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作 者:李寅超[1] 吴翠萍[1] 杨景华 周甜[1] 赵新年 陈富君 赵宜红[1] 陈蕴[3] 张雁冰[1]
机构地区:[1]郑州大学药学院,河南郑州450001 [2]河南省新四方制药有限公司,河南周口466000 [3]河南省药品审评认证中心,河南郑州450004
出 处:《中国医院药学杂志》2011年第23期1942-1944,共3页Chinese Journal of Hospital Pharmacy
摘 要:目的:观察阿胶补血软胶囊原料对小鼠的急性毒性及耐缺氧作用。方法:采用小鼠灌胃途径,评价阿胶补血软胶囊原料的急性毒性;另取小鼠随机分为7组,试验组给予2.21,1.10,0.55,0.28 g.kg-1剂量的阿胶补血软胶囊原料,阳性对照组给予18 mL.kg-1的复方阿胶浆,原剂型对照组给予12 g.kg-1阿胶补血膏,阴性对照组给予等容量的纯化水,均灌胃(ig)14 d,观察、检测常压下小鼠的耐缺氧情况。结果:阿胶补血软胶囊原料对小鼠的最大给药量为79.2 g.kg-1,约为模拟临床剂量的1 292倍,动物未见死亡,至实验结束剖检主要脏器未见明显病理变化;阿胶补血软胶囊原料药1.10,0.28 g.kg-1剂量组小鼠的平均存活时间(min)和平均延长率(%)较阿胶补血膏组呈明显增加趋势,但无统计学差异(P>0.05)。结论:本实验条件下阿胶补血软胶囊原料未见明显毒性,且对小鼠耐缺氧能力有明显的增强作用,值得进一步探讨。OBJECTIVE To observe the acute toxicity and the tolerance to hypoxia of raw materials of Colla Corii Asini hematinic soft capsule in mice. METHODS By using the intra-gastrie route of administration, the acute toxicity of raw materials of Colla Corii Asini hematinie soft capsule was evaluated. Mice were divided randomly into 7 groups, the experimental groups were given with raw materials of Colla Corii Asini hematinic soft capsule 2. 21g·kg-1 , 1.10g·kg-1 ,0. 55 g·kg-1 ,0. 28 g·kg-1 ,respectively. The positive control group was given with Colla Corii Asini compound liquid 18 mL·kg-1. The original formulation of the control group was given with Colla Corii Asini hematinc ointment 12 g·kg-1 , negative control group was given with distilled water of equal volume. In each group the drug was given by intragastric administration, to observe and assess the tolerance to hypoxia at constant pressure in mice. RESULTS The maximum dose of raw materials of Colla Corii Asini was 79. 2 g.kg 1 , and it was about 1292 times of the clinic dose. Neither the animals died, nor the pathological changes of the primary organs occurred. In the Colla Corii Asini hematinic soft capsule 1.10 g·kg-1 and 0. 28 g·kg-1 experimental group, the mean survival time (rain) and the average extension rate (%) in mice showed an obvious increasing trend as compared with the original formulation of the control group,but there was no significant difference(P〉0. 05). CONCLUSION Under our experimental condition, raw materials of Colla Corii Asini showed without any obvious toxicity, and had the enhancement effect on the tolerance to hypoxia.
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