Abstract：
BACKGROUND: Lepidium sativum (LS) seed extract has various pharmacological properties, such as antioxidant, hepatoprotective, and anticancer activities. However, the translation of L. sativum seed extract to the clinical phase is still tedious due to its bioavailability and stability issues. This problem can be solved by encapsulating it in a nanodelivery system to improve its therapeutic potency.
METHODS: In this study, we have determined and compared the in vivo toxicity of ethanolic extracts of L. sativum seeds (EELS) and solid lipid nanoparticles (SLNs). To conduct toxicity (acute and subacute toxicity) assessments, EELS and SLNs were orally administered to Swiss albino mice. Animal survival, body weight, the weight of vital organs in relation to body weight, haematological profile, biochemistry profile, and histopathological alterations were examined.
RESULTS: Animals administered with 2000 mg/kg and 5000 mg/kg in an acute toxicity study exhibited no toxicological symptoms regarding behaviour, gross pathology, and body weight. As per a study on acute toxicity, the LD50 (lethal dose) for SLNs and EELS was over 400 mg/kg and over 5000 mg/kg, respectively. When animals were given SLNs (50 and 100 mg/kg, orally) and EELS (250, 500, and 1000 mg/kg, orally) for 28 days, subacute toxicity study did not exhibit any clinical changes. There were no differences in weight gain, haematological parameters, or biochemical parameters compared to the control groups (p > 0.05). The organs of the treated animals showed no abnormalities in the histological analysis (liver, heart, kidney, and spleen).
CONCLUSIONS: The result confirms ethanolic extracts of L. sativum seeds and their SLNs to not have harmful effects following acute and subacute administration to mice. For further studies, patents available on Lepidium may be referred for its preclinical and clinical applications.
METHODS: In this study, we have determined and compared the in vivo toxicity of ethanolic extracts of L. sativum seeds (EELS) and solid lipid nanoparticles (SLNs). To conduct toxicity (acute and subacute toxicity) assessments, EELS and SLNs were orally administered to Swiss albino mice. Animal survival, body weight, the weight of vital organs in relation to body weight, haematological profile, biochemistry profile, and histopathological alterations were examined.
RESULTS: Animals administered with 2000 mg/kg and 5000 mg/kg in an acute toxicity study exhibited no toxicological symptoms regarding behaviour, gross pathology, and body weight. As per a study on acute toxicity, the LD50 (lethal dose) for SLNs and EELS was over 400 mg/kg and over 5000 mg/kg, respectively. When animals were given SLNs (50 and 100 mg/kg, orally) and EELS (250, 500, and 1000 mg/kg, orally) for 28 days, subacute toxicity study did not exhibit any clinical changes. There were no differences in weight gain, haematological parameters, or biochemical parameters compared to the control groups (p > 0.05). The organs of the treated animals showed no abnormalities in the histological analysis (liver, heart, kidney, and spleen).
CONCLUSIONS: The result confirms ethanolic extracts of L. sativum seeds and their SLNs to not have harmful effects following acute and subacute administration to mice. For further studies, patents available on Lepidium may be referred for its preclinical and clinical applications.
摘要：
背景：Lepidiumsativum（LS）种子提取物具有多种药理特性，如抗氧化剂，保肝,和抗癌活动。然而,由于其生物利用度和稳定性问题,因此将L.sativum种子提取物转化到临床阶段仍然是繁琐的。这个问题可以通过将其封装在纳米递送系统中以提高其治疗效力来解决。
方法：在本研究中，我们已经确定并比较了李斯特菌种子乙醇提取物（EELS）和固体脂质纳米颗粒（SLN）的体内毒性。进行毒性（急性和亚急性毒性）评估，EELS和SLN口服给予瑞士白化病小鼠。动物生存,体重,重要器官的重量与体重的关系，血液学概况，生物化学概况，并检查了组织病理学改变。
结果：在一项急性毒性研究中，给予2000mg/kg和5000mg/kg的动物没有表现出关于行为的毒理学症状。大体病理学，和体重。根据一项关于急性毒性的研究，SLN和EELS的LD50（致死剂量）超过400mg/kg和超过5000mg/kg，分别。当动物服用SLN（50和100mg/kg，口服)和鳗鱼(250、500和1000毫克/千克，口服)28天，亚急性毒性研究未出现任何临床变化.体重增加没有差异，血液学参数，或生化指标与对照组相比（p>0.05）。接受治疗的动物的器官在组织学分析中没有显示异常（肝脏，心,肾,和脾脏）。
结论：结果证实了对小鼠急性和亚急性给药后，植物种子及其SLN的乙醇提取物没有有害作用。为了进一步研究，Lepidium上可用的专利可用于其临床前和临床应用。
方法：在本研究中，我们已经确定并比较了李斯特菌种子乙醇提取物（EELS）和固体脂质纳米颗粒（SLN）的体内毒性。进行毒性（急性和亚急性毒性）评估，EELS和SLN口服给予瑞士白化病小鼠。动物生存,体重,重要器官的重量与体重的关系，血液学概况，生物化学概况，并检查了组织病理学改变。
结果：在一项急性毒性研究中，给予2000mg/kg和5000mg/kg的动物没有表现出关于行为的毒理学症状。大体病理学，和体重。根据一项关于急性毒性的研究，SLN和EELS的LD50（致死剂量）超过400mg/kg和超过5000mg/kg，分别。当动物服用SLN（50和100mg/kg，口服)和鳗鱼(250、500和1000毫克/千克，口服)28天，亚急性毒性研究未出现任何临床变化.体重增加没有差异，血液学参数，或生化指标与对照组相比（p>0.05）。接受治疗的动物的器官在组织学分析中没有显示异常（肝脏，心,肾,和脾脏）。
结论：结果证实了对小鼠急性和亚急性给药后，植物种子及其SLN的乙醇提取物没有有害作用。为了进一步研究，Lepidium上可用的专利可用于其临床前和临床应用。
