摘要
目的:评价六仲养骨药贴经皮肤给药后的急性毒性、刺激性以及过敏性等安全性。方法:急性毒性实验设有空白对照组和六仲养骨药贴浸膏51.8408倍临床剂量组(即399.6045 mg·cm^(-2)·d^(-1)),观察和记录动物一般状况,死亡情况、体重和饲料消耗量,血常规和血生化指标。在刺激性实验中六仲养骨药贴浸膏0.5 mL(剂量为66.6008 mg·cm^(-2)·d^(-1)),进行刺激强度评价和统计学处理。在豚鼠主动皮肤过敏性实验中六仲养骨药贴浸膏0.2 mL(即26.6403 mg·cm^(-2)·d^(-1)),观察动物是否有哮喘、站立不稳或休克等严重的全身性过敏反应出现。结果:急性毒性实验能降低雄性兔的平均红细胞血红蛋白浓度;降低雌性兔的葡萄糖、尿素、甘油三酯、总蛋白和总胆红素的含量。过敏性实验中受试物减轻雄性动物体重,升高雌性动物体重;能减轻实验后期一个时间点时雄性和雌性动物的饲料消耗量。结论:六仲养骨药贴浸膏经皮给药后均无明显的皮肤急性毒性、刺激性以及过敏性,故临床上可在说明书的指导下合理使用六仲养骨药贴。
Objective:To evaluate the safety including acute toxicity,irritation and anaphylaxis of Liuzhong Yanggu Patch after transdermal administration.Method:A blank control group and a Liuzhong Yanggu Patch extract group with 51.8408 times of the clinical dose(399.6045 mg·cm^(-2)·d^(-1))were set up in the acute toxicity experiment.The general conditions,death,body weight,feed consumption,blood routine and blood biochemical indexes of the animals were observed and recorded.In the irritation experiment,0.5 mL(66.6008 mg·cm^(-2)·d^(-1))Liuzhong Yanggu Patch extract was used for irritation intensity evaluation and statistical processing.In the active skin allergic experiment of guinea pigs,0.2 mL(26.6403 mg·cm^(-2)·d^(-1))Liuzhong Yanggu Patch extract was used to observe whether the animals had serious systemic allergic reactions such as asthma,being unsteady or shock.Result:The mean erythrocyte hemoglobin concentration of male rabbits was reduced,and the contents of glucose,urea,triglyceride,total protein and total bilirubin were decreased in female rabbits in the acute toxicity test.In the allergic experiment,the test substance decreased the body weight of male animals and increased that of female animals,and reduced the feed consumption of male and female animals at a time point in the later stage of the experiment.Conclusion:Liuzhong Yanggu Patch extract has no obvious acute toxicity,irritation and anaphylaxis of skins after transdermal administration,which can be rationally used clinically under the guidance of the instructions.
作者
甘学容
赵美玲
伍春梅
梁艳
李昭
陈婉月
张敬文
宋映莲
王张
何浚治
GAN Xue-rong;ZHAO Mei-ling;WU Chun-mei;LIANG Yan;LI Zhao;CHEN Wan-yue;ZHANG Jing-wen;SONG Ying-lian;WANG Zhang;HE Jun-zhi(Sichuan Tianxiang Orthopedic Hospital,Chengdu 610036,Sichuan;School of Pharmacy,Chengdu University of Traditional Chinese Medicine,Chengdu 611137,Sichuan;School of Ethnic Medicine,Chengdu University of Traditional Chinese Medicine,Chengdu 611137,Sichuan)
出处
《中药与临床》
2023年第2期58-63,共6页
Pharmacy and Clinics of Chinese Materia Medica
基金
四川省应用基础研究计划项目(2019YJ0286):归芪健骨药贴治疗骨质疏松症的作用机制研究。
关键词
六仲养骨药贴
皮肤给药
急性毒性
刺激性
过敏性
Liuzhong Yanggu Patch
transdermal administration
acute toxicity
irritation
anaphylaxis
