Freeze dried HGF preparations
A freeze-dried preparation, freeze-dried technology, applied in the direction of freeze-dried transportation, antiviral agents, medical preparations of non-active ingredients, etc., can solve problems such as poor effect of stabilizers, achieve good physical and chemical stability, and stable storage excellent effect
Examples
example 1
[0035] Example 1: Preparation of low-concentration HGF freeze-dried preparation (comparative example)
[0036] HGF was dissolved in 10 mM phosphate buffer (pH 6.5) containing 140 mM sodium chloride and 0.01% polysorbate 80 to a final concentration of 1 mg / mL, and filtered to obtain an aqueous HGF solution. After adjusting the pH of the solution, fill each vial with 2 mL under aseptic conditions, and freeze-dry according to the conditions shown in Table 1 to obtain a low-concentration HGF freeze-dried preparation. "β" in the table indicates a change in temperature.
[0037] Table 1
example 2
[0038] Freezing process Primary drying process Secondary drying process Temperature (Β°C) 20β-40 -40 -40β-20 -20 -20β20 20 Time (Hr) 1 5 3 48 2 24 Pressure (mmHg) 760 760 <1 < 1 <1 <1 Example 2: Preparation of low-concentration HGF freeze-dried preparation (comparative example)
example 3
[0039] HGF was dissolved by heating with 10 mM phosphate buffer (pH 6.5) containing 140 mM sodium chloride and 0.01% polysorbate 80, and the final concentration of HGF was 5 mg / mL. After sterilization by filtration, HGF aqueous solution was obtained. After adjusting the pH of this solution, fill 2 mL in each vial under aseptic conditions, and freeze-dry according to the conditions shown in Table 1 to obtain a low-concentration HGF freeze-dried preparation. Example 3: Preparation of high-concentration HGF freeze-dried preparation (comparative example)
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Description
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Application Information
- IPC
- A61K9/19; A61K38/18; A61K47/18
- CPC
- A61K9/0019; A61K9/19; A61K38/1833; A61K47/183; A61P31/14
- Inventors
- εεΆι δΏ