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Recombination human soluble tumor necrosis factor related apoptosis inducing ligand freeze dried protection agents and preparation method thereof

A technology of tumor necrosis factor and apoptosis-inducing ligand, which is applied in the fields of anti-tumor drugs, freeze-dried delivery, and pharmaceutical formulations, and can solve problems such as reduction, yellowing of products, protein activity, and blood-borne pathogen contamination.

Inactive Publication Date: 2008-11-19
深圳未名新鹏生物医药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The problem of potential blood-borne pathogen contamination of albumin is that current biological products tend not to be used. Lactose is a reducing sugar, and some amino acids exposed on proteins may randomly undergo Maillard reactions, making products yellow and Problems such as decreased protein activity

Method used

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  • Recombination human soluble tumor necrosis factor related apoptosis inducing ligand freeze dried protection agents and preparation method thereof
  • Recombination human soluble tumor necrosis factor related apoptosis inducing ligand freeze dried protection agents and preparation method thereof
  • Recombination human soluble tumor necrosis factor related apoptosis inducing ligand freeze dried protection agents and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] A recombinant human soluble tumor necrosis factor-related apoptosis-inducing ligand lyoprotectant, the composition of which is: every 1000ml of recombinant human soluble tumor necrosis factor-related apoptosis-inducing ligand lyoprotectant contains Na 2 HPO 4 0.866g, NaH 2 PO 4 0.538g, mannitol 40g, sucrose 10g, NaCl 2.93g, all the other are water, namely the total concentration of phosphate ion is 10mmol / L, the final concentration of sodium chloride is 50mmol / L, the ratio of mannitol quality and solution volume is 4%, the ratio of sucrose mass to solution volume is 1%.

Embodiment 2

[0026] A recombinant human soluble tumor necrosis factor-related apoptosis-inducing ligand lyoprotectant, the composition of which is: every 1000ml of recombinant human soluble tumor necrosis factor-related apoptosis-inducing ligand lyoprotectant contains Na 2 HPO 4 8.66g, NaH 2 PO 4 5.38g, mannitol 5g, trehalose 5g, NaCl 5.86g, that is, the total concentration of phosphate ions is 100mmol / L, the final concentration of sodium chloride is 100mmol / L, and the ratio of mannitol mass to solution volume is 0.5%, The ratio of trehalose mass to solution volume is 0.5%.

Embodiment 3

[0028] A recombinant human soluble tumor necrosis factor-related apoptosis-inducing ligand lyoprotectant, the composition of which is: every 1000ml of recombinant human soluble tumor necrosis factor-related apoptosis-inducing ligand lyoprotectant contains Na 2 HPO 4 0.433g, NaH 2 PO 4 0.269g, mannitol 60g, sucrose 30g, NaCl 1.172g, namely the total concentration of phosphate ion is 5mmol / L, the final concentration of sodium chloride is 20mmol / L, the ratio of mannitol mass to solution volume is 6%, sucrose The ratio of mass to solution volume is 3%.

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Abstract

The invention relates to the field of the freeze dehydration of a biological preparation, in particular to a freeze-drying protective agent for recombinant human soluble tumor necrosis factor related apoptosis induced ligands, and a method for preparing the protective agent. The freeze-drying protective agent for recombinant human soluble tumor necrosis factor related apoptosis induced ligands consists of phosphate, sodium chloride, mannitol, sugar and water. The rhTRAIL freeze-dry preparation prepared with the freeze-dry protective agent has the advantages of low water content of less than 3 percent; white loose body without shrinking, and smooth surface; biological activity of more than 10<5>upsilon; excellent stability; maintaining the activity of 10<5>upsilon, and remarkable protective results.

Description

technical field [0001] The invention relates to the field of freeze-drying of biological products, in particular to a recombinant human soluble tumor necrosis factor-related apoptosis-inducing ligand freeze-drying protectant and a preparation method thereof Background technique [0002] Because freeze-dried drugs are porous, can be stored stably for a long time, and are easy to rehydrate to restore activity, freeze-drying technology is widely used in the preparation of solid protein drugs, oral instant drugs, and drug embedding agent liposomes. Freeze-dried preparations can protect protein activity very well, but various stresses generated during the freeze-drying process, such as low temperature stress, freezing stress, and drying stress can denature proteins. In order to protect protein activity, it is necessary to add Protective agent to protect the activity of protein. According to literature reports, commonly used lyoprotectants mainly include polyols, sugars, amino ac...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/19A61K47/36A61K47/26A61K9/19A61P35/00
Inventor 李继东于玉根陈红霞蒙国基
Owner 深圳未名新鹏生物医药有限公司