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Propafenone hydrochloride sustained-release pellet capsule as well as preparation method and application thereof

A technology of propafenone hydrochloride and sustained-release pellets, which can be used in pharmaceutical formulations, medical preparations containing active ingredients, drug delivery, etc. It can solve the problems of wet and soft materials, difficult extrusion and spheronization processes, and material agglomeration , to achieve the effects of slow and stable drug release, increased production efficiency, and improved compliance

Inactive Publication Date: 2016-01-06
SALUS PHARMA TECH SHANGHAI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Although the extrusion spheronization method has great advantages with respect to the microtablet method, there is no report on preparing propafenone hydrochloride sustained-release capsules by the extrusion spheronization method so far, which is mainly due to the fact that the propafenone hydrochloride bulk drug will induce self-infection when it encounters a solvent. The viscosity of the material makes the material agglomerate, making the process of preparing wet and soft materials and extrusion spheronization very difficult

Method used

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  • Propafenone hydrochloride sustained-release pellet capsule as well as preparation method and application thereof
  • Propafenone hydrochloride sustained-release pellet capsule as well as preparation method and application thereof
  • Propafenone hydrochloride sustained-release pellet capsule as well as preparation method and application thereof

Examples

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Effect test

Embodiment 1

[0049] In this embodiment, the propafenone hydrochloride sustained-release pellet capsules comprise the following components in mass percent:

[0050] Propafenone Hydrochloride 69%

[0051] Filler 30%

[0052] Binder 1%

[0053] The filler is a mixture of microcrystalline cellulose (AvicelPH101) and pregelatinized starch (STARCH1500) at a mass ratio of 2:1, and the binder is hypromellose (MethocelK100MCR).

[0054] It is prepared by extrusion spheronization, which specifically includes the following steps:

[0055] (1) Pass propafenone hydrochloride and filler (a mixture of microcrystalline cellulose and pregelatinized starch) through a 30-mesh sieve respectively, mix evenly according to the formula quantity, and add binder (hypromellose) according to the formula quantity element) solution (concentration is 1%) to make soft material;

[0056] (2) The soft material prepared by step (1) is extruded strip material in the extrusion equipment with a sieve plate aperture of 0.8-...

Embodiment 2

[0062] In this embodiment, the propafenone hydrochloride sustained-release pellet capsules comprise the following components in mass percent:

[0063] Propafenone Hydrochloride 72.7%

[0064] Filler 27%

[0065] Binder 0.3%

[0066] The filler is microcrystalline cellulose (AvicelPH102), and the binder is polyoxyethylene (WSR301).

[0067] It is prepared by extrusion spheronization, which specifically includes the following steps:

[0068] (1) After propafenone hydrochloride and filler (microcrystalline cellulose) are passed through a 30-mesh sieve respectively, mix uniformly according to the formula quantity, and add the binder (polyoxyethylene) solution (concentration is 5%) according to the formula quantity made into soft material;

[0069] (2) The soft material prepared in step (1) is extruded into a strip material in a 16-20 mesh extrusion equipment, and the strip material is put into a rounding equipment, and the edge line at 942 m / s Carry out spheronization at high...

Embodiment 3

[0073] In this embodiment, the propafenone hydrochloride sustained-release pellet capsules comprise the following components in mass percent:

[0074] Propafenone Hydrochloride 72.7%

[0075] Filler 27%

[0076] Binder 0.3%

[0077] The filler is a mixture of microcrystalline cellulose (AvicelPH102) and crospovidone (BASF) at a mass ratio of 1:1, and the binder is hypromellose (MethocelK4MCR).

[0078] It is prepared by extrusion spheronization, which specifically includes the following steps:

[0079] (1) After propafenone hydrochloride and the filler (the mixture of microcrystalline cellulose and crospovidone) are passed through a 30-mesh sieve respectively, they are mixed evenly according to the formula quantity, and the binder (hypromellose) is added according to the formula quantity Cellulose) solution (concentration is 0.01%) is made soft material;

[0080] (2) The soft material prepared in step (1) is extruded strip material in the extrusion equipment with a sieve p...

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Abstract

The invention provides a propafenone hydrochloride sustained-release pellet capsule as well as a preparation method and application thereof. The sustained-release pellet capsule consists of the following components in percentage by mass: 40-89.99% of propafenone hydrochloride, 10-50% of a filling agent and 0.01-10% of a binding agent. The propafenone hydrochloride sustained-release pellet capsule disclosed by the invention, on the basis of an extrusion-spheronization method, is successfully prepared by controlling the contents of various ingredients in a formula and by controlling conditions of a preparation process, and defects of the prior art which fails to prepare propafenone hydrochloride sustained-release pellets by virtue of the extrusion-spheronization method are overcome. Compared with a propafenone hydrochloride sustained-release micro-tablet capsule, the process of preparing the pellets by the extrusion-spheronization method is simple in step, and the process is capable of improving a production efficiency, significantly reducing differences between preparation batches and improving the stability of a sample; and the prepared propafenone hydrochloride sustained-release pellet capsule is stable in drug release, and the capsule is capable of improving medication compliance in patients and reducing toxic and side effects.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a propafenone hydrochloride sustained-release pellet capsule and a preparation method and application thereof. Background technique [0002] With the increase of cardiovascular diseases, arrhythmia diseases also increase, accounting for about 20% of cardiovascular diseases. There are many types of arrhythmias, which can be roughly divided into rapid heart rate, chronic heart rate and There are three categories of irregular early contractions. The common manifestations of rapid heart rhythm are upper ventricle and atrioventricular conduction disturbance. [0003] Propafenone hydrochloride (C 21 h 27 NO 3 HCl) is a class Ic antiarrhythmic drug with local anesthetic effect. The chemical name of propafenone hydrochloride is: 3-phenyl-1-[2-[3-(propylamino)-2-hydroxypropoxy]- Phenyl]-1-propanone hydrochloride has the following structure, molecular formula: C 21 h 27 NO ...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K31/138A61P9/06
Inventor 田武李伟贾小娟
Owner SALUS PHARMA TECH SHANGHAI
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