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Amlodipine benzenesulfonate slow-releasing capsule and its preparing method

A technology of amlodine besylate and capsules, which can be used in pharmaceutical formulations, cardiovascular system diseases, drug combinations, etc., can solve the problem of not exceeding 2.5 mg per day, and achieve shortened processing time, easy operation and control, and complete absorption Effect

Inactive Publication Date: 2005-01-12
天津米克莱特生物技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The content of common amlodipine besylate tablets currently available on the market is 5 mg, and the doctor’s recommended dosage is 2.5 mg to 10 mg per day. The initial dose of frail or elderly patients and patients with liver insufficiency should not exceed 2.5 mg per day. The therapeutic effect is exact, but its side effects and adverse reactions are also obvious, such as: flushing of the autonomic nervous system, general fatigue, general cardiovascular edema, abdominal pain in the gastrointestinal tract, nausea, palpitations and lethargy, etc.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0011] Based on 1000 amlodipine besylate sustained-release capsules, place 105 g of commercially available hollow ball cores between 25 and 30 meshes in a CF300 granulator, and spray 50% sucrose syrup until the hollow ball cores Fully wet; mix 1.5g of amlodipine besylate passing through a 100-mesh sieve, 20g of lactose passing through a 80-mesh sieve, and 20g of starch powder passing through a 100-mesh sieve and add them to the above-mentioned granulator for 50 minutes to obtain a surface Smooth main drug granules, after the main drug granules are wrapped, continue to spray 50% sucrose syrup, and add 8g of starch to wrap the main drug protective layer, and then dry the wrapped main drug granules in a vacuum drying oven at 80°C 3 hours, or 6 hours in an ordinary electric drying oven at 80°C; dissolve 10g of acrylic resin sustained-release material EUDRAGIT RS100 with an appropriate amount of 95% ethanol, and add 3g of talcum powder, an auxiliary material for coating, into an app...

Embodiment 2

[0013] Based on 1000 amlodipine besylate sustained-release capsules, place 105 g of commercially available hollow ball cores between 25 and 30 meshes in a CF300 granulator, and spray 50% sucrose syrup until the hollow ball cores Fully wet; mix 1.5g of amlodipine besylate passing through a 100-mesh sieve, 15g of polyethylene glycol 6000 passing through a 80-mesh sieve, and 13g of pregelatinized starch powder passed through a 100-mesh sieve and add to the above granulator Treat in the middle for 50 minutes to obtain the main drug granules with smooth surface, after the main drug granules are wrapped, continue to spray 50% sucrose syrup, and add 5g of starch to wrap the main drug protective layer, then place the wrapped main drug granules in 80 Dry in a vacuum oven at ℃ for 3 hours, or dry in an ordinary electric drying oven at 80℃ for 6 hours; dissolve 8g of polyvinylpyrrolidone with an appropriate amount of 95% ethanol and 12g of hydroxypropyl methylcellulose with 5mL of water ...

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PUM

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Abstract

A slowly-releasing capsule of amlodipine benzosulfonate is prepared from amlodipine benzosulfonate, auxiliaries and slow-releasing material chosen from acrylic resin, hydroxypropylmethyl cellulose, ethylcellulose, etc.

Description

technical field [0001] The invention relates to the field of medicines and preparation thereof, in particular to an amlodipine besylate sustained-release capsule capable of treating hypertension and angina pectoris and a preparation method thereof. Background technique [0002] Hypertension and angina pectoris are common and frequently-occurring diseases with a high incidence rate. If treated improperly or not treated in time, it may lead to serious complications and endanger the patient's physical and mental health, even life-threatening. Amlodipine besylate is a calcium ion blocker, which is mainly used clinically to treat hypertension and angina pectoris. The content of common amlodipine besylate tablets currently available on the market is 5 mg, and the doctor’s recommended dosage is 2.5 mg to 10 mg per day. The initial dose of frail or elderly patients and patients with liver insufficiency should not exceed 2.5 mg per day. The therapeutic effect is definite, but the si...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K31/4422A61P9/10A61P9/12
Inventor 杨恩久
Owner 天津米克莱特生物技术有限公司
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