Verapamil hydrochloride sustained release microsphere and preparation method thereof

A technology of verapamil hydrochloride and sustained-release microspheres, which is applied in the directions of pharmaceutical formulations, medical preparations of inactive ingredients, and pill delivery, etc. Unique, increase the ability to control drug release, improve drug distribution uniformity and particle size uniformity effect

Inactive Publication Date: 2014-01-22
INNER MONGOLIA MEDICAL UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The preparation of verapamil hydrochloride sustained-release microspheres in the prior art has been reported in this regard, for example, CN1245956C, but it is prepared by a secondary spray-drying method, the preparation process is relatively complicated, and the sustained-release performance of the prepared microspheres is general.

Method used

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  • Verapamil hydrochloride sustained release microsphere and preparation method thereof
  • Verapamil hydrochloride sustained release microsphere and preparation method thereof
  • Verapamil hydrochloride sustained release microsphere and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] (1) Take ethyl cellulose (EC) with a viscosity of 7CP, add 85% ethanol to make the mass concentration 1:10, let it stand and soak overnight to fully swell, and then stir to dissolve.

[0028] (2) Add PEG400 to the above solution at 25°C, stir evenly, and emulsify for 10 minutes to obtain solution a.

[0029] (3) Weigh EC and verapamil hydrochloride with a mass ratio of 2:1, and add verapamil hydrochloride (crushed through a 300 mesh sieve) with 85% ethanol solution with a mass concentration of 1:5, and stir well to obtain Solution b.

[0030] (4) Add solution b to solution a under the stirring state of 250rpm to form an emulsified system. Keep the stirring state and stir completely for 30 minutes. The outlet air temperature of the spray dryer is 40°C, and the inlet air temperature is 75°C It can be obtained after spray drying.

Embodiment 2

[0032] (1) Take ethyl cellulose (EC) with a viscosity of 50CP, add 85% ethanol to make the mass concentration 1:20, let it stand and soak overnight to fully swell, and then stir to dissolve.

[0033] (2) Add PEG600 to the above solution at 40°C, stir evenly, and emulsify for 20 minutes to obtain solution a.

[0034] (3) Weigh the mass ratio of EC and verapamil hydrochloride to be 3.5:1, and add verapamil hydrochloride (crushed through a 300 mesh sieve) with 85% ethanol solution with a mass concentration of 1:15, and stir well to obtain Solution b.

[0035](4) Add solution b to solution a under the stirring state of 300rpm to form an emulsified system. Keep the stirring state and stir completely for 80 minutes. The outlet air temperature of the spray dryer is 55°C, and the inlet air temperature is 90°C It can be obtained after spray drying.

Embodiment 3

[0037] (1) Take ethyl cellulose (EC) with a viscosity of 100CP, add 85% ethanol to make the mass concentration 1:30, let it stand and soak overnight to fully swell, and then stir to dissolve.

[0038] (2) Add polyethylene glycol PEG8000 to the above solution at 50°C, stir evenly, and emulsify for 30 minutes to obtain solution a.

[0039] (3) Weigh EC and verapamil hydrochloride with a mass ratio of 5:1, and add verapamil hydrochloride (crushed through a 300 mesh sieve) with 85% ethanol solution with a mass concentration of 1:25, and stir well to obtain Solution b.

[0040] (4) Add solution b to solution a under the stirring state of 400rpm to form an emulsified system. Keep the stirring state and stir completely for 120 minutes. The outlet air temperature of the spray dryer is 70°C, and the inlet air temperature is 105°C It can be obtained after spray drying.

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Abstract

The invention relates to a preparation method of a verapamil hydrochloride sustained release microsphere. The preparation method mainly comprises the three major steps of preparation of raw materials, preparation of microsphere forming auxiliary materials and preparation of a sustained release microsphere. A low-temperature spray drying method is adopted, so that the characteristics of a drug are not damaged, the preparation can be completed in one step, the operation is convenient, fast and economical, and the method is suitable for large-scale industrial production. The invention further relates to the verapamil hydrochloride sustained release microsphere prepared with the method.

Description

technical field [0001] The invention relates to the field of preparation of pharmaceutical preparations, in particular to the preparation of verapamil hydrochloride sustained-release microsphere preparations Background technique [0002] Hypertension is one of the most common cardiovascular diseases, and it is also one of the important causes of death and disability in humans. Effective treatment of hypertension can significantly reduce the incidence of cardiovascular events, complications and mortality. At home and abroad, high blood pressure is the first risk factor leading to death. It is estimated that by 2025, the prevalence of hypertension in the world will reach 29%, which means that there will be 1.5 billion hypertensive patients in the world, which is a terrible figure. When the cause of high blood pressure is still unclear, prevention becomes ineffective, and treatment becomes the only effective means. Currently commonly used clinical antihypertensive drugs are:...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/277A61K47/34A61K9/14A61K9/08A61K9/10A61K9/20A61K9/06A61K9/02A61K9/00A61K9/48A61P9/12
Inventor 顾艳丽张微
Owner INNER MONGOLIA MEDICAL UNIV
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