Gabard B, Chatelain E, Bieli E, Haas S
Biopharmacy Department, Spirig Pharma Ltd., Egerkingen, Switzerland.
Skin Res Technol. 2001 Feb;7(1):49-55. doi: 10.1034/j.1600-0846.2001.007001049.x.
BACKGROUND/AIMS: Irritant reactions to surfactants, cleansing products, soaps and detergents are common in clinical and occupational dermatology. Mildness has become a major benefit claimed, and testing for mildness now ranks among the first concerns of the manufacturing industry. A wealth of publications deals with this problem, trying to improve the methodology, reduce the costs of testing and facilitate decision-making. Differences in vivo can be measured clinically and/or instrumentally. This is difficult, as commercially available products are generally safe to use and none are harsh in the absolute sense.
Nineteen different products (syndets, shampoos, personal cleansers), all claiming to be mild, were tested in vitro by a newly introduced method, corneosurfametry. For evaluating the aggressiveness of the products, the calculation of an index of irritation (IOI) was proposed. A concentration-effect curve of sodium lauryl sulfate (SLS) as standard and model surfactant was obtained. Some of the products were further tested in vivo with a flex wash test and with a soap chamber test and compared to SLS. Bioengineering methods (transepidermal water loss TEWL, skin color) were used to evaluate the results.
The results of the corneosurfametry allowed us to classify the products in three categories, with increasing aggressiveness towards the stratum corneum, according to their IOIs. The in vivo tests were not able to discriminate between the products, but ranks from the results of the bioengineering measurements showed a good correlation between TEWL changes, but not between colour changes, and IOIs from corneosurfametry. Corneosurfametry emerged as a simple, low-cost and fast method for ranking commercial products according to their mildness. However, the skin bioengineering techniques showed that some products could lead to skin reactions, such as erythema, that could not be detected by the in vitro technique.
背景/目的:在临床和职业皮肤病学中,对表面活性剂、清洁产品、肥皂和洗涤剂的刺激性反应很常见。温和性已成为宣称的一项主要优势,如今温和性测试已位列制造业首要关注事项之中。大量出版物探讨了这一问题,试图改进方法、降低测试成本并便于决策。体内差异可通过临床和/或仪器测量。这颇具难度,因为市售产品通常使用安全,从绝对意义上讲没有一种是刺激性强的。
采用一种新引入的方法——角质层表面活性测定法,对19种均宣称温和的不同产品(合成洗涤剂、洗发水、个人清洁用品)进行体外测试。为评估产品的刺激性,提出了刺激性指数(IOI)的计算方法。获得了作为标准和模型表面活性剂的月桂醇硫酸酯钠(SLS)的浓度-效应曲线。部分产品进一步通过灵活洗涤试验和肥皂室试验进行体内测试,并与SLS进行比较。采用生物工程方法(经表皮水分流失TEWL、皮肤颜色)评估结果。
角质层表面活性测定法的结果使我们能够根据产品的IOI将其分为三类,对角质层的刺激性依次增强。体内测试无法区分这些产品,但生物工程测量结果的排名显示,TEWL变化与角质层表面活性测定法的IOI之间具有良好的相关性,而颜色变化与IOI之间则没有。角质层表面活性测定法成为一种根据商业产品温和性进行排名的简单、低成本且快速的方法。然而,皮肤生物工程技术表明,一些产品可能会导致皮肤反应,如红斑,而体外技术无法检测到这些反应。