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.

Inactive Publication Date: 2014-10-22
石药集团百克(山东)生物制药股份有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This program focuses on low-dose E4 preparations, and it was found in the research that when the excipients used are used in rE4 preparations, precipitation occurs occasionally, which affects the stability of the preparations

Method used

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  • Pharmaceutical composition of recombinant glucagon-like peptide-1 receptor stimulant for injection
  • Pharmaceutical composition of recombinant glucagon-like peptide-1 receptor stimulant for injection
  • Pharmaceutical composition of recombinant glucagon-like peptide-1 receptor stimulant for injection

Examples

Experimental program
Comparison scheme
Effect test

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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Abstract

The invention relates to a pharmaceutical composition of recombinant glucagon-like peptide-1 receptor stimulant for injection; wherein the recombinant glucagon-like peptide-1 receptor stimulant is prepared by escherichia coli expression and purification and has a sequence represented by the SEQ ID No.2. The pharmaceutical composition for injection comprises a recombinant glucagon-like peptide-1 receptor stimulant, critic acid-sodium citrate buffering salts, and polyol. The invention further relates to an injection liquid and freeze-dried powder injection containing the recombinant glucagon-like peptide-1 receptor stimulant. The pharmaceutical composition of recombinant glucagon-like peptide-1 receptor stimulant for injection has the advantages of safety, stability, convenience in transportation and storage, and suitability for industrial production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a pharmaceutical composition for injection of a recombinant glucagon-like peptide-1 receptor agonist. Background technique [0002] The natural glucagon-like peptide-1 receptor agonist (Exendin-4) is a biologically active polypeptide consisting of 39 amino acid residues isolated from the saliva of Giant lizard (Eng, J et al., J. Biol. Chem., 267:7402-05, 1992). Its amino acid sequence is as follows [SEQ.ID.NO.1]: [0003] His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp- Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH 2 . [0004] Exendin-4 has 53% homology with human glucagon-like peptide-1 (GLP-1) (Goke et al., J. Biol Chem., 268: 19650-55, 1993), the study found that Exendin -4 produces biological activity similar to GLP-1 in animals and humans, and the action time of Exendin-4 is significantly longer...

Claims

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Application Information

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IPC IPC(8): A61K38/26A61K9/08A61K9/19A61K47/12A61K47/10A61P3/10
Inventor 张锋窦燕峰解茹赵丽艳张璇贾锴盖文丽曹卫荣王莉芳
Owner 石药集团百克(山东)生物制药股份有限公司
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