A kind of immune cell cryopreservation solution for direct venous reinfusion and its application

Abstract

The invention discloses an immune cell cryopreservation liquid for direct intravenous reinfusion and application thereof. The present invention uses dimethyl sulfoxide, human serum albumin, dextran, hydroxyethyl starch, heparin sodium and other clinical pharmaceutical grade raw materials, and optimizes the ratio of the usage of each raw material to finally prepare a direct Immune cell cryopreservation fluid infused intravenously. In addition, the present invention also simplifies the operation steps and improves the freezing effect by optimizing the freezing storage method. On the one hand, the present invention avoids the potential risk of introducing animal-derived antigenic substances in the process of cell therapy; on the other hand, the immune cell cryopreservation effect of the present invention is better than conventional cryopreservation solutions, thus ensuring the safety and effectiveness of clinical use sex. The present invention preserves by two components, so that the cryopreservation solution can be stored stably for a long time. The method of the invention is simple to operate, provides stronger operability for the implementation of large-scale cryopreservation, and provides basic technical support for the implementation of immune cell therapy.

Description

Technical field

[0001] The invention relates to a cell cryopreservation solution, in particular to a direct intravenous infusion of immune cell cryopreservation solution and an application method thereof. The invention belongs to the field of biomedicine technology.Background technique

[0002] Cancer is the primary problem that plagues human health. Cellular immunotherapy provides broad prospects for tumor prevention and treatment. However, in the process of clinical application, there are many problems such as difficulty in collecting autoimmune cells of some tumor patients, poor cell expansion, and difficulty in matching the time window of immune cells with other treatment methods. In addition, from the perspective of drug development and production, The off-site transportation, storage conditions and survival time of fresh immune cells are all limited. Therefore, the effective cryopreservation of immune cells provides the necessary basic technical support for the industrial applicatio...

Examples

Embodiment 1

[0033]Example 1: Preparation and application of immune cell cryopreservation solution for direct intravenous infusion

[0034]1. Raw materials and specifications

[0035]Hydroxyethyl starch and sodium chloride injection: 500ml: Hydroxyethyl starch (200 / 0.5) 30g

[0036]Dextran 40 glucose injection: 500ml: 30g dextran 40 and 25g glucose

[0037]Heparin Sodium Injection: 2ml: 12,500 units

[0038]Human albumin injection: 50ml: 10g total protein

[0039]2. Preparation and application of immune cell cryopreservation solution for direct intravenous infusion

[0040]1) Prepare liquid A and liquid B separately

[0041]A solution (100ml): 8.3ml dimethyl sulfoxide + 45.8ml hydroxyethyl starch sodium chloride injection + 45.8ml dextran 40 glucose injection + 0.1ml heparin sodium injection.

[0042]The content of each component in A solution is: dimethyl sulfoxide 8.3v / v%, hydroxyethyl starch 2.75w / v%, dextran 2.75w / v%, glucose 2.29w / v%, heparin sodium 625U / ml, The rest are medical injections.

[0043]B solution (100ml): 2...

Embodiment 2

[0056]Example 2: Preparation and application of immune cell cryopreservation solution for direct intravenous infusion

[0057]1. Raw materials and specifications

[0058]Hydroxyethyl starch and sodium chloride injection: 500ml: Hydroxyethyl starch (200 / 0.5) 30g

[0059]Dextran 40 glucose injection: 500ml: 30g dextran 40 and 25g glucose

[0060]Heparin Sodium Injection: 2ml: 12,500 units

[0061]Human albumin injection: 50ml: 5g total protein

[0062]2. Preparation and application of immune cell cryopreservation solution for direct intravenous infusion

[0063]1) Prepare liquid A and liquid B separately

[0064]A solution (100ml): 10ml dimethyl sulfoxide + 70ml hydroxyethyl starch sodium chloride injection + 19.9ml dextran 40 glucose injection + 0.1ml heparin sodium injection

[0065]The content of each component in A solution is: dimethyl sulfoxide 10v / v%, hydroxyethyl starch 4.2w / v%, dextran 1.19w / v%, glucose 1.0w / v%, heparin sodium 625U / ml, the rest For medical injection;

[0066]B solution (100ml): 10w / v% hum...

Embodiment 3

[0079]Example 3: Preparation and application of immune cell cryopreservation solution for direct intravenous infusion

[0080]1. Raw materials and specifications

[0081]Hydroxyethyl starch and sodium chloride injection: 500ml: Hydroxyethyl starch (200 / 0.5) 30g

[0082]Dextran 40 glucose injection: 500ml: 30g dextran 40 and 25g glucose

[0083]Heparin Sodium Injection: 2ml: 12,500 units.

[0084]Human albumin injection: 50ml: 5g total protein

[0085]2. Preparation and application of immune cell cryopreservation solution for direct intravenous infusion

[0086]1) Prepare liquid A and liquid B separately

[0087]A solution (100ml): 9ml dimethyl sulfoxide + 33ml hydroxyethyl starch sodium chloride injection + 57.9ml dextran glucose injection + 0.1ml heparin sodium injection.

[0088]The content of each component in A solution is: dimethyl sulfoxide 9v / v%, hydroxyethyl starch 1.98w / v%, dextran 3.47w / v%, glucose 2.9w / v%, heparin sodium 625U / ml, the rest For medical injection;

[0089]Solution B (100ml): 10w / v% human...

Technical field

[0001] The invention relates to a cell cryopreservation solution, in particular to a direct intravenous infusion of immune cell cryopreservation solution and an application method thereof. The invention belongs to the field of biomedicine technology.Background technique

[0002] Cancer is the primary problem that plagues human health. Cellular immunotherapy provides broad prospects for tumor prevention and treatment. However, in the process of clinical application, there are many problems such as difficulty in collecting autoimmune cells of some tumor patients, poor cell expansion, and difficulty in matching the time window of immune cells with other treatment methods. In addition, from the perspective of drug development and production, The off-site transportation, storage conditions and survival time of fresh immune cells are all limited. Therefore, the effective cryopreservation of immune cells provides the necessary basic technical support for the industrial applicatio...

Examples

Embodiment 1

[0033]Example 1: Preparation and application of immune cell cryopreservation solution for direct intravenous infusion

[0034]1. Raw materials and specifications

[0035]Hydroxyethyl starch and sodium chloride injection: 500ml: Hydroxyethyl starch (200 / 0.5) 30g

[0036]Dextran 40 glucose injection: 500ml: 30g dextran 40 and 25g glucose

[0037]Heparin Sodium Injection: 2ml: 12,500 units

[0038]Human albumin injection: 50ml: 10g total protein

[0039]2. Preparation and application of immune cell cryopreservation solution for direct intravenous infusion

[0040]1) Prepare liquid A and liquid B separately

[0041]A solution (100ml): 8.3ml dimethyl sulfoxide + 45.8ml hydroxyethyl starch sodium chloride injection + 45.8ml dextran 40 glucose injection + 0.1ml heparin sodium injection.

[0042]The content of each component in A solution is: dimethyl sulfoxide 8.3v / v%, hydroxyethyl starch 2.75w / v%, dextran 2.75w / v%, glucose 2.29w / v%, heparin sodium 625U / ml, The rest are medical injections.

[0043]B solution (100ml): 2...

Embodiment 2

[0056]Example 2: Preparation and application of immune cell cryopreservation solution for direct intravenous infusion

[0057]1. Raw materials and specifications

[0058]Hydroxyethyl starch and sodium chloride injection: 500ml: Hydroxyethyl starch (200 / 0.5) 30g

[0059]Dextran 40 glucose injection: 500ml: 30g dextran 40 and 25g glucose

[0060]Heparin Sodium Injection: 2ml: 12,500 units

[0061]Human albumin injection: 50ml: 5g total protein

[0062]2. Preparation and application of immune cell cryopreservation solution for direct intravenous infusion

[0063]1) Prepare liquid A and liquid B separately

[0064]A solution (100ml): 10ml dimethyl sulfoxide + 70ml hydroxyethyl starch sodium chloride injection + 19.9ml dextran 40 glucose injection + 0.1ml heparin sodium injection

[0065]The content of each component in A solution is: dimethyl sulfoxide 10v / v%, hydroxyethyl starch 4.2w / v%, dextran 1.19w / v%, glucose 1.0w / v%, heparin sodium 625U / ml, the rest For medical injection;

[0066]B solution (100ml): 10w / v% hum...

Embodiment 3

[0079]Example 3: Preparation and application of immune cell cryopreservation solution for direct intravenous infusion

[0080]1. Raw materials and specifications

[0081]Hydroxyethyl starch and sodium chloride injection: 500ml: Hydroxyethyl starch (200 / 0.5) 30g

[0082]Dextran 40 glucose injection: 500ml: 30g dextran 40 and 25g glucose

[0083]Heparin Sodium Injection: 2ml: 12,500 units.

[0084]Human albumin injection: 50ml: 5g total protein

[0085]2. Preparation and application of immune cell cryopreservation solution for direct intravenous infusion

[0086]1) Prepare liquid A and liquid B separately

[0087]A solution (100ml): 9ml dimethyl sulfoxide + 33ml hydroxyethyl starch sodium chloride injection + 57.9ml dextran glucose injection + 0.1ml heparin sodium injection.

[0088]The content of each component in A solution is: dimethyl sulfoxide 9v / v%, hydroxyethyl starch 1.98w / v%, dextran 3.47w / v%, glucose 2.9w / v%, heparin sodium 625U / ml, the rest For medical injection;

[0089]Solution B (100ml): 10w / v% human...