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Tacrolimus slow-releasing capsule and preparation method thereof

A technology for tacrolimus and sustained-release capsules is applied in the field of tacrolimus sustained-release capsules and its preparation, which can solve the problems of low utilization rate of raw materials and excipients, and achieve economical packaging methods, universal packaging equipment, and preparation technology. mature effect

Inactive Publication Date: 2013-12-11
JIANGSU QINGJIANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparation method solves the problem of low utilization rate of raw materials and auxiliary materials caused by crushing and sieving of raw materials and auxiliary materials in the existing preparation method of tacrolimus sustained-release capsules

Method used

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  • Tacrolimus slow-releasing capsule and preparation method thereof
  • Tacrolimus slow-releasing capsule and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0031] Name of raw material 200 capsules dosage Tacrolimus 1 g lactose 2.7 g Ethyl cellulose 1 g Hydroxypropylmethylcellulose 0.3 g Absolute ethanol 20 ml Ball core 70 g

[0032] Measure the prescribed amount of ethanol, weigh the prescribed amount of tacrolimus, and stir to dissolve the two. Weigh the prescribed amount of ethyl cellulose, slowly add the above dissolving solution, stir well to make it mix and dissolve. Weigh the prescribed amount of hypromellose, slowly add the above mixture, and keep stirring for 1 hour to make it fully swell. Add the prescribed amount of lactose and stir continuously to disperse evenly.

[0033] Add the prescribed amount of ball cores in the fluidized bed coating machine, and apply the drug coating. After the coating is finished, it is fully dried, discharged, and the obtained pellets are filled into capsules.

Embodiment 2

[0035] Name of raw material 200 capsules dosage Tacrolimus 1 g Mannitol 3 g Ethyl cellulose 0.7 g Hydroxypropylmethylcellulose 0.3 g Absolute ethanol 20 ml Ball core 50 g

[0036] Measure the prescribed amount of ethanol, weigh the prescribed amount of tacrolimus, and stir to dissolve the two. Weigh the prescribed amount of ethyl cellulose, slowly add the above dissolving solution, stir well to make it mix and dissolve. Weigh the prescribed amount of hydroxypropyl methylcellulose, slowly add the above mixture, and keep stirring for 1 hour to make it fully swell. Add the prescribed amount of mannitol and keep stirring to disperse evenly.

[0037] Add the prescribed amount of ball cores in the fluidized bed coating machine, and apply the drug coating. After the coating is finished, it is fully dried, discharged, and the obtained pellets are filled into capsules.

Embodiment 3

[0039] Name of raw material 200 capsules dosage Tacrolimus 1 g lactose 3 g Ethyl cellulose 0.5 g Hydroxypropylmethylcellulose 0.5 g Absolute ethanol 20 ml Ball core 50 g

[0040] Measure the prescribed amount of ethanol, weigh the prescribed amount of tacrolimus, and stir to dissolve the two. Weigh the prescribed amount of ethyl cellulose, slowly add the above dissolving solution, stir well to make it mix and dissolve. Weigh the prescribed amount of hydroxypropyl methylcellulose, slowly add the above mixture, and keep stirring for 1 hour to make it fully swell. Add the prescribed amount of lactose and stir continuously to disperse evenly.

[0041] Add the prescribed amount of ball cores in the fluidized bed coating machine, and apply the drug coating. After the coating is finished, it is fully dried, discharged, and the obtained pellets are filled into capsules.

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Abstract

The invention discloses a tacrolimus slow-releasing capsule and a preparation method thereof. The tacrolimus slow-releasing capsule is a pellet capsule and has the characteristic of slowness in releasing, and is stable in dissolution degree and good in bioavailability. According to the preparation method, tacrolimus and relative auxiliary materials are prepared into coating liquid, the coating liquid is wrapped on pellet cores to form micro pellets in a coating manner, and the capsule is prepared after packing. Since the crushing, grinding or filtering of the bulk drugs or the auxiliary materials are needless in the preparation process, the bulk drugs and the auxiliary materials can be utilized to the greatest extent, as a result, the problem in the conventional preparation method of the tacrolimus slow-releasing capsule that the utilization rate of the bulk drugs and the auxiliary materials is low since composition containing the tacrolimus is required to be smashed and sieved, is solved.

Description

technical field [0001] The invention relates to a slow-release capsule whose main component is tacrolimus used in the field of medicine and a preparation method thereof. technical background [0002] Tacrolimus is a macrolide antibiotic that can be used as an immunosuppressive drug after organ transplantation. It is mainly used to reduce the activity of the patient's immune system, thereby reducing the risk of organ rejection. Its chemical structure is as follows: [0003] [0004] Tacrolimus sustained-release capsule is a sustained-release preparation that only needs to be taken orally once a day. At present, the preparation method of this sustained-release preparation is to prepare tacrolimus raw material drug and excipients such as hypromellose and ethyl cellulose into a solid dispersion composition, and then encapsulated into capsules (such as Chinese patent ZL99806415.7). Since tacrolimus is a poorly soluble substance, in order to effectively control its particle s...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K31/436A61P37/06
Inventor 朱武欣
Owner JIANGSU QINGJIANG PHARMA
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