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Amlodipine besylate liposome tablet

A technology of amlodipine besylate and amlodipine besylate, applied in the field of medicine, can solve the problems of low bioavailability, poor stability, poor product stability and the like of oral disintegrating tablets

Inactive Publication Date: 2011-11-09
HAINAN LINGKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Current amlodipine besylate tablet is due to the reason of preparation process and formula, causes the stability of amlodipine besylate is poor, often produces some unexpected side effects when taking clinically
[0005] Patent document CN101161241A discloses a preparation process of amlodipine besylate tablet, which is composed of amlodipine besylate, filler, disintegrant, lubricant, etc. Granulation, made by rotary pressing after spray drying, the disadvantage is that the product has poor stability and low dissolution rate
[0006] Patent document CN1686121A discloses a kind of amlodipine besylate dispersible tablet, made of amlodipine besylate, microcrystalline cellulose, anhydrous lactose, sodium carboxymethyl starch, micropowder silica gel and magnesium stearate, disintegrating The solution is fast, but it also has the disadvantage of poor stability
[0007] Patent document CN1546024A discloses a kind of amlodipine besylate orally disintegrating tablet, its main drug is amlodipine besylate, and auxiliary materials include lactose, mannitol, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, Divinylpyrrolidone, sodium bicarbonate, etc. The disadvantage is that the bioavailability of orally disintegrating tablets is low

Method used

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  • Amlodipine besylate liposome tablet
  • Amlodipine besylate liposome tablet
  • Amlodipine besylate liposome tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] The preparation of embodiment 1 amlodipine besylate liposome sheet

[0056] Prescription (1000 tablets):

[0057] Amlodipine Besylate 5g

[0058] Soy Lecithin 25g

[0059] Cholesterol 5g

[0060] Sodium deoxycholate 1.5g

[0061] Starch 40g

[0062] Dextrin 30g

[0063] Crospovidone 10g

[0064] Povidone K30 3g

[0065] Talc powder 4g

[0066] Preparation Process

[0067] (1) Dissolve 25g of soybean lecithin, 5g of cholesterol, and 1.5g of sodium deoxycholate in 400ml of a mixed solvent of ethanol and isopropanol with a volume ratio of 3:1, mix well, and remove the mixture under reduced pressure on a rotary thin film evaporator. Solvent to prepare phospholipid film;

[0068] (2) Add 200 ml of potassium dihydrogen phosphate-dipotassium hydrogen phosphate buffer solution with a pH value of 6.8, shake and stir to completely hydrate the phospholipid membrane...

Embodiment 2

[0073] The preparation of embodiment 2 amlodipine besylate liposome sheet

[0074] Prescription (1000 tablets):

[0075] Amlodipine Besylate 5g

[0076] Soy Lecithin 60g

[0077] Cholesterol 20g

[0078] Sodium deoxycholate 15g

[0079] Starch 90g

[0080] Dextrin 50g

[0081] Crospovidone 20g

[0082] Povidone K30 7.5g

[0083] Talc powder 12g

[0084] Preparation Process

[0085] (1) Dissolve 60g of soybean lecithin, 20g of cholesterol, and 15g of sodium deoxycholate in 1500ml of a mixed solvent of ethanol and isopropanol with a volume ratio of 3:1, mix well, and remove the mixed solvent under reduced pressure on a rotary thin film evaporator , to prepare a phospholipid film;

[0086] (2) Add 500ml of potassium dihydrogen phosphate-dipotassium hydrogen phosphate buffer solution with a pH value of 6.8, shake and stir to completely hydrate the phospholipid memb...

Embodiment 3

[0091] The preparation of embodiment 3 amlodipine besylate liposome sheet

[0092] Prescription (1000 tablets):

[0093] Amlodipine Besylate 2.5g

[0094] Soy Lecithin 12.5g

[0095] Cholesterol 10g

[0096] Sodium deoxycholate 2.5g

[0097] Starch 80g

[0098] Mannitol 20g

[0099] Low-substituted hydroxypropyl cellulose 10g

[0100] Sodium Carboxymethyl Cellulose 2g

[0101] Talc powder 3g

[0102] Preparation Process

[0103] (1) Dissolve 12.5g soybean lecithin, 10g cholesterol, and 2.5g sodium deoxycholate in 500ml of ethanol and isopropanol mixed solvent with a volume ratio of 3:1, mix well, and remove under reduced pressure on a rotary thin film evaporator Mixing solvents to prepare a phospholipid film;

[0104] (2) Add 200 ml of potassium dihydrogen phosphate-dipotassium hydrogen phosphate buffer solution with a pH value of 6.8, shake and stir to complet...

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Abstract

The invention provides an amlodipine besylate liposome tablet which is mainly prepared from the following components by weight part: 1 part of amlodipine besylate, 3 to 15 parts of soybean lecithin, 0.5 to 10 parts of cholesterol, 0.1 to 5 parts of sodium deoxycholate and 5 to 50 parts of pharmaceutically acceptable excipients.

Description

technical field [0001] The invention relates to a liposome solid preparation, in particular to an amlodipine besylate liposome tablet and a preparation method thereof, and further relates to its application in treating essential hypertension, belonging to the technical field of medicine. Background technique [0002] With the aging of the social population, the incidence of hypertension in the elderly is increasing year by year. Hypertension is the most common cardiovascular and cerebrovascular risk factor, but hypertension is a controllable risk factor. A number of clinical studies have shown that long-term effective control of blood pressure can significantly reduce the risk of cardiovascular and cerebrovascular diseases. Therefore, antihypertensive treatment has become an important strategy for the prevention of cardiovascular and cerebrovascular diseases, and blood pressure control is the core of the entire antihypertensive strategy. [0003] Calcium antagonists (CAS) a...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20
Inventor 郝志艳
Owner HAINAN LINGKANG PHARMA CO LTD
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