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Method for preparing oxygen carrier freeze-dried preparation of haemoglobin

A technology for hemoglobin and freeze-dried preparations, which can be used in freeze-dried delivery, peptide/protein components, blood diseases, etc., and can solve problems such as difficult storage and poor stability.

Active Publication Date: 2010-02-10
西安血氧生物技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0030] The invention provides a preparation method of a hemoglobin oxygen carrier freeze-dried preparation, which solves the technical problems of poor stability and difficult storage at room temperature in the background technology

Method used

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  • Method for preparing oxygen carrier freeze-dried preparation of haemoglobin
  • Method for preparing oxygen carrier freeze-dried preparation of haemoglobin
  • Method for preparing oxygen carrier freeze-dried preparation of haemoglobin

Examples

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Effect test

example 1

[0101] Hemoglobin oxygen carrier was provided by Xi'an North America Pharmaceutical Co., Ltd. The hemoglobin oxygen carrier was diluted with 20% glucose solution to make the final concentration of 40 mg / ml, and the final concentration of glucose was 4%.

[0102] (1) Subpackage of hemoglobin oxygen carrier: subpackage the prepared product into 5ml centrifuge tubes, 2.5ml per tube;

[0103] (2) Freeze dryer pre-cooling: the vacuum freeze dryer is operated according to the freeze-drying routine, so that the temperature of the cold trap is reduced to about -80°C;

[0104] (3) Pre-freezing: put the product in a -40°C refrigerator for 2 hours;

[0105] (4) Sublimation and drying: turn on the vacuum pump to evacuate. The sublimation drying process is divided into 2 stages:

[0106] Initial drying: shelf temperature -10°C, last 18h;

[0107] Secondary drying: shelf temperature 20°C, last 2h. The vacuum degree of the freeze-drying process is lower than 1Pa;

[0108] (5) After the...

example 2

[0117] Hemoglobin oxygen carrier was provided by Xi'an North America Pharmaceutical Co., Ltd. The hemoglobin oxygen carrier was diluted with 1 mol / LLys-Asp, the concentration of the hemoglobin oxygen carrier was adjusted to 40 mg / ml, and the final concentration of the amino acid salt Lys-Asp was 0.2 mol / L.

[0118] (1) Packing of hemoglobin-like oxygen carriers: Pack the prepared product into 5ml centrifuge tubes, each containing 2.5ml.

[0119] (2) Freeze dryer pre-cooling: the vacuum freeze dryer is operated according to the freeze-drying routine, so that the temperature of the cold trap is reduced to about -80°C;

[0120] (3) Pre-freezing: put the product in a -40°C refrigerator for 2 hours.

[0121] (4) Sublimation and drying: turn on the vacuum pump to evacuate. The sublimation drying process is divided into two stages, primary drying: shelf temperature -10°C, lasts 18h; secondary drying: shelf temperature 20°C, lasts 2h. The vacuum degree of the freeze-drying process ...

example 3

[0131] Hemoglobin oxygen carrier was provided by Xi'an North America Pharmaceutical Co., Ltd. The hemoglobin oxygen carrier was diluted with 20% trehalose solution, the concentration of the hemoglobin oxygen carrier was adjusted to 40 mg / ml, and the final concentration of trehalose was 4%.

[0132] (1) Packing of hemoglobin-like oxygen carriers: Pack the prepared product into 5ml centrifuge tubes, each containing 2.5ml.

[0133] (2) Freeze dryer pre-cooling: the vacuum freeze dryer is operated according to the freeze-drying routine, so that the temperature of the cold trap is reduced to about -80°C;

[0134] (3) Pre-freezing: put the product in a -40°C refrigerator for 2 hours.

[0135] (4) Sublimation and drying: turn on the vacuum pump to evacuate. The sublimation drying process is divided into two stages, primary drying: shelf temperature -10°C, lasts 18h; secondary drying: shelf temperature 20°C, lasts 2h. The vacuum degree of the freeze-drying process is lower than 1Pa...

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Abstract

The invention provides a method for preparing an oxygen carrier freeze-dried preparation of haemoglobin. The method comprises five steps of treatment before pre-cooling, pre-cooling, pre-freezing, freeze drying and storage, wherein at the stage of treatment before pre-cooling, a special single protective agent or compound protective agent is added; and the oxygen carrier freeze-dried preparation of haemoglobin prepared by the method has the advantages of high stability, normal temperature storage, and convenient transportation; moreover, the normal biological activities of the preparation canbe kept after the preparation is dissolved into water.

Description

technical field [0001] The invention relates to a preparation method of a freeze-dried preparation, in particular to a preparation method of a hemoglobin oxygen carrier freeze-dried preparation. Background technique [0002] The method of obtaining relatively stable and easy-to-transport protein drugs is usually to prepare them into solid preparations. The most commonly used method is vacuum freeze drying (vacuum freeze drying), but there are unfavorable factors that cause protein denaturation to varying degrees during the freeze-drying process. , such as the process there are a variety of stress, usually including low temperature stress, freezing stress (including the formation of dendritic ice crystals, increase in ionic strength, pH change, phase separation, etc.), drying stress (removal of protein surface monolayer of water molecules), etc., these stresses often directly or indirectly lead to the denaturation of protein drugs. Therefore, analyzing the factors that lead ...

Claims

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Application Information

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IPC IPC(8): A61K38/42A61K47/26A61K47/18A61K47/36A61K9/19A61P7/08
Inventor 高文运陈超陈佳一
Owner 西安血氧生物技术有限公司
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