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加速稳定性对含有不同生物粘附聚合物的实验性漂白凝胶的物理、化学和机械性能的影响。

Effect of accelerated stability on the physical, chemical, and mechanical properties of experimental bleaching gels containing different bioadhesive polymers.

机构信息

Department of Restorative Dentistry, Operative Dentistry Division, Piracicaba Dental School, University of Campinas - UNICAMP, P.O. BOX 52, Piracicaba, SP, 13414-903, Brazil.

Department of Chemistry, University of São Paulo - USP, Ribeirão Preto, SP, 140040-900, Brazil.

出版信息

Clin Oral Investig. 2022 Mar;26(3):3261-3271. doi: 10.1007/s00784-021-04308-6. Epub 2022 Jan 10.

Abstract

OBJECTIVE

To evaluate the physical-chemical (weight, pH, quantification of hydrogen peroxide) and mechanical (texture profile and rheology tests) properties of the experimental bleaching gel based on the bioadhesive polymer Aristoflex® AVC, after accelerated stability testing.

MATERIALS AND METHODS

A total of 300 syringes of bleaching gels were divided into 5 groups (n = 60): Whiteness Perfect® 10%-FGM (WP); carbamide peroxide 10% with aristoflex (CPa); carbamide peroxide 10% with Carbopol (CPc); aristoflex thickener (A); and Carbopol thickener (C). According to the following requirements and time, the accelerated stability test was performed: in an incubator at 40 °C and 75% humidity per 1, 3, and 6 months, and baseline (refrigerator at 5 °C and 25% humidity). The variables were analyzed following the statistical tests: Two-way ANOVA and Tukey's test were applied to pH; weight data were analyzed using a mixed model for repeated measurements over time and the Tukey-Kramer test; one-way ANOVA and Tukey's test analyzed the rheology test; generalized linear models were used to quantify the peroxide amount and texture profile data. A significance level of 5% was considered.

RESULTS

The experimental bleaches CPa and CPc had the highest pH values when compared to the others in 6 months. Thickeners A and C did not change the pH, weight, and active content over the accelerated stability times (p > 0.05). Furthermore, there was weight loss after 3 months of storage for CPa and CPc (p < 0.05). In the quantification of hydrogen peroxide, the WP group showed the highest values over time (p < 0.0001), only showing a significant loss after the 3rd month. Meanwhile, CPa and CPc showed a reduction in quantification from the 1st month.

CONCLUSIONS

Temperature and humidity directly influenced the active content and properties of bleaching gels. In addition, the presence of components regardless of thickeners, such as stabilizers, in the commercial gel allowed for greater stability over time.

CLINICAL RELEVANCE

The development of experimental bleaching gels for clinical use requires careful testing. Therefore, accelerated stability testing represents a valuable tool in the development and evaluation of cosmetic formulations.

摘要

目的

评价基于生物粘附聚合物 Aristoflex® AVC 的实验性漂白凝胶的物理化学性质(重量、pH 值、过氧化氢定量)和机械性质(质地剖面和流变学测试),经过加速稳定性测试。

材料和方法

共 300 支漂白凝胶注射器分为 5 组(n=60):Whiteness Perfect® 10%-FGM(WP);含 10%过氧化脲和 Aristoflex(CPa);含 10%过氧化脲和 Carbopol(CPc);Aristoflex 增稠剂(A);和 Carbopol 增稠剂(C)。根据以下要求和时间进行加速稳定性测试:在孵育箱中于 40°C 和 75%湿度下进行 1、3 和 6 个月,并进行基线(冰箱在 5°C 和 25%湿度下)。使用统计测试分析变量:采用双向方差分析和 Tukey 检验分析 pH 值;使用随时间重复测量的混合模型分析重量数据,并使用 Tukey-Kramer 检验;采用单向方差分析和 Tukey 检验分析流变学测试;采用广义线性模型分析过氧化物量和质地剖面数据。置信水平为 5%。

结果

在 6 个月时,CPa 和 CPc 这两种实验性漂白剂的 pH 值与其他组相比最高。增稠剂 A 和 C 在加速稳定性期间并未改变 pH 值、重量和有效含量(p>0.05)。此外,CPa 和 CPc 在储存 3 个月后出现重量损失(p<0.05)。在过氧化氢的定量方面,WP 组随着时间的推移显示出最高值(p<0.0001),仅在第 3 个月后显示出显著损失。同时,CPa 和 CPc 从第 1 个月开始显示出定量减少。

结论

温度和湿度直接影响漂白凝胶的活性含量和性质。此外,商业凝胶中存在成分(无论增稠剂如何),如稳定剂,这使得其在时间上更稳定。

临床意义

实验性漂白凝胶的临床应用开发需要仔细测试。因此,加速稳定性测试是化妆品配方开发和评估的有价值工具。

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