Biodegradable injectable filler, its preparation method and its application

A biodegradable and filling technology, applied in drug delivery, pharmaceutical formulations, prostheses, etc., can solve problems such as uneven particle size distribution of PLLA, affect injection effectiveness and safety, increase injection stimulation and adverse reactions, etc., to improve Adhesion ability and residence time, natural cosmetic effect, effect of improving cell affinity

Active Publication Date: 2021-07-06
MEIYAN SPACE (HEBEI) BIOTECHNOLOGY CO LTD +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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, and the needle needs to be replaced repeatedly, and the dosage is difficult to accurately control, 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, bruising, 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 scope of application
[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
However, the amount of hyaluronic acid in the mixed gel is relatively large, which increases injection irritation and adverse reactions

Method used

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  • Biodegradable injectable filler, its preparation method and its application
  • Biodegradable injectable filler, its preparation method and its application
  • Biodegradable injectable filler, its preparation method and its application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0167] Example 1 Preparation of PLLA polymer

[0168] Add 500g of L-lactide to a 2000mL single-necked bottle, and heat it to 130°C under nitrogen protection. After the L-lactide is completely melted, add 0.15g of stannous isooctanoate and 1.5g of lauryl alcohol, and keep warm at 130°C React for 24 hours, after cooling the reaction solution to room temperature, add 1L of dichloromethane, stir to dissolve, filter, transfer the resulting solution to a 50L reaction kettle, add 4L of dichloromethane, dropwise add 25L of methanol, crystallize at room temperature, filter, The filter cake was dried at 50°C to obtain PLLA polymer with a weight average molecular weight of 36,000.

Embodiment 2

[0169] Example 2 Preparation of PLLA polymer

[0170] Add 500g of L-lactide to a 2000mL single-necked bottle, and heat it to 120°C under nitrogen protection. After the L-lactide is completely melted, add 0.1g of stannous chloride and 1.2g of lauryl alcohol, and keep the reaction at 120°C. After 48 hours, after the reaction solution was lowered to room temperature, 1 L of chloroform was added, stirred to dissolve, filtered, the solution was transferred to a 50 L reaction kettle, 4 L of chloroform was added, 25 L of n-heptane was added dropwise, crystallized at room temperature, filtered, The filter cake was dried at 50°C to obtain PLLA polymer with a weight average molecular weight of 39,000.

Embodiment 3

[0171] Example 3 Preparation of PLLA polymer microparticles

[0172] Weigh 200 g of the PLLA polymer prepared in Example 1, add 4 L of tetrahydrofuran, stir to dissolve, slowly add 12 L of anhydrous methanol dropwise, after the dropwise addition, stir for about 1 hour, filter, and rinse the filter cake with anhydrous methanol, Vacuum-dried at 35°C and passed through a 200-mesh sieve to obtain PLLA particles with a heat of fusion of 54.3J / g, D(3,2) of 21.7μm, D(4,3) of 32.4μm, and a maximum particle size of about 66.9 μm, see the attached particle size distribution figure 1 .

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Abstract

The invention provides a biodegradable injection filler and its preparation method and application, especially provides an injectable implant composition and its preparation method, the composition contains biodegradable polymer particles and content Not higher than 0.1% hyaluronic acid. Hyaluronic acid significantly improves the hydrophobicity of the surface of the PLLA polymer scaffold, promotes the adhesion and growth of collagen cells on the surface, significantly improves the filling effect or filling effect of the composition, removes wrinkles, enhances the aesthetics of the facial skin, and is beneficial to improve the PLLA particles in the freeze-dried state. Suspension stability after reconstitution, and it is beneficial to reduce the hydrolysis and degradation of PLLA ester bonds, and reduce swelling, inflammation, allergic reactions and other adverse reactions that may be caused by acidic degradation products.

Description

technical field [0001] The invention relates to a biodegradable injection filler, a preparation method and an application thereof. Background technique [0002] Medical Cosmetology (Medical Cosmetology) refers to the use of drugs, surgery, medical equipment and other traumatic or irreversible medical technology methods to repair and reshape the appearance of people 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 m...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61L27/18A61L27/20A61L27/50A61L27/58A61L31/04A61L31/06A61L31/14
CPCA61L27/18A61L27/20A61L27/50A61L27/58A61L31/042A61L31/06A61L31/14A61L31/148A61L2400/06C08L67/04C08L5/08
Inventor 王晔王爽蔡永钢陈子阳邓声菊徐艳君王田园夏洋
Owner MEIYAN SPACE (HEBEI) BIOTECHNOLOGY CO LTD
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