遵义医科大学学报2026，Vol.49Issue(5)：517-524,8.
含高比例大风藤茎为原料生产的宁泌泰胶囊的安全性评价
Safety evaluation of Ningmitai capsules produced with a high proportion of stem of Cocculus orbiculatus(L.)DC
摘要
Abstract
Objective To evaluate the safety of Ningmitai capsules prepared by substituting the stem of Cocculus orbiculatus(L.)DC.for high proportion of stem as the raw material,which provide experimental evidence for clinical medication.Methods Acute toxicity experiment;30 C57BL/6J mice were randomly divided into control group(Control),high-proportion Cocculus orbiculatus(L.)DC.stem-prepared Ningmitai group(DFTJ),and a commercially available Ningmitai capsule group(NMT),with 10 mice in each group(half male and half fe-male).Mice in the DFTJ and NMT groups received a single oral gavage dose of 3 g/(kg·d)within 24 hours,and acute toxic reactions were observed for 14 days.Long-term toxicity experiment:50 SD rats were randomly divided into a control group(Control),low-dose(DFTJ-L,205 mg/(kg·d)and high-dose(DFTJ-H,820 mg/(kg·d)groups of high-proportion Cocculus orbiculatus(L.)DC.stem-prepared Ningmitai,and low-dose NMT-L,205 mg/(kg·d)and high-dose NMT-H,820 mg/(kg·d)groups of commercially available Ningmitai cap-sules(n=10 per group,half male and half female).The Ctrl group received an equal volume of normal saline.All administrations were performed once daily via oral gavage for 13 consecutive weeks to observe the general condition and toxicity of the rats.Rat biochemical indices,organ coefficients,and histopathology were examined.Results In the acute toxicity experiment,mice in all groups exhibited good mental status,blank and shiny fur,normal activity levels,and normal urine and feces,with no significant toxic reactions observed.In the long-term toxicity experiment,the rats in each group showed no abnormalities in mental status,fur color,diet,activity,or u-rine and feces.There were no statistically significant differences(P＞0.05)in organ coefficients or ALT and AST levels among all groups.No significant abnormalities were observed in the heart,liver,spleen,lungs,or kid-neys of rats in each group.Conclusion Ningmitai capsules prepared with a high proportion of Cocculus orbicula-tus(L.)DC.stem show no significant acute or long-term toxicity,indicating a high safety profile.关键词
宁泌泰胶囊/大风藤/安全性评估/急性毒性/长期毒性Key words
ningmitai capsules/cocculus orbiculatus L.DC./safety evaluation/acute toxicity/long-term toxicity分类
医药卫生引用本文复制引用
彭江樱,吴迪,巫兴东,谢健,熊媛,谭道鹏,秦琳,魏茂陈,何芋岐..含高比例大风藤茎为原料生产的宁泌泰胶囊的安全性评价[J].遵义医科大学学报,2026,49(5):517-524,8.基金项目
贵州省科技创新人才团队建设项目[NO:黔科合平台人才-CXTD(2023)024] （2023）
贵州省中医药管理局中医药、民族医药科学技术研究课题(NO:QZYY-2025-072) （NO:QZYY-2025-072）
贵州省教育厅"揭榜挂帅"科技攻关项目[NO:QJJ(2023)005]. （2023）
