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Sustained-release composition preparation of polypeptide protein drugs and preparation method thereof

A slow-release composition and peptide protein technology, which is applied in the fields of peptide/protein components, drug delivery, pharmaceutical formulations, etc., can solve the problems of complex formulation design, achieve structure and biological activity, high drug content, and stability Effect

Active Publication Date: 2020-06-19
ZHEJIANG UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It adopts the blending of at least two temperature-sensitive polymers and the addition of various excipients to fine-tune the release of the gel, and the design of the preparation is relatively complicated

Method used

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  • Sustained-release composition preparation of polypeptide protein drugs and preparation method thereof
  • Sustained-release composition preparation of polypeptide protein drugs and preparation method thereof
  • Sustained-release composition preparation of polypeptide protein drugs and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Accurately weigh 200mg PLGA1500-PEG1450-PLGA1500 (both are number average molecular weight, the weight percentage of PEG block is 32.6%, the weight percentage of PLGA block is 67.4%, the molar ratio of LA / GA is 3:1), add 0.80ml to remove Ionized water was dissolved under magnetic stirring at room temperature to obtain a temperature-sensitive polymer aqueous solution with a concentration of 20% (w / w), and an LCST of 32°C. Accurately weigh 1mg of recombinant human growth hormone (rhGH), add 0.3ml of water to dissolve to obtain rhGH aqueous solution; accurately weigh 1mg of protamine (Tokyo Chemical Industry Co., Ltd. (TCI)), add 0.3ml of water to dissolve to obtain protamine aqueous solution; under magnetic stirring conditions, the protamine aqueous solution was added dropwise to the rhGH aqueous solution, and mixed uniformly to obtain a suspension of the rhGH complex; the suspension of the rhGH complex was centrifuged, and the supernatant was removed, that is The rhGH co...

Embodiment 2

[0043] Accurately weigh 200mg of PLGA1200-PEG1000-PLGA1200 (both are number-average molecular weight, the weight percent of PEG block is 29.4%, the weight percent of PLGA block is 70.6%, and the molar ratio of LA / GA is 3:1), add 0.80ml of Dissolve in deionized water under magnetic stirring at 15°C to obtain a temperature-sensitive polymer aqueous solution with a concentration of 20% (w / w), and an LCST of 20°C. Accurately weigh 1 mg of recombinant human growth hormone, add 0.3 ml of water to dissolve it, and obtain rhGH aqueous solution; accurately weigh 1 mg of protamine (Tokyo Chemical Industry Co., Ltd. (TCI)), add 0.3 ml of water to dissolve it, and obtain protamine Aqueous solution; add the protamine aqueous solution dropwise to the rhGH aqueous solution under stirring, mix evenly to obtain a suspension of the rhGH complex; centrifuge the suspension of the rhGH complex, remove the supernatant, and obtain the rhGH complex things. The rhGH complex and the temperature-sensit...

Embodiment 3

[0045] Accurately weigh 200 mg of PLGA1500-PEG1450-PLGA1500 (both are number average molecular weight, the weight percentage of PEG block is 32.6%, the weight percentage of PLGA block is 67.4%, the molar ratio of LA / GA is 3:1), add 0.80 ml of deionized water was dissolved under magnetic stirring at 15°C to obtain a temperature-sensitive polymer aqueous solution with a concentration of 20% (w / w), and an LCST of 32°C. Accurately weigh 1mg of recombinant human growth hormone, add 0.3ml of water to dissolve, obtain rhGH aqueous solution; accurately weigh 1mg of zinc acetate, add 0.3ml of water to dissolve, obtain zinc acetate aqueous solution; accurately weigh 1mg of protamine (Tokyo Chemical Industry Co., Ltd. (TCI)), add 0.3ml of water to dissolve to obtain an aqueous solution of protamine; add the aqueous solution of zinc acetate and aqueous solution of protamine dropwise to the aqueous solution of rhGH under stirring, and mix evenly to obtain a rhGH complex The suspension of t...

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Abstract

The invention discloses a sustained-release composition preparation of polypeptide protein drugs and a preparation method thereof. The sustained-release composition preparation is prepared from the polypeptide protein drugs, a compound reagent and temperature-sensitive polymer aqueous solutions; the compound reagent is protamine, composition of the protamine and metal salt, composition of protamine, sodium phosphates and calcium chloride, a composition of protamine, sodium carbonate and calcium chloride or ethyl lauroyl arginate. According to the sustained-release composition preparation disclosed by the invention, accurate controlled sustained release of the polypeptide protein drugs can be realized under the premise of no influencing a drug effect of the polypeptide protein drugs, and the injection dosage times of the drugs can be reduced, and thus, the compliance of a patient is improved, and release velocity is stable. All steps of the preparation method of the sustained-release composition preparation are carried out in an aqueous phase, so that the structure and the biological activity of the polypeptide protein drugs are effectively maintained.

Description

technical field [0001] The invention belongs to the field of polypeptide protein drug preparations, and in particular relates to a sustained-release composition preparation of polypeptide protein drug and a preparation method thereof. Background technique [0002] Compared with the traditional small molecule drugs that have dominated the entire drug market, peptide protein drugs have higher specificity, higher activity and lower toxicity, and can be used for tumors, chronic metabolic diseases, central nervous system, immune system , cardiovascular and other diseases. However, most polypeptide drugs require repeated or even long-term administration, and the treatment with ordinary injections has poor patient compliance. Therefore, prolonging the drug release time through drug sustained release technology to reduce the number of administrations and improve drug compliance has always been the key to the development of polypeptide and protein drugs. The currently marketed poly...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/06A61K38/21A61K38/26A61K38/28A61K38/38A61K39/395A61K47/34A61K47/42
CPCA61K9/0024A61K9/06A61K38/21A61K38/26A61K38/28A61K38/38A61K39/395A61K39/3955A61K47/34A61K47/42
Inventor 邱利焱薛佳平郑程
Owner ZHEJIANG UNIV
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