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Long-acting subcutaneous implant and preparation method thereof

An implant, long-acting technology, used in drug delivery, pharmaceutical formulations, pharmaceutical sciences, etc., can solve problems such as increased safety risks, patient pain, poor PLLA elasticity, and short degradation time.

Inactive Publication Date: 2016-11-02
YUANRONG BIOLOGICAL PHARMA WUXI CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] In recent years, the development of injectable gels for micro-plastic surgery has been very rapid. Among them, sodium hyaluronate has been widely used because of its good biocompatibility and immunogenicity. However, the degradation cycle in vivo can be improved by cross-linking. Sodium hyaluronate gel can only last for 6-12 months in the human body. Repeated injections are required to maintain the effect of micro-shaping, which increases safety risks and patients' pain. It is clinically necessary to have biodegradable and elastic properties. Long-lasting sculpting soft tissue fillers
[0003] There are also subdermal fillers made of collagen (also known as collagen) on the market, which also have the problem of short degradation time. A product called Tongyan needle has been approved abroad. Its main component is PLLA, and the degradation time can be shortened. It has reached more than 2 years, but due to the poor elasticity of PLLA, the local acidic environment generated during the degradation process causes local inflammation to be obvious. For this reason, it has not been approved by SFDA in China. Therefore, our company has gone through many years of research and development. Isocyanate is used as a chain extender, and the degradation product is neutral biocompatible and degradable polyurethane. Using this polyurethane as the basic material, it can be made into a subcutaneously injectable microplastic with good elasticity and a degradation time of more than 3 years. The ball is very suitable for subcutaneous filling, wrinkle removal, breast prosthesis filling and drug carrier, etc. It has good practical value and a broad market prospect

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] A. Dissolve 0.1g of collagen with a molecular weight of 2000 into a paste with 10ml of acetic acid solution with a mass concentration of 2%, put 50g of degradable polyurethane with a molecular weight of 1000 in 500ml of methylene chloride, and put the collagen paste into polyurethane mixed with polylactic acid In the solution, emulsify and disperse into a uniform emulsion, and the particle size of the emulsion is 20um-100um; B. Dissolve 49.9g of sodium hyaluronate powder (average molecular weight is 1,000,000) in 20L of water for injection, and the emulsion droplets prepared by A Add it to the sodium hyaluronate solution, stir to disperse, the stirring speed is 60r / min, gradually increase the temperature after 2h to volatilize the methylene chloride, adjust the pH value to be neutral, sub-package and freeze-dry the obtained product, the size and diameter of the composite particles range from 50um -350um.

Embodiment 2

[0034] A. 50g of collagen with a molecular weight of 50,000 is dissolved into a paste with 2% acetic acid solution with a mass concentration of 500ml, and 49.9g of degradable polyurethane with a molecular weight of 100,000 and 0.1g siromucci are dissolved in 2,500ml of chloroform , put the collagen paste into the solution of polyurethane mixed with siromucci, emulsify and disperse into a uniform emulsion, and the particle size of the emulsion is 20um-80um;

[0035] B. Dissolve 1000g of sodium hyaluronate powder (average molecular weight: 800,000) in 50L of water for injection, add the emulsion prepared in A dropwise into the sodium hyaluronate solution, stir and disperse at a stirring speed of 60r / min, after 2h Gradually raise the temperature to volatilize the chloroform, adjust the pH value to be neutral, sub-package and freeze-dry to get the result. The size and diameter of the composite particles range from 45um to 500um.

Embodiment 3

[0037] A, 10g molecular weight is that the collagen of 20000 is that the mass concentration of 600ml is that the acetic acid solution of 2% is dissolved into pasty state with the mass concentration of 600ml, and the degradable polyurethane that 10g molecular weight is 50000 is dissolved in 1500ml tetrahydrofuran, and collagen pasty liquid is dropped into polyurethane In the solution, emulsify and disperse into a uniform emulsion, and the particle size of the emulsion is 20um-80um;

[0038] B. Dissolve 150g of sodium hyaluronate powder (average molecular weight: 800,000) in 15L of water for injection, add the emulsion prepared in A dropwise into the sodium hyaluronate solution, stir and disperse, the stirring speed is 60r / min, after 2h Gradually raise the temperature to volatilize the tetrahydrofuran, adjust the pH value to be neutral, sub-package and freeze-dry the obtained product. The size and diameter of the composite particles range from 60um to 400um.

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Abstract

The invention discloses a long-acting subcutaneous implant that contains degradable polyurethane coated collagen and is used for subcutaneous soft tissue filling and a preparation method thereof. The implant has the advantages of good elasticity, excellent degradation resistance, and long duration after injection, is very suitable for subcutaneous filling, wrinkle removing, breast prosthesis filling and use as a drug carrier, etc.

Description

technical field [0001] The application relates to a long-acting subcutaneous implant containing degradable polyurethane-wrapped collagen, which is used for subcutaneous soft tissue filling and belongs to the field of degradable biomaterials. Background technique [0002] In recent years, the development of injectable gels for micro-plastic surgery has been very rapid. Among them, sodium hyaluronate has been widely used because of its good biocompatibility and immunogenicity. However, the degradation cycle in vivo can be improved by cross-linking. Sodium hyaluronate gel can only last for 6-12 months in the human body. Repeated injections are required to maintain the effect of micro-shaping, which increases safety risks and patients' pain. It is clinically necessary to have biodegradable and elastic properties. Long-lasting sculpting soft tissue filler. [0003] There are also subdermal fillers made of collagen (also known as collagen) on the market, which also have the probl...

Claims

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Application Information

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IPC IPC(8): A61L27/24A61L27/18A61L27/58
CPCA61L27/24A61L27/18A61L27/58A61L2400/06A61L2430/34C08L75/04
Inventor 张文芳杜晓威
Owner YUANRONG BIOLOGICAL PHARMA WUXI CO LTD
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