Pharmaceutical composition of recombinant glucagon-like peptide-1 receptor stimulant for injection
A technology for glucagon and receptor agonists, which is applied in the field of pharmaceutical compositions for injection of recombinant glucagon-like peptide-1 receptor agonists, and can solve problems affecting the stability of preparations, precipitation and precipitation, etc.
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Embodiment 1
[0104] Embodiment 1: Preparation of rE4 freeze-dried powder injection
[0105] Component Weight (g)
[0106] Recombinant glucagon-like peptide-1 receptor agonist 0.12
[0107] Citric acid 2.45
[0108] Sodium citrate 2.36
[0109] Mannitol 30
[0110] ① Weigh citric acid, sodium citrate, and mannitol according to the above prescription quantities, and add 800mL of water for injection to pre-dissolve;
[0111] ② Add appropriate amount of rE4 stock solution;
[0112] ③ Dilute the water for injection to 1000mL, the pH of the solution is 4.5, and the concentration of citric acid-sodium citrate buffer salt is 20mM;
[0113] ④ Sterilize and filter with a 0.22 μm filter membrane;
[0114] ⑤Aliquot 1mL / cartridge and freeze-dry.
Embodiment 2
[0115] Embodiment 2: Preparation of rE4 injection
[0116] Component Weight (g)
[0117] Recombinant glucagon-like peptide-1 receptor agonist 0.25
[0118] Citric acid 1.16
[0119] Sodium citrate 4.26
[0120] Mannitol 30
[0121] Phenol 2.5
[0122] ① Weigh citric acid, sodium citrate, mannitol, and phenol according to the above prescription quantities, and add 800mL of water for injection to pre-dissolve;
[0123] ② Add appropriate amount of rE4 stock solution;
[0124] ③ Dilute the water for injection to 1000mL, the pH of the solution is 5.6, and the concentration of citric acid-sodium citrate buffer salt is 20mM;
[0125] ④ Sterilize and filter with a 0.22 μm filter membrane;
[0126] ⑤ Dispense according to 1.2mL / cartridge.
Embodiment 3~7
[0127] Embodiment 3~7: the investigation of rE4 concentration
[0128] Referring to the prescription and preparation process of Example 1, only the specifications of the freeze-dried powder injection were changed to 0.03, 0.05, 0.10, 0.15, 0.20 mg / bottle respectively, and the freeze-dried powder injection was prepared.
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