由不同研究方法确定的一种防腐剂的皮肤毒性

V. Kushnir
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引用次数: 0

摘要

本文介绍了一种以鱼腥醇为基础的抗菌软膏的急性和亚急性皮肤毒性的研究结果。这项研究是根据经济合作与发展组织(经合发组织第410号)的方法使用经典方法进行的。经经典方法对所研究产品的皮肤毒性研究表明,试验组动物长期使用该药物,在血红蛋白浓度、红细胞、白细胞数量、红细胞压积值、红细胞中血红蛋白平均浓度(MCHC)、红细胞平均体积(MCV)、红细胞中血红蛋白平均含量(MCH)和血小板数量等方面均未发生显著变化。根据OECD第410号方法对所研究产品的皮肤毒性进行的研究表明,第一、第二和第三研究组的动物红细胞数量分别增加了- 10.7 (Р < 0.01)、6.0 (Р < 0.05)和7.5% (Р < 0.05)。同时,血红蛋白浓度没有变化。此外,在I和II实验组的动物中,建立了红细胞压积增加的趋势。1、2、3实验组动物红细胞指数变化;特别是红细胞中血红蛋白(MCH)的平均含量可能分别降低了平均红细胞体积(MCV)的- 5.2 (P < 0.05)、5.2 (P < 0.01)和7.1% (P < 0.001),分别降低了- 6.9 (P < 0.01)、5.5% (P < 0.01)和7.2% (P < 0.001)。药物在治疗剂量的使用造成了轻微的总蛋白水平的下降,尿素、肌酐和轻微的活动增加AST和ALT。与此同时,第二和第三的动物研究小组,接受药物正在调查在治疗剂量5倍和10倍,指出提高尿素的水平,分别为- 3.3和8.5%,肌酐,分别由8.0%和1.9 (P < 0.05), AST的活动,与对照组相比,ALT分别降低了- 2.3和3.2%,ALT分别降低了- 10.4和13.4% (P < 0.05) (Р < 0.05)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The dermal toxicity of an antiseptic preparation as determined by the different research methods
The article presents the results of the study of acute and subacute skin toxicity of an antiseptic ointment based on ichthyol. The research was conducted using the classic method and according to the methodology of the Organization for Economic Cooperation and Development (OECD No. 410). The study of the dermal toxicity of the product under study by the classic method showed that long-term use of the drug in animals of the experimental groups did not cause significant changes in the concentration of hemoglobin, the number of erythrocytes, leukocytes, the value of hematocrit, the average concentration of hemoglobin in the erythrocyte (MCHC), the average volume of the erythrocyte (MCV), the average content of hemoglobin in the erythrocyte (MCH) and the number of platelets, the content of total protein, the level of creatinine and the activity of AST. The study of skin toxicity of the product under study according to the OECD method No. 410 showed that the number of erythrocytes increased in the animals of the I, II, and III research groups, respectively, by – 10.7 (Р < 0.01), 6.0 (Р < 0.05), and 7.5 % (Р < 0.05). At the same time, the concentration of hemoglobin did not change. In addition, in the animals of the I and II experimental groups, a tendency towards an increase in hematocrit was established. In the animals of the I, II, and III experimental groups, changes in the erythrocyte index were noted; in particular, a probable decrease in the average content of hemoglobin in the erythrocyte (MCH) was established, respectively by – 5.2 (P < 0.05), 5.2 (P < 0.01) and 7.1 % (P < 0.001) of the average erythrocyte volume (MCV), respectively by – 6.9 (P < 0.01), 5.5 % (P < 0.01) and 7.2 % (P < 0.001). The use of the drug in a therapeutic dose caused a slight decrease in the level of total protein, urea, and creatinine against a slight increase in the activity of AST and ALT. At the same time, the animals of the II and III research groups, which received the drug under investigation at five times and ten times the therapeutic dose, noted an increase in the level of urea, respectively, by – 3.3 and 8.5 %, and creatinine, respectively, by – 1.9 and 8.0 % (P < 0.05), the activity of AST, respectively, by – 2.3 and 3.2 %, and ALT, respectively, by – 10.4 (P < 0.05) and 13.4 % (Р < 0.05) compared to the values of animals of the control group.
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