A kind of injection preparation containing exendin-4 Fc fusion protein

Abstract

The invention relates to the field of biological medicines, and particularly provides an injection preparation containing Exendin-4Fc fusion protein. The injection preparation is prepared from the Exendin-4Fc fusion protein and injection mixed liquid, wherein a pH value of the injection mixed liquid is 6.0-6.7, each millilitre of the injection preparation contains 1.5-2.5 mg of the Exendin-4Fc fusion protein, and the injection mixed liquid is prepared from the following components in parts by weight: 0.1-2.0 parts of surfactant, 0.1-0.8 part of a solution buffering agent, 5-10 parts of an osmotic pressure adjusting agent and 50-90 parts of stabilizer. The injection preparation containing the Exendin-4Fc fusion protein can be stably stored for at least 36 months under circumstances in whichvarious detection indexes are stable, and corresponding physicochemical quality standards are met, so that a storage life of the Exendin-4Fc fusion protein is effectively prolonged.

Description

technical field [0001] The invention relates to the technical field of biomedicine, in particular to an injection preparation containing Exendin-4 Fc fusion protein. Background technique [0002] Diabetes is a chronic metabolic disorder that occurs when the human pancreas cannot produce enough insulin or cannot effectively use the insulin produced. At present, diabetes is one of the four major non-communicable diseases of human beings. Global public health has posed a serious threat. [0003] Diabetes mainly includes type I and type II. Among them, type I diabetes, also known as insulin-dependent diabetes, is an insulin deficiency caused by the body's immune system damaging pancreatic β cells. Type II diabetes is a complex disease caused by factors such as relative insulin deficiency, or insulin resistance in liver, muscle and adipocytes, or excessive glucagon secretion. [0004] GLP-1 (glucagon-like peptide-1) is a peptide hormone composed of 31 amino acids encoded by the...

AI Technical Summary

Problems solved by technology

These four drugs are all small-molecule chemical drugs, among which Exenatide Microsphere Injection (Bida Yang) is a long-acting sustained-release drug, and the other three drugs are all short-acting GLP-1 analogues, which not only have a short half-life, but also give The high frequency of medication increases the patient’s medication burden and pain, and the patient has obvious gastrointestinal reactions after each administration, and long-term administration will bring great inconvenience and pain to the patient; exenatide microspheres Injection (Baidayang), its preparation uses polyethylene lactide and sucrose as auxiliary materials, although it has a sustained release effect and can reduce the frequency of medication, but the microsphere preparation has a burst release effect, which is likely to cause unstable blood drug concentrations in patients , because the microspheres cannot be sterilized and filtered, the entire aseptic process is required, the production cost is high, the process and quality controllability is poor, and there is a risk of microbial contamination. In addition, recent studies have confirmed that exenatide microspheres and exenatide common Compared with injections, it can significantly increase the risk of thyroid C-cell cancer, and has significant adverse effects. The drug has been marked with a black box warning in the instructions by the US Food and Drug Administration

In addition, the existing injections or microsphere injections have a short storage period, and the stability of the drug molecules in the injection cannot be guaranteed during storage. Therefore, there is an urgent need for a long-term storage that can ensure the stability of the drug during long-term storage. GLP-1 analog preparation products with high quality, long-acting, small side effects, safe and reliable preparation process, and low adverse reactions

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