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Sustained release composition preparation of polypeptide protein drug and preparation method of sustained release composition preparation

A sustained-release composition and drug complex technology, which is applied in the fields of peptide/protein components, drug delivery, pharmaceutical formulations, etc., can solve the problems of complex formulation design, maintain structure and biological activity, and improve biocompatibility. The effect of medication compliance

Inactive Publication Date: 2019-07-30
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 drug and preparation method of sustained release composition preparation
  • Sustained release composition preparation of polypeptide protein drug and preparation method of sustained release composition preparation
  • Sustained release composition preparation of polypeptide protein drug and preparation method of sustained release composition preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] 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 1 mg of recombinant human growth hormone (rhGH), add 0.3 ml of water to dissolve it, and obtain an aqueous solution of rhGH; accurately weigh 1 mg of protamine, add 0.3 ml of water to dissolve it, and obtain an aqueous solution of protamine; The protamine aqueous solution is added dropwise to the rhGH aqueous solution, and mixed evenly to obtain a suspension of the rhGH complex; the suspension of the rhGH complex is centrifuged, and the supernatant is removed to obtain the rhGH complex. The rhGH complex and the temperature-sensitive pol...

Embodiment 2

[0036] 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 1mg of recombinant human growth hormone, add 0.3ml of water to dissolve to obtain rhGH aqueous solution; accurately weigh 1mg of protamine, add 0.3ml of water to dissolve to obtain protamine aqueous solution; add protamine aqueous solution drop by drop into the stirred rhGH aqueous solution, and mix evenly to obtain a suspension of the rhGH complex; centrifuge the suspension of the rhGH complex, and remove the supernatant to obtain the rhGH complex. The rhGH complex and the temperature-sensitive polymer aqueous solution are evenly mixed to obtain the rhG...

Embodiment 3

[0038] 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). Accurately weigh 1mg of recombinant human growth hormone, add 0.3ml of water to dissolve to obtain rhGH aqueous solution; accurately weigh 1mg of zinc acetate, add 0.3ml of water to dissolve to obtain zinc acetate aqueous solution; accurately weigh 1mg of protamine, add 0.3ml of water was dissolved to obtain a protamine aqueous solution; the zinc acetate aqueous solution and the protamine aqueous solution were respectively added dropwise to the stirred rhGH aqueous solution, and mixed evenly to obtain a suspension of the rhGH complex; the rhGH complex The suspension is centrifuged, a...

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Abstract

The invention discloses a sustained release composition preparation of a polypeptide protein drug and a preparation method of the sustained release composition preparation. The sustained release composition preparation is composed of the polypeptide protein drug, a composite reagent and an aqueous solution of a temperature-sensitive polymer; the composite reagent is protamine or a combination of the protamine and metal salt; the sustained release preparation composition can achieve the precise and controllable sustained release of the polypeptide protein drug in the premise of not affecting the pharmacological effect of the polypeptide protein drug, so that the injection frequency of the drug is effectively reduced, thereby improving adaptability of a patient. All the steps of the preparation method of the sustained release composition preparation are carried out in an aqueous phase, and the structure and biological activity of the polypeptide protein drug 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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