흑생강의 단회투여독성시험과 안전성등급화 (Single oral toxicity test and safety classification for Kaempferia parviflora)

서지정보

· 발행기관 : 대한본초학회
· 수록지 정보 : 대한본초학회지 / 33권 / 4호 / 53 ~ 58페이지
· 저자명 : 한영훈, 박영철

초록

Objectives : Kaempferia parviflora Rhizome is black ginger indigenous to Laos and Thailand. It has been used as a folk medicine to improve blood flow and promote vitality and longevity with good health and well being. For these reasons, Kaempferia parviflora Rhizome has been focused on developing it as a food or food supplement. In addition, Kaempferia parviflora Rhizome could be under consideration of new prescription based on its characteristic compounds, polymethoxyflavonoids. However, it needs to be certified as safe before it can be used. Here, a single-oral toxicity test and safety classification was carried out to identity acute information of the toxicity of Kaempferia parviflora Rhizome powder and to make sure of its safety in clinical applications.
Methods : Test substance was orally administered to male and female SD-rat at dose levels of 5000 ㎎/㎏ to estimate approximate lethal dose(ALD). Based on the acute information of the toxicity, the safety classification was estimated using the HED(human equivalent dose)-based MOS(margin of safety).
Results : At 14 days after treatment with test substance. there were no of test substance related with mortalities and clinical signs. In addition, no changes in the body or organ weights and no gross or histopathological findings were observed. Thus, the ALD of Kaempferia parviflora Rhizome powder was considered over 5,000 ㎎/㎏ in both female and male mice.
Conclusions : Based on the single oral toxicity test using the highest and limit dose, 5,000 ㎎/㎏ and the decision guideline for safety classification based on HED-based MOS, it was estimated that Kaempferia parviflora Rhizome powder is classified as “Specified class B” indicating that clinical dose is not limited to patients as safe as food.

영어초록

Objectives : Kaempferia parviflora Rhizome is black ginger indigenous to Laos and Thailand. It has been used as a folk medicine to improve blood flow and promote vitality and longevity with good health and well being. For these reasons, Kaempferia parviflora Rhizome has been focused on developing it as a food or food supplement. In addition, Kaempferia parviflora Rhizome could be under consideration of new prescription based on its characteristic compounds, polymethoxyflavonoids. However, it needs to be certified as safe before it can be used. Here, a single-oral toxicity test and safety classification was carried out to identity acute information of the toxicity of Kaempferia parviflora Rhizome powder and to make sure of its safety in clinical applications.
Methods : Test substance was orally administered to male and female SD-rat at dose levels of 5000 ㎎/㎏ to estimate approximate lethal dose(ALD). Based on the acute information of the toxicity, the safety classification was estimated using the HED(human equivalent dose)-based MOS(margin of safety).
Results : At 14 days after treatment with test substance. there were no of test substance related with mortalities and clinical signs. In addition, no changes in the body or organ weights and no gross or histopathological findings were observed. Thus, the ALD of Kaempferia parviflora Rhizome powder was considered over 5,000 ㎎/㎏ in both female and male mice.
Conclusions : Based on the single oral toxicity test using the highest and limit dose, 5,000 ㎎/㎏ and the decision guideline for safety classification based on HED-based MOS, it was estimated that Kaempferia parviflora Rhizome powder is classified as “Specified class B” indicating that clinical dose is not limited to patients as safe as food.

참고자료

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