{"title":"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)","authors":"Prasad Thakurdesai, Savita Nimse, Pallavi Deshpande","doi":"10.18311/ti/2023/v30i3/32171","DOIUrl":null,"url":null,"abstract":"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.","PeriodicalId":23205,"journal":{"name":"Toxicology International","volume":"27 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2023-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Characterization and Preclinical Toxicity Assessment of Intranasal Administration of Standardized Extract of <i>Centella asiatica</i> (L.) Urban Leaves (INDCA-NS) in Laboratory Rats\",\"authors\":\"Prasad Thakurdesai, Savita Nimse, Pallavi Deshpande\",\"doi\":\"10.18311/ti/2023/v30i3/32171\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"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.\",\"PeriodicalId\":23205,\"journal\":{\"name\":\"Toxicology International\",\"volume\":\"27 1\",\"pages\":\"0\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-09-20\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Toxicology International\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.18311/ti/2023/v30i3/32171\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"Pharmacology, Toxicology and Pharmaceutics\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Toxicology International","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.18311/ti/2023/v30i3/32171","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"Pharmacology, Toxicology and Pharmaceutics","Score":null,"Total":0}
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.
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.