摘要
目的通过BN大鼠全身主动过敏(ASA)、被动皮肤过敏(PCA)和比格犬类过敏模型考察注射用益气复脉(冻干)(YQFM)的致敏性。方法 ASA和PCA过敏试验:BN大鼠随机分成5组,即阴性对照组、卵白蛋白(阳性药,2%)组和YQFM低、中、高剂量(230.30、460.60、921.20 mg/kg,460.60 mg/kg为临床等效剂量)组,每组9只,ip给药,隔日注射1次,共致敏5次。致敏结束后随机每组取3只用于取血得血清混匀后用于PCA试验;另外6只用于ASA试验的激发,激发30 min内,观察BN大鼠的全身过敏反应症状,评分并记录;观察结束后取血得血清用于IgE、组胺及β-氨基己糖苷酶水平检测。比格犬类过敏试验:比格犬随机分为阴性对照组、吐温-80(阳性药,2%)组、YQFM(460.60 mg/kg,临床等效剂量)组,每组4只。iv给药1次,分别于给药前、给药后30 min取血,检测血中组胺、IgE、β-氨基己糖苷酶的含量变化;观察给药后比格犬的行为学变化。结果 ASA试验结果显示,除阳性药组外,其他组别BN大鼠未出现阳性过敏反应症状;PCA试验结果显示,除阳性药组外,其他各组大鼠均未出现阳性蓝斑;与阴性对照组比较,阳性药组中的BN大鼠致敏血清IgE、β-氨基己糖苷酶、组胺水平均显著升高(P<0.05、0.01),YQFM各组无显著性变化。比格犬类过敏试验结果显示,与阴性对照组比较,给药后吐温-80组的组胺、β-氨基己糖苷酶显著升高(P<0.05),IgE未见明显升高,个别犬出现流涎、嗜睡等现象;YQFM组别均无明显变化。结论 YQFM在ASA、PCA试验中过敏反应为阴性,对犬类过敏反应也为阴性。
Objective To investigate sensitization of Yiqi Fumai Lyophilized Injection(YQFM)on BN rats systemic active allergy(ASA)passive skin allergy(PCA)and Beagle dogs allergy models.Methods Allergic test of ASA and PCA:BN rats were randomly divided into five groups:negative control group,ovalbumin(positive drug,2%)group,YQFM low,medium and high dose(230.30,460.60,921.20 mg/kg,460.60 mg/kg as clinical equivalent dose)groups,nine rats in each group,ip administration,injection once every other day,a total of five times.At the end of sensitization,three rats in each group were randomly selected for taking blood,and the serum was mixed for PCA test;the other six rats were used for the stimulation of ASA experiment,and the systemic allergic reaction symptoms of BN rats were observed,scored and recorded within 30 min after stimulation;after the observation,the serum was taken for the detection of IgE,histamine andβ-aminohexosidase levels.Beagle dog allergy test:Beagle dogs were randomly divided into negative control group,Tween-80(positive drug,2%)group and YQFM(460.60 mg/kg,clinical equivalent dose)group,with four dogs in each group.Blood samples were taken before and 30 min after administration to detect the changes of histamine,IgE andβ-aminohexosidase in blood,and the behavioral changes of beagle dogs after administration were observed.Results ASA test showed that BN rats in other groups did not show positive allergic reaction symptoms except the positive drug group;PCA:Rats in other groups did not show positive blue spots except the positive drug group;Compared with the negative control group,the contents of IgE,β-hex and histamine in the sensitized serum of BN rats in the positive drug group were significantly increased(P<0.05 and 0.01),and there was no significant difference between YQFM groups.The results of Beagle allergy test showed that compared with the negative control group,the histamine andβ-aminohexosidase of Tween-80 group were significantly increased(P<0.05),IgE was not significantly increased,salivation
作者
万梅绪
张燕欣
王蕴华
宋美珍
李智
李德坤
鞠爱春
WAN Meixu;ZHANG Yanxin;WANG Yunhua;SONG Meizhen;LI Zhi;LI Dekun;JU Aichun(Tianjin Tasly Pride Pharmaceutical Co.,Ltd.,Tianjin 300410,China;Tianjin Key Laboratory of Safety Evaluation Enterprise of Traditional Chinese Medicine Injections,Tianjin 300410,China)
出处
《药物评价研究》
CAS
2020年第8期1548-1553,共6页
Drug Evaluation Research
基金
天津市科技计划项目(18YFCZZC00430)。
