L-amlodipine besilate dripping pill and its preparing method

A technology of levamlodipine besylate and levamlodipine besylate, which is applied in the field of levamlodipine besylate and its preparation field, can solve the problems such as ineffectiveness and toxicity, and can overcome the problems of strong hygroscopicity and bioavailability. High, increase the effect of stability

Inactive Publication Date: 2007-01-24
AOLING BODA MEDICINE SCI & TECH DEV BEIJING
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In "amlodipine", it is the L-form that actually interacts with

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] (1) Formulation:

[0037] Levoamlodipine Besylate 1250mg Macrogol 6000 5250mg

[0038] Polyethylene glycol 4000 3500mg tert-butyl-4-hydroxyanisole 2.5mg

[0039] 3% HPMC coating solution

[0040] Makes 1000 pills

[0041] Specifications The amount of levamlodipine besylate in the formula is 1.25mg / pill

[0042] Pill weight 10mg / pill

[0043] (2) Preparation method

[0044] Take 5250 mg of polyethylene glycol 6000 and 3500 mg of polyethylene glycol 4000, heat and melt, add 2.5 mg of tert-butyl-4-hydroxyanisole, stir well, add benzene sulfonate with a fineness of more than 150 mesh Mix 1250mg of levamlodipine fine powder and 250mg of Tween 80 evenly to form a uniform dispersion, then transfer it to the dripping equipment for dripping, keep it warm at 80°C, drop it into liquid paraffin (-2°C to -8°C), Drop and make 1000 pills of pills, wipe the pills, dry, and coat with HPMC coating solution. Each drop pill contains 1.25 mg of levamlodipine bes...

Embodiment 2

[0046] (1) Formulation:

[0047] Levoamlodipine Besylate 2500mg Macrogol 6000 16500mg

[0048] Macrogol 4000 11000mg

[0049] 3% HPC coating solution

[0050] Makes 1000 pills

[0051] Specifications The amount of levamlodipine besylate in the formula is 2.5mg / pill

[0052] Pill weight 30mg / pill

[0053] (2) Preparation method

[0054] Take 16500mg of polyethylene glycol 6000 and 11000mg of polyethylene glycol 4000, after heating and melting, add 2500mg of levoamlodipine besylate fine powder with a crushing fineness of more than 150 mesh, mix evenly to form a uniform dispersion, and transfer to the dripping system Dropping in equipment, keeping warm at 80°C, dropping into liquid paraffin (-5°C to -10°C), dripping into 1000 pills, wiping the pills, drying in the air, and coating with HPC coating solution. Each drop pill contains 2.5mg of levamlodipine besylate.

Embodiment 3

[0056] (1) Formulation:

[0057] Levoamlodipine Besylate 5000mg Macrogol 6000 45000mg

[0058] Stearic acid 1500mg 8% PVP coating solution

[0059] Makes 1000 pills

[0060] Specifications The amount of levamlodipine besylate in the formula is 5mg / pill

[0061] Pill weight 50mg / pill

[0062] (2) Preparation method

[0063] Take 45000mg of polyethylene glycol 6000, heat and melt, add 5000mg of levamlodipine besylate fine powder with a crushing fineness above 150 mesh and 1500mg of stearic acid, mix well to form a uniform dispersion, and then transfer it to the dripping equipment Dropping, keeping warm at 75°C, dropping into liquid paraffin (-5°C to -10°C), dripping into 1000 pellets, wiping the pellets, drying in the air, and coating with PVP coating solution. Each drop pill contains 5mg of levamlodipine besylate.

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PUM

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Abstract

The present invention relates to L-amlodipine besilate dripping pill and its preparation process and belongs to the field of medicine preparing technology. The recipe of the L-amlodipine besilate dripping pill includes L-amlodipine besilate, dripping pill substrate, antioxidant, surfactant, coating material, etc. The preparation process includes the first preparing L-amlodipine besilate into fine powder over 150 mesh, the subsequent melting the substrate, adding fine L-amlodipine besilate powder and supplementary material, mixing to form dispersed liquid, and dropping the dispersed liquid into condensating liquid to form dripping pill with or without coating. Each of the dripping pills contains L-amlodipine besilate in 1.25-15mg and weighs 10-100 mg.

Description

technical field [0001] The invention relates to levamlodipine besylate dripping pills and a preparation method thereof, belonging to the technical field of medicine preparation. Background technique [0002] Cardiovascular disease is one of the major diseases that endanger human health in the world. In China alone, millions of people die of cardiovascular disease every year. According to the latest medical data, the incidence of cardiovascular disease is increasing year by year, and the age of patients is getting younger. Cardiovascular disease has the characteristics of high morbidity, high mortality, high disability rate, and high recurrence rate. People pay more and more attention to the treatment of cardiovascular disease, and its drug market potential is huge. [0003] In recent years, due to the increasing incidence of cardiovascular diseases and other diseases, many patients are increasingly looking forward to safer and more effective drugs for clinical use. Many sc...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4422A61P9/10A61P9/12
Inventor 庄洪波
Owner AOLING BODA MEDICINE SCI & TECH DEV BEIJING
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