宝根续筋药贴经皮给予的急性毒性、刺激性和过敏性研究  

Study on the Acute Toxicity,Pungency and Irritability of Baogenxujin Paste Administered Through Skin

作　　者：梁艳 伍春梅[2] 陈婉月 张宪哲 张敬文 宋映莲 赵美玲 王张[3] 何浚治 LIANG Yan;WU Chunmei;CHEN Wanyue;ZHANG Xianzhe;ZHANG Jingwen;SONG Yinglian;ZHAO Meiling;WANG Zhang;HE Junzhi(School of Pharmacy,Chengdu University of Traditional Chinese Medicine,Chengdu 611137,China;Sichuan Tianxiang Orthopedic Hospital,Chengdu 610036,China;School of Ethnic Medicine,Chengdu University of Traditional Chinese Medicine,Chengdu 611137,China)

机构地区：[1]成都中医药大学药学院,四川成都611137 [2]四川天祥骨科医院,四川成都610036 [3]成都中医药大学民族医药学院,四川成都611137

出　　处：《中国民族民间医药》2023年第15期15-22,共8页Chinese Journal of Ethnomedicine and Ethnopharmacy

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。

摘　　要：目的:评价宝根续筋药贴经皮肤给药后的急性毒性、刺激性以及过敏性。方法:在急性毒性实验研究中将兔按性别和体重随机分为空白对照组和宝根续筋药贴浸膏45.76倍临床剂量组,选择最大给药量[即405.151 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,测试血常规和血生化指标。在刺激性实验研究中给予宝根续筋药贴浸膏0.5 mL[剂量为67.525 mg·(cm^(2)·d)^(-1)],按评分标准对皮肤红斑和水肿进行评分,并进行统计学处理。在豚鼠主动皮肤过敏性实验研究中将宝根续筋药贴浸膏0.2 mL[即27.0101 mg·(cm^(2)·d)^(-1)],观察动物是否有严重的全身性过敏反应出现。结果:观察期内未见动物死亡、中毒症状和肉眼可见的脏器异常,体重和饲料消耗量无明显变化,但急性毒性实验中部分血细胞指标(红细胞数、血红蛋白、红细胞压积数、白细胞数和中性粒细胞数)和血液生化指标(总胆固醇含量)出现异常,皮肤未见刺激性及过敏性。结论:宝根续筋药贴浸膏经皮肤给药后未见明显的急性毒性、刺激性和过敏性,安全性良好,但在临床使用时仍需监测血常规和血液生化学指标。Objective To evaluate the safety of acute toxicity,pungency and irritability of Baogenxujin Paste after skin administration.Method Rabbits were randomly divided into blank control group and Baogenxujin paste 45.76 times clinical dose group according to gender and body weight.The maximum dose[405.151 mg·(cm^(2)·d)^(-1)]was selected.The general condition,death,body weight and feed consumption of the animals were observed and recorded.Blood routine and biochemical parameters were tested In the experimental study of pungency,Baogenxujin paste was given 0.5 mL[67.525 mg·(cm^(2)·d)^(-1)].Skin erythema and edema were scored according to the scoring standard,and statistically processed.In the active skin allergy experimental study of guinea pigs,Baogenxujinpaste 0.2 mL[27.0101 mg·(cm^(2)·d)^(-1)]was used to observe whether the animals had severe systemic allergic reactions.Result During the observation period,there were no animal death,poisoning symptoms and organ abnormalities visible to the naked eye,and there were no significant changes in body weight and feed consumption;but part of the blood cells in acute toxicity experiment indicators(red blood cell count,hemoglobin,red blood cell pressure accumulation of,leukocyte count and neutrophil)and blood biochemical indicators(total cholesterol)is abnormal,the skin is not allergic and irritating.Conclusion After skin administration of Baogenxujin Paste,the safety is good,but we still need to pay attention to the monitoring of blood routine and blood biochemical indexes.

关 键 词：宝根续筋药贴 皮肤给药 急性毒性 刺激性 过敏性 

分 类 号：R285.5[医药卫生—中药学]