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低浓度下透明质酸与羟基磷灰石微分子聚乙二醇交联物的生物安全性评估

Evaluation of the Biosafety of Hyaluronic Acid PEG Cross-Linked with Micromolecules of Calcium Hydroxyapatite in Low Concentration.

作者信息

Zerbinati Nicola, Lotti Torello, Monticelli Damiano, Rauso Raffaele, González-Isaza Pablo, D'Este Edoardo, Calligaro Alberto, Sommatis Sabrina, Maccario Cristina, Mocchi Roberto, Lotti Jacopo, Wollina Uwe, Tchernev Georgi, França Katlein

机构信息

Universita degli Studi dell'Insubria Dipartimento di Scienze Chirurgiche e Morfologiche, Varese, Italy.

University of Rome "G. Marconi" - Centro Studi per la Ricerca Multidisciplinare e Rigenerativa (CSRMR), Rome, Italy.

出版信息

Open Access Maced J Med Sci. 2018 Jan 7;6(1):15-19. doi: 10.3889/oamjms.2018.044. eCollection 2018 Jan 25.

DOI:10.3889/oamjms.2018.044
PMID:29483971
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5816290/
Abstract

OBJECTIVE

Neauvia Stimulate is biocompatible, injectable hyaluronic acid (HA) filler (26 mg/ml) PEG cross-linked with 1% of calcium hydroxyapatite (CaHA) for facial soft-tissue augmentation that provides volume to tissues, followed by process of neocollagenesis for improving skin quality.

AIM

The aim of the present study is to evaluate the biosafety of the product (Lot. 160517-26-1/2 PEG) on human keratinocytes cultured in vitro.

MATERIAL AND METHODS

The experimental model proposed, despite being an in vitro system, allows the derivation of useful information to predict the possible activity of the product in further in vivo application. Human keratinocytes (HaCaT cells) were treated with the product for 24h at increasing concentrations of product respect to control (untreated cells).

RESULTS

The biosafety of the product to be tested has been evaluated performing different methods: MTT test, NRU test, Kenacid Blue assay. Moreover, any possible effect on the structure, morphology, and viability of cells has been evaluated.

CONCLUSION

In conclusion, the results obtained by the different methods show that the product Neauvia Stimulate® does not cause any cytotoxic effect and does not affect the correct structure and morphology of cells cultures.

摘要

目的

Neauvia Stimulate是一种生物相容性可注射透明质酸（HA）填充剂（26毫克/毫升），与1%的羟基磷灰石钙（CaHA）进行聚乙二醇交联，用于面部软组织填充，为组织提供容积，随后通过新胶原形成过程改善皮肤质量。

目的

本研究的目的是评估该产品（批次160517 - 26 - 1/2 PEG）对体外培养的人角质形成细胞的生物安全性。

材料与方法

所提出的实验模型尽管是体外系统，但能得出有用信息以预测该产品在进一步体内应用中的可能活性。将人角质形成细胞（HaCaT细胞）用该产品处理24小时，产品浓度相对于对照（未处理细胞）逐渐增加。

结果

通过不同方法评估了待测试产品的生物安全性：MTT试验、中性红摄取试验、肯那酸蓝测定法。此外，还评估了对细胞结构、形态和活力的任何可能影响。

结论

总之，不同方法获得的结果表明，Neauvia Stimulate®产品不会引起任何细胞毒性作用，也不会影响细胞培养的正确结构和形态。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d944/5816290/6230f406383c/OAMJMS-6-15-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d944/5816290/7a54fe361c96/OAMJMS-6-15-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d944/5816290/0060472d5733/OAMJMS-6-15-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d944/5816290/fc745f5431ef/OAMJMS-6-15-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d944/5816290/895b037707c3/OAMJMS-6-15-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d944/5816290/6230f406383c/OAMJMS-6-15-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d944/5816290/7a54fe361c96/OAMJMS-6-15-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d944/5816290/0060472d5733/OAMJMS-6-15-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d944/5816290/fc745f5431ef/OAMJMS-6-15-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d944/5816290/895b037707c3/OAMJMS-6-15-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d944/5816290/6230f406383c/OAMJMS-6-15-g005.jpg

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