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新型皮肤粘合剂的粘结强度评估及皮肤刺激性试验

Evaluation of bond strength and skin irritation test for new skin adhesive.

作者信息

Kongkon Paweena, Pichayakorn Wiwat, Sanohkan Sasiwimol

机构信息

Department of Prosthetic Dentistry, Faculty of Dentistry, Prince of Songkla University, Songkhla, 90112, Thailand.

Department of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, Prince of Songkla University, Songkhla, 90112, Thailand.

出版信息

J Oral Biol Craniofac Res. 2023 Nov-Dec;13(6):731-738. doi: 10.1016/j.jobcr.2023.10.001. Epub 2023 Oct 19.

DOI:10.1016/j.jobcr.2023.10.001
PMID:37915313
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10616549/
Abstract

OBJECTIVES

This study developed a new skin-deproteinized natural rubber latex (DNRL) silicone adhesive for adhering to silicone prostheses and compared the properties with a commercial Daro-Hydrobond adhesive.

MATERIALS AND METHODS

The new DNRL skin adhesive formulation was made from non-vulcanized natural rubber-based adhesives consisting of DNRL, 20% polyvinyl alcohol, cumarone resin, 2% methylcellulose, and Wingstay L. The peel bond strength of the adhesives was tested using a 90-degree peel test. Biocompatibility was accessed using i keratinocyte cell viability. Animals (rabbits) and humans were tested for skin irritation tests. Results were analyzed using SPSS Version 24 and compared between the two adhesives.

RESULTS

The peel bond strength of the new DNRL skin adhesive was 103.61 ± 23.18 N/m whereas that of the Daro-hydrobond adhesive was 131.52 ± 21.72 N/m. There was no significant difference (0.05) between the peel bond strengths of the two test adhesives. Cell proliferation under the DNRL skin adhesive-soaked medium showed higher cell viability than the positive control (0.05). The DNRL skin adhesive produced moderate erythema and edema on rabbit skins, however, the skin lesions recovered within 14 days. Two volunteers showed mild irritation at the first hour of the contact which was reduced within an hour without any therapy. The patient satisfaction with the DNRL skin adhesive ranged from slightly satisfied to completely satisfied.

CONCLUSION

The new DNRL skin adhesive showed comparable peel bond strength and patient satisfaction to those of commercial adhesives. The adhesive was biocompatible and can be used carefully.

摘要

目的

本研究开发了一种用于粘贴硅胶假体的新型皮肤脱蛋白天然橡胶乳胶(DNRL)硅胶粘合剂,并将其性能与市售的Daro-Hydrobond粘合剂进行比较。

材料与方法

新型DNRL皮肤粘合剂配方由非硫化天然橡胶基粘合剂制成,该粘合剂由DNRL、20%聚乙烯醇、香豆酮树脂、2%甲基纤维素和Wingstay L组成。使用90度剥离试验测试粘合剂的剥离粘结强度。通过角质形成细胞活力评估生物相容性。对动物(兔子)和人类进行皮肤刺激性试验。使用SPSS 24版分析结果,并在两种粘合剂之间进行比较。

结果

新型DNRL皮肤粘合剂的剥离粘结强度为103.61±23.18N/m,而Daro-hydrobond粘合剂的剥离粘结强度为131.52±21.72N/m。两种测试粘合剂的剥离粘结强度之间无显著差异(P>0.05)。在DNRL皮肤粘合剂浸泡培养基下的细胞增殖显示出比阳性对照更高的细胞活力(P>0.05)。DNRL皮肤粘合剂在兔皮肤上产生中度红斑和水肿,然而,皮肤损伤在14天内恢复。两名志愿者在接触的第一小时表现出轻度刺激,无需任何治疗,一小时内刺激减轻。患者对DNRL皮肤粘合剂的满意度从略满意到完全满意不等。

结论

新型DNRL皮肤粘合剂的剥离粘结强度和患者满意度与市售粘合剂相当。该粘合剂具有生物相容性,可以谨慎使用。

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