摘要
目的观察新西兰兔完整皮肤或破损皮肤给予活血通络搽剂外搽所产生的刺激反应及其他不良反应,为临床用药提供依据,并为进一步申请医院制剂提供毒理研究的依据。方法选用检疫合格的新西兰兔40只,分为4组,分别为完整皮肤阴性组、完整皮肤给药组、破损皮肤阴性组、破损皮肤给药组,10只/组,雌雄各半。各组动物完整皮肤或破损皮肤的背部两侧同时给药,96cm^2/侧(8cm×12cm/侧), 8mL/侧/只/次,给药浓度均为2.25g生药量/mL,阴性对照组给予等体积、等范围的纯水作对照,一天给药3次。观察并记录给药部位红斑及水肿并评分,检测血液学、血液生化学和凝血功能指标,大体剖检后肉眼观察各器官和组织的变化。结果完整皮肤和破损皮肤阴性对照组动物的给药部位皮肤均未见明显刺激性反应;一般观察未见明显异常,体重呈上升趋势,血生化和血液学均未见明显异常变化,大体剖检亦未见明显异常改变。完整皮肤和破损皮肤给药组均可产生一过性、可恢复的刺激性反应;动物的行为活动、腺体分泌、呼吸及粪便性状、体重、血液学、血生化、大体解剖等均未见明显异常,且体重呈上升趋势。结论完整皮肤给予活血通络搽剂未见明显的毒性反应及毒性靶器官;破损皮肤有中度皮肤刺激,但未见明显毒性靶器官。
Objective To observe the irritation and other adverse reactions caused by external application of Huoxuetongluo Liniment to intact or damaged skin of New Zealand rabbits, thereby providing a basis for clinical medication and toxicological studies for further application of hospital preparations. Methods 40 New Zealand rabbits qualified for quarantine were selected and divided into 4 groups: intact skin negative group, intact skin administration group, broken skin negative group, broken skin administration group with 10 rabbits in each, half male and half male. Both sides of the intact skin or broken skin of each group were administered at the same time, 96 cm2/side(8 cm×12 cm/side), 8 mL/side/head/time, the administration concentration was 2.25 g crude drug/mL. Negative control group was given the same volume and range of pure water as control factors, administered 3 times a day. Then experimenters observe and record the erythema and edema at the administration site and score them, check the hematology, blood biochemistry and coagulation function indexes, and visually observethe changes of various organs and tissues after gross autopsy. Results There was no obvious irritation in the skin of the intact skin and broken skin negative control group animals;there was no obvious abnormality in general observation, and the weight showed an upward trend. There were no obvious abnormal changes in blood biochemistry and hematology. No obvious abnormal changes were seen. Both intact skin and damaged skin administration groups can produce transient and recoverable irritation. Animal behavior, glandular secretion, respiratory and fecal characteristics, weight, hematology, blood biochemistry, general anatomy, etc. were not obviously abnormal, and the weight is increasing. Conclusion There are no obvious toxic reactions and toxic target organs when the intact skin is administered with Huoxuetongluo liniment while the damaged skin has moderate skin irritation, but no obvious toxic target organs are found.
作者
王晓娟
李娟
郑芳昊
Wang Xiaojuan;Li Juan;Zheng Fanghao(Luoyang Hospital of Traditional Chinese Medicine,Luoyang Henan,471003;Foshan Hospital of Traditional Chinese Medicine,Foshan Guangdong,528000)
出处
《现代中医药》
CAS
2020年第6期15-19,共5页
Modern Chinese Medicine
基金
广东省中医药局中医药强省建设专项资金-医院中药制剂开发项目(粤财社[2015]77号)。
关键词
活血通络搽剂
急性毒性
新西兰兔
皮肤给药
皮肤不良反应
Huoxue Tongluo Liniment
Acute Toxicity
New Zealand Rabbit
Skin Administration
Skin Adverse Reaction
