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Compound enteric-coated orally disintegrating table and preparation method thereof

An orally disintegrating tablet and enteric-coated technology, which is applied in the field of compound enteric-coated orally disintegrating tablets and its preparation, can solve the problems of reducing the dosage of tacrolimus, toxic side effects, dysphagia, and reducing long-term mortality, so as to improve medication compliance Sexuality, high bioavailability, superior inhibitory effect

Inactive Publication Date: 2018-01-19
WUXI FORTUNE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The purpose of the present invention is to disclose a compound enteric-coated orally disintegrating tablet, which is used to solve the inhibitory effect of the compound enteric-coated orally disintegrating tablet using tacrolimus alone on various types of rejection reactions in kidney transplant patients in the prior art. And reduce the dosage of tacrolimus and its toxic and side effects on the human body, reduce long-term mortality; at the same time, the present invention also proposes a preparation method of compound enteric-coated orally disintegrating tablets, in order to accelerate absorption and improve drug The purpose of the utilization of traditional anti-rejection drugs, and to solve the technical problems of organ transplantation patients with dysphagia

Method used

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  • Compound enteric-coated orally disintegrating table and preparation method thereof
  • Compound enteric-coated orally disintegrating table and preparation method thereof
  • Compound enteric-coated orally disintegrating table and preparation method thereof

Examples

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Embodiment 1

[0026] A compound enteric-coated orally disintegrating tablet disclosed in this example, per 1000 tablets, is mainly made of the following main ingredients and auxiliary materials:

[0027]

[0028] In this embodiment, the preparation method of the compound enteric-coated orally disintegrating tablet comprises the following steps:

[0029] Step (1): Coating for the first time: after taking the above-mentioned prescription amount of mycophenolate sodium, tacrolimus, stabilizer, and hydroxypropyl methylcellulose as a film-forming material respectively through an 80-mesh sieve, the mycophenolate A mixed solution of sodium phenate, tacrolimus, stabilizer, ethanol and water is used to make a suspension, and the mixed solution is sprayed onto the blank ball core by the bottom spraying process, and then the ethanol containing hydroxypropyl methylcellulose The blank ball core is coated with the aqueous solution for the first time, dried, and the weight gain is 1.2%. As a film-form...

Embodiment 2

[0035] A compound enteric-coated orally disintegrating tablet disclosed in this example, per 1000 tablets, is mainly made of the following main ingredients and auxiliary materials:

[0036]

[0037]

Embodiment 3

[0039] A compound enteric-coated orally disintegrating tablet disclosed in this example, per 1000 tablets, is mainly made of the following main ingredients and auxiliary materials:

[0040]

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Abstract

The invention provides a compound enteric-coated orally disintegrating table and a preparation method thereof, wherein the compound enteric-coated orally disintegrating table is prepared from the following components in parts by weight: 20-30 parts of sodium mycophenolate, 0.3-3 parts of tacrolimus, 30-40 parts of core pellet, 2-10 parts of stabilizer, 2-10 parts of separant, 2-10 parts of entericcoating material, 10-20 parts of filling agent, 10-30 parts of disintegrating agent, and 0.1-3 parts of lubricating agent. The compound enteric-coated orally disintegrating table disclosed by the invention has the advantages of being small in particle size, quick in absorption, high in bioavailability, good in taste and easy to swallow, improves the medicine taking compliance of the patient, andis beneficial for treatment of diseases; meanwhile, under the synergistic effect of sodium mycophenolate and tacrolimus, tacrolimus and sodium mycophenolate can be prepared into a compound preparationwhile reducing the use dosage of tacrolimus so as to achieve a synergistic effect of decrement and equivalence; and the compound enteric-coated orally disintegrating table has a more remarkable advantage in inhibiting effect than the medicine of any formula which generates various rejection reactions in postoperation of renal transplantation patients, and remarkably reduces various side effects.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a compound enteric-coated orally disintegrating tablet and a preparation method thereof. Background technique [0002] About 70,000 people around the world receive organ transplants every year, most of which are kidney transplants. In China, more than 5,000 patients receive kidney transplants every year. How to improve the long-term survival rate of transplanted organs has always been a major problem in the medical field. The human immune system has the ability to recognize "self" and "non-self". Usually, it only produces an immune response to foreign antigens, but immune tolerance to self-antigens. Therefore, the immune system's rejection of allografted organs hinders the success of organ transplantation. Although the immunosuppressive regimen consisting of macrocyclic lactone antibiotic structure immunosuppressants, calcineurinase inhibitors, and adrenal c...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K9/30A61K31/365A61K31/436A61P37/06
Inventor 魏鑫华李晓明李标有郁晨燕
Owner WUXI FORTUNE PHARMA