Metroprolol succinate sustained-release pellet and preparation method thereof

A technology of metoprolol succinate and sustained-release pellets, which is applied to a sustained-release preparation containing metoprolol succinate and its preparation, and the field of metoprolol succinate sustained-release pellets and its preparation, which can solve the problem of There are no commercialized products, difficult to obtain in large quantities, and no unified quality standards.

Inactive Publication Date: 2017-02-22
YAOPHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] a) There is no commercial product for the starting ball core, it is dif

Method used

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  • Metroprolol succinate sustained-release pellet and preparation method thereof
  • Metroprolol succinate sustained-release pellet and preparation method thereof
  • Metroprolol succinate sustained-release pellet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0038] Example 1:

[0039] Preparation of Metoprolol Succinate Sustained-Release Pellets

[0040] prescription:

[0041]

[0042]

[0043] *removed during process

[0044] Preparation Process:

[0045] 1) Dissolve metoprolol succinate and hypromellose in purified water, place the sucrose pellets in a fluidized bed, set the air inlet temperature to 50-70°C, and the air inlet volume to 70-120m 3 / h, atomization pressure 1.5~2.5bar, spray speed 6~20g / min. After the coating liquid is sprayed, keep the air inlet temperature and dry for 0.5 to 2 hours to obtain pellet A1.

[0046] 2) Dissolve ethyl cellulose and hydroxypropyl cellulose in ethanol, place the pellets A1 prepared in the previous step in a fluidized bed, set the air inlet temperature to 40-50°C, and the air inlet volume to 70-120m 3 / h, atomization pressure 1.5~2.5bar, spray speed 3~16g / min. After the coating liquid is sprayed, keep the air inlet temperature and dry for 0.5 to 2 hours to obtain pellets B1....

Example Embodiment

[0054] Example 2:

[0055] Preparation of Metoprolol Succinate Sustained-Release Pellets

[0056] prescription:

[0057]

[0058]

[0059] *removed during process

[0060] Preparation Process:

[0061] 1) Dissolve metoprolol succinate and polyvinylpyrrolidone in acetone, place the sucrose pellets in a fluidized bed, set the inlet air temperature to 40-60 °C, the air inlet volume to 70 to 120 m3 / h, and the atomization pressure to 1.5 ~2.5bar, spray speed 6~20g / min. After the coating liquid is sprayed, keep the inlet air temperature and dry for 0.5-2 hours to obtain pellet A2.

[0062] 2) Dissolve ethyl cellulose and hypromellose in methylene chloride, place the pellets A2 prepared in the previous step in a fluidized bed, set an inlet air temperature of 35 to 50 °C, and an inlet air volume of 70 to 120 m3 / h, atomization pressure 1.5~2.5bar, spray speed 3~16g / min. After the coating liquid is sprayed, keep the inlet air temperature and dry for 0.5 to 2 hours to obta...

Example Embodiment

[0069] Example 3

[0070] Preparation of Metoprolol Succinate Sustained-Release Pellets

[0071] prescription:

[0072]

[0073] *removed during process

[0074] Preparation Process:

[0075] 1) Dissolve metoprolol succinate and hydroxypropyl cellulose in ethanol, place the sucrose pellets in a fluidized bed, set the inlet air temperature to 40-60°C, and set the inlet air volume to 70-120m 3 / h, atomization pressure 1.5~2.5bar, spray speed 6~20g / min. After the coating liquid is sprayed, keep the inlet air temperature and dry for 0.5 to 2 hours to obtain pellet A3.

[0076] 2) Dissolve ethyl cellulose and polyethylene glycol in acetone, place the pellets A3 prepared in the previous step in a fluidized bed, set an inlet air temperature of 35 to 50 °C, and an inlet air volume of 70 to 120 m3 / h, The atomization pressure is 1.5~2.5bar, and the spraying speed is 3~16g / min. After the coating liquid is sprayed, keep the air inlet temperature and dry for 0.5 to 2 hours to ob...

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Abstract

The invention discloses a metroprolol succinate sustained-release pellet. The metroprolol succinate sustained-release pellet sequentially comprises a hollow pellet core, a main medicine layer, a sustained-release layer, a quick-release medicine layer and a selectable buffer layer from inside to outside. According to a method in the United States Pharmacopeia, the release degree of the metroprolol succinate sustained-release pellet is determined in 50 ml of phosphoric acid buffer solution medium with the pH of 6.8 through a paddle method at the speed of 50 rpm, the sustained-release pellet can release 5% or above of metroprolol succinate within one hour and meets limit requirements specified in the United States Pharmacopeia, and a linear release curve is presented within the first eight hours.

Description

technical field [0001] The invention belongs to the technical field of oral sustained and controlled release administration, in particular to a sustained release preparation containing metoprolol succinate and a preparation method thereof. More specifically, the present invention relates to a kind of metoprolol succinate sustained-release pellets and a preparation method thereof, as well as tablets, capsules and other dosage forms comprising such sustained-release pellets. Background technique [0002] Metoprolol is a highly selective beta 1 Receptor blocker, its chemical name is 1-isopropylamino-3-[to-(2-methoxyethyl) phenoxy]-2-propanol, and its structural formula is as follows: [0003] [0004] Metoprolol is one of the commonly used drugs in the treatment of high blood pressure, heart failure and arrhythmia. In 2005, Metoprolol Succinate Sustained Release Tablets (trade name "Betaloc") produced by AstraZeneca was launched in China. At present, there is no similar m...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K9/20A61K9/48A61K31/138A61P9/12A61P9/04A61P9/06
Inventor 刘丽朱锋曹呈勇
Owner YAOPHARMA CO LTD
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