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Mycophenolate mofetil lyophilized powder injection for injection and preparation method thereof

A technology of mycophenolate mofetil and freeze-dried powder injection, which is applied in the field of pharmaceutical preparations, can solve the problems of poor reconstitution effect, incomplete freeze-drying, and decreased blood pressure, and achieves the advantages of avoiding nausea, stable quality, and reducing toxic and side effects. Effect

Inactive Publication Date: 2011-01-26
SHANXI PUDE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, Tween 80 has a certain range of safe applications, which may cause blood pressure drop, hemolysis and other toxic side effects; in addition, if the product contains more Tween 80, it will cause incomplete freeze-drying, poor appearance, and poor reconstitution effect And other issues

Method used

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  • Mycophenolate mofetil lyophilized powder injection for injection and preparation method thereof
  • Mycophenolate mofetil lyophilized powder injection for injection and preparation method thereof
  • Mycophenolate mofetil lyophilized powder injection for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Example 1 0.5g mycophenolate mofetil for injection freeze-dried powder injection

[0033] 1. Prescription composition (prescription volume of 1000 bottles):

[0034] Mycophenolate Mofetil 500g

[0035] Polyethylene glycol-12-hydroxystearate 200g

[0036] Water for injection 6000mL

[0037] Fill in 20mL colorless control bottles to make 1000 bottles.

[0038] 2. Preparation:

[0039] 1) In the full amount of 80% water for injection, add polyethylene glycol-12-hydroxystearate, stir to dissolve, then add mycophenolate mofetil, and then add 2mol / L hydrochloric acid under stirring until Until the mycophenolate mofetil is dissolved; the pH value is adjusted to 3.5 with 2mol / L hydrochloric acid, and the water for injection is added to the full amount to prepare the medicinal solution;

[0040] 2) Add 0.05% (g / mL) wet activated carbon, stir and adsorb for 30min, and then filter with a 0.45μm polypropylene microporous membrane;

[0041] After the filtrate passed the inspec...

Embodiment 2

[0048] Example 2 1.0 g of mycophenolate mofetil for injection freeze-dried powder injection

[0049] 1. Prescription composition (prescription volume of 1000 bottles):

[0050] Mycophenolate Mofetil 1000g

[0051] Polyethylene glycol-12-hydroxystearate 400g

[0052] Water for injection 6000mL

[0053] Fill in 20mL colorless control bottles to make 1000 bottles.

[0054] 2. Preparation:

[0055] 1) Add polyethylene glycol-12-hydroxystearate to the full amount of 80% water for injection, stir to dissolve, then add mycophenolate mofetil, and then add 1mol / L hydrochloric acid to the mofetil under stirring Until the mycophenolate mofetil is dissolved, the pH value is adjusted to 4.5 with 2mol / L sodium hydroxide, and the water for injection is added to the full amount to obtain a medicinal solution;

[0056] 2) Add 0.05% (g / mL) wet activated carbon, stir and adsorb for 30min, and then filter with a 0.45μm microporous membrane (mixed cellulose acetate membrane);

[0057] After ...

Embodiment 3

[0064] Embodiment 3 influence factor test

[0065] According to the requirements of Appendix X IX C (Guiding Principles for Drug Stability Tests) of Part Two of the Chinese Pharmacopoeia (2005 Edition) and the "Key Items Table for Stability Inspection of Raw Materials and Pharmaceutical Preparations" in "Guiding Principles for Research on Chemical Drugs and Therapeutic Biological Products", The mycophenolate mofetil mofetil injection freeze-dried powder for injection of Example 1 is subjected to the influence factor test, focusing on the sample appearance, acidity, moisture, clarity, content and related substances. The specific process is as follows:

[0066] Take three batches of mycophenolate mofetil mofetil injection freeze-dried powder injection of Example 1, according to the commercially available package, carry out high temperature (60 ℃) and strong light irradiation (4500 ± 500LX) test, measure according to the above-mentioned key investigation items. The results are sh...

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Abstract

The invention provides a mycophenolate mofetil lyophilized powder injection for injection. The injection is prepared from mycophenolate mofetil serving as an active ingredient and polyethylene glycol-12-hydroxy stearate serving as a solubilizing agent in a weight ratio of 250-1,250:100-500. The invention also provides a method for preparing the mycophenolate mofetil lyophilized powder injection for injection. The mycophenolate mofetil lyophilized powder injection for injection has the advantages of simple and reasonable prescription, stable quality, convenient use, capabilities of preventing adverse reactions such as nausea, vomit, diarrhea and the like caused by oral preparations and the like and preventing toxic or side effects such as drop of blood pressure, hemolysis and the like caused by solubilizing agents such as Twain 80 and the like, high safety and good application prospect.

Description

technical field [0001] The invention relates to a mycophenolate mofetil injection form, in particular to a mycophenolate mofetil injection freeze-dried powder injection and a preparation method thereof, belonging to the field of pharmaceutical preparations. 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 "fertility". Usually, it only produces immune responses 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, ca...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/5377A61K47/34A61P37/06A61K47/14
Inventor 胡成伟解晓荣李立忠李润宝王勇高文
Owner SHANXI PUDE PHARMA CO LTD
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