Abstract

Objective: The expression of therapeutic proteins in plant oil body bioreactors has attracted much attention. But its safety is not yet clear. This article determines the risk of safety after using the drug.

Methods: 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.

Results: The OBEME did not produce dermal erythema/eschar or oedema 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 behaviour of experimental animals, were not abnormal. In addition, no abnormality was found in haematological 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

目的：治疗性蛋白在植物油体生物反应器中的表达备受关注。但其安全性尚不清楚。本文确定了使用该药物后的安全风险。

方法：将合适浓度的黄原胶按适当比例混合制备油体连接油质蛋白-hEGF微凝胶乳液（OBEME）。使用 OBEME 作为试验品在大鼠和豚鼠中研究了皮肤刺激和致敏反应。

结果： OBEME 没有产生皮肤红斑/焦痂或水肿反应。根据经合组织指南评估了 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、采食、饮水、排泄、行为等基本体征均无异常。此外，血液学参数、生化指标、器官相对重量、器官组织病理学观察均未见异常，与生理盐水治疗组比较无显着性差异。因此，我们得出结论，OBEME 没有毒性作用，用于局部应用是安全可靠的。