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SapC-phosphatide nano vesicle freezed-drying preparation, and preparation method and application thereof

A technology for nanovesicles and freeze-dried preparations, applied in the field of biomedicine, can solve the problems of uneven distribution of the size and number of bilayer membranes, increased differences in the size of lipid vesicles, exposure of active pharmaceutical ingredients, etc., and achieve complete freezing. , rapid drying, good stability

Active Publication Date: 2012-08-01
CHANGZHOU CHANGJI BIOTECH DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] 2) Lipid vesicle preparation often shows a very uneven distribution in the size and number of bilayer membranes, which is not conducive to large-scale production
[0009] 3) The problem of stability
However, this lyophilization method is costly and time-consuming, and in this case, the size difference of lipid vesicles will increase, and the active pharmaceutical ingredients contained in it may be exposed

Method used

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  • SapC-phosphatide nano vesicle freezed-drying preparation, and preparation method and application thereof
  • SapC-phosphatide nano vesicle freezed-drying preparation, and preparation method and application thereof
  • SapC-phosphatide nano vesicle freezed-drying preparation, and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] Example 1: Preparation of SapC-phospholipid nanovesicle freeze-dried preparation sample 1

[0061] Specific steps are as follows:

[0062] 1) Prepare SapC aqueous solution. Add 3.34 g / L SapC protein (manufactured by GMP, Changji Company) and 16.67 g / L disaccharide auxiliary material, and filter sterilize.

[0063] 2) Prepare phospholipid (DOPS) organic solution (organic aqueous solution). Phospholipid dry powder (1 g / L) was dissolved in 80% tert-butanol (filter sterilized).

[0064] 3) Add SapC aqueous solution (0.6 ml / cart) to phospholipid organic solution (1.0 ml / cart), and mix. Phospholipid organic solution: SapC aqueous solution = 1:1 (v / v).

[0065] 4) Freezing: 1.6 ml / cartridge, -40°C, 6 hours.

[0066] 5) Vacuum drying: heating up to 25°C for 6 hours, drying time for 24 hours.

[0067] A polypeptide protein-phospholipid nanovesicle freeze-dried preparation, namely sample 1, with SapC:DOPS:adjuvant ratio of 2:1:10 (weight ratio) was obtained. The product...

Embodiment 2

[0068] Example 2: Preparation of SapC-phospholipid nanovesicle freeze-dried preparation sample 2

[0069] Specific steps are as follows:

[0070] 1) Prepare SapC aqueous solution. Add 3 g / L SapC protein (manufactured by GMP, Changji Company) and 20 g / L disaccharide auxiliary material, and filter sterilize.

[0071] 2) Prepare phospholipid (DOPS) organic solution (organic aqueous solution). Phospholipid dry powder (1 g / L) was dissolved in 80% tert-butanol (filter sterilized).

[0072] 3) Add SapC aqueous solution (1.0 ml / tube) to phospholipid organic solution (1.0 ml / tube) and mix. Phospholipid organic solution:SapC aqueous solution=0.8:1 (v / v).

[0073] 4) Freezing: 2.0 ml / cartridge, -40°C, 12 hours.

[0074] 5) Vacuum drying: heating up to 25°C for 6 hours, drying time for 24 hours.

[0075] A polypeptide protein-phospholipid nanovesicle freeze-dried preparation, namely sample 2, with SapC:DOPS:adjuvant ratio of 3:1:20 (weight ratio) was obtained.

Embodiment 3

[0076] Example 3: Preparation of SapC-phospholipid nanovesicle freeze-dried preparation sample 3

[0077] Specific steps are as follows:

[0078] 1) Prepare SapC aqueous solution. Add 4 g / L SapC protein (manufactured by GMP, Changji Company) and 20 g / L disaccharide auxiliary material, and filter sterilize.

[0079] 2) Prepare phospholipid (DOPS) organic solution (organic aqueous solution). Phospholipid dry powder (1 g / L) was dissolved in 80% tert-butanol (filter sterilized).

[0080] 3) Add SapC aqueous solution (1.0 ml / tube) to phospholipid organic solution (1.0 ml / tube) and mix. Phospholipid organic solution:SapC aqueous solution=0.8:1 (v / v).

[0081] 4) Freezing: 2.0 ml / cartridge, -40°C, 12 hours.

[0082] 5) Vacuum drying: heating up to 25°C for 6 hours, drying time for 24 hours.

[0083] A polypeptide protein-phospholipid nanovesicle freeze-dried preparation, namely sample 3, with a SapC:DOPS:adjuvant ratio of 6:1:30 (weight ratio) was obtained.

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Abstract

The invention, belonging to the field of biomedicine, relates to a SapC-phosphatide nano vesicle freezed-drying preparation and its preparation method and application. specifically, the preparation method of the SapC-phosphatide nano vesicle freezed-drying preparation comprises the following steps: 1)preparing a co-solution of SapC and phosphatide, wherein the co-solution comprises water and organic solvent, one or more organic solvents selected from 1-propyl alcohol, 2-propyl alcohol, methanol, tert-butyl alcohol, and acetonitrile; 2) carrying out vacuum freeze drying: carrying out vacuum freeze drying on the co-solution obtained by the step 1) to obtain the SapC-phosphatide nano vesicle freezed-drying preparation. The invention also relates to a SapC-phosphatide nano vesicle freezed-drying injection preparation. The SapC-phosphatide nano vesicle freezed-drying preparation disclosed herein has no need of high-temperature disinfection, and has uniform particle size and good stability.

Description

technical field [0001] The invention belongs to the field of biomedicine and relates to a protein drug preparation, in particular to a SapC-phospholipid nanovesicle freeze-dried preparation, its preparation method and application. The invention also relates to a SapC-phospholipid nanovesicle injection preparation. Background technique [0002] Saposin C (Saposin C, referred to as SapC) is one of the members of the saposin family and plays an important role in controlling lysosomal sphingolipid and glycosphingolipid metabolism (see Grabowski, G.A., Gatt, S ., and Horowitz, M. (1990) Crit. Rev. Biochem. Mol. Biol. 25, 385-414; Furst, W., and Sandhoff, K., (1992) Biochim. Biophys. Acta 1126, 1-16 ; Kishimoto, Y., Kiraiwa, M., and O'Brien, J.S. (1992) J. Lipid. Res. 33, 1255-1267). Further studies have found that SapC is a biomembrane fusion protein that has special selectivity and affinity for anionic phospholipids exposed on the outer layer of the cell membrane of pathologic...

Claims

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Application Information

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IPC IPC(8): A61K9/127A61K38/17A61P25/00A61P29/00A61P31/00A61P35/00A61P35/02
Inventor 不公告发明人
Owner CHANGZHOU CHANGJI BIOTECH DEV
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