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[硼酸从软膏剂中的释放及体外皮肤渗透]

[Liberation and in vitro skin permeation of boric acid from an ointment].

作者信息

Dusemund B

机构信息

Max-von-Pettenkofer-Institut, Bundesgesundheitsamtes, Berlin.

出版信息

Arzneimittelforschung. 1987 Oct;37(10):1197-201.

PMID:3435593
Abstract

In connection with the discussion on a uniform regulation within the European Communities for baby-care products containing boric acid, it was of interest to which degree boric acid can be absorbed through normal or damaged skin from a common baby ointment. Studies performed by an in vitro permeation method using excised human skin and by a liberation method in the absence of a membrane are described. Boron was not detectable in the acceptor compartment when intact skin was tested, while using damaged skin, prepared by removing the horny layer, a maximum permeation of 2.46 micrograms/cm2 boron, corresponding to 14.1 micrograms/cm2 boric acid, was measured. Accordingly the stratum corneum functions as an effective barrier for the cutaneous permeation of boric acid under the given conditions. Thus there is no cause for concern that the ointment under consideration could evoke unwanted systemic effects when applied to healthy skin. The results showing permeation of boric acid through damaged skin are of special interest, since it has to be taken into account, that skin care preparations for babies may be applied on irritated skin, e.g. in cases of napkin dermatitis. On the basis of the permeation results for damaged skin the possible daily boron uptake of babies, treated with the test product, is estimated and compared to the daily alimental intake of boron. With respect to quantities of boric acid delivered per unit of surface in the skin model and in the liberation system, the permeation through damaged skin amounts to 86% of the release. The results indicate, that the degree of permeation through damaged skin depends on the degree of liberation from the vehicle. The liberation model presented here could be suitable for the assessment to which extent boric acid may be absorbed from an ointment through damaged skin in worst case.

摘要

关于欧洲共同体对含硼酸的婴儿护理产品进行统一监管的讨论,硼酸能从普通婴儿软膏中通过正常或受损皮肤被吸收到何种程度是个值得关注的问题。本文描述了采用离体人皮肤的体外渗透法以及在无膜情况下的释放法所进行的研究。测试完整皮肤时,接受池中未检测到硼,而使用去除角质层制备的受损皮肤时,测得硼的最大渗透量为2.46微克/平方厘米,相当于硼酸14.1微克/平方厘米。因此,在给定条件下,角质层对硼酸的皮肤渗透起到了有效的屏障作用。所以,当所考虑的软膏应用于健康皮肤时,无需担心会引发不良的全身影响。硼酸通过受损皮肤渗透的结果特别令人关注,因为必须考虑到,婴儿护肤品可能会用于受刺激的皮肤,例如在尿布皮炎的情况下。根据受损皮肤的渗透结果,估算了使用受试产品治疗的婴儿可能每日摄入的硼量,并与硼的每日饮食摄入量进行了比较。就皮肤模型和释放系统中每单位表面积输送的硼酸量而言,通过受损皮肤的渗透量占释放量的86%。结果表明,通过受损皮肤的渗透程度取决于从载体中的释放程度。这里提出的释放模型可能适用于评估在最坏情况下硼酸从软膏中通过受损皮肤可能被吸收的程度。

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