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Exendin-4-Fc fusion protein injection preparation and preparation method thereof

An injection preparation and fusion protein technology, which is applied in the field of glucagon-like peptide analogs, can solve the problems of multiple components of excipients, poor stability of protein drugs, and discomfort of patients, and achieve simple components of excipients, stable and controllable quality, and reduced medication The effect of frequency

Active Publication Date: 2022-02-18
HUALAN BIOLOGICAL ENG INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the freeze-dried powder injection must be dissolved in a solution before use, and the activity of the protein cannot be guaranteed, the use is cumbersome, the patient is inconvenient to use, and even safety problems may arise
At present, the existing injections have short shelf life, poor stability of protein drugs, many excipients, difficult to control the quality of drugs, and frequent injections; for example, the Chinese patent application number 201811310774.9 discloses an injection preparation containing Exendin-4Fc fusion protein , the content of active ingredients in it is low, and frequent injections are required; the amount of excipients is large and the ingredients are complex, which is not conducive to product quality control and production, and at the same time, the osmotic pressure is high, which is likely to cause discomfort to patients when used; and the above injections are combined with Exendin-4Fc fusion protein The increase in the amount of addition makes the injection preparation unstable. If the above problems can be effectively solved, there will be huge market potential

Method used

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  • Exendin-4-Fc fusion protein injection preparation and preparation method thereof
  • Exendin-4-Fc fusion protein injection preparation and preparation method thereof
  • Exendin-4-Fc fusion protein injection preparation and preparation method thereof

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Experimental program
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Effect test

Embodiment 1

[0031]

[0032] Preparation method: (1) Weigh the prescription amount of poloxamer-188, mannitol, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate dodecahydrate and water for injection in proportion; (2) add injection Water, add pH adjuster - sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate dodecahydrate and adjust the pH to 7.6, add stabilizer - mannitol, stir for 15 minutes until completely dissolved, as solution A; (3) take part Solution A, add poloxamer-188 to a concentration of 100g / L, stir for 10min, as solution B; (4) use ultrafiltration to replace the purified and handed-over sample with ultrafiltration to solution A, as solution C; ( 5) Mix solutions A, B, and C according to the amount, filter through a 0.22 μm filter membrane, and pass through N 2 filling;

Embodiment 2

[0034]

[0035]

[0036] Preparation method: (1) Weigh the prescription amount of poloxamer-188, mannitol, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate dodecahydrate and water for injection in proportion; (2) add injection Water, add pH adjuster - sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate dodecahydrate and adjust the pH to 7.7, add stabilizer - mannitol, stir for 10 minutes until completely dissolved, as solution A; (3) take part Solution A, add poloxamer-188 to a concentration of 100g / L, stir for 5min, as solution B; (4) use ultrafiltration to replace the purified and handed-over sample with ultrafiltration to solution A, as solution C; ( 5) Mix solutions A, B, and C according to the amount, filter through a 0.22 μm filter membrane, and pass through N 2 filling;

Embodiment 3

[0038]

[0039] Preparation method: (1) Weigh Tween-20, mannitol, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate dodecahydrate and water for injection in proportion to the prescribed amount; (2) add water for injection into the preparation container, Add pH regulators - sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate dodecahydrate and adjust the pH to 7.7, add stabilizer - mannitol, stir for 12 minutes until completely dissolved, as solution A; (3) take part of solution A , add Tween-20 to a concentration of 80g / L, stir for 5min, and use it as solution B; (4) use ultrafiltration to replace the purified sample with ultrafiltration to solution A, as solution C; (5) Mix solutions A, B, and C, filter through a 0.22 μm filter membrane, pass through N 2 filling.

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Abstract

The invention provides an Exendin-4-Fc fusion protein injection preparation and a preparation method, the injection preparation comprises 0.28%-0.35% (w / v) of Exendin-4-Fc fusion protein, 0.01%-0.05% (w / v) of a surfactant, 1.8%-5.5% (w / v) of a stabilizer, a pH regulator and a solvent, and the pH of the injection preparation is 7.0-7.7. The Exendin-4-Fc fusion protein injection preparation is free of preservative, colorless to faint yellow, and is a clear to slightly opalescent liquid, the physical and chemical stability of the fusion protein can still be maintained within a long time, and the storage period is effectively prolonged; the Exendin-4-Fc fusion protein injection preparation provided by the invention is relatively high in fusion protein content and pH, can reduce the medication frequency and reduce the irritation of low pH to blood vessels, is suitable for blood vessel injection, relieves the pain of patients caused by high-frequency and dependent injection of hypoglycemic injections such as insulin and the like, and is good in patient medication compliance.

Description

technical field [0001] The invention relates to the technical field of glucagon-like peptide analogs, in particular to an Exendin-4-Fc fusion protein injection preparation and a preparation method thereof. Background technique [0002] Diabetes mellitus is a metabolic disorder characterized by hyperglycemia caused by defects in insulin secretion or its biological function. Type Ⅱ diabetes accounts for more than 90% of diabetic patients, and its main pathological manifestations are insulin resistance and relative insufficiency of insulin secretion caused by insulin cell dysfunction, resulting in persistent hyperglycemia and various fatal complications. [0003] Drugs for the treatment of type 2 diabetes include drugs that promote insulin secretion (such as sulfonylurea hypoglycemic agents), and drugs that increase peripheral tissue uptake and utilization of glucose (biguanide hypoglycemic agents). Among them, drugs that promote insulin secretion are still the main drugs for ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/02A61K47/26A61K47/10A61K38/22A61K47/68A61P3/10
CPCA61K9/0019A61K9/08A61K47/02A61K47/26A61K47/10A61K38/22A61K47/68A61P3/10Y02A50/30
Inventor 安文琪李学琴毕利利王斌马小伟
Owner HUALAN BIOLOGICAL ENG INC
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