Injectable implant and preparation method thereof

Abstract

The invention relates to an injectable implant and a preparation method thereof. The implant is amnion microparticles mixed in a sodium chloride phosphate physiological solution with a pH of 7.0-7.5. The preparation method comprises the following steps of disinfection processing, decellularization processing, modification processing, and amnion microparticle preparation, and in particular, comprises: taking amnion microparticles as a component A and a sodium chloride phosphate physiological solution as a component B, performing vibration and well mixing according to a mass volume ratio of 20:1-100:1 to prepare an amnion microparticle suspension with a concentration of 20-100 mg / mL by high-speed microjet equipment, wherein the particle size of the amnion microparticles is 50-200 microns. The injectable implant of the invention maintains the natural three dimensional stereo structure and a lot of natural active components of human amnion, reduces immunological rejection reaction caused by raw material source after clinical application of cosmetic injection products, is suitable for injection into deep subcutaneous dermal layer to subcutaneous superficial layer to repair moderate to severe wrinkles or folds, and has good cosmetic repair effect.

Description

technical field [0001] The invention belongs to the technical field of medical cosmetology and plastic surgery, and in particular relates to an injectable implant derived from amniotic membrane biomaterials and capable of promoting autologous collagen regeneration and a preparation method thereof. Background technique [0002] Soft tissue fillers have been widely used in cosmetic surgery for a century to improve facial contours, correct wrinkles, fill in sunken scars, and fill volumes (such as lips), etc. Today, there is an increasing demand for soft tissue fillers. [0003] The ideal soft tissue filler should be cheap and easy to obtain, good biological inertness, biocompatibility and stability, non-toxic, non-carcinogenic, non-infectious, no acute or chronic inflammatory response, easy to inject and remove, and able to maintain Long-term or even permanent cosmetic restoration with short recovery times. But so far, there is still no such ideal injectable filler. [0004] ...

AI Technical Summary

Problems solved by technology

The disadvantages of the above bovine collagen implants are: a skin test is required 30 days before the injection to prevent allergies in the patient, the duration of the cosmetic repair effect is relatively short, and repeated injections are often required, and possible complications after the injection may cause Hemorrhagic spots, granulomas, acute allergies, delayed allergic reactions and systemic discomfort reactions, etc.

This patent only uses the physical milling method to prepare human hair keratin particle homogenate with a particle size of 60-80 μm. According to the inventor's experimental experience, different solid substances that are insoluble in water are physically milled without sieving, homogenization, etc. In the subsequent steps, the obtained particle size distribution range is usually 100-1000 μm, and it is difficult to obtain a smaller particle size range

[0017] Chinese patent CN02156797.2 discloses a preparation method of injectable collagen and its products and applications. In this patent, injectable collagen is prepared by extracting collagen fibers in animal tissues, and the original animal tissue will be completely destroyed during the preparation process. There are structural and other components, and the natural components with biological activity or biological function in natural tissues are lost, and it can only play a pure collagen filling role

[0029] At present, there is no product that uses amniotic membrane as raw material to prepare injectable filling materials, and there are no patents and literature reports

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