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Recombinant human interleukin-2 freeze-dried preparation for injection and preparation method thereof

The technology of interleukin and freeze-dried preparation is applied in the field of recombinant human interleukin-2 freeze-dried preparation for injection and its preparation, which can solve the problem that the performance of recombinant human interleukin-2 for injection is prone to change, the activity is decreased, and the Affect product quality and expiration date and other issues, and achieve the effect of being conducive to large-scale production, stable performance, easy transportation and storage

Inactive Publication Date: 2014-02-12
江苏金丝利药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Since the performance of recombinant human interleukin-2 for injection is prone to change during storage and transportation, the degradation of the main components leads to a decrease in activity, which affects the quality and expiration date of the product

Method used

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  • Recombinant human interleukin-2 freeze-dried preparation for injection and preparation method thereof
  • Recombinant human interleukin-2 freeze-dried preparation for injection and preparation method thereof
  • Recombinant human interleukin-2 freeze-dried preparation for injection and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0029] Take an appropriate amount of recombinant human interleukin-2 stock solution and an appropriate amount of mannitol injection, add sodium citrate solution, add SDS, add human serum albumin, stir well, control the pH value between 6.0 and 8.0, and dilute with water for injection , to obtain a solution containing recombinant human interleukin-2.1 million IU and 0.1 g of mannitol per milliliter. The solution was sterilized by filtration with a 0.22 μm microporous membrane, and under aseptic conditions, the resulting solution was placed in a sterile vial of 1.0 ml per bottle, half-stoppered with a venting rubber stopper, and freeze-dried in a freeze dryer for about 24 hours. Hours later, full vacuum plugging was performed to obtain the recombinant human interleukin-2 freeze-dried powder injection A of the present invention.

Embodiment 2～4

[0031] Take appropriate amount of recombinant human interleukin-2 stock solution and appropriate amount of mannitol injection, add sodium dihydrogen phosphate and disodium hydrogen phosphate buffer, add SDS, add human serum albumin, stir well, and control the pH value at 6.0-8.0 Between them, dilute with water for injection to obtain solutions containing 0.05g, 0.1g, and 0.15g of recombinant human interleukin-2.1 million IU and mannitol per milliliter. The solution is sterilized by filtration with a 0.22 μm microporous membrane, and the resulting solution is placed in a sterile vial at 1.0 ml per bottle under aseptic conditions, half stoppered with a venting rubber stopper, and placed in a freeze dryer according to Example 8 After freeze-drying by the method according to the above method, full vacuum plugging is used to obtain recombinant human interleukin-2 freeze-dried powder injections B, C, and D of the present invention.

Embodiment 5

[0033] Take an appropriate amount of recombinant human interleukin-2 stock solution and an appropriate amount of lactose aqueous solution, add sodium dihydrogen phosphate and disodium hydrogen phosphate buffer, add SDS, add human serum albumin, stir well, and control the pH value between 6.0 and 8.0, Dilute to volume with water for injection to obtain a solution containing recombinant human interleukin-2.1 million IU and lactose 0.1 g per milliliter. The solution is sterilized by filtration with a 0.22 μm microporous membrane, and the resulting solution is placed in a sterile vial at 1.0 ml per bottle under aseptic conditions, half stoppered with a venting rubber stopper, and placed in a freeze dryer according to Example 8 After freeze-drying according to the method described above, full vacuum plugging is used to obtain the recombinant human interleukin-2 freeze-dried powder injection E of the present invention.

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Abstract

The invention provides a recombinant human interleukin-2 freeze-dried preparation for injection and a preparation method thereof. The preparation is a freeze-dried solution comprising the following components: recombinant human interleukin-2 and a pharmaceutically acceptable solubilizer, wherein the pH (potential of Hydrogen) of the solution is 6.0-8.0; the solubilizer is a mixture of one or more than one of mannitol, sorbitol, sodium chloride, SDS (Sodium Dodecyl Sulfate), glucose, sucrose, lactose or dextran. The preparation method comprises the steps of (1) preparing a solution containing the recombinant human interleukin-2 and the pharmaceutically acceptable solubilizer, wherein the pH of the solution is 6.0-8.0; (2) carrying out pyrogen removal and filtration sterilization on the solution obtained in the step (1) by using a conventional method; and (3) carrying out freeze drying on the solution obtained in the step (3). The recombinant human interleukin-2 freeze-dried powder-needle preparation provided by the invention is stable in performance, easy to transport and store and convenient in clinic use; the preparation method provided by the invention is simple, practicable and low in cost and is beneficial for mass production.

Description

technical field [0001] The invention relates to the technical field of interleukin-2, in particular to a freeze-dried preparation of recombinant human interleukin-2 for injection and a preparation method thereof. Background technique [0002] Human interleukin-2 (hIL-2) can improve the body's immune response to infections such as viruses, bacteria, fungi, and protozoa, and activate cytotoxic T lymphocytes (CTL), natural killer cells (NK), and lymphokines to kill Cells (LAK) and tumor-infiltrating lymphocytes (TIL) proliferate and enhance their killing activity, thereby eliminating tumor cells and virus-infected cells in the body. It can also increase the secretion of cytokines such as antibodies and interferon (IFN), which plays a very important role in the body's immune response. [0003] Interleukin-2 is a cytokine with a wide range of immune regulation effects, whether it is systemic application, local application, combined with other cytokine biological response regulat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K38/20A61P37/04A61P35/00A61P31/12
Inventor 杜连强
Owner 江苏金丝利药业股份有限公司
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