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Levamlodipine besylate composition and preparation method thereof

A technology of levamlodipine besylate and its composition, which is applied in the field of levamlodipine besylate composition and its preparation, can solve problems such as difficulty in taking medicine and poor patient compliance, and achieve the goal of avoiding swallowing, asphyxiation, and dosage Accurate, portable effect

Inactive Publication Date: 2011-05-11
ZHEJIANG ANGLIKANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The existing marketed dosage forms need to be taken with water when taking them. For the elderly, children, and patients with difficulty swallowing and inconvenient water intake, it will cause certain difficulties in taking medicine and poor patient compliance.

Method used

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  • Levamlodipine besylate composition and preparation method thereof
  • Levamlodipine besylate composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] prescription

[0020] Levoamlodipine Besylate 5g

[0021] Hydroxypropyl starch 30g

[0022] Citric acid 3g

[0023] Aspartame 5g

[0024] Glycerin 5g

[0025] Tween 800.5g

[0026] Orange essence 1g

[0027] Purified water 400ml

[0028]

[0029] Made into 10000cm 2 cut into 1000 pieces

[0030] Preparation

[0031] 30g hydroxypropyl starch ( NG 73, Roquette, France) was dissolved in 300ml of water, 5g of levamlodipine besylate, 3g of citric acid, 5g of aspartame, 5g of glycerin, 0.5g of Tween 80 and 1g of orange essence were added to 100ml of water and stirred Dissolve, mix the two solutions, stir evenly, remove air bubbles, coat into a film, dry, cut into 10cm 2 Small piece, Co 60 Sterilize by irradiation, pack with plastic film, and seal to get ready. Each small tablet contains 5mg of levamlodipine besylate.

[0032] Disintegration time limit

[0033] The disintegration...

Embodiment 2

[0036] prescription

[0037] Levoamlodipine Besylate 2.5g

[0038] Hypromellose (E5) 25g

[0039] Tartaric acid 3g

[0040] Aspartame 5g

[0041] Macrogol 200 4g

[0042] Poloxamer 407 1g

[0043] Menthol 1g

[0044] Ethanol 200ml

[0045] Purified water 400ml

[0046]

[0047] Made into 10000cm 2 cut into 1000 pieces

[0048] Preparation

[0049] Add 25g of hydroxypropylmethylcellulose (E5) (Shanghai Colorcon) into 300ml of hot water to disperse, let it cool, mix 2.5g of levamlodipine besylate, 3g of tartaric acid, 5g of aspartame, 4g of polyethylene glycol Diol, 1g poloxamer 407 (BASF company F127) and 1g of menthol are added to the mixed solution of 100ml of water and 200ml of ethanol, stirred and dissolved, the two solutions are mixed, stirred evenly, air bubbles are removed, coated to form a film, dried, cut into 10cm 2 Small pieces, ready to pack. Each small tablet contains...

Embodiment 3

[0053] prescription

[0054] Levoamlodipine Besylate 5g

[0055] Hypromellose (LF) 15g

[0056] Polyvinylpyrrolidone (K30) 20g

[0057] Citric acid 3g

[0058] Mannitol 5g

[0059] Aspartame 5g

[0060] Glycerin 4g

[0061] Poloxamer 407 1g

[0062] Ethanol 200ml

[0063] Purified water 400ml

[0064]

[0065] Made into 10000cm 2 cut into 1000 pieces

[0066] Preparation

[0067] With 15g hydroxypropyl cellulose (LF) (U.S. Aqualon company's HPC LF) was dispersed in 300ml of hot water, 20g of polyvinylpyrrolidone (K30) (PVP K30 from ISP, USA) was added to dissolve, let it cool, and 5g of levamlodipine besylate, 3g of citric acid, 5g of mannitol, and 5g of albino Spartan, 4g glycerin, 1g poloxamer 407 (BASF company F 127) Add to the mixed solution of 100ml water and 200ml ethanol and stir to dissolve, mix the two solutions, stir evenly, remove air bubbles, coat to form a film, dry, cut ...

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PUM

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Abstract

The invention belongs to the technical field of medicines, and relates to a levamlodipine besylate composition and a preparation method thereof. The levamlodipine besylate composition provided by the invention contains levamlodipine besylate and also contains at least one water-soluble or water-dispersible polymer. The preparation method comprises the following steps: firstly, dissolving, swelling or dispersing the water-soluble or water-dispersible polymer in a good solvent; then, dissolving the levamlodipine besylate and the rest components in the good solvent; mixing the two liquids; uniformly stirring; defoaming; coating; and drying to obtain the levamlodipine besylate composition. The composition can be taken without water, thereby improving the compliance of patients.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a levamlodipine besylate composition and a preparation method thereof. Background technique [0002] Amlodipine besylate is the third-generation 1,4-dihydropyridine calcium ion antagonist successfully developed by Pfizer Pharmaceuticals Co., Ltd. in the mid-1980s. Its mechanism of action is to relax vascular smooth muscle and dilate coronary arteries, improve lateral It can improve myocardial ischemia and hypoxia, and the effect is mild and long-lasting. It is convenient to take and has mild adverse reactions. It is mainly used in the treatment of hypertension, angina pectoris, and heart failure complicated by hypertension or coronary heart disease. The calcium antagonistic activity of amlodipine besylate L-isomer is 1000 times that of D-isomer, and is 2 times of racemate. Levoamlodipine besylate can be used as an antianginal drug, and it is also effective for coronary spastic an...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4422A61K9/70A61P9/12A61P9/10A61P9/04
Inventor 徐成苗周军马海岭黄伟莉徐爱放杨国栋
Owner ZHEJIANG ANGLIKANG PHARMA
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