工作区域空气中抗逆转录病毒药物替诺福韦的卫生管理

M. I. Golubeva, M. V. Bidevkina, I. A. Bobrineva, E. A. Fedorova, L. Krymova
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摘要

介绍。替诺福韦是逆转录病毒-人类免疫缺陷病毒核苷逆转录酶抑制剂组的抗病毒药物。材料和方法。通过口服(小鼠、大鼠、家兔)、腹腔注射(小鼠)、皮肤注射(小鼠、家兔)、吸入(大鼠)等多种途径,对替诺福韦在实验动物(小鼠、大鼠)体内的毒性和危险性进行了毒理学和卫生学研究,以制定和证明工作区域空气中替诺福韦的指示性限值。结果。替诺福韦胃内注射时,对小鼠和大鼠的DL50超过10,000 mg/kg,属于第4类危险(GOST 12.1.007-76)。雄性小鼠腹腔注射DL50 1443 mg/kg (OECD毒性5级)。替诺福韦对家兔眼睛粘膜有中度刺激作用,不刺激皮肤;不具有皮肤吸收、累积和增敏作用。在亚急性实验中,替诺福韦大鼠灌胃(1000mg /kg, 28天),具有一般毒性作用,主要是肾功能和肝功能受损。替诺福韦Limac设定为17.3 mg/m3对肾功能的影响。的局限性。制定和证实工作区域空气中抗逆转录病毒药物替诺福韦的卫生标准时。结论。工作区空气中富马酸替诺福韦二氧吡酯气溶胶的建议指示极限值为0.1 mg/m3。
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Hygienic regulation of the antiretroviral drug tenofovir in the air of the working area
Introduction. Tenofovir is an antiviral drug of the group of nucleoside reverse transcriptase inhibitors of retrovirus - human immunodeficiency virus. Material and methods. A toxicological and hygienic study of the toxicity and danger of tenofovir in laboratory animals (mice, rats, rabbits) was carried out with various routes of intake: orally (mice, rats), intraperitoneally (mice), cutaneous (mice, rabbits), inhalation (rats) for development and justification of indicative limit values of tenofovir in the air of the working area. Results. When injected into the stomach, tenofovir belongs to the 4th hazard class in terms of DL50 for mice and rats over 10,000 mg/kg (GOST 12.1.007-76). When injected into the abdominal cavity DL50 for male mice 1443 mg/kg (OECD toxicity class 5). Tenofovir has a moderate irritant effect on the mucous membranes of the eyes of rabbits, does not irritate the skin; does not have a skin-resorptive, cumulative and sensitizing effect. In a subacute experiment in rats with intragastric administration (1000 mg/kg, 28 days), tenofovir had a general toxic effect with a predominant impairment of kidney and liver function. Tenofovir Limac is set at 17.3 mg/m3 for effects on renal function. Limitations. When developing and substantiating hygienic standards for the anti-retroviral drug tenofovir in the air of the working area. Conclusion. The recommended indicative limit values for tenofovir disoproxil fumarate aerosol in the air of the working area is 0.1 mg/m3.
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