Abstract

The expression of therapeutic proteins in plant oil body bioreactors has attracted much attention. The oil body-linked oleosin-hEGF microgel emulsion (OBEME) was prepared by mixing the xanthan gum with suitable concentrations in an appropriate proportion. Skin irritation and sensitization reaction were investigated in rats and guinea pigs using OBEME as test article. The OBEME did not produce dermal erythema/eschar or edema responses. The dermal subacute and subchronic toxicity of OBEME were evaluated in accordance with OECD guidelines. Compared with the control group, the basic physical signs such as weight, feed, drinking, excretion and behavior of experimental animals, were not abnormal. In addition, no abnormality was found in hematological parameters, biochemical indexes, relative organ weight and histopathological observation of organs, and there was no significant difference compared with normal saline treatment group. Therefore, we conclude that OBEME has no toxic effects and is safe and reliable to be used for topical application.

摘要

治疗性蛋白质在植物油体生物反应器中的表达引起了广泛关注。通过将黄原胶与合适的浓度以适当的比例混合来制备油体连接的油质蛋白-hEGF微凝胶乳液（OBEME）。以OBEME为测试对象，对大鼠和豚鼠的皮肤刺激和致敏反应进行了研究。OBEME不会产生皮肤红斑/焦or或水肿反应。根据OECD指南评估了OBEME的皮肤亚急性和亚慢性毒性。与对照组相比，实验动物的体重，饲料，饮水，排泄和行为等基本体征没有异常。此外，在血液学参数，生化指标，相对器官重量和器官的组织病理学观察中未发现异常，与生理盐水处理组相比无明显差异。因此，我们得出结论，OBEME没有毒性作用，并且安全可靠地用于局部应用。