Pre-filled recombinant human interferon injection

A technology of recombinant human interferon and injection, applied in the field of recombinant human interferon injection, can solve the problems of protein aggregation, affecting the titer of interferon, etc.

Inactive Publication Date: 2010-07-21
BEIJING KAWIN TECH SHARE HLDG +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In order to solve the problem that interferon injections are packed in glass vials to produce protein aggregation and affect the potency of interferon, and reduce the types and amounts of auxiliary materials as much as possible, the present invention provides an interferon, buffer system, amino acid and Tween- 80 made of interferon injections, wherein the amount of Tween-80 is less than 0.1mg / mL

Method used

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  • Pre-filled recombinant human interferon injection
  • Pre-filled recombinant human interferon injection
  • Pre-filled recombinant human interferon injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Prescription: recombinant human interferon α2b: 2.5×10 9 (IU), sodium acetate trihydrate 395mg, glacial acetic acid 125mg, arginine hydrochloride 7900mg, Tween-80 12.5mg, water for injection was added to 250mL;

[0039] Configuration method:

[0040] (1) Take the raw materials of the prescription amount, dissolve arginine hydrochloride, sodium acetate trihydrate, and glacial acetic acid with sterile pyrogen-free water for injection;

[0041] (2) Take Tween-80 and add it to the above-mentioned dissolved raw material solution;

[0042] (3) Add the recombinant human interferon α2b of the prescribed amount to the solution obtained in step (2), and mix well;

[0043] (4) Dilute water for injection to 250mL, pass through a microporous membrane with a pore size of 0.22μm, store in a refrigerator at 8±2°C, and take samples for sterility and heat source inspection;

[0044] (5) Subpackage the qualified injection in the step (4) into 1 mL vials, each containing 0.5 mL, to obta...

Embodiment 2

[0046]Prescription: recombinant human interferon α2b: 2.5×10 9 (IU), sodium acetate trihydrate 395mg, glacial acetic acid 125mg, arginine hydrochloride 7900mg, Tween-80 12.5mg, water for injection was added to 250mL;

[0047] Configuration method:

[0048] (1) Take the raw materials of the prescription amount, dissolve arginine hydrochloride, sodium acetate trihydrate, and glacial acetic acid with sterile pyrogen-free water for injection;

[0049] (2) Take Tween-80 and add it to the above-mentioned dissolved raw material solution;

[0050] (3) Add the recombinant human interferon α2b of the prescribed amount to the solution obtained in step (2), and mix well;

[0051] (4) Dilute water for injection to 250mL, pass through a microporous membrane with a pore size of 0.22μm, store in a refrigerator at 8±2°C, and take samples for sterility and heat source inspection;

[0052] (5) Divide the qualified injection in step (4) into prefilled syringes, and fill each syringe with 0.5 m...

Embodiment 3

[0054] Prescription: recombinant human interferon α2b: 1.5×10 9 (IU), sodium acetate trihydrate 237mg, glacial acetic acid 75mg, lysine hydrochloride 4740mg, Tween-80 12mg, water for injection was added to 150mL;

[0055] Configuration method:

[0056] (1) Take by weighing the prescription amount of raw materials, lysine hydrochloride, sodium acetate trihydrate, and glacial acetic acid are dissolved with sterile pyrogen-free water for injection;

[0057] (2) Take Tween-80 and add it to the above-mentioned dissolved raw material solution;

[0058] (3) Add the recombinant human interferon α2b of the prescribed amount to the solution obtained in step (2), and mix well;

[0059] (4) Dilute water for injection to 150mL, pass through a microporous membrane with a pore size of 0.22 μm, store in a refrigerator at 8±2°C, and take samples for sterility and heat source inspection;

[0060] (5) Subpackage the qualified injection in the step (4) into 1 mL vials, each containing 0.3 mL, ...

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Abstract

The invention relates to a pre-filled recombinant human interferon injection which is prepared from recombinant human interferon, arginine hydrochloride or lysine hydrochloride, acetic acid-acetate buffer solution with the pH value of 4.5 to 5.5 and tween-80; the injection prepared by the formula of the invention can be immediately filled into a small glass bottle for injection, or can be directly filled into a prefilled syringe; the injection of the invention is filled into the small glass bottle, the problems of a large amount of protein aggregation and greatly reduced interferon titer caused by the surface absorption of the small glass bottle are solved, and after being stored for a long time, interferon still has quite high titer.

Description

technical field [0001] The invention belongs to the field of interferon preparations, in particular to a stable recombinant human interferon injection. Background technique [0002] Recombinant human interferon has broad-spectrum anti-virus, anti-tumor, inhibition of cell proliferation and improvement of immune function, and is the first choice for the treatment of acute and chronic viral hepatitis. At present, the most widely used dosage forms of recombinant human interferon are freeze-dried powder injections and small-volume injections. Among them, injections are more convenient to use, but their prescriptions are required to protect the long-term stability of interferon molecules in aqueous solution. Human blood white is usually used. Protein acts as a stabilizer for interferon. However, human albumin has its own defects. As a blood product, patients are at risk of contracting blood diseases when using it, and the threshold for export is high. [0003] At present, in ad...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K38/21A61K47/34A61P1/16A61P31/14A61P31/20A61P35/00A61P37/04A61K47/18A61K47/26
Inventor 张春丽关晶华许晓陈新玲袁京云张晓溪
Owner BEIJING KAWIN TECH SHARE HLDG
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