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[局部及全身给药后浅色磺化页岩油的耐受性]

[The tolerability of pale sulfonated shale oil following local and systemic administration].

作者信息

Cholcha W, Leuschner J, Leuschner F

机构信息

Ichthyol-Gesellschaft Cordes, Hermanni & Co., Hamburg.

出版信息

Arzneimittelforschung. 1994 Feb;44(2):170-7.

PMID:7908523
Abstract

Ichthyol, pale, a pale sulfonated shale oil, is used for the treatment of inflammatory skin diseases. The studies conducted were carried out to obtain information on the risk following dermal application of sulfonated shale oil, pale. Corresponding to the administration route planned for man the drug was applied by topical and systemic administration. Studies were conducted on the acute, subacute and chronic toxicity, and the teratogenic, mutagenic and carcinogenic potential. Sulfonated shale oil, pale was found to be very well tolerated whether administered for a short period or over a long time. There were no indications for teratogenic, mutagenic or carcinogenic effects. The therapeutic range (ratio of the toxic dose in animals and the therapeutic human dose) for topical administration is > 30 depending on animal species, frequency of administration, dose-level employed and the toxicological question posed. The results of the toxicological studies coincide with the almost 70 years of experience that the drug is well-tolerated by man.

摘要

浅色鱼石脂,一种浅色的磺化页岩油,用于治疗炎症性皮肤病。开展这些研究是为了获取有关外用浅色磺化页岩油后的风险信息。根据计划用于人体的给药途径,该药物通过局部和全身给药方式应用。进行了急性、亚急性和慢性毒性以及致畸、致突变和致癌潜力的研究。结果发现,无论是短期还是长期给药,浅色磺化页岩油的耐受性都非常好。没有致畸、致突变或致癌作用的迹象。局部给药的治疗范围(动物毒性剂量与人体治疗剂量之比)根据动物种类、给药频率、所用剂量水平和提出的毒理学问题而>30。毒理学研究结果与该药物在人体中耐受性良好的近70年经验相符。

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