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A kind of preparation method of compound micropill capsule and the prepared compound micropill capsule

A technology of teriflunomide compound pellets and capsules is applied in the preparation of compound pellets and capsules, and the field of compound pellets and capsules can solve the problems of inconvenience in taking, high production cost and high medical cost, and achieve convenient administration and low production and medical cost. , the effect of reducing irritation

Inactive Publication Date: 2018-09-04
HYBIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Both teriflunomide and dimethyl fumarate are administered orally and both have significant curative effects on multiple sclerosis, but they are taken at the same time as marketed products, which is inconvenient to take, and the production cost and medical cost are relatively high

Method used

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  • A kind of preparation method of compound micropill capsule and the prepared compound micropill capsule
  • A kind of preparation method of compound micropill capsule and the prepared compound micropill capsule
  • A kind of preparation method of compound micropill capsule and the prepared compound micropill capsule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Embodiment 1: the preparation of dimethyl fumarate-teriflunomide compound pellet capsule

[0027] 1. Preparation of drug-loaded pills

[0028] (1) Prescription (1000 capsules)

[0029]

[0030] (2) Preparation

[0031] Mix the recipe amount of dimethyl fumarate, microcrystalline cellulose, sodium starch glycolate, silicified microcrystalline cellulose, Tween-80, silicon dioxide and purified water, and add EudragitRL PO binder Solution, wet granulation, put the wet granules into a rotary extruder, the extruded strips are pelletized in a centrifugal spheronizer, the extrusion speed is 70rpm, the screen diameter is 1.0mm, the spheronizer speed is 300rpm, and the spheronization time For 5 to 7 minutes, the extrusion spheronizer was a WL-350 extrusion spheronizer from Zhejiang Xiaolun Pharmaceutical Co., Ltd. After making pellets, it was put into an oven for drying at 35°C.

[0032] 2. Preparation of delayed release layer coating

[0033] (1) Prescription (coating wei...

Embodiment 2

[0043] Embodiment 2: the preparation of dimethyl fumarate-teriflunomide compound pellet capsule

[0044] 1. Preparation of drug-loaded pills

[0045] (1) Prescription (1000 capsules)

[0046]

[0047] (2) Preparation

[0048] Mix the recipe amount of dimethyl fumarate, microcrystalline cellulose, sodium starch glycolate, silicified microcrystalline cellulose, Tween-80, silicon dioxide and purified water, and add EudragitRL PO binder Solution, wet granulation, put the wet granules into a rotary extruder, the extruded strips are pelletized in a centrifugal spheronizer, the extrusion speed is 70rpm, the screen diameter is 1.0mm, the spheronizer speed is 300rpm, and the spheronization time For 5 to 7 minutes, the extrusion spheronizer was a WL-350 extrusion spheronizer from Zhejiang Xiaolun Pharmaceutical Co., Ltd. After making pellets, it was put into an oven for drying at 35°C.

[0049] 2. Preparation of delayed release layer coating

[0050] (1) Prescription

[0051] ...

Embodiment 3

[0061] Embodiment 3: the preparation of dimethyl fumarate-teriflunomide compound pellet capsule

[0062] 1. Preparation of drug-loaded pills

[0063] (1) Prescription (1000 capsules)

[0064]

[0065]

[0066] (2) Preparation

[0067] Mix the recipe amount of dimethyl fumarate, microcrystalline cellulose, sodium starch glycolate, silicified microcrystalline cellulose, Tween-80, silicon dioxide and purified water, and add EudragitRL PO binder Solution, wet granulation, put the wet granules into a rotary extruder, the extruded strips are pelletized in a centrifugal spheronizer, the extrusion speed is 70rpm, the screen diameter is 1.0mm, the spheronizer speed is 300rpm, and the spheronization time For 5 to 7 minutes, the extrusion spheronizer was a WL-350 extrusion spheronizer from Zhejiang Xiaolun Pharmaceutical Co., Ltd. After making pellets, it was put into an oven for drying at 35°C.

[0068] 2. Preparation of delayed release layer coating

[0069] (1) Prescription ...

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Abstract

The invention belongs to the technical field of medicine preparation, and discloses a preparation method for a compound pellet capsule and the prepared compound pellet capsule. The capsule structure comprises a medicine-carrying pill, a delayed-release layer and a rapid-release layer; the medicine-carrying pill is prepared by employing an extrusion-spheronization process; and the delayed-release layer and the rapid-release layer are prepared by employing a fluidized bed coating process. The prepared capsule is substantial in curative effect, safe, stable, convenient to take, small in side effect and low in production medical cost. The medicine effective compositions dimethyl fumarate and teriflunomide are different in drug action mechanism, also medicine administration is simple and convenient, and the curative effect of the two medicine effective compositions generates synergic effect, the indication scope is larger than that of a single medicine, multiple sclerosis is treated through multiple targets, and the curative effect is better than that of a single medicine.

Description

technical field [0001] The invention relates to the technical field of drug preparation, in particular to a preparation method of compound micropill capsules and compound micropill capsules prepared by the method. Background technique [0002] Multiple sclerosis (MS) is an autoimmune disease characterized by inflammatory demyelinating lesions of the central nervous system. Injuries that cause visual disturbances, loss of balance, poor coordination, slurred speech, tremors, numbness, extreme fatigue, intellectual changes, muscle weakness, paresthesias, and blindness account for more than 350,000 people with MS in the U.S. and about 2.5 million worldwide. Symptoms usually appear between the ages of 20 and 40, the number of female patients is twice that of males, and most patients are in the relapse period of the disease. There is no cure for the disease, only symptomatic treatment can reduce the relapse rate and disability rate of sclerosis to alleviate the suffering of patie...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/277A61K9/60A61P25/00A61K31/194
CPCA61K9/5042A61K31/194A61K31/277A61K2300/00
Inventor 王博郑春莲马亚平袁建成
Owner HYBIO PHARMA
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