<strong>Background:</strong> Titanium dioxide and zinc oxide were often criticized over the last decade because of their supposed noxious effects on human health. Moreover, these compounds which are freque...<strong>Background:</strong> Titanium dioxide and zinc oxide were often criticized over the last decade because of their supposed noxious effects on human health. Moreover, these compounds which are frequently introduced in sunscreen products as UV filter, are sometimes associated with poor UVA protection factors. So, in order to clarify the real efficacy and safety status of these products, we provide here some bibliographic and experimental data regarding 1) their “real” protective effect against UVA rays and 2) their real harmful effects on human skin notably by studying their capability to penetrate through the human cutaneous tissue. <strong>Materials and Methods:</strong> We studied here 4 sunscreen products containing titanium dioxide and zinc oxide for 3 of them. First, because the UVA-PF values obtained for these compounds by using the “classical” <em>in vitro</em> ISO 24443 procedure seem to be significantly different from to those obtained by using the <em>in vivo</em> method ISO 24442, we chose to develop a new <em>in vitro</em> methodology in order to more precisely define the UVA-PF of titanium and zinc oxides. This new methodology was then used to lead UVA-PF studies with the 4 selected solar products. We also provide here an evaluation of the toxicological effects of titanium and zinc oxides on human skin based on the SCCS reports and analysis of recent and relevant bibliographic studies. Moreover, as the harmful effects of this type of products are closely linked to their ability to penetrate cutaneous tissue, we tested 7 sunscreen products to precise the skin penetration profiles of titanium dioxide and zinc oxide by using human skin explants mounted on Franz cells. <strong>Results:</strong> We here demonstrated that our new <em>in vitro</em> methodology gave some UVA-PF values very close to those obtained with <em>in vivo</em> methods and we took advantage of it to define more realistic UVA-PF for titanium dioxide and zinc oxide. Additionally, we here evaluated the human skin permeation展开更多
目的:比较试验和参比制剂2.5%复方利多卡因乳膏透皮作用的一致性。方法:以大鼠和巴马香猪的皮肤作为透皮渗透的材料,选用立式改良Franz扩散池测定复方利多卡因乳膏的渗透吸收规律,以高效液相色谱法分别测定接收液中药物的吸收总量和猪...目的:比较试验和参比制剂2.5%复方利多卡因乳膏透皮作用的一致性。方法:以大鼠和巴马香猪的皮肤作为透皮渗透的材料,选用立式改良Franz扩散池测定复方利多卡因乳膏的渗透吸收规律,以高效液相色谱法分别测定接收液中药物的吸收总量和猪皮中药物的滞留量随时间的变化关系。结果:复方利多卡因乳膏试验与参比制剂在鼠皮及巴马香猪皮这两种不同透皮材料中5 h利多卡因的单位面积累积渗透量分别为(0.380±0.019)和(0.351±0.017)mg·cm^(-2),(0.228±0.012)和(0.217±0.023)mg·cm^(-2);丙胺卡因的单位面积累积渗透量分别为(0.422±0.022)和(0.382±0.029)mg·cm^(-2),(0.263±0.015)和(0.238±0.008)mg·cm^(-2);试验制剂与参比制剂在巴马香猪皮中5h的利多卡因,丙胺卡因的皮内滞留量分别为(2.021±0.094)和(1.999±0.118)mg·cm^(-2),(2.240±0.115)和(2.208±0.053)mg·cm^(-2);试验和参比制剂的体外释放比较的结果均符合FDA(U.S.Food and Drug Administration)和欧盟的指导原则。结论:2.5%复方利多卡因乳膏试验与参比制剂的透皮渗透程度和速率均符合外用制剂的一致性要求,且在猪皮内药物滞留特征相似。展开更多
文摘<strong>Background:</strong> Titanium dioxide and zinc oxide were often criticized over the last decade because of their supposed noxious effects on human health. Moreover, these compounds which are frequently introduced in sunscreen products as UV filter, are sometimes associated with poor UVA protection factors. So, in order to clarify the real efficacy and safety status of these products, we provide here some bibliographic and experimental data regarding 1) their “real” protective effect against UVA rays and 2) their real harmful effects on human skin notably by studying their capability to penetrate through the human cutaneous tissue. <strong>Materials and Methods:</strong> We studied here 4 sunscreen products containing titanium dioxide and zinc oxide for 3 of them. First, because the UVA-PF values obtained for these compounds by using the “classical” <em>in vitro</em> ISO 24443 procedure seem to be significantly different from to those obtained by using the <em>in vivo</em> method ISO 24442, we chose to develop a new <em>in vitro</em> methodology in order to more precisely define the UVA-PF of titanium and zinc oxides. This new methodology was then used to lead UVA-PF studies with the 4 selected solar products. We also provide here an evaluation of the toxicological effects of titanium and zinc oxides on human skin based on the SCCS reports and analysis of recent and relevant bibliographic studies. Moreover, as the harmful effects of this type of products are closely linked to their ability to penetrate cutaneous tissue, we tested 7 sunscreen products to precise the skin penetration profiles of titanium dioxide and zinc oxide by using human skin explants mounted on Franz cells. <strong>Results:</strong> We here demonstrated that our new <em>in vitro</em> methodology gave some UVA-PF values very close to those obtained with <em>in vivo</em> methods and we took advantage of it to define more realistic UVA-PF for titanium dioxide and zinc oxide. Additionally, we here evaluated the human skin permeation
文摘目的:比较试验和参比制剂2.5%复方利多卡因乳膏透皮作用的一致性。方法:以大鼠和巴马香猪的皮肤作为透皮渗透的材料,选用立式改良Franz扩散池测定复方利多卡因乳膏的渗透吸收规律,以高效液相色谱法分别测定接收液中药物的吸收总量和猪皮中药物的滞留量随时间的变化关系。结果:复方利多卡因乳膏试验与参比制剂在鼠皮及巴马香猪皮这两种不同透皮材料中5 h利多卡因的单位面积累积渗透量分别为(0.380±0.019)和(0.351±0.017)mg·cm^(-2),(0.228±0.012)和(0.217±0.023)mg·cm^(-2);丙胺卡因的单位面积累积渗透量分别为(0.422±0.022)和(0.382±0.029)mg·cm^(-2),(0.263±0.015)和(0.238±0.008)mg·cm^(-2);试验制剂与参比制剂在巴马香猪皮中5h的利多卡因,丙胺卡因的皮内滞留量分别为(2.021±0.094)和(1.999±0.118)mg·cm^(-2),(2.240±0.115)和(2.208±0.053)mg·cm^(-2);试验和参比制剂的体外释放比较的结果均符合FDA(U.S.Food and Drug Administration)和欧盟的指导原则。结论:2.5%复方利多卡因乳膏试验与参比制剂的透皮渗透程度和速率均符合外用制剂的一致性要求,且在猪皮内药物滞留特征相似。
