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Mycophenolate mofetil nano preparation for long-acting stable release and preparation method thereof

A technology of mycophenolate mofetil and nano-formulation is applied in the field of preparation of mycophenolate mofetil nano-formulation to achieve the effects of safety guarantee, yield assurance and stable encapsulation performance.

Active Publication Date: 2021-06-22
XIAN MEDICAL UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, ellagic acid can be used as a stabilizer for PDA-loaded mycophenolate mofetil nanoparticles, but there is no report on the application of ellagic acid in related aspects

Method used

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  • Mycophenolate mofetil nano preparation for long-acting stable release and preparation method thereof
  • Mycophenolate mofetil nano preparation for long-acting stable release and preparation method thereof
  • Mycophenolate mofetil nano preparation for long-acting stable release and preparation method thereof

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preparation example Construction

[0037] The invention provides a mycophenolate mofetil nano-preparation for long-term stable release and a preparation method thereof, comprising the following steps:

[0038] Step 1. Prepare the required mother liquor:

[0039] After mixing mycophenolate mofetil and poloxamer (labels include: 237, 338, 407) according to the mass ratio of 2:1-4:1, and dimethyl sulfoxide according to the mass of 20 mg:1 ml Mixing by volume ratio to prepare the mixed mother liquor of mycophenolate mofetil and poloxamer, and filtering to remove impurities with a fat-soluble filter membrane with a pore size of 0.22 microns;

[0040]The preparation concentration is the ellagic acid dimethyl sulfoxide solution of 20 mg / mL to prepare the ellagic acid mother liquor, and remove impurities by filtering with a fat-soluble filter membrane with a pore size of 0.22 microns;

[0041] Configure a Tris aqueous solution with a concentration of 30 mg / ml, and adjust the pH of the solution to 8.8-9.0 with dilute h...

Embodiment 1

[0050] Step 1. Prepare the required mother liquor:

[0051] After MMF and poloxamer 237 are mixed according to the mass ratio of 2:1, and dimethyl sulfoxide is mixed according to the ratio of 20 mg: 1 ml, the MMF-poloxamer mixed solution is prepared, and the pore size is 0.22 Micron fat-soluble membrane filtration to remove impurities;

[0052] Prepare a solution of ellagic acid dimethyl sulfoxide with a concentration of 20 mg / ml, and filter to remove impurities with a fat-soluble filter membrane with a pore size of 0.22 microns;

[0053] Configure a Tris aqueous solution with a concentration of 30 mg / ml, and adjust the pH of the solution to 8.8 with dilute hydrochloric acid;

[0054] Prepare an aqueous solution of dopamine hydrochloride with a concentration of 20 mg / ml, and filter to remove impurities with a water-soluble filter membrane with a pore size of 0.22 microns;

[0055] Step 2. Slowly add the mixed solution of mycophenolate mofetil and poloxamer dropwise to 10 tim...

Embodiment 2

[0060] Step 1. Prepare the required mother liquor:

[0061] After MMF and poloxamer 237 are mixed according to the mass ratio of 3:1, and dimethyl sulfoxide is mixed according to the ratio of 20 mg: 1 ml, the MMF-poloxamer mixed solution is prepared, and the pore size is 0.22 micron Fat-soluble membrane filtration to remove impurities;

[0062] Prepare a solution of ellagic acid dimethyl sulfoxide with a concentration of 20 mg / ml, and filter to remove impurities with a fat-soluble filter membrane with a pore size of 0.22 microns;

[0063] Configure a Tris aqueous solution with a concentration of 30 mg / ml, and adjust the pH of the solution to 8.8 with dilute hydrochloric acid;

[0064] Prepare an aqueous solution of dopamine hydrochloride with a concentration of 20 mg / ml, and filter to remove impurities with a water-soluble filter membrane with a pore size of 0.22 microns;

[0065] Step 2. Slowly add the mixed solution of mycophenolate mofetil and poloxamer to 13 times the vo...

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Abstract

The invention discloses a mycophenolate mofetil nano preparation for long-acting stable release and a preparation method thereof. The preparation method comprises the steps: preparing a mixed mother solution of mycophenolate mofetil and poloxamer, ellagic acid, Tris-HCl and a dopamine hydrochloride mother solution, dropwise adding the mixed mother solution of mycophenolate mofetil and poloxamer into the Tris-HCl mother solution, adding an ellagic acid mother solution and a dopamine hydrochloride mother solution into the mixed solution, and finally removing impurities to obtain the mycophenolate mofetil nano preparation. MMF is made into a nanoparticle preparation, ellagic acid is used for enhancing the stability of pi bond accumulation between MMF molecules and a PDA nano packaging material, the defects of an existing PDA nano drug-loaded particle preparation technology are overcome, the yield in the production process of the monodisperse MMF nanoparticle preparation can be effectively ensured, related materials are all clinically common auxiliary materials and drugs, and the safety is guaranteed. The nano drug-loaded particles prepared according to the method are relatively uniform and moderate in particle size, good in monodispersity and more stable in entrapment performance.

Description

technical field [0001] The invention belongs to the technical field of nano preparations, in particular to a nano-preparation of mycophenolate mofetil for long-acting and stable release, and the invention also relates to a nano-preparation of mycophenolate mofetil for long-acting and stable release Preparation. Background technique [0002] Organ transplantation is the final choice for a variety of organ failure diseases in the terminal stage. Patients who receive transplantation must take appropriate immunosuppressants for life, otherwise the body will experience rejection mediated by cellular immunity and humoral immunity, which will seriously affect the survival of transplanted organs Rate. Mycophenolic acid (MPA) has a highly selective effect on lymphocytes, and is a highly selective, reversible, non-competitive hypoxanthine mononucleotide dehydrogenase inhibitor, which can inhibit lymphocyte bird Synthesis of purine nucleotides, thereby inhibiting the proliferation of...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K47/34A61K47/22A61K31/5377A61P37/06
CPCA61K9/5146A61K9/5123A61K31/5377A61P37/06
Inventor 李科周韵左杨
Owner XIAN MEDICAL UNIV