with a volume ratio of 2:1 and isopropanol mixed solvent, stirring to dissolve;

[0100] (2) Place the above solution in an eggplant-shaped bottle, remove methylene chloride and isopropanol under reduced pressure in a 45°C water bath, and form a uniform transparent film on the wall of the bottle;

[0101] (3) Add 1400ml of phosphate buffer solution with a pH value of 6.8 to the eggplant-shaped bottle, and continue to rotate in a water bath at 45°C under normal pressure to make the film swell and hydrate;

[0102] (4) The above solution is filtered with a 0.45 μm microporous membrane, and the filtrate is placed in a -20°C refrigerator to freeze overnight, t...

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Abstract

The invention discloses an irbesartan liposome solid preparation and a preparation method thereof. By means of preparing the active ingredient of irbesartan and specific combination of beta-sitosterol, stearic amide, dipalmitoyl phosphatidylglycerol and tween 80 into the liposome, the stability, dissolution and bioavailability of the medicine are greatly improved, a stable and enduring function and remarkable therapeutic effects are achieved, the product quality of the preparation is promoted and toxic and side effects are reduced.

Description

technical field [0001] The invention relates to a new solid preparation of irbesartan, in particular to a solid preparation of irbesartan liposome and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Irbesartan (Irbesartan), the chemical name is 2-butyl-3-4-2-(1H-tetrazol-5-yl)phenylbenzyl-1,3-diazaspiro-4.4nonan-1 -en-4-one, the molecular weight is 428.5, and the molecular formula is C 25 h 28 N 6 O, the structural formula is as follows: [0003] [0004] Hypertension is one of the most common cardiovascular diseases in the world today and the leading cause of death and disability in adults. Due to the improvement of people's living standards and the increasingly tense job competition, the number of people suffering from high blood pressure has greatly increased. The prevalence of hypertension in my country has increased significantly. According to statistics from my country, my country has become the country ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/127A61K9/20A61K9/48A61K31/4184A61K47/28A61K47/24A61K47/26A61K47/18A61P9/12
Inventor 杨明贵
Owner HAINAN MEILAN SMITH KLINE PHARMA