积雪草标准化提取物鼻内给药的特性及临床前毒性评价(l)实验大鼠的城市叶(INDCA-NS)

Q4 Pharmacology, Toxicology and Pharmaceutics Toxicology International Pub Date : 2023-09-20 DOI:10.18311/ti/2023/v30i3/32171
Prasad Thakurdesai, Savita Nimse, Pallavi Deshpande
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引用次数: 0

摘要

本研究的目的是表征和评估积雪草(L.)总三萜标准化提取物的鼻内毒性。城市叶(INDCA-NS)。对Wistar大鼠鼻灌给INDCA-NS的急性和28天重复给药毒性进行了评价。在急性鼻内毒性研究中,5只雄性和雌性大鼠单次给药100 μg/大鼠/天,观察14天的死亡率和毒性迹象。在亚急性毒性研究中,将INDCA-NS(10、30和100 μg/大鼠/天)分别给予5只雄性和雌性大鼠鼻内28天,随后进行14天的行为、生化和组织学参数逆转期。通过埋藏食物试验评估亚急性给药INDCA-NS对大鼠嗅觉能力的影响。在单次或28天重复给药期间,用INDCA-NS治疗未导致死亡或治疗相关不良症状。此外,在埋藏食物试验中观察到,鼻内INDCA-NS不影响嗅觉。在急性和亚急性鼻内毒性研究中,NDCA-NS对雄性和雌性大鼠的最大耐受剂量(MTD)均大于100 μg/大鼠/天,无观察到的不良反应水平(NOAEL)均大于100 μg/大鼠/天时是安全的。
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Characterization and Preclinical Toxicity Assessment of Intranasal Administration of Standardized Extract of <i>Centella asiatica</i> (L.) Urban Leaves (INDCA-NS) in Laboratory Rats
The objective of the present work was to characterize and assess the intranasal toxicity of a solution of total triterpenoids - based standardized extract of Centella asiatica (L.) Urban leaves (INDCA-NS). The acute and 28-day repeated-dose toxicity of intranasal administrated INDCA-NS in Wistar rats was evaluated. For the acute intranasal toxicity study, a single dose of 100 μg/rat/day was administered to five male and female rats and observed for mortality and signs of toxicity for 14 days. In the subacute toxicity study, the INDCA-NS (10, 30, and 100 μg/rat/day) were intranasally administered to a separate group of five male and female rats for 28 days, followed by a 14-day reversal period for behavioral, biochemical, and histological parameters. The effect of subacute administration of INDCA-NS on the ability to smell in rats was evaluated by a buried food test. Treatment with INDCA-NS did not result in mortality or treatment-related adverse signs during single or 28-day repeated-dose administration. In addition, intranasal INDCA-NS did not affect the sense of smell, as observed in the buried food test. Intranasal NDCA-NS was found safe in rats with a Maximum Tolerated Dose (MTD) of more than 100 μg/rat/day and No-Observed Adverse Effect Level (NOAEL) of more than 100 μg/rat/day in male and female rats during acute and subacute intranasal toxicity study respectively.
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来源期刊
Toxicology International
Toxicology International Environmental Science-Health, Toxicology and Mutagenesis
CiteScore
0.60
自引率
0.00%
发文量
23
期刊介绍: Toxicology International is a peer-reviewed International Research Journal published bi-annually by the Society of Toxicology, India. The Journal is concerned with various disciplines of Toxicology including man, animals, plants and environment and publishes research, review and general articles besides opinions, comments, news-highlights and letters to editor.
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