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Amlodipine dry suspension and preparation method thereof

A technology for dry suspensions and amlodipine besylate, which is applied in the direction of pharmaceutical formulas, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc. Low solubility and other issues, to achieve good market prospects, good stability, easy to carry the effect

Active Publication Date: 2021-04-30
GUANGZHOU YIPINHONG PHARMA +4
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In addition, the amlodipine oral preparation provided by the invention is prepared into a salt-forming form with lower solubility from commercially available amlodipine besylate, which solves the problem of Amlodipine besylate is slightly soluble in water and is not suitable for preparation of dry suspension

Method used

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  • Amlodipine dry suspension and preparation method thereof
  • Amlodipine dry suspension and preparation method thereof
  • Amlodipine dry suspension and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] prescription:

[0034] Material name Prescription amount Amlodipine 13.9g sodium benzoate 13.9g purified water a

1155.0g Mannitol 621.1g Hypromellose K4M 13.0g purified water b

200.0g

[0035] The preparation process is as follows:

[0036] a) in purified water a Amlodipine besylate in the prescription amount was added to it, prepared by a high-speed homogeneous process, with a speed of 5000 RPM, prepared for 2 minutes to make the dispersion uniform, and to obtain mixture 1;

[0037]b) Mixture 1 was prepared by adding the prescribed amount of sodium benzoate, prepared by a high-speed homogenization process at a speed of 10,000 RPM, prepared for 10 minutes, and prepared into Mixture 2 for later use;

[0038] c) Add mannitol and hypromellose K4M into the wet mixing granulator, and add purified water b Granulate, dry and granulate to obtain blank granules; add the blank granules to a fluidized bed granulation dr...

Embodiment 2

[0042] prescription:

[0043] Material name Prescription amount Amlodipine 13.9g sodium benzoate 28g purified water a

250.2g ethanol 27.8g Erythritol 677.1g Hypromellose K1500 31.9g Simethicone 1.0g

[0044] The preparation process is as follows:

[0045] a) in purified water a Add the prescribed amount of amlodipine besylate to the mixed solvent of ethanol, prepare by high-speed homogenization process, the speed is 8000RPM, prepare for 2 minutes to make the dispersion uniform, and obtain mixture 1;

[0046] b) Mixture 1 was prepared by adding the prescribed amount of sodium benzoate, prepared by a high-speed homogenization process at a speed of 8000 RPM, and prepared for 10 minutes to prepare mixture 2 for later use;

[0047] c) adding erythritol, hypromellose K1500 and simethicone into the fluidized bed granulation dryer, spraying into the mixture 2 prepared in step b, and performing one-step granulation;

[004...

Embodiment 3

[0051] prescription:

[0052] Material name Prescription 7 Amlodipine 13.9g sodium benzoate 66.8g purified water a

334g Maltitol 1488.0g Erythritol 600.1 Hypromellose K750 33.2g Simethicone 1.3g aspartame 15g talcum powder 4.2g

[0053] The preparation process is as follows:

[0054] a) in purified water a Amlodipine besylate in the prescribed amount was added to it, prepared by a high-speed homogeneous process, with a speed of 8000 RPM, prepared for 2 minutes to make the dispersion uniform, and to obtain mixture 1;

[0055] b) Mixture 1 was prepared by adding the prescribed amount of sodium benzoate, prepared by a high-speed homogenization process at a speed of 8000 RPM, and prepared for 10 minutes to prepare mixture 2 for later use;

[0056] c) Add maltitol, erythritol, hypromellose K750 and simethicone into the fluidized bed granulation dryer, spray the mixture 2 prepared in step b, and perform one-s...

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Abstract

The invention discloses an amlodipine dry suspension which contains a diluent, a suspending aid and the like and does not contain a surfactant. The preparation method comprises the following steps: a) preparing a water-basedamlodipine dry suspension mixture 1 containing amlodipine besylate by a high-speed homogenization method; b) adding sodium benzoate into the mixture 1, and homogenizing at a high speed to obtain a mixture 2; and c) granulating the mixture 2 and other components, and drying. According to the invention, the raw materials are homogenized and mixed at a high speed, a surfactant is not added in the preparation process, amlodipine is fully wetted through a high-speed homogenization process, prescription components are simplified, and the amlodipine tablet is more suitable for children to use; compared with an ultrasonic stirring and high-speed homogenizing process, amplification and industrial production are easier to realize, Meanwhile, the preparation is good in stability and convenient to carry and has a relatively good market prospect.

Description

technical field [0001] The invention belongs to the technical field of amlodipine preparation, and more specifically relates to an amlodipine dry suspension and a preparation method thereof. Background technique [0002] Amlodipine is a calcium channel blocker, used in the treatment of hypertension, coronary heart disease, etc. Amlodipine has been widely used clinically for many years, with definite curative effect, and is one of the most frequently used antihypertensive drugs. [0003] The most widely used dosage form of amlodipine clinically is oral tablet, such as Norvasc. However, up to a quarter of the population has difficulty ingesting and swallowing solid dosage forms, and this population has poor compliance with solid dosage form drug therapy, resulting in ineffective therapy. In addition, solid dosage forms are generally unfriendly to children or the elderly due to the increased risk of choking; in addition, the dose of amlodipine given to children is calculated b...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/4422A61K47/12A61K47/10A61K47/38A61P9/10A61P9/12
CPCA61K31/4422A61K9/1617A61K9/1652A61P9/12A61P9/10A61K9/1682A61K9/1623A61K31/4418A61K9/1694
Inventor 李捍雄王显著陈伟棠陈元郭萍吴泳仪覃永梅黄洪雪王丽
Owner GUANGZHOU YIPINHONG PHARMA
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