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Tacrolimus sustained release tablets and preparation method thereof

A tacrolimus and sustained-release tablet technology, which is applied in the field of medicine, can solve the problems of unaffordable patients, unstable blood drug concentration, and short duration of action, so as to improve drug efficacy and drug safety, and improve drug intake. Compliant, less toxic and side effects

Inactive Publication Date: 2009-02-11
贾祥波 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Due to the frequent administration of ordinary tablets and capsules, the side effects are large, and the phenomenon of missed doses is prone to occur, and the blood drug concentration is not stable, and the duration of action is short; injections are inconvenient for patients to take medicine; sustained-release capsules can overcome the above Shortcomings
[0007] Japan's Fujisawa Pharmaceutical Company has obtained the import license of FK506 preparations, but due to its high price, most patients cannot afford it economically, so its application is limited

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Embodiment 1: A tacrolimus sustained-release tablet and preparation method thereof of the present invention adopts the following process steps: the proportion of its components (prescription amount) is calculated in parts by weight:

[0036]First, weigh 1 part of the prescribed amount of tacrolimus, 5 parts of povidone K305 dissolved in 40 parts of ethanol, make it completely dissolved and make it completely dissolve into a tacrolimus solution, and set aside; weigh the prescribed amount of hypromellose 30 parts of K15M, 30 parts of microcrystalline cellulose, 32 parts of mannitol, and 1 part of talcum powder were sieved (60 mesh), placed in a high-speed mixing granulator, stirred for 10 minutes, fully mixed and dispersed evenly, and mixed and granulated at the above-mentioned high speed Add tacrolimus solution into the machine and stir for 10 minutes, start the chopping motor to make wet granules, the rotational speed in the granulator is: 15r / min, the moisture content o...

Embodiment 2

[0041] Embodiment 2: A sustained-release tablet of tacrolimus of the present invention and its preparation method adopts the following process steps: the proportion of its components (prescription amount) is calculated in parts by weight:

[0042] Weigh 5 parts of tacrolimus and 10 parts of polyethylene glycol in 50 parts of ethanol to make it completely dissolved into a tacrolimus solution for subsequent use; weigh 15 parts of hypromellose K15M and 15 parts of hypromellose Sieve 5 parts of propyl methylcellulose K4M, 20 parts of dextrin, 42 parts of lactose, and 2 parts of micropowdered silica gel (80 mesh), place in a high-speed mixing granulator, stir for 15 minutes, fully mix and disperse evenly, and mix in the above-mentioned high-speed mixing system Add the tacrolimus solution into the granulator and stir for 15 minutes. Start the chopping motor to make wet granules. The rotational speed in the granulator is 15r / min. In the tray, put it in an oven for drying, the drying ...

Embodiment 3

[0047] Embodiment 3: A tacrolimus sustained-release tablet and preparation method thereof of the present invention adopts the following process steps: the proportion of its components (prescription amount) is calculated in parts by weight:

[0048] First weigh 8 parts of the prescribed amount of tacrolimus, 6 parts of povidone K306 dissolved in 60 parts of ethanol, make it completely dissolved into a tacrolimus solution, and set aside; weigh 10 parts of the prescribed amount of hypromellose K100M, 25 parts of hypromellose K4M, 25 parts of sorbitol, 23 parts of tricalcium phosphate, and 2 parts of talcum powder were sieved (100 mesh), placed in a high-speed mixing granulator, stirred for 30 minutes, fully mixed and dispersed evenly, and Add the tacrolimus solution to the above-mentioned high-speed mixing granulator and stir and mix for 30 minutes. Start the chopping motor to make wet granules. The rotational speed in the granulator is: 20r / min. Spread the granules on a tray and...

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Abstract

The invention relates to a sustained release tablet dosage, in particular to a Tacrolimus sustained release tablet used for liver and kidney transplantation patients and a preparation method thereof, belonging to the field of medicine technology. The invention is characterized in that Tacrolimus and adhesive are taken and dissolved in ethanol to prepare Tacrolimus solution; sustained release materials, thinner and flow agent are taken, mixed and dispersed uniformly and then added into the Tacrolimus solution to prepare wet particles, which are dried, ground and added and mixed with lubricant; finally, the Tacrolimus sustained release tablet is prepared after tabletting and drying. The sustained release tablet has the unique advantages of: reducing administration times, improving the administration adaptability of patients; after administration, having stable blood concentration, small toxic and side effects and improving the drug effect and safety; reducing the total dosage of drugs so as to achieve the greatest curative effect by the lowest dosage; being capable of being realized on most of tablet production lines and easily accepted by manufacturing units and manufacturers due to relatively simple preparation process; and having relatively low manufacturing cost and broad clinical application prospect.

Description

technical field [0001] The invention relates to a dosage form of a sustained-release tablet, in particular to a tacrolimus sustained-release tablet for liver and kidney transplant patients and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] The research and development of sustained-release preparations has a history of more than 40 years. It releases slowly and at a non-constant rate as required in a prescribed environment. extended. This kind of preparation can make the human body maintain this kind of blood drug concentration for a long time, instead of dropping rapidly like ordinary preparations, so as to avoid the "peak and valley" phenomenon that occurs when common preparations are frequently administered, and ensure the safety of the drug. Sexuality, effectiveness or adaptability are improved, thereby reducing the number of medications, which greatly facilitates patients, especially those who take medication fo...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K31/436A61P37/06
Inventor 贾祥波陆继好
Owner 贾祥波
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