Biodegradable injection filler as well as preparation method and application thereof

Abstract

The invention provides a biodegradable injection filler as well as a preparation method and application thereof, and particularly provides an injectable implant composition. The composition contains biodegradable polymer particles, cyclodextrin and / or a derivative thereof, and a mass ratio of the biodegradable polymer particles to the cyclodextrin and / or the derivative thereof is (1: 3)-(1: 15). According to the invention, cyclodextrin inclusion PLLA particles (particle size: 10-150 [mu] m, weight-average molecular weight: 10,000-100,000) have unsmooth and rough microstructure, which increases contact area with the cyclodextrin, and is beneficial to adsorption and bonding of the cyclodextrin molecules, the inclusion reaction can occur in a single water phase system, the preparation is simple, environmentally friendly, has low cost, avoids injection irritation that may be caused by residual solvents, and is conducive to product quality, safety and controllability.

Description

technical field [0001] The invention relates to a biodegradable injection filler, a preparation method and an application thereof. Background technique [0002] Medical Cosmetology refers to the beauty method that uses drugs, surgery, medical equipment and other traumatic or irreversible medical techniques to repair and reshape the appearance of a person and the shape of various parts of the human body. With the advancement of science and technology and the continuous improvement of people's living standards, the public is more concerned about quality of life issues such as facial wrinkles and anti-aging. The "2015-2020 China Medical Beauty Industry Market Size and Growth Report" released by the Ministry of Commerce shows that the scale of China's medical beauty market continues to grow. In 2018, China's medical beauty market reached 224.5 billion yuan, accounting for 10% of the global medical beauty market. %, becoming the third largest market in the world for medical cosm...

AI Technical Summary

Problems solved by technology

[0007] 2. The particle size distribution of PLLA is uneven, and needle blockage is very likely to occur during the injection process. The needle needs to be replaced repeatedly, and the dosage is difficult to control accurately, which seriously affects the effectiveness and safety of the injection.

[0008] 3. PLLA injection can cause adverse reactions, and there are potential safety hazards

PLLA is degraded into lactic acid in the body to form an acidic microenvironment, which in turn causes redness, ecchymosis, bruises, edema, papules, visible nodules, periorbital nodules, hardening of the injection area, abscesses, allergic reactions, urticaria, skin hypertrophy and atrophy, angioedema, telangiectasia, skin sarcoidosis, scarring, skin discoloration and other adverse reactions, limiting its application range

[0009] 4. The redispersibility of the freeze-dried product needs to be improved after reconstitution, and it is prone to sedimentation and stratification, which makes the injection operation inconvenient

[0011] Pan Tong et al. (Pan Tong, Zhang Guolin, Ma Jianbiao. Synthesis and Characterization of β-Cyclodextrin / Poly(DL-Lactide) Graft Copolymer[J]. Acta Polymerica Sinica, 2006(2):330-334) The β-cyclodextrin / poly(DL-lactide) graft copolymer was synthesized by using β-cyclodextrin as the graft backbone and DL-lactide as the graft monomer, but the β-cyclodextrin directly Participating in the chemical reaction of grafting, the number of hydrophilic groups -OH is greatly reduced, and the solubilization effect is not ideal

[0012] Li Ya et al. (Li Ya, Zhen Weijun, Zhou Yufang, Effect of PLA-β-CD inclusion compound on the properties of PLA [J]. Plastics, 2017 (46) 31-34) prepared polylactic acid-β- Cyclodextrin inclusion compound, choose polylactic acid with a molecular weight of 100,000 as the reaction raw material, the long chain of polylactic acid constitutes steric hindrance, the inclusion reaction is not complete, the solubilization effect is not ideal, and the reaction solvent is toxic chloroform which may aggravate the stimulus

[0013] Xie DM et al. (Xie DM, Yang KS, Sun WX. Formation and characterization of polylactide and β-cyclodextrin inclusion complex [J]. Current Applied Physics, 2007, 7S: e15-e18.) prepared polylactic acid- β-cyclodextrin inclusion compound, but the organic solvent N-methylpyrrolidone is selected as the reaction solvent, which also has problems such as safety and environmental pollution

[0014] To sum up, the molecular weight and spatial configuration of PLLA do not match well with the cavity size of cyclodextrin, making it difficult for the inclusion reaction to occur; The organic solvent in which dextrin and PLLA are co-dissolved is the reaction solvent, which has high production costs and is not conducive to the controllability of product quality and safety

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