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Recombination interleukin-2 frozen-dried preparation, and its preparing method

A freeze-dried preparation and interleukin technology, which is applied in freeze-dried delivery, drug combination, pharmaceutical formulation, etc., can solve the problem of reducing the freedom of molecular movement of proteins

Inactive Publication Date: 2007-07-25
SHANGHAI HUAXIN HIGH BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The general idea is to reduce the degrees of freedom of molecular motion (including vibration) of the protein, but in general, the formulation is empirical and must be experimentally verified before it can be really used

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Embodiment 1, specification 100,000 IU / bottle test

[0034] Take: Mannitol Injection (20%) 2000ml

[0035] Human albumin (20%) 200ml

[0036] Tween 80 (5%) 200ml is sterilized by high-pressure steam at 0.1Mpa, 121.3°C, 15-30 minutes

[0037] Phosphate buffer solution 0.2mol / L 250ml, sterilized by high pressure steam 0.1Mpa, 121.3℃, 15-30 minutes

[0038] After mixing the above reagents, dilute to 10000ml with water for injection. Used as a diluent for the preparation of recombinant interleukin-2 preparations, for later use.

[0039] The prescription components of the diluent are:

[0040] Mannitol 4%

[0041] Human Albumin 0.4%

[0042] Tween 80 0.1%

[0043] Phosphate buffer 5mmol / L

[0044] The recombinant interleukin-2 stock solution was calculated according to the potency and diluted to prepare 100,000 IU / bottle of recombinant interleukin-2, which was sterilized and filtered, divided into 1ml / bottle, and freeze-dried.

[0045] The freeze-dried preparations ...

Embodiment 2

[0052] Embodiment 2, specification 200,000 IU / bottle test

[0053] The experimental method is the same as implementation 1. The recombinant interleukin-2 stock solution was calculated according to the potency and diluted to prepare 200,000 IU / bottle, which was sterilized and filtered, then packed into 1ml / bottle, and freeze-dried. The freeze-dried preparations were stored at low temperature (2-8°C) and normal temperature (25°C±2°C) respectively, and the stability test was carried out. (See Table 3 and Table 4)

[0054] Table 3: Stability test of recombinant interleukin-2 freeze-dried preparation

[0055] Product name: recombinant interleukin-2 Specification: 200,000 IU / bottle temperature: 2～8℃

[0056]

batch number

project

result

0 months

3 months

6 months

9 months

12 months

18 months

24 months

30 months

36 months

42 months

48 months

60 months

20000701

...

Embodiment 3

[0059] Embodiment 3, specification 500,000 IU / bottle test

[0060] The experimental method is the same as implementation 1. The recombinant interleukin-2 stock solution was calculated according to the potency and diluted to prepare 500,000 IU / bottle, which was sterilized and filtered, then packed into 1ml / bottle, and freeze-dried. The freeze-dried preparations were stored at low temperature (2-8°C) and normal temperature (25°C±2°C) respectively, and the stability test was carried out. (See Table 5 and Table 6)

[0061] Table 5: Stability test of recombinant interleukin-2 lyophilized preparation

[0062] Product name: recombinant interleukin-2 Specification: 500,000 IU / bottle temperature: 2～8℃

[0063]

batch number

project

result

0 months

3 months

6 months

9 months

12 months

18 months

24 months

30 months

36 months

42 months

48 months

60 months

20000104 ...

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Abstract

A freeze-dried recombinant interleukin-2 able to be stored at ordinary temp for 5 years is prepared from recombinant interleukin-2, buffer, stabilizer, non-ionic surfactant and freeze-drying excipient through mixing said auxiliary components, diluting with the water for injection, proportionally adding interleukin-2, sterilizing, filtering, filling it in bottles, and freeze-drying.

Description

technical field [0001] The invention relates to a biological freeze-dried product, more specifically to a recombinant interleukin-2 freeze-dried preparation. Background technique [0002] Since the advent of recombinant interleukin-2, it has been widely used in the drug treatment of various cancer patients, such as kidney cancer, melanoma, liver cancer, gastric cancer, leukemia, hydrothorax, etc., and has achieved good curative effect, and the social demand is constantly increasing . Due to the instability of biological products, people are constantly looking for ways to overcome difficulties so that biological products can benefit human beings. [0003] But at present, recombinant interleukin-2 needs to be stored under refrigerated conditions, which will be very unfavorable for the production, storage and transportation of enterprises. Therefore, there is an urgent need to develop a preparation and method capable of preserving recombinant interleukin-2 at room temperature...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K38/20A61P35/00
Inventor 杨果诗周正徐惊平陈裕
Owner SHANGHAI HUAXIN HIGH BIOTECH
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