Freeze-dried composition of mycophenolate mofetil and preparation method thereof

A technology of mycophenolate mofetil and a composition is applied in the field of mycophenolate mofetil freeze-dried composition and preparation thereof, which can solve the problems of increased cost, prone to shrinkage, complicated freeze-drying method and the like, and saves production. Cost, good reconstitution effect

Active Publication Date: 2017-07-04
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The mycophenolate mofetil mofetil freeze-dried composition that utilizes prior art to make is poor in appearance stability, and shrinks easily in high temperature and long-term storage process; the cost of its preparation

Method used

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  • Freeze-dried composition of mycophenolate mofetil and preparation method thereof
  • Freeze-dried composition of mycophenolate mofetil and preparation method thereof
  • Freeze-dried composition of mycophenolate mofetil and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] prescription

[0021]

[0022] Preparation

[0023] Weigh the prescribed amount of mycophenolate mofetil, citric acid, and sodium benzoate, add 2000ml of water for injection pre-cooled to room temperature, stir and mix well, adjust the pH value of the solution with 1M hydrochloric acid, dilute to the total amount, and stir until colorless and clear Liquid; filtered, filled, freeze-dried, and visually inspected to obtain the finished product.

[0024] Freeze-drying curve:

[0025]

Embodiment 2

[0027] prescription

[0028]

[0029] Preparation method (with embodiment 1)

Embodiment 3

[0031] prescription

[0032]

[0033]

[0034] Preparation method (with embodiment 1)

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PUM

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Abstract

The invention provides a freeze-dried composition of mycophenolate mofetil. The freeze-dried composition of mycophenolate mofetil is mainly composed of the active component mycophenolate mofetil, a stabilizing agent, a cosolvent, a pH regulating agent and injection water. The freeze-dried composition of mycophenolate mofetil is in the shape of a loose block, can be rapidly dissolved after addition of water, has good dissolvability and is free of shrinkage after long-term preservation; and freeze-drying time is short, so production cost is greatly reduced.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a mycophenolate mofetil freeze-dried composition 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 composed of macrolide antibiotic structure immunosuppressants, calcineurinase inhibitors, and adrenal cortex hormones has been re...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/5377A61P37/06
CPCA61K9/19A61K31/5377A61K47/12
Inventor 张贵民董其松孙宗彬李婷
Owner SHANDONG NEWTIME PHARMA
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