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SAPC-phospholipid nanovesicle freeze-dried preparation, its preparation method and use

A technology of nanovesicles and freeze-dried preparations, which is applied in the field of biomedicine, can solve the problems of uneven distribution of bilayer membrane size and quantity, increased size difference of lipid vesicles, exposure of active pharmaceutical ingredients, etc., and achieve complete freezing , fast drying, good stability

Active Publication Date: 2018-11-02
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-phospholipid nanovesicle freeze-dried preparation, its preparation method and use
  • SAPC-phospholipid nanovesicle freeze-dried preparation, its preparation method and use
  • SAPC-phospholipid nanovesicle freeze-dried preparation, its preparation method and use

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] Example 1: Preparation of SapC-phospholipid nanovesicle lyophilized formulation sample 1

[0061] Specific steps are as follows:

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

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

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

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

[0066] 5) Vacuum drying: the temperature was raised to 25°C for 6 hours, and the drying time was 24 hours.

[0067] The lyophilized preparation of polypeptide protein-phospholipid nanovesicles with SapC:DOPS:adjuvant of 2:1:10 (weight ratio) was obtained, namel...

Embodiment 2

[0068] Example 2: Preparation of SapC-phospholipid nanovesicle lyophilized formulation sample 2

[0069] Specific steps are as follows:

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

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

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

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

[0074] 5) Vacuum drying: the temperature was raised to 25°C for 6 hours, and the drying time was 24 hours.

[0075] The lyophilized preparation of polypeptide protein-phospholipid nanovesicles with SapC:DOPS:adjuvant of 3:1:20 (weight ratio) was obtained, namely s...

Embodiment 3

[0076] Example 3: Preparation of SapC-phospholipid nanovesicle lyophilized formulation sample 3

[0077] Specific steps are as follows:

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

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

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

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

[0082] 5) Vacuum drying: the temperature was raised to 25°C for 6 hours, and the drying time was 24 hours.

[0083] The lyophilized preparation of polypeptide protein-phospholipid nanovesicles with SapC:DOPS:adjuvant in a 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 pharmaceutical preparation, in particular to a SapC-phospholipid nanovesicle freeze-dried preparation, a preparation method and use thereof. The invention also relates to a SapC-phospholipid nanovesicle injection preparation. Background technique [0002] Saposin C (Saposin C, referred to as SapC) is a member of the saposin family and has important functions 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 research found that SapC is a biomembrane fusion protein with special selectivity and affinity for anionic phospholipids exposed in the outer layer of the cell membrane of pathological cells....

Claims

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Application Information

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Patent Type & Authority Patents(China)
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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